Allergan, PLC announced Monday that it has submitted an abbreviated new drug application (ANDA) with the U.S. Food and Drug Administration (FDA) for its Carbidopia and Levodopa products.
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.
