Zydus Cadila has settled a patent litigation related to the US-based Supernus Pharmaceuticals’ Trokendi XR (extended-release topiramate) capsules. “Cadila Healthcare Limited and its subsidiary Zydus Pharmaceutical (USA) Inc have finalised an agreement Supernus Pharmaceuticals to settle all outstanding patent litigation related to Trokendi XR (extended-release topiramate) capsules,” said Zydus in a press release.
Two sides were involved in a patent litigation regarding Zydus’ abbreviated new drug application (ANDA) seeking approval to market generic versions of Supernus' Trokendi XR capsules.
The settlement agreement permits Zydus to begin selling a generic version of Trokendi XR on January 1, 2023, or earlier under certain circumstances. The agreement will be submitted to the applicable governmental agencies.
Trokendi XR is prescribed for treat certain types of seizures (partial onset seizures and primary generalized tonic-clonic seizures) in people 6 years of age and older, and with other medicines to treat certain types of seizures (partial onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome) in adults and children 6 years and older.
“Supernus intends to continue its vigorous enforcement of its patent rights for Trokendi XR. Patent protection for Trokendi XR expires no earlier than 2027,” said Supernus in a press statement.
Supernus Pharmaceuticals Inc is a specialty pharmaceutical company focused on developing and commercialising products for the treatment of central nervous system (CNS) diseases.
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