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[Lindsay]

Today: May 22, 2006 at 14:36:21 PDT

FDA Approves First Generic Lexapro
WASHINGTON (AP) - The first generic version of Lexapro, one of the most widely prescribed antidepressants, with more than $2 billion in sales last year, received federal approval Monday.

Ivax Corp. of Miami, part of Israel's Teva Pharmaceutical Industries Ltd., becomes the first company cleared to make a generic version of the prescription drug, according to the Web site of the Food and Drug Administration. The agency approved 5, 10 and 20 milligram doses of the drug, also called escitalopram oxalate, for the treatment of major depression.

Lexapro, the brand-name version of the drug, is made by New York-based Forest Laboratories Inc.

In 2005, Lexapro was the No. 2 antidepressant in the United States, behind Zoloft, with 29.6 million prescriptions filled, according to IMS Health, a prescription information provider. Lexapro's U.S. sales last year were $2.1 billion.

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On the Net:

Food and Drug Administration: http://www.fda.gov/

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[Escitalopram]

Just curious...how could they come out with a generic so quickly? since lexapro is still relatively new

does it have anything to do with the fact that it's so similar to Celexa?

[KeepingAwake]

Just curious...how could they come out with a generic so quickly? since lexapro is still relatively new

does it have anything to do with the fact that it's so similar to Celexa?

Forest, the makers of Lexapro, challenged this decision and won because the patent has not yet expired.

KA

[emera]

Just curious...how could they come out with a generic so quickly? since lexapro is still relatively new

does it have anything to do with the fact that it's so similar to Celexa?

Forest, the makers of Lexapro, challenged this decision and won because the patent has not yet expired.

KA

I wonder when it will come on the market then, with this patent decision. It would nice if it was soon, since my insurance company doubled our costs per year and now refuses to cover lexapro, only celexa.

[Girly]

Lexapro isn't available in generic form yet, but its predecessor Celexa is. The generic name for Celexa is citalopram, Lexapro and Cipralex are escitalopram. I've taken both citalopram and escitalopram, and gotten the same results from it. The only difference is that you need to take twice the milligrams of citalopram to equal the escitalopram. For example, 20mgs of Celexa/citalopram would equal 10mgs of Lexapro/Cipralex/escitalopram.

A great update here from suburgatory

[Lindsay]

Feb. 2007 Update

After reviewing the status of generic Lexapro, we discovered that the company that was trying to bring it to market, Teva, lost a patent fight with Lexapro’s maker, Forest Labs. To put this in perspective of how big a deal this was for Forest, in the 2nd quarter of 2006, Lexapro made up 60% of Forest’s revenues (according to this blog entry). Bloomberg News also carried the judge’s July 12 2006 ruling.

What this means is that although the FDA approved a generic formulation of Lexapro, a generic version of Lexapro is not coming to a store near you anytime soon. The Lexapro patent does not run out until 2012. Sorry!

[Dooin' it]

In the patent case, Forest alleges that IVAX's ANDA for generic Lexapro infringes U.S. Pat. No. Re. 34,712, which is a reissue patent of U.S. Pat. No. 4,943,590. The '712 patent claims substantially pure (+)-citalopram, the active ingredient in Lexapro, also known as "S-citalopram" or "escitalopram." (+)-citalopram is also the active ingredient in Forest's older generation SSRI, Celexa, which is a racemic mixture of (+) and (-) citalopram. The patents on Celexa have expired. According to the Orange Book, the '712 patent will not expire until June, 2009. [Update: An alert reader just informed me that Forest was recently granted a patent term extension. The '712 patent is now set to expire in March, 2012. Forest announced the extension in a recent press release.]

In its post-trial brief, IVAX argues that the '712 patent is invalid for anticipation and obviousness, invalid for broadening reissue, and unenforceable for inequitable conduct. In its lead argument, IVAX argues that a prior art reference, Smith, describes (+) and (-) citalopram as individual enantiomers in a form separated from each other. Forest counters in its post-trial brief that Smith does not anticipate the '712 patent because it does not enable one of skill in the art to make substantially pure (+)-citalopram without undue experimentation.



As if the judge's ruling wasn't a low blow to patients around the world already......How did this "extension" happen???

Edited by Dooin' it, 09 September 2008 - 01:05 AM.

[chickapea]

Every time I go to the chemist to get my prescription they ask me if I want a generic version. I have never said yes, but I presumed that they are asking me because there is one. Next time I might do it. I know they are the same, but I'm just too nervous with this medication. It makes such a difference to my life.

[russiangirl]

this post is from 2006, but yesterday I went to pharmacy (I'm new to Lexapro) and they told me that there is no generic version of this drug?...

[Spiritual_Wanderer]

This is interesting because I noticed when I picked up my first prescription for Lexapro it is the name brand by Forest and cost a lot more than other medications I've had ($40 USD with insurance). If it works, I won't mind paying extra, and I've heard several people swear by name brand antidepressants.

Teva (according to a post above) who was attemtping to make a generic version, is known by word-of-mouth for having a faulty extended-release (XR) generic version of Wellbutrin. Hopefully, if they do get to do one in 2012, they get it right!!

[Football305]

Are generics less effective than brand name?

[Exelion]

Are generics less effective than brand name?

Generally they are identical. By the book, they are SUPPOSED to be identical, but there are always reports that say otherwise.

[SoulComa]

Are generics less effective than brand name?

Generally they are identical. By the book, they are SUPPOSED to be identical, but there are always reports that say otherwise.

This is usually true. Most times when people think the name brand is better it is simply a placebo effect. But, there are instances where generics are worse, or rarely, can even be dangerous.
There was a heart medicine - I forget the name - in Canada that had an expired patent a few years back, and the Government quit covering the name brand. The price difference was significant, too.
(I think with the socialized medicine, it was free for the plan-covered generic, but over $100 if not on the approved list.) Shortly thereafter a number of people got quite sick and I'm pretty sure a few people died [Sorry, no citations].
Doctors were writing "dispense as written" using the brand name on the scripts, but patients couldn't afford the brand in many cases anyway.
It got (Canadian) National attention, there was a big brouhaha, and the government went back to covering the name brand.

I also remember reading in a medical journal for a paper I wrote that name brand diazepam (Valium) has a higher bio-availability and quicker absorption rate compared to the dozens of generic versions of that old drug. But, the price ratio is around 20:1. The generic is safe, just not as good.

Also, Teva is a terrible company. I had first hand experience with one of their generics many years ago. (I was on Oxycontin at the time, and they were the first to come out with the generic version; they were shaped somewhat like a football.) They were terrible. I wasn't abusing them either, just swallowing, but they screwed up the matrix or something, because taking two still wasn't equivalent to one name brand pill. I think they quit making them. I heard they completely changed the formula for those pills now, but this was back before that happened, about 6-7 years ago.

Edited by SoulComa, 30 November 2011 - 01:25 AM.

[TedD]

About a week ago, a generic form of Lexapro became available. It is manufactured by Mylan. I have a prescription for 20 mg tablets.

[TedD]

I just renewed my lexapro prescription and this time the generic was made by Teva.

[GeorgiaR51]

What is the generic name? My daughter was put on Lexapro and when she went to get the script (it was the generic brand...starts with an E?) t, it was $110 for a 30 day supply. Thankfully, a friend of mine just happened to call me the next day and we were talking about it Lexapro. She had about 40 days worth of sample boxes from her doctor from a few months back and gave them to me. Same dosage. You must have good insurance.

[rubycat]

I mentioned on another forum that I think the generic Lexapro has different side effects than the regular one. The fatigue with the generic is really debilatating (sp?)