Zevra Therapeutics (NASDAQ:ZVRA) said it has submitted a patent covering its product MIPLYFFA for listing in the US Food and Drug Administration's Orange Book, with patent protection extending to 2041.
The submission seeks to list the patent in the Orange Book, the FDA's register of approved drug products and the patents associated with them, the company said.
An Orange Book listing tied to a patent running to 2041 strengthens the exclusivity around MIPLYFFA, the brand name for arimoclomol. Patents listed in the Orange Book can trigger an automatic stay on generic approvals when a generic filer challenges them, giving branded drugmakers a procedural tool to defend market exclusivity.
Extending protection to 2041 lengthens the period over which Zevra can market the product without direct generic competition tied to that patent, supporting the long-term revenue outlook for the asset.
Zevra Therapeutics is a commercial-stage company focused on developing and commercializing therapies for rare diseases, with a portfolio that includes MIPLYFFA (arimoclomol).
Shares of Zevra gained over 9.5% on Monday.