These drugs are generic versions of Rytary, a drug developed by Impax Laboratories. These drugs are meant to treat symptoms associated with Parkinson's disease, parkinsonism following carbon monoxide intoxication and post-encephalitic parkinsonism.
Allergan said that it is likely the first applicant to file an application for a generic form of Rytary. If its application is approved, Allergan would benefit from 180 days of generic market exclusivity for its drugs.
Impax Laboratories filed a lawsuit against Allergan on Aug. 17 in order to prevent the company from commercializing on an ANDA under the Hatch-Waxman Act. This case resulted in a stay of final approval from the FDA on Carbidopa and Levodopa extended-release capsules. The stay is reported to last until a court decision is made or after 30 months of the ANDA being filed and confirmed.
Allergan specializes in the development, commercialization and manufacture of branded pharmaceuticals and high-quality generic medications and biological products used in medical practice globally. The company is based in Dublin and has commercial operations in approximately 100 countries.