celexa vs. lexapro: clinical questions

[stoic]

i know that lexapro (escitalopram) is the active isomer of celexa (citalopram) and that lexapro is dosed as being exactly twice as powerful as celexa. i've got a couple questions about their use.

1. are the drugs clinically interchangeable at the appropriate dose? can a patient be switched from 10mg lexapro to 20mg celexa without first titrating down the lexapro and titrating up the celexa?

2. clinically, do you guys notice any difference in side effects?

3. are there any applications where one of these drugs is better than the other?

thanks for educating a grateful and curious MSII.

Dave

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[Anasazi23]

i know that lexapro (escitalopram) is the active isomer of celexa (citalopram) and that lexapro is dosed as being exactly twice as powerful as celexa. i've got a couple questions about their use.

1. are the drugs clinically interchangeable at the appropriate dose? can a patient be switched from 10mg lexapro to 20mg celexa without first titrating down the lexapro and titrating up the celexa?

Generally, yes. See below.

2. clinically, do you guys notice any difference in side effects?

Slightly less with Lexapro, but small differences overall.

3. are there any applications where one of these drugs is better than the other?

Lexapro has no known active metabolite secondary properties. As such, any side effects seen are generally from the serotonergic effect that any other SSRI might have (insomnia, diarrhea, etc).

According to Stahl, the R isomer of citalopram can interfere with the S isomer at the 5-HT transporter. So, the S enantomer is reported to be twice as potent. He states that 10mg of escitalopram may be equivalent to about 40 of citalopram. Further, he states that it therefore has a faster onset and with reduced side effect profile in comparison to regular citalopram.

It has the least interaction with CYP 450 2D6 and 3A4, and is therefore often the agent of choice in complicated patients taking multiple medications, since there are less drug-drug interactions.

thanks for educating a grateful and curious MSII.

Dave

No problem...

 

[OldPsychDoc]

...
2. clinically, do you guys notice any difference in side effects?

Lexapro will lighten the patient's (or his payor's) wallet 4 times faster, while producing in 2 weeks the same clinical effect that Celexa produces in 4 weeks.

...
3. are there any applications where one of these drugs is better than the other?

Celexa no longer buys lunch for me.

 

[Doctor Bagel]

Lexapro will lighten the patient's (or his payor's) wallet 4 times faster, while producing in 2 weeks the same clinical effect that Celexa produces in 4 weeks.



Celexa no longer buys lunch for me.

On a serious note, isn't the patent on lexapro going to expire fairly soon? Then you'll have to get your lunches from cymbalta. 🙂

Oops, guess I'm wrong. Apparently they get to keep their patent until 2012 based on the latest litigation. Well, guess I'll be taking celexa from now on.

 

[stoic]

According to Stahl, the R isomer of citalopram can interfere with the S isomer at the 5-HT transporter. So, the S enantomer is reported to be twice as potent. He states that 10mg of escitalopram may be equivalent to about 40 of citalopram. Further, he states that it therefore has a faster onset and with reduced side effect profile in comparison to regular citalopram.

so is this something you notice in practice? does the patient who was on lexapro 10mg need celexa 30 or 40mg to get the same benifit? or is this highly pt dependent?

i ask because i see a lot of pts who have been started on lexapro coming in for following up/prescriptions (in a pcp office) and it's always confused me why we use so much less celexa when it's basically the same drug. i guess i've become a little sick of how often drugs are repackaged as much more expensive formulations with not much clear clinical benifit. anyway, i'm buiding my case to recommend using celexa in pts who are on lexapro (my preceptor uses a lot of it), stable, and w/few other medical issues. (as a second year i have to present these cases and hope my attending agree's to sign the rx's i've written). we do see a large number of patients without rx coverage, so cost is always a major factor with compliance. i know that many of the patients i've seen would be very pleased to get the same benifit that they get from lexapro at 1/2 the cost

i'm wondering about the mechanics of actually making the switch from lexapro to celexa. can you just have a patient finish their lexapro script and then the next day start on the appropriate dose of celexa?

thanks again,
dave

 

[ntubebate]

i'm wondering about the mechanics of actually making the switch from lexapro to celexa. can you just have a patient finish their lexapro script and then the next day start on the appropriate dose of celexa?

thanks again,
dave

In a word, yes.

 

[Doctor Bagel]

so is this something you notice in practice? does the patient who was on lexapro 10mg need celexa 30 or 40mg to get the same benifit? or is this highly pt dependent?

And would this be a negative to take 40 mg of celexa vs 10 mg of lexapro? Would most patients notice more side effects, etc.? Even with 40 mg of generic celexa, you would pay way, way less than you would pay for 10 mg of lexapro? Believe me, I've priced it out.

