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SNTS > SEC Filings for SNTS > Form 8-K on 18-Apr-2012All Recent SEC Filings

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Form 8-K for SANTARUS INC


18-Apr-2012

Other Events


Item 8.01. Other Events

Santarus, Inc. ("Santarus") was notified by Depomed, Inc. ("Depomed") that Depomed has filed a lawsuit in the United States District Court for the District of Delaware against Watson Laboratories, Inc. - Florida, Watson Pharmaceuticals, Inc. and Watson Pharma, Inc. (collectively, "Watson"), for infringement of certain patents related to GlumetzaŽ (metformin hydrochloride extended release tablets). Valeant International (Barbados) SRL is joined in the lawsuit as a co-plaintiff. The patents asserted include the patents listed in the Orange Book for Glumetza 1000 mg (U.S. Patent Nos. 6,488,962 and 7,780,987). Santarus promotes Glumetza prescription products in the U.S. under the terms of a commercialization agreement with Depomed.

The lawsuit is in response to an Abbreviated New Drug Application ("ANDA") filed by Watson with the U.S. Food and Drug Administration ("FDA") regarding Watson's intent to market a generic version of the 1000 mg dosage strength of Glumetza prior to the expiration of the asserted patents.

Depomed has commenced the lawsuit within the 45 days required to automatically stay, or bar, the FDA from approving Watson's ANDA for 30 months or until a district court decision that is adverse to the patents, whichever may occur earlier. Absent a court decision, the 30-month stay is expected to expire in September 2014.


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