PatentJun 8, 2026, 07:31 AM
Zevra submits MIPLYFFA patent for Orange Book, protection to 2041
AI Summary
Zevra