You know, this was the one thing I really admired about Kaiser. Sure, they probably had greedy motivations, but they started everybody out on the cheapest, most established treatment plan and went from there. If you were depressed, they'd start you on fluoxetine, not lexapro for god's sakes.

 

[OldPsychDoc]

And would this be a negative to take 40 mg of celexa vs 10 mg of lexapro? Would most patients notice more side effects, etc.? Even with 40 mg of generic celexa, you would pay way, way less than you would pay for 10 mg of lexapro? Believe me, I've priced it out.

You know, this was the one thing I really admired about Kaiser. Sure, they probably had greedy motivations, but they started everybody out on the cheapest, most established treatment plan and went from there. If you were depressed, they'd start you on fluoxetine, not lexapro for god's sakes.

Kaiser is non-profit, so I don't know what you mean by greedy motivations. I would call the motivation that of managing healthcare costs, of which prescription drugs are a major proportion. The only advantage I've seen of lexapro is a moderately faster response rate, but if you look at Stahl's meta-analysis, even though the response to escitalopram is significantly higher at 2 weeks, citalopram "catches up" and there is no significant difference at 4 weeks.

I guess one advantage of using lexapro is the ability to start an indigent pt on samples...then maybe you could switch them to celexa at one month and save the payors lots of money.

 

[stoic]

I guess one advantage of using lexapro is the ability to start an indigent pt on samples...then maybe you could switch them to celexa at one month and save the payors lots of money.

this is exactly why i raise the issue. i see a lot of pts started on lexapro samples who get a good response with the drug but often don't continue to take it once samples run out because of cost. so i'm thinking if they're taking 10mg qd (and most are), switch them to generic celexa 20mg qd.

according to walgreens.com:

lexapro 10mg #30 $79.00
celexa 20mg #30 $42.00

or to save even more:
1/2 tab celexa 40mg qd. #30 also cost $42.00. so $21.00/month!. $20month vs $80t/month... that's a pretty significant savings.

 

[Doctor Bagel]

Kaiser is non-profit, so I don't know what you mean by greedy motivations. I would call the motivation that of managing healthcare costs, of which prescription drugs are a major proportion. The only advantage I've seen of lexapro is a moderately faster response rate, but if you look at Stahl's meta-analysis, even though the response to escitalopram is significantly higher at 2 weeks, citalopram "catches up" and there is no significant difference at 4 weeks.

I guess one advantage of using lexapro is the ability to start an indigent pt on samples...then maybe you could switch them to celexa at one month and save the payors lots of money.

Even better then.

About the samples thing, I read about some insurance companies supplying samples of generic drugs to doctors, which would encourage doctors to start with generic.

 

[Doctor Bagel]

this is exactly why i raise the issue. i see a lot of pts started on lexapro samples who get a good response with the drug but often don't continue to take it once samples run out because of cost. so i'm thinking if they're taking 10mg qd (and most are), switch them to generic celexa 20mg qd.

according to walgreens.com:

lexapro 10mg #30 $79.00
celexa 20mg #30 $42.00

or to save even more:
1/2 tab celexa 40mg qd. #30 also cost $42.00. so $21.00/month!. $20month vs $80t/month... that's a pretty significant savings.

and if you go to drugstore.com, you can get 180 days of 10 mg of lexapro for $420, while you can get 180 days of 40 mg of generic celexa for $180. pretty amazing difference in price.

 

[50960]

I am not a fan of the current use of enanomers, and how they are being marketed. Example, zopiclone is much more effective than its enanomer eszopiclone (lunesta), and lexapro is well known for its akathisia and agitation properties while its parent drug is not?? Dosing?? Maybe?

😎

 

[Anasazi23]

I am not a fan of the current use of enanomers, and how they are being marketed. Example, zopiclone is much more effective than its enanomer eszopiclone (lunesta), and lexapro is well known for its akathisia and agitation properties while its parent drug is not?? Dosing?? Maybe?

😎

I've seen one case of ssri switching on lexapro. never agitation or akathisia when dosed properly. I've prescribed it a few hundred times. Even if it were true, it would make sense and speak to the possible effectiveness of the medication based on it's pharmacodynamics. Look up the concept of required weight gain for effectiveness of clozapine and olanzapine.

 

[sdn1977]

There have been a few misconceptions thrown around.....

First - insurance companies don't give samples - drug companies give samples.

Insurance companies give preferential pricing based on all sorts of different considerations. Sometimes they bundle drugs - they price many drugs made by the same manufacturer (altho diffferent drug classes) so their whole "package" is priced preferentially - Merck is a good example.

