Supernus secures seven years of ONAPGO exclusivity
- Supernus announced FDA recognition of seven years of orphan-drug exclusivity for ONAPGO, approved to treat motor fluctuations in adults with advanced Parkinson's disease.
- The exclusivity period began February 3, 2025, while Supernus confirmed that an earlier ONAPGO supply issue has been resolved.
- Supernus submitted an application for a second ONAPGO supplier and expects potential FDA approval by mid-year 2027.
Supernus (NASDAQ:SUPN) announced FDA recognition of seven years of orphan-drug exclusivity for ONAPGO, its treatment for motor fluctuations in advanced Parkinson's disease.
The exclusivity period began February 3, 2025, when the FDA approved ONAPGO for adults, providing regulatory protection through February 2032.
“Securing orphan-drug exclusivity marks an important milestone for individuals and families navigating Parkinson's disease,” said Supernus Chief Executive Officer Jack Khattar.
Supernus also submitted a supplemental New Drug Application for a second ONAPGO supplier after resolving a supply disruption experienced earlier in 2026.
The company expects potential FDA approval of the additional supplier by mid-year 2027, although regulatory clearance remains pending.
ONAPGO launched in April 2025 and generated $13.5 million in second-quarter 2026 sales, with approximately 2,600 enrollment forms submitted through July.
Supernus also agreed to merge with Indivior in August 2026, with shareholders approving the proposed transaction on October 15.
