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

Supernus Pharmaceuticals announced that the FDA has granted seven years of orphan-drug market exclusivity for ONAPGO (apomorphine HCl), a subcutaneous infusion device for treating motor fluctuations in advanced Parkinson's disease patients. The exclusivity period began February 3, 2025. Additionally, the company submitted a supplemental New Drug Application for a second supplier with expected FDA approval by mid-2027.