Supernus gets orphan exclusivity for ONAPGO, files sNDA for second supplier
FDA recognized seven years of orphan-drug exclusivity for ONAPGO starting February 3, 2025, as Supernus seeks a second manufacturing supplier with potential approval by mid-2027.
Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN) announced on October 21, 2026 that the U.S. Food and Drug Administration has recognized seven years of orphan-drug exclusive approval for ONAPGO (apomorphine HCl) for the treatment of motor fluctuations in adults with advanced Parkinson's disease.1 The seven-year market exclusivity for ONAPGO began on February 3, 2025, the date of FDA approval.1 The FDA's Orphan Drug Designation program is designed to advance the development of drugs that treat a condition affecting 200,000 or fewer U.S. patients annually.1
ONAPGO is described by the company as the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson's disease.1
On the manufacturing side, the company submitted a supplemental New Drug Application (sNDA) to the FDA for a second supplier for ONAPGO and continues to expect potential FDA approval of the second supplier by mid-year 2027.1 CEO Jack Khattar said in addition to resolving the supply issue from earlier this year, submitting the sNDA reinforces the company's ongoing commitment to providing treatments for Parkinson's disease patients, backed by its focus on ensuring an uninterrupted drug supply.1
Separately, in an October 19, 2026 release, Supernus said it will report third quarter 2026 financial and business results after the market closes on Thursday, October 29, 2026.2 Jack Khattar and CFO Tim Dec will host a conference call and webcast that day at 4:30 p.m. ET to discuss the results.2 A replay will be available on the company's investor relations website following the live call and will remain available for 60 days.2
The company's broader portfolio, as described in its filings, includes approved treatments for attention-deficit hyperactivity disorder (ADHD), dyskinesia in Parkinson's disease (PD) patients receiving levodopa-based therapy, hypomobility in PD, postpartum depression (PPD), epilepsy, migraine, cervical dystonia, and chronic sialorrhea.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.