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Watson files for generic copy of Wyeth's Lybrel drug
14 Mar 2008
Regulatory Affairs
Watson has filed for an application to produce a generic copy of Wyeth's birth control drug.
The pharmaceutical firm has applied to the US Food and Drug Administration (FDA) for an Abbreviated New Drug Application (ANDA) regarding Wyeth's levonorgestrel and ethinyl estradiol drug.
Watson's application comes before Wyeth's patent has expired on the contraception drug Lybrel.
As Watson believes it is the first ANDA filed for the Lybrel drug the company may be afforded 180 days of generic market exclusivity, if the application is approved.
Wyeth has filed a case against the application, meaning the final decision is in the FDA's hands.
In related news, a trial date for applications to produce generic versions of one of AstraZeneca's drug, filed by Teva Pharmaceuticals and Novartis's AG Sandoz has been set.
The applications regard producing a cheaper version of the anti-psychotic drug Seroquel, whose patent is not due to expire until 2011.
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