Impax Sues Allergan Over Parkinson’s Disease Drug

Impax Laboratories is suing Allergan, claiming patent infringement of its Parkinson’s disease drug Rytary.

In its lawsuit filed in U.S. District Court for the District of New Jersey, Impax seeks to prevent Allergan from obtaining ANDA approval and selling Rytary until expiration of six patents for the drug. One patent for Rytary (levodopa/carbidopa) expires in May 2022, while the other five expire in December 2028, according to the Orange Book.

Allergan has filed an ANDA for the generic version of Rytary extended-release capsules, indicated for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.

Allergan says it believes it may be a first applicant, meaning the company could be entitled to 180 days of market exclusivity pending approval.

The FDA approved Rytary in January, after Impax agreed to not use a troubled manufacturing facility in Hayward, Calif., for production.

Rytary had annual U.S. sales of roughly $15 million as of July 31, according to IMS Health data.

The lawsuit is Impax Laboratories v. Actavis Laboratories and Actavis Pharma. Impax could not be reached for comment by press time. — Jonathon Shacat