April 09, 2005

Generic Zyprexa Approved

Zyprexa Generic Tentatively Approval

Mylan Pharmaceuticals confirmed recently that it has received tentative approval from the FDA to market a generic version of fellow-US pharmaceutical firm Eli Lilly's schizophrenia drug Zyprexa (olanzapine). Mylan's abbreviated new drug application (ANDA) covers the 2.5 mg, 5.0 mg, 7.5 mg, 10.0 mg, 15.0 mg and 20.0 mg dosages of Zyprexa.

Also, the FDA granted tentative approval for Teva Pharmaceutical Industries 'ANDA for olanzapine tablets 2.5, 5, 7.5, 10, 15 and 20mg. Final approval is subject to the resolution of patent litigation and the expiration of any exclusivity period applying to another ANDA filer. The product is an AB-rated generic equivalent of Eli Lilly 's psychotropic agent, Zyprexa , used in the treatment of schizophrenia and bipolar disorders.

Zyprexa's sales success, which remains the best-selling in Eli Lilly's portfolio, generates annual sales of around US$2.8bn; is a clear incentive for a number of generic drug manufacturers that are challenging the validity of the patent on the drug.

This is just a tentative announcement. It will likely take some time (a number of months) before there is more news, or availability of this new generic drug).

Mylan Pharmaceuticals

Teva Pharmaceutical Industries, inc.


When will the generic version of Zyprexa be available

Posted by: Marie Maglio at March 25, 2007 07:46 AM

I have been using Zyprexa
for a number of years. It is the only drug that helps me noticably in treating my extreme anxiety (GAD) and is prescribed by my psychiatrist.(I also suffer from severe unipolar depression and am unemployed) However the flip side is that the high cost and the unfortunate weight gain causes extreme anxiety as well. I there any help forthcoming re the generic approval in South Africa and is it dangerous to use chronically re one's metabolic rate. Any help out there?

Posted by: Karin Lorenc at September 15, 2007 02:46 AM

Generic available in Canada. Try the online canadian pharmacies

Posted by: G Holder at October 24, 2007 10:27 AM

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