ONAPGO exclusivity has been recognized by the U.S. Food and Drug Administration for treating motor fluctuations in adults with advanced Parkinson’s disease, Supernus announced on October 21, 2026. The company also said it has submitted an application seeking approval for a second supplier of the treatment.
Key Takeaways
- The seven-year orphan-drug exclusivity period began with ONAPGO’s FDA approval on February 3, 2025.
- Supernus has submitted a supplemental New Drug Application for a second ONAPGO supplier.
- The company continues to expect potential approval of that supplier by mid-year 2027.
Table of Contents
- ONAPGO exclusivity runs from its original approval
- Second-supplier application awaits FDA action
- Conclusion
ONAPGO exclusivity runs from its original approval
The FDA’s recognition covers ONAPGO, or apomorphine HCl, for motor fluctuations in adults with advanced Parkinson’s disease. The seven-year period dates from the treatment’s February 3, 2025 approval, rather than from the latest announcement.
According to Supernus, ONAPGO is the first and only subcutaneous apomorphine infusion device for that indication. The company described the FDA’s Orphan Drug Designation program as supporting development of treatments for conditions affecting 200,000 or fewer U.S. patients annually.
Second-supplier application awaits FDA action
Supernus said its supplemental New Drug Application seeks FDA approval for a second supplier of ONAPGO. The company maintained its expectation of potential approval by mid-year 2027; that regulatory step has not yet been completed.
President and Chief Executive Officer Jack Khattar said the company had resolved a supply issue from earlier in the year. He presented the second-supplier filing as another step in its effort to maintain uninterrupted patient access.
The release identified the timing and receipt of regulatory approval to manufacture ONAPGO at the second supplier among the uncertainties affecting its forward-looking statements.
Conclusion
The announcement confirms exclusivity dating from ONAPGO’s original approval, while FDA approval of the proposed second supplier remains pending.
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