Also....enantiomers or chemical alternatives to a drug have been used for decades to allow another drug to come into the marketplace - this has often driven the price of the parent drug down. Cephalosporins have been the extreme example of manufacturing changes which allow broader spectrums, but most of the changes have been done solely to allow a new drug to be released which has no particular preference over another. P & T committees have been always had to make decisions to choose which one to keep on formularies. This same concept works within many drug classes - SSRI's, ace inhibitors, proton pump inhibitors, etc, etc, etc...

Often they are interchangeable.....you just have to get the pt to steady state. If a pt has a side effect which becomes intolerable - change it (this often happens to proton pump inhibitor pts).

However, when a pt has a money issue - we do try to help the pt choose the least costly alternative. It is not always the generic (the recent release last month of generic Zocor is a prime example!!!! - Merck has lowered the price of Zocor to LESS THAN the generic to some insurance companies).

If the pts insurance company has the formulary alternative as one or the other, we might request you to change it, particularly when the pt has not yet been stabilized or started on the drug. If the pt has private insurance, we give the best possible price - & yes, I do advise mail order, but only if the pt is stabilized (it is never wise to buy 90 days supply if the pt won't tolerate it after 30 days...)

A drug patent is 17 years - a long time! Try the generic first unless you have a compelling reason otherwise! That is what I advise the patients who come to me to have their rx filled!

 

[50960]

😀 😀 My non-scientific (applied) experience is that most of the time a drug company takes a usefull drug from europe (zopiclone) and tries to market the enanomer version (as it in lexapro and lunesta) we get a good chance of bad things happening; One, dose for dose it is not as effective. We know 10 mg of straight zopiclone is much more effective than 2-3 or eszopiclone, with less side effects. Trying to get the "bad taste" problem fixed, actually lessened the potency and duration of the drug. Ephedrine/p-ephedrine, lexapro, celexa etc.... I see this all the time. Zopiclone is not availbable here in the US, but Lunesta is, and most people have to take 4-6 mg to get reliable sleep. What do you folks feel about these new enanomer drugs, as well as the push for partial agonists. I have found such drugs useless (abilify, BuSpar etc...) Let's argue this stuff!!!!!!! 😀

 

[Solideliquid]

😀 😀 My non-scientific (applied) experience is that most of the time a drug company takes a usefull drug from europe (zopiclone) and tries to market the enanomer version (as it in lexapro and lunesta) we get a good chance of bad things happening; One, dose for dose it is not as effective. We know 10 mg of straight zopiclone is much more effective than 2-3 or eszopiclone, with less side effects. Trying to get the "bad taste" problem fixed, actually lessened the potency and duration of the drug. Ephedrine/p-ephedrine, lexapro, celexa etc.... I see this all the time. Zopiclone is not availbable here in the US, but Lunesta is, and most people have to take 4-6 mg to get reliable sleep. What do you folks feel about these new enanomer drugs, as well as the push for partial agonists. I have found such drugs useless (abilify, BuSpar etc...) Let's argue this stuff!!!!!!! 😀

In my limited experience, I have found abilify to work quite well for my patients. It seems to alleviate psychotic symptoms better than the others (zyprexa, seroquel, geodon) in many people.

For example, we have a patient that has used a few of the antipsychotics before he was admitted. We started him on seroquel and he said the next day or two that he had a wierd feeling around his eyes and forehead...possible EPS/mild extra occular muscle dystonia? Who knows, we switched him to abilify and he is liking it.

And it has the potential for far less EPS. Why don't you like it (except the expense)? So far it's my favorite of the neuroleptics for non-emergent treatment, although it doesn't even stand up to Clozapine.

 

[Anasazi23]

😀 😀 My non-scientific (applied) experience is that most of the time a drug company takes a usefull drug from europe (zopiclone) and tries to market the enanomer version (as it in lexapro and lunesta) we get a good chance of bad things happening; One, dose for dose it is not as effective. We know 10 mg of straight zopiclone is much more effective than 2-3 or eszopiclone, with less side effects. Trying to get the "bad taste" problem fixed, actually lessened the potency and duration of the drug. Ephedrine/p-ephedrine, lexapro, celexa etc.... I see this all the time. Zopiclone is not availbable here in the US, but Lunesta is, and most people have to take 4-6 mg to get reliable sleep. What do you folks feel about these new enanomer drugs, as well as the push for partial agonists. I have found such drugs useless (abilify, BuSpar etc...) Let's argue this stuff!!!!!!! 😀

Just for the record, it's 'enantiomer.'

Tachyphylaxis quickly develops in the benzodiazepine-like compounds. Hence the 4-6mg for sleep.

