Supernus Awarded 7-Year Orphan-Drug Exclusivity for Parkinson's Drug ONAPGO

Supernus Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has recognized a seven-year period of orphan-drug market exclusivity for ONAPGO (apomorphine HCl), a treatment for motor fluctuations in adults with advanced Parkinson’s disease. The company also submitted a supplemental New Drug Application (sNDA) to the FDA to secure a second supplier for the drug.

Key Details

• Drug Exclusivity: The seven-year market exclusivity period for ONAPGO began on its FDA approval date of February 3, 2025.
• Indication: ONAPGO is the first subcutaneous apomorphine infusion device for treating motor fluctuations ("off" episodes) in adults with advanced Parkinson's disease.
• Supply Chain Update: The company submitted an sNDA for a second supplier for ONAPGO and expects potential FDA approval by mid-year 2027 to ensure uninterrupted drug supply.