Supernus Announces Orphan Drug Exclusivity for ONAPGO™ (apomorphine HCl)
Supernus said the FDA recognized seven years of orphan-drug exclusivity for ONAPGO (apomorphine HCl), the first and only subcutaneous apomorphine infusion device for motor fluctuations in advanced Parkinson's disease. The exclusivity period began on February 3, 2025, the date of FDA approval, providing market protection through early 2032 against competing apomorphine products.
Key figures
- Drug Name
- ONAPGO (apomorphine HCl)
- Exclusivity start
- February 3, 2025
- Exclusivity years
- 7
- Second supplier snda decision
- expected mid-year 2027
AI analysis
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