Partial agonists are not useless in their entirety. They work for the right patients at the right dosages. You just have to know whom to give it to, and how. Prescribing Abilify to a florid psychotic won't help you or him. For the outpatient thought disordered, bipolar maintained, or augmented patient on VPA, or the overweight or high BMI patient, it may be a reasonable choice. The partial dopamine agonism prevents the snowing effect and flattened affect and cognitive slowing commonly seen in more conventional or other second generation neuroleptics.

 

[Doc Samson]

Just for the record, it's 'enantiomer.'

Tachyphylaxis quickly develops in the benzodiazepine-like compounds. Hence the 4-6mg for sleep.

Partial agonists are not useless in their entirety. They work for the right patients at the right dosages. You just have to know whom to give it to, and how. Prescribing Abilify to a florid psychotic won't help you or him. For the outpatient thought disordered, bipolar maintained, or augmented patient on VPA, or the overweight or high BMI patient, it may be a reasonable choice. The partial dopamine agonism prevents the snowing effect and flattened affect and cognitive slowing commonly seen in more conventional or other second generation neuroleptics.

In my N of 5 patients I have started on Abilify, 4 became agitated/frankly manic, and 1 had no change. Probably doesn't stand up to statistical testing, but it is WAY down the list of options for me.

 

[Doctor Bagel]

There have been a few misconceptions thrown around.....

First - insurance companies don't give samples - drug companies give samples.

Insurance companies give preferential pricing based on all sorts of different considerations. Sometimes they bundle drugs - they price many drugs made by the same manufacturer (altho diffferent drug classes) so their whole "package" is priced preferentially - Merck is a good example.

Also....enantiomers or chemical alternatives to a drug have been used for decades to allow another drug to come into the marketplace - this has often driven the price of the parent drug down. Cephalosporins have been the extreme example of manufacturing changes which allow broader spectrums, but most of the changes have been done solely to allow a new drug to be released which has no particular preference over another. P & T committees have been always had to make decisions to choose which one to keep on formularies. This same concept works within many drug classes - SSRI's, ace inhibitors, proton pump inhibitors, etc, etc, etc...

Often they are interchangeable.....you just have to get the pt to steady state. If a pt has a side effect which becomes intolerable - change it (this often happens to proton pump inhibitor pts).

However, when a pt has a money issue - we do try to help the pt choose the least costly alternative. It is not always the generic (the recent release last month of generic Zocor is a prime example!!!! - Merck has lowered the price of Zocor to LESS THAN the generic to some insurance companies).

If the pts insurance company has the formulary alternative as one or the other, we might request you to change it, particularly when the pt has not yet been stabilized or started on the drug. If the pt has private insurance, we give the best possible price - & yes, I do advise mail order, but only if the pt is stabilized (it is never wise to buy 90 days supply if the pt won't tolerate it after 30 days...)

A drug patent is 17 years - a long time! Try the generic first unless you have a compelling reason otherwise! That is what I advise the patients who come to me to have their rx filled!

I know drug cmpanies give samples. However, I heard about insurance companies thinking about giving samples of generic drugs to discourage docs from prescribing non-generic drugs. Insurance companies and consumers are the ones who are screwed by samples. Here's a source.

http://www.bizjournals.com/twincities/stories/2005/02/07/daily14.html

Also, aren't patents 20 years now? I think that changed a few years ago. The amount of time on the market is usually way less than the full patented period because the patent starts once the product is developed, not once it's been through the whole review process. It's conceivable that a patended drugs will only hold its patent for 10 or so years while it's on the market. I know it's pretty hairy to determine when the patent actually started, which is why we have all this patent litigation. Still a long time, and I don't understand why anyone would ever not start on a generic drug unless the patented spendy drug is truly revolutionary.

 

[Demosthenes]

I've seen one case of ssri switching on lexapro. never agitation or akathisia when dosed properly. I've prescribed it a few hundred times.

Have you ever seen it go the other way? Inhibited movement, without reported fatigue/sedation? (I saw that once, and have wondered about it, but never heard of it in any other case. I guess my asking is like Inigo Montoya asking if someone has six fingers on his right hand...)

 

[50960]

Dosed properly is the main point!! And don't get high and mighty with me Sazi about spellings, or I will kick your butt. You know I know what it is. Perhaps you are taking it out on me that you got dinged on your english recently...notice I let that go. Yes enantiomers!! Remember I work in primary care with no psychiatrists so I see dosing mistakes daily and that may skew my view on certain drugs a bit...like abilify.

😎

 

[Anasazi23]

Dosed properly is the main point!! And don't get high and mighty with me Sazi about spellings, or I will kick your butt. You know I know what it is.

No biggie...just helping us all review the word's spelling. I had to look it up to confirm the correct spelling myself.

