GlaxoSmithKline files suit against Watson over generic JALYN

Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc. - Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market  dutasteride and tamsulosin hydrochloride capsules. Watson's dutasteride and tamsulosin hydrochloride capsules are a generic version of GlaxoSmithKline's JALYN™. JALYN™ capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate.

GlaxoSmithKline filed suit against Watson on July 21, 2011 in the United States District Court for the District of Delaware seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent No. 5,565,467. GlaxoSmithKline's lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA until December 30, 2013, or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.  

For the twelve months ending May 31, 2011, JALYN™ capsules had total U.S. sales of over $30 million according to IMS Health data.

Source:

Watson Pharmaceuticals, Inc.

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
Study finds social and psychological factors fuel teen cravings for ultra-processed foods during screen time