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News Breaks
March 13, 2014
08:01 EDTDEPODepomed price target raised to $18 from $11 at JMP Securities
JMP Securities increased its price target on Depomed after the company provided 2014 guidance that the firm views as strong. The firm reiterates an Outperform rating on the stock.
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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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