Perhaps you are taking it out on me that you got dinged on your english recently...notice I let that go. Yes enantiomers!!

My English? I'm not sure what you're talking about. Where did I get 'dinged?'
Are you inferring that I'm foreign born and that me english - he's a not so good?

Remember I work in primary care with no psychiatrists so I see dosing mistakes daily and that may skew my view on certain drugs a bit...like abilify.
😎

Don't get me wrong. Believe me, Abilify isn't high on my list of atypicals for use in psychotic disorders. In the inpatient setting, even when you load the dose, decrease it and retitrate like the reps want us to, it rarely works well in my experience. I've had a number of patients decompensate on it when we've switched to it or cross tapered for whatever reason. I think it has its place in certain situations. It's part of the art of clinical psychopharmacology.

 

[sdn1977]

I know drug cmpanies give samples. However, I heard about insurance companies thinking about giving samples of generic drugs to discourage docs from prescribing non-generic drugs. Insurance companies and consumers are the ones who are screwed by samples. Here's a source.

http://www.bizjournals.com/twincities/stories/2005/02/07/daily14.html

Also, aren't patents 20 years now? I think that changed a few years ago. The amount of time on the market is usually way less than the full patented period because the patent starts once the product is developed, not once it's been through the whole review process. It's conceivable that a patended drugs will only hold its patent for 10 or so years while it's on the market. I know it's pretty hairy to determine when the patent actually started, which is why we have all this patent litigation. Still a long time, and I don't understand why anyone would ever not start on a generic drug unless the patented spendy drug is truly revolutionary.

No - there are strict laws on providing medical samples. When a rep comes to a provider's office - the samples are documented, counted & signed for - not by the provider, usually by the office staff. They must do this for federal law.

Medica is a discounted managed health care provider. They only provide a discounted amount on the drugs they contract for. This is done by third parties with manufacturers to help market their product - that is the ONLY reason it is done - to market the product. If you perceive it as anything else - you are mistaken. McKesson is another which markets many discounted plans for 1 - 3 months of introductory "sample" supplies - nothing more than incentive to get you stabilized on the drug which makes it all the more difficult to get you switched when your own insurance kicks in to deny it. Medica and many others do not allow flexibility for the provider to prescribe the best medication for the patient - they are helping to market a particular product which they have an interest in (usually financial) then make it difficult to have the patient switch to a different medication if it is later required. Medco (Paid Prescriptions) is another common "insurer" with this same agenda - Medco is owned by Merck Pharmaceuticals!

Drug patents expire 20 years from the date of filing. A patent is ususally awarded years before a drug actually becomes marketable (the filing date) - which is why we consider a "marketable" patent 17 years. There is also the concept of "exclusivity" which is awarded depending on the type of drug. For a new drug (new to a class) - the exclusivity is generally 5 years. For an orphan drug (with limited application) - the exclusivity is 7 years. There are other exceptions, which are not germain to this discussion.

Generic manufacturers can accelerate the process & do by getting their drug application approved (they don't need a new drug application if they are doing a strict generic - loratidine for Claritin, for example) & they can get all marketing & business approvals in place well ahead of time so the drug can sometimes be brought to market before the patent or exclusivity expire (they don't necessarily run concurrently) But...the litigation, if done within 2 years, is not worth the effort for the primary patent holder. Which was why Claritin obtained OTC status 3 years before patent expiration (which coincidentially occurred with the OTC marketing of generic alternatives) & which also was preceded by the approval of Clarinex - which is absolutely no different from loratidine other than its prescription status. You can watch this same thing unfold in the years ahead with Astelin, Prevacid and many others.....

Totally "new" drugs - which means a different side chain or stereospecificity needs an NDA - a new drug application. But....they just add to the already existing group of drugs within a specific drug classification. Some have advantages for some - others for a different subset of patients. An enantiomer is classifed as a new drug & requires all new testing, altho it is usually more site specific, but not necessarily with fewer side effects. No matter what - it is a very expensive process & generally takes about 10 years of development & testing. That is why they are patent protected for so long & depending on what their exclusivity status is, is why they are not available generically.

This is nothing new & has been around for decades!

 

[Anasazi23]

Generic manufacturers can accelerate the process & do by getting their drug application approved (they don't need a new drug application if they are doing a strict generic - loratidine for Claritin, for example) & they can get all marketing & business approvals in place well ahead of time so the drug can sometimes be brought to market before the patent or exclusivity expire (they don't necessarily run concurrently) But...the litigation, if done within 2 years, is not worth the effort for the primary patent holder. Which was why Claritin obtained OTC status 3 years before patent expiration (which coincidentially occurred with the OTC marketing of generic alternatives) & which also was preceded by the approval of Clarinex - which is absolutely no different from loratidine other than its prescription status. You can watch this same thing unfold in the years ahead with Astelin, Prevacid and many others.....

