FDA grants Supernus 7-year market exclusivity for Parkinson's drug

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Go back to FDA grants Supernus 7-year market exclusivity for Parkinson's drug

Supernus Announces Orphan Drug Exclusivity for ONAPGO™ (apomorphine HCl)

October 21, 2026 7:45 PM EDT

Orphan-drug exclusivity provides seven years of market exclusivity for ONAPGO

Additionally, the Company submitted an sNDA to the FDA for a second supplier for ONAPGO, with potential approval by mid-year 2027

ROCKVILLE, Md., Oct. 21, 2026 (GLOBE NEWSWIRE) -- Supernus, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced today that the U.S. Food and Drug Administration (FDA) has recognized seven years of orphan-drug exclusive approval for ONAPGO (apomorphine... More