CANONSBURG (dpa-AFX) - Santarus Inc. (SNTS) disclosed in a regulatory filing that it has filed a lawsuit in the U.S. District Court for the District of Delaware against Mylan Inc. (MYL) and Mylan Pharmaceuticals Inc. for infringement of the patents listed in the Orange Book for Santarus' prescription product, Fenoglide (fenofibrate) tablets, 40 mg and 120 mg. Veloxis Pharmaceuticals A/S, licensor of the patents, is joined in the litigation as a co-plaintiff.
The lawsuit is in response to an Abbreviated New Drug Application or ANDA filed by Mylan with the U.S. Food and Drug Administration regarding Mylan's intent to market generic versions of Fenoglide prior to the 2024 expiration of the two listed patents.
The lawsuit was commenced within the 45 days required to automatically stay, or bar, the FDA from approving Mylan's ANDA for 30 months or until a district court decision that is adverse to the plaintiffs, whichever may occur earlier.
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