FDA recognizes seven-year orphan-drug exclusivity for Supernus' ONAPGO

Bitget2026/10/21 23:45

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FDA recognizes seven-year orphan-drug exclusivity for Supernus Pharmaceuticals' ONAPGO for motor fluctuations in adults with advanced Parkinson's disease.
The market exclusivity period began February 3, 2025, when ONAPGO received FDA approval.
A submitted supplemental new drug application seeks clearance for a second ONAPGO supplier, with potential FDA approval by mid-year 2027.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Supernus Pharmaceuticals Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202610211945PRIMZONEFULLFEED9850927) on October 21, 2026, and is solely responsible for the information contained therein.

Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.

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FDA recognizes seven-year orphan-drug exclusivity for Supernus' ONAPGO

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