Cadila and Supernus settle patent dispute over epilepsy generic

pharmafile | March 7, 2017 | News story | Manufacturing and Production, Sales and Marketing Cadila, Supernus, Trokendi XR, Zydus Cadila 

A patent dispute between Indian pharmaceutical firm Cadila Healthcare and US-based Supernus Pharmaceuticals has been ended with legal calls for a ceasefire after the pair reached a settlement over patent infringement accusations.

Supernus, which focuses on central nervous systems treatments, originally filed a lawsuit in the US District Court for the District of New Jersey against Cadila in November 2014. The lawsuit claimed that Cadila had infringed upon three patents covering its epilepsy treatment Trokendi XR by filing an Abbreviated New Drug Application for a generic version of the drug while its patent was still active. According to the company, patent protection for Trokendi XR remains active until 2027.

The settlement reached by the two companies now enables Cadila to market a generic version of the drug from January 1, 2023, or earlier in special circumstances. The other terms of the agreement are not known.

Trokendi XR was approved by the FDA in 2013, with a supplemental New Drug Application adding migraine treatment to its list of indications in 2015. The drug generated $158 million in sales last year.

Matt Fellows

Related Content

Cadila scores FDA approval for BMS and Alvogen generics

Cadila Healthcare has announced that it has gained FDA final approval to market nifedipine ER …

Zydus Cadila scores twin FDA approvals

Indian pharmaceutical firm Zydus Cadila has announced that the US Food and Drug Administration (FDA) …


Takeda partners with Zydus to develop chikungunya vaccine

Zydus Cadila has teamed up with Takeda to develop a vaccine for the chikungunya virus. …

Latest content