Allergan Files ANDA for Generic Rytary Following Patent ChallengeBy
Allergan has filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) to begin marketing 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, a generic version of Impax Laboratories’ Rytary. Rytary is indicated for treating Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.
Impax recently filed suit against Allergan to prevent the marketing of carbidopa and levodopa prior to expiration of certain US patents. The lawsuit results 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.
If Allergan's ANDA is approved, the product may be entitled to 180 days of generic market exclusivity. Rytary's total US sales were approximately $15 million for the 12 months ending July 31, 2015, according to IMS Health and as reported by Allergan.