Supernus hits Zydus with repeat suit over migraine drug
Supernus Pharmaceuticals has once again accused Indian generic drugmaker Zydus Cadila and its US unit of allegedly infringing 10 patents with its copycat of Trokendi XR (topiramate), a drug for migraines and seizures.
The pharmaceutical company filed the complaint at the US District Court for the Southern District of New York, on Friday, September 17.
The first dispute arose in 2014 when Zydus submitted an abbreviated new drug application (ANDA) seeking approval from the US Food and Drug Administration to create a copy of the blockbuster drug treatment.
Supernus sued Zydus in a New Jersey federal court holding that the Zydus generic, if sold and marketed, would infringe the patents.
This action was later settled in 2017 and the two companies negotiated licensing agreements that permitted Zydus to launch its products in 2023.
But in its new complaint, Supernus contended that Zydus’ new ANDA submitted in August contravened the terms of the agreement.
According to Supernus, this action infringed patents, US numbers 8,298,576, 8,298,580, 8,663,683, 8,877,248, 8,889,191, 8,992,989, 9,549,940, 9,555,004, 9,622,983, and 10,314,790.
These patents cover the antiepileptic drug Trokendi XR, used for the treatment of seizures and for the preventive treatment of migraine.
Patent protection for Trokendi XR expires in 2027. Trokendi XR is the Maryland-based Supernus’ best-selling drug, generating nearly $320 million for the company in 2020.
Supernus has also sued Lupin, Ajanta and Torrent for alleging infringing patents covering the same drug treatment.
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