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News Breaks
January 23, 2013
17:23 EDTSNTS, DEPOSantarus announces receipt of paragraph IV certification for generic glumetza
Santarus (SNTS) disclosed that on January 21, Santarus received a paragraph IV certification from Watson Laboratories advising Santarus of the filing of an Abbreviated New Drug Application ANDA with the U.S. FDA for a generic version of Glumetza. Santarus promotes Glumetza in the U.S. under the terms of a commercialization agreement with Depomed (DEPO). Watson’s certification notice alleges that the four U.S. patents listed in the FDA’s Orange Book for Glumetza 500 mg, with expiration dates in 2016, 2020 and 2021, will not be infringed by Watson’s proposed product, are invalid and/or are unenforceable. Santarus and Depomed are evaluating the paragraph IV certification. The parties have 45 days from the receipt of the paragraph IV certification to commence a patent infringement lawsuit against Watson that would 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 asserted patents, whichever is earlier. In April 2012, Depomed filed a lawsuit against Watson in the U.S. District Court for the District of Delaware, in response to an ANDA and paragraph IV certification filed by Watson regarding Watson’s intent to market a generic version of Glumetza 1000 mg, which litigation is ongoing.
News For SNTS;DEPO From The Last 14 Days
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August 19, 2014
11:18 EDTDEPODepomed announces favorable ruling in Gralise case
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10:32 EDTDEPODepomed higher after favorable ruling in Gralise case
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