Generic version of Rytary for Parkinsons filed with FDA- Allergan

Allergan has filed an Abbreviated New Drug Application with the FDA seeking approval to market carbidopa and levodopa extended-release capsules, 61.25 mg/245 mg, 23.75 mg/95 mg, 36.25 mg/145 mg and 48.75 mg/195 mg. Allergan's ANDA product is a generic version of Impax Laboratories' Rytary, which is indicated for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.

Impax Laboratories filed a suit against Allergan on 17 August 2015 in the US District Court for New Jersey seeking to prevent Allergan from commercialising its ANDA product prior to the expiration of certain US patents. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Allergan's ANDA for up to 30 months from the date the plaintiffs received notice of Allergan's ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.

Allergan believes it may be a first applicant to file an ANDA for the generic version of Rytary and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.