I had wondered this exact thing when I saw it unfolding. I know that generics are so worthy of production since the company producing the generic compound does not have to complete an NDA, and does not have to conduct clinical trials, which can take years and millions of dollars.

But, are you saying that in this case, the company producing generic loratidine will begin the process of creating the generic, leaving it to Schering-Plough to sue for patent infringement, with the presumption that the litigation will cost more than the money made from continued patent exclusivity?

That doesn't seem right.

 

[sdn1977]

I had wondered this exact thing when I saw it unfolding. I know that generics are so worthy of production since the company producing the generic compound does not have to complete an NDA, and does not have to conduct clinical trials, which can take years and millions of dollars.

But, are you saying that in this case, the company producing generic loratidine will begin the process of creating the generic, leaving it to Schering-Plough to sue for patent infringement, with the presumption that the litigation will cost more than the money made from continued patent exclusivity?

That doesn't seem right.

Yep - thats exactly what I'm saying. They just have to obtain an ANDA in which they have to show their drug performs the same way as the parent drug - it blood level, tissue level, synovial fluid level, etc....all show the same pharmacokinetic & pharmacodynamic parameters. Then they must show the dissolution & absorption of their product is the same. These are steps which make it difficult to make a generic therapeutic equivalent to some drugs (Dilantin for example - there is a generic equivalent which is not a therapeutic equivalent).

Now.....the really interesting story this month is Zocor (Merck). The generic simvastatin was released last month (the end of July). By Aug 1, Merck had undercut the price of the generic's price to some major insurers (Perscare - the CA state employees & retirees for example - a huge group of insured) to keep it the primary formulary alternative the brand name Zocor. This essentially keeps the generic brands (lovastatin, simvastatin & the next to be released - atorvastatin) from competing in the statin market.

Its business - all business & not just about the business of good medical care. 🙁

 

[Anasazi23]

Yep - thats exactly what I'm saying. They just have to obtain an ANDA in which they have to show their drug performs the same way as the parent drug - it blood level, tissue level, synovial fluid level, etc....all show the same pharmacokinetic & pharmacodynamic parameters. Then they must show the dissolution & absorption of their product is the same. These are steps which make it difficult to make a generic therapeutic equivalent to some drugs (Dilantin for example - there is a generic equivalent which is not a therapeutic equivalent).

So in this case, a company that wants to make a generic of a popular drug can do so, as long as the pharmacokinetics and dynamics are exactly the same?

I guess that if that is true, then the company must conduct clinical trials to prove its efficacy and bioequivalence...which would in theory not be worth the money since it wasn't the brand?

i.e. If my lab can make the exact same drug as brand X, with complete bioequivalence, and prove it....the patent doesn't mean anything?

 

[sdn1977]

So in this case, a company that wants to make a generic of a popular drug can do so, as long as the pharmacokinetics and dynamics are exactly the same?

I guess that if that is true, then the company must conduct clinical trials to prove its efficacy and bioequivalence...which would in theory not be worth the money since it wasn't the brand?

i.e. If my lab can make the exact same drug as brand X, with complete bioequivalence, and prove it....the patent doesn't mean anything?

I'm sure this is way more information than you ever wanted to know about pharmacy, but your patients might ask....so here is the answer:

There are "patents" & there is "exclusivity" - they work similarly, but are distinct from each other. Patents are granted by the patent & trademark office & can occur anywhere along the development lifeline of a drug (there are far, far more patents on chemicals which might become drugs than there are on marketed drugs) & they can encompass a wide range of claims. Remember - a patent is for a chemical which is related to a claim - propranolol lowers blood pressure - not for the chemical itself, especially if it has to be "tweaked" to make it more physiologically compatible (hence - the proton pump inhibitors.....Prilosec & Nexium - the closest first cousins you'll ever meet.)

Exclusivity is the exclusive marketing rights which is granted by the FDA upon approval of a drug & can run concurrently with a patent or not. Exclusivity is a statutory provision & is granted to an NDA (new drug application). Exclusivity was designed to promote a balance between new drug innovation & generic drug competition (the Waman-Hatch Act in 1984).

A patent for drugs expire 20 years from the date of filing (remember - filing - this could have been when the scientists first felt a chemical had a possibility).

Exclusivity is granted for:
7 years for orphan drugs
5 years for a new chemical
6 months can be added to exclusivity if a pediatric designation is met
there are other exceptions which can go on and on and on......

