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| SNTS > SEC Filings for SNTS > Form 8-K on 1-Mar-2013 | All Recent SEC Filings |
1-Mar-2013
Other Events
On February 28, 2013, Depomed, Inc. ("Depomed") filed a lawsuit in the U.S. District Court for the District of Delaware against Watson Laboratories, Inc. - Florida, Actavis, Inc., and Watson Pharma, Inc. (collectively, "Watson") for infringement of the patents listed in the Orange Book for the prescription product GlumetzaŽ (metformin hydrochloride extended release tablets) 500 mg. Santarus, Inc. ("Santarus") promotes Glumetza 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 generic versions of Glumetza 500 mg prior to the 2016, 2020, and 2021 expiration dates of the four listed patents (U.S. Patent Nos. 6,340,475, 6,488,962, 6,635,280, and 6,723,340).
The lawsuit was commenced within the 45 days required to automatically stay, or bar, the FDA from approving Watson's ANDA for Glumetza 500 mg for 30 months or until a district court decision that is adverse to the asserted patents, whichever may occur earlier.
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