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 May 22 2006, 05:51 PM
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QUOTE 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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Forum Super AdministratorDF member since Dec 2001  ---- "I cannot make my mark for all time...those concepts are mutually exclusive.
"Lasting effect" is a self -contradictory term. Meaning does not exist in the future, nor do I.
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My meaningfulness is in the here and now. It is enough that I may be of value to someone today.
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Apr 10 2007, 09:46 PM
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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?
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 Jan 28 2008, 08:05 AM
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QUOTE (KeepingAwake @ Apr 11 2007, 12:16 AM)  QUOTE (Escitalopram @ Apr 10 2007, 10:46 PM) 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.
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Jun 4 2008, 05:56 PM
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Forum Super Administrator
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QUOTE 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!
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Be Well....
~Lindsay, Forum Super Administrator
Founder, depressionforums.org
Forum Super AdministratorDF member since Dec 2001 ---- "I cannot make my mark for all time...those concepts are mutually exclusive.
"Lasting effect" is a self -contradictory term. Meaning does not exist in the future, nor do I.
Nothing will have meaning, "ultimately."
Nothing will even mean tomorrow what it did today. Meaning changes with the context.
My meaningfulness is in the here and now. It is enough that I may be of value to someone today.
It is enough that I make a difference now." ~Lindsay
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Sep 9 2008, 01:04 AM
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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??? 
This post has been edited by Dooin' it: Sep 9 2008, 01:05 AM
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Isaiah 54:17a "No weapon forged against you will succeed;"
I Peter 5: 6,7 "Humble yourselves, therefore, under the mighty hand of God, that he may lift you up in due time. Cast all your anxiety upon Him for he cares for you."
Recommended reading........"Feeling Good; The New Mood Therapy" by Dr. David Burns
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FDA Approves First Generic Lexapro |
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Depression Forums - A Depression & Mental Health Community Support Group > DEPRESSION & ANXIETY MEDICATIONS - LOOKING FOR ANSWERS > Celexa® (Citalopram) / Lexapro®/Cipralex® (escitalopram)
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