Supernus Pharmaceuticals, Inc. SUPN has entered into a settlement agreement with Par Pharmaceutical Companies, a wholly owned subsidiary of Endo International plc ENDP for an ongoing patent litigation regarding Trokendi XR (extended-release topiramate).
We remind investors that on Dec 9, 2014, Supernus had announced the receipt of a Paragraph IV notice from Par, which was looking to get its generic version of Supernus’ Trokendi XR capsules approved in the U.S.
Both the companies signed the settlement agreement subject to a consent judgment by the U.S. District Court for the District of New Jersey, under which Par recognized the Orange Book-listed U.S. Patent Nos. 8,298,576, 8,298,580, 8,663,683, 8,877,248, 8,889,191, and 8,992,989 for Trokendi XR, as owned by Supernus, to be valid and enforceable, and admitted that these patents were infringed by Par’s submission of an abbreviated new drug application for its generic version of the drug. Supernus stated that the agreement will be submitted to the relevant governmental agencies.
Following the settlement, Par will be able to start selling its generic version of Trokendi XR from Apr 1, 2025, or earlier, under certain circumstances.
Trokendi XR is approved for the treatment of epilepsy.
Supernus has two marketed products in its portfolio – Trokendi XR and Oxtellar XR, with the company depending highly on Trokendi XR for growth. In the first six months of 2015, Trokendi XR generated revenues of $47.2 million, up 76.8% year over year and accounting for 75.6% of net product sales. We believe that earlier-than-expected entry of generic versions of Trokendi XR would have a major impact on the company’s financials.
Meanwhile, Supernus remains active on protecting Trokendi XR from generics. The company is engaged in a series of patent infringement lawsuits involving the drug with companies like Allergan AGN and Zydus. Supernus confirmed that Trokendi XR is protected until 2027.
Additionally, the company is working on advancing its pipeline in the field of psychiatry. The company intends to initiate a phase III program on SPN-810 (impulsive aggression in patients suffering from attention deficit hyperactivity disorder (ADHD) who receive standard treatment) and a phase IIb program on SPN-812 (ADHD) in the fourth quarter of 2015.
Meanwhile, Alcobra Ltd. ADHD is evaluating MDX in a phase III study for the treatment of ADHD.
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