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FDA recognizes seven years of orphan-drug exclusivity for ONAPGO
SUPNSupernus, Inc.
The U.S. Food and Drug Administration has recognized seven years of orphan-drug exclusive approval for ONAPGO (apomorphine HCl), a treatment for motor fluctuations in adults with advanced Parkinson’s disease. This market exclusivity began on February 3, 2025, the date of initial FDA approval. Additionally, Supernus submitted a supplemental New Drug Application to the FDA for a second supplier for ONAPGO and expects potential approval by mid-year 2027. Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases.