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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.
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September 17, 2014
16:18 EDTDEPODepomed says FDA recognizing 7 years orphan-drug exclusivity for Gralise in PHN
Depomed (DEPO) disclosed in a filing that on September 16 the company received a letter from the FDA informing the company that pursuant to the order issued on September 5 by a judge of the U.S. District Court for the District of Columbia, the FDA is recognizing seven years of orphan-drug exclusive approval for the company’s Gralise for the management of postherpetic neuralgia. The letter also confirms the FDA will not approve any abbreviated New Drug Application referencing Gralise during the period of orphan-drug exclusive approval, which began on January 28, 2011. The FDA has 60 days after issuance of the order in Depomed, Inc. v. HHS to file a notice appealing the order to the United States Court of Appeals for the Federal Circuit. The period of orphan drug exclusivity applicable to Gralise for PHN is separate from marketing exclusivity arising from the previously disclosed decision issued on August 19 in the company’s patent litigation lawsuit against Actavis (ACT) related to an ANDA filed by Actavis seeking to market generic versions of Gralise. The decision found that Actavis infringed all seven of the company’s patents asserted in the litigation, upheld the validity of the patents and enjoined FDA approval of the Actavis ANDA until February 26, 2024, the latest expiration date of the infringed patents. On September 15, Actavis filed a notice appealing the decision to the United States Court of Appeals for the Federal Circuit, Depomed stated. Previously disclosed settlement agreements between the Company and two other Gralise ANDA filers permit the sale of generic Gralise beginning on January 1, 2024.

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