Supernus Announces Orphan Drug Exclusivity for ONAPGO™ (apomorphine HCl)
Globe Newswire•21/10/2026•19:45 ET
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Key Highlights
- ➤ONAPGO receives seven years of FDA orphan-drug market exclusivity
- ➤Seven-year exclusivity began February 3, 2025, ONAPGO’s FDA approval date
- ➤Supernus submits sNDA for a second ONAPGO supplier
- ➤Second ONAPGO supplier could receive FDA approval by mid-year 2027
Expert Statements
Jack Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals
“Securing orphan-drug exclusivity marks an important milestone for individuals and families navigating Parkinson's disease. This designation validates the urgent need for targeted therapies and helps safeguard continued innovation in a long-underserved community.”
Jack Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals
“In addition to resolving the supply issue from earlier this year, submitting our sNDA further reinforces our ongoing commitment to providing novel treatments for patients with Parkinson's disease, backed by our unwavering focus on ensuring an uninterrupted drug supply for every patient in need.”
Orphan-drug exclusivity provides seven years of market exclusivity for ONAPGO
Additionally, the Company submitted an sNDA to the FDA for a second supplier for ONAPGO, with potential approval by mid-year 2027
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