Supernus Pharmaceuticals (Nasdaq: SUPN) announced that the U.S. Food and Drug Administration has recognized seven years of orphan-drug market exclusivity for ONAPGO (apomorphine HCl), a subcutaneous apomorphine infusion device approved for treating motor fluctuations in adults with advanced Parkinson's disease.

The exclusivity period began Feb. 3, 2025, the date of the drug's FDA approval, and runs through 2032. The FDA's Orphan Drug Designation program applies to treatments for conditions affecting 200,000 or fewer U.S. patients annually.

Supernus also disclosed that it has submitted a supplemental New Drug Application (sNDA) to the FDA for a second manufacturing supplier for ONAPGO. The company said it expects potential FDA approval of the second supplier by mid-year 2027.

"Securing orphan-drug exclusivity marks an important milestone for individuals and families navigating Parkinson's disease," said Jack Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals. "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."

The information is based on a press release issued by Supernus Pharmaceuticals.