Supernus receives seven‑year U.S. orphan‑drug exclusivity for ONAPGO and files sNDA for second supplier
Supernus announced that the FDA granted seven years of orphan‑drug market exclusivity for its ONAPGO apomorphine infusion device, effective February 3 2025. The company also submitted a supplemental New Drug Application for a second supplier of ONAPGO, with FDA approval expected by mid‑2027. The exclusivity and additional supplier aim to protect the product’s market position and address earlier supply constraints.
Why it matters
The exclusivity shields ONAPGO from generic competition for seven years, potentially supporting higher sales and margins for Supernus. The pending second‑supplier approval could improve supply reliability and sustain market demand.
Key facts
- 1The FDA granted seven years of orphan‑drug exclusivity for ONAPGO. stocktitan.net
- 2Exclusivity began on February 3 2025, the date of FDA approval. stocktitan.net
- 3Supernus submitted a supplemental New Drug Application for a second supplier for ONAPGO. stocktitan.net
- 4The company expects potential FDA approval of the second supplier by mid‑year 2027. stocktitan.net
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.