Patents can expire before drug approval, can be issued after drug approval & anywhere in between. Exclusivity is granted upon approval of a drug product if certain criteria is met. Some drugs have both patent & exclusivity protection while others can have just one or none (ie - the dual marketing of the same drug - Zestril & Prinivil both came out at the same time). Exclusivity is not added to the patent life.

For an NDA - a new drug application - this is an expensive process. The company must not only prove the chemical efficacy, it must also prove safety, do kinetic & dynamic testing, stability testing & some must have studies which show all the same information in the extreme ages - pediatrics & geriatrics if there is any possibilty the drug may have a use there. Clinical trials take years & years - there are 4 levels - 2 with animals which simulate the human physiology (the animal can change - it depends upon the drug tested) & 2 with humans. The length of time it takes to start development on a drug & actually bring it to market can be 20+ years (research started on propranolol in the 50's - the patent expired in 1966 - the researcher for this drug won the Nobel prize in 1988).

When a company wants to maket a generic of a currently approved drug they submit an ANDA - an abbreviated new drug application. Generic drugs are "abbreviated" because they are not required to include preclinical (animal) & clinical (human) data to establish safety & efficacy. Instead, they must scientifically demonstrate their product is bioequivalent (performs in the same manner as the innovator drug). The generic must be shown to be comparable to the innovator in dosage form, strength, route of administration, quality, performance characteristics & intended use. All generics are linked to their brand name counterpart (ie not all levothyroxine products are bioequivalent. Some are bioequivalent to Levoxyl & some are bioequivalent to Synthroid. It is our job to keep the patient with the same bioequivalent product).

When a company applies for an ANDA to market a generic product, at the same time, the brand name company can apply for up to five additonal years longer patent protection to make up for lost time while their products were going thru the FDA approval process. This worked for Claritin - those years allowed them to obtain approval to market loratidine OTC & be exclusive for about 10 months while the generic rx market was being invaded by generic manufacturers. The end result of that was......insurance companies decided they didn't want to pay for something the pt could buy without an rx, so loratidine is rarely covered by insurance - took the starch right out of the generic & brand market. But......Claritin bought themselves some "name recognition" time while they were the first on the OTC market.

So.....again....business - all business. Back to the original question - if I were to be asked & there were no extenuating circumstances (a big "if" right there!) .....start with the generic citalopram. If you see a side effect or do not see the therapeutic effect you are seeking...then it might be worth the change to the Lexapro. It really doesn't matter how much better you think the drug might be for the pt - it the pt's insurance won't pay for it & they can't afford it - they won't take it. That has been shown in study after study!

In drugs - the money part is a big, big issue - unfortunately!

More than you wanted to know - right 😉 ?

 

[Anasazi23]

More than you wanted to know - right 😉 ?

The patent vs. exclusivity is what helped clear things us. I knew the concepts existed, but didn't know the details until you explained it so well.

Thanks!

I still think all things being equal (medicaid) Lexapro is slightly different from Celexa.

Thanks!

 

[sdn1977]

Anasazi - There was a timely article in the NY Times (at least the CA edition) on Tues Aug 15 - Business section on the story of Apotex - the big Canadian generic manufacturer & how they used the "at-risk launch" of Paxil (which is the industry jargon meaning the generic company sells its drug before patent litigation is concluded).

Brand name companies which are successful with litigation win the possible of triple damages, based on three times the generic drug's sales (few win...). However, in this circumstance, as well as others, the brand name companies "negotiated" the win-loss potential which resulted in allowing early patent infringment without the 5 year extension (involved about 40 million dollars I think.) Complicated, surely......but generic Plavix was released this month & the patent expires in 2011 & exclusivity about a few years before that. This article is an intersting insight into the marketing practices of drug companies.

Now...specifically to your practice. Generic Zoloft has been released & is being shipped tomorrow (or today, depending on where you live...) Thursday, Aug 17. The manufacturer is Greenstone - a subsidary of Pfizer (who makes..........Zoloft 😱 ) So....potentially, as of tomorrow - your patients might save some money.

Business - again.....just business!

 

[Anasazi23]

Anasazi - There was a timely article in the NY Times (at least the CA edition) on Tues Aug 15 - Business section on the story of Apotex - the big Canadian generic manufacturer & how they used the "at-risk launch" of Paxil (which is the industry jargon meaning the generic company sells its drug before patent litigation is concluded).

Brand name companies which are successful with litigation win the possible of triple damages, based on three times the generic drug's sales (few win...). However, in this circumstance, as well as others, the brand name companies "negotiated" the win-loss potential which resulted in allowing early patent infringment without the 5 year extension (involved about 40 million dollars I think.) Complicated, surely......but generic Plavix was released this month & the patent expires in 2011 & exclusivity about a few years before that. This article is an intersting insight into the marketing practices of drug companies.

