Supernus says FDA recognized seven-year orphan-drug exclusivity for ONAPGO
Supernus said the FDA recognized seven years of orphan-drug exclusive approval for ONAPGO (apomorphine HCl) for motor fluctuations in adults with advanced Parkinson's disease, with the exclusivity period starting on the February 3, 2025 approval date. The company also submitted a supplemental New Drug Application for a second supplier of ONAPGO and continues to expect potential FDA approval of that supplier by mid-year 2027. The filing gives no financial figures, but the exclusivity period is a regulatory protection for the product.
Key points
- FDA recognized seven years of orphan-drug exclusive approval for ONAPGO, with the period starting February 3, 2025.
- ONAPGO is described as the first and only subcutaneous apomorphine infusion device for motor fluctuations in adults with advanced Parkinson's disease.
- Supernus submitted an sNDA for a second supplier of ONAPGO and expects potential FDA approval by mid-year 2027.
The filing
Written by AI (Anthropic Claude, claude-haiku-5-5) on Nov 7, 2026, 11:17 PM ET, from the text of the filing and its press-release exhibits only.
Briefs are written by AI from the filing text (each brief's own page names the model) and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the model's reading of the filing for shareholders, not a price forecast. Not investment advice.