Supernus announces 7 years of Onapgo exclusivity starting in February 2025
Key Facts
Supernus announced that the U.S. Food and Drug Administration had recognized 7 years of orphan drug exclusivity for Onapgo, effective from its approval date of February 3, 2025. The company said in its statement that the recognition concerns the drug approved to treat motor fluctuations in adults with advanced Parkinson's disease. The regulatory protection covers approval of the same drug for the same approved use or indication, under U.S. law governing orphan drug exclusivity. The law allows an exception to this exclusivity when its holder cannot ensure sufficient quantities of the drug to meet patients' needs. It specifies the inability to "assure the availability of sufficient quantities of the drug."
On supply, Supernus Chief Executive Jack Khattar said the company had resolved the earlier Onapgo supply problem, citing the "resolution of the supply issue that occurred earlier this year." The company had temporarily halted shipments of the drug to patients who had not started treatment, according to a filing with the U.S. Securities and Exchange Commission. The shipment halt followed a supply disruption, with priority given to patients already receiving treatment. The company said at the time that this required "pausing shipments to patients who have not yet started Onapgo." New patients resumed starting treatment during the first quarter of 2026, according to the company's current report and earnings release.
On the commercial front, Onapgo net sales reached $13.5 million in the second quarter of 2026, according to Supernus' earnings release filed with the U.S. Securities and Exchange Commission. The company reported total revenue of $219.1 million for the same period, up 32% year on year. By the end of July 2026, treatment enrollment forms totaled about 2,600, according to the earnings release. About 720 prescribers submitted those forms between the drug's launch and the end of that month. By comparison, enrollment forms had exceeded 750 by the end of the second quarter of 2025. More than 300 prescribers had submitted those forms, according to the company's earnings release for that quarter.
Onapgo is administered only by subcutaneous infusion, according to its FDA-approved prescribing information. Approval of the treatment was based on results from a 12-week phase 3 study involving 107 participants, according to the approval announcement Supernus filed with the U.S. Securities and Exchange Commission. The study was conducted at multiple centers with parallel groups and randomized assignment of participants. It was double-blind and placebo-controlled, with the placebo used for comparison with the treatment. The results showed a reduction in daily motor "off" time of 2.6 hours among Onapgo recipients, compared with a reduction of 0.9 hours in the placebo group.
On next steps, Supernus submitted a supplemental application to regulators to approve a second supplier for Onapgo, according to its statement on exclusivity. Khattar said the application supports the company's commitment to maintaining treatment availability for patients. The company continues to expect potential approval of the additional supplier by mid-2027, according to its announced timeline. Before then, Supernus will announce its financial and commercial results for the third quarter of 2026. The company scheduled the release for Thursday, October 29, 2026, after the market closes.