Now...specifically to your practice. Generic Zoloft has been released & is being shipped tomorrow (or today, depending on where you live...) Thursday, Aug 17. The manufacturer is Greenstone - a subsidary of Pfizer (who makes..........Zoloft 😱 ) So....potentially, as of tomorrow - your patients might save some money.

Business - again.....just business!

Interesting, to be sure.

Thanks again for your input. I was relaying some elements of this discussion the other day in rounds when the topic of Pexiva came up again. Lots of market forces at work. Then again, it's these market forces that allow for profit, which allows for the development of newer, improved drugs.

A double-edged sword to be sure.

 

[DavidIR]

Hi, both celexa and lexapro are selective serotonin reuptake inhibitors. The difference between the two drugs is on the chemical level. I will not bother you with the explanation of this difference but basically, lexapro is an active form contained in celexa. Because of this the mechanism of action is the same. But, since lexapro does not contain the inactive component found in celexa, it is a more selective serotonin reuptake inhibitor. This means that lexapro works more effectively in treatment of depression. However, these advantages are not that significant in patients that are responding well to celexa therapy.

 

[TexasPhysician]

Holy necro-bump Batman!

 

[michaelrack]

Since this thread started in 2006, the whole QTc prolongation issue/FDA warning for celexa has come out

 

[Crayola227]

Hi, both celexa and lexapro are selective serotonin reuptake inhibitors. The difference between the two drugs is on the chemical level. I will not bother you with the explanation of this difference but basically, lexapro is an active form contained in celexa. Because of this the mechanism of action is the same. But, since lexapro does not contain the inactive component found in celexa, it is a more selective serotonin reuptake inhibitor. This means that lexapro works more effectively in treatment of depression. However, these advantages are not that significant in patients that are responding well to celexa therapy.

Why does this sound like a spammy advert?

 

[Amygdarya]

Why does this sound like a spammy advert?

Yep, sounds like a drug rep to me, too.

Nonetheless I don't mind the necrobump since it gave me an opportunity to read the interesting discussion above.

 

[Mass Effect]

LOL, I was reading along wondering what people are talking about with regard to Lexapro and Cymbalta patents and then realized it was a thread from 12 years ago.

 

[Messerschmitts]

Yeah I was going to write a long thing about cardiac side effects, and how you can't give patients over the age of 60 more than 20mg of Celexa anymore, and that's why I now prefer Lexapro, but this thread was started in 2006.

 

[Monocles]

So... now that both are generic and cheap as hell, plus there is more data out... can we visit the discussion again? Would anyone in 2018 ever have a reason to use citalopram over escitalopram?

 

[WingedOx]

So... now that both are generic and cheap as hell, plus there is more data out... can we visit the discussion again? Would anyone in 2018 ever have a reason to use citalopram over escitalopram?

Patient has been on it for years and insists upon it and no amount of explanation or counseling will change their mind. That's basically it.

 

[st2205]

Here are a few:

1. Generic is still twice as much as citalopram.
2. “Lexapro made me fat.”
3. “My cousin took Lexapro and it made her crazy.”
4. “Lexapro. I don’t like the sound of that.”
5. They had specific side effects on Lexapro.
6. They had a bad transference reaction with a previous “prescriber” who put them on Lexapro.
7. The QTc data’s a little fuzzy.
8. They’ve been on it for years.

There are many more.

 

[OldPsychDoc]

Here are a few:
...
4. “Lexapro. I don’t like the sound of that.”
...

It makes me think of Lex Luthor and he tried to kill Superman...

 

[NickNaylor]

I typically avoid starting citalopram on new patients but continue it for patients that are stable and doing well with it. I would rather use escitalopram or another SSRI given the black box warning which effectively acts as a ceiling for dosing. Perhaps the one exception would be in the elderly with neurocognitive disorders (ironically), since, for whatever reason, there is a relative paucity of evidence in this population for the other SSRIs except for citalopram. I doubt citalopram has magical effects in this population, but nevertheless that’s the only exception when I might use citalopram over another SSRI.

 

[hamstergang]

I would rather use escitalopram or another SSRI given the black box warning which effectively acts as a ceiling for dosing.

Isn't Lexapro's dosing just as limited as Celexa's now?

 

[randomdoc1]

Isn't Lexapro's dosing just as limited as Celexa's now?

I did a presentation in residency about SSRIs and QTc prolongation. Lexapro is associated with some QTc prolongation relative to most other SSRIs. But it is not as bad as Celexa. For this reason, sometimes I switch from Celexa to Lexapro if I have a concern for this in a particular patient (e.g. risk factors). In some cases I avoid Lexapro altogether depending on the individual case. I thought the max dose for Lexapro was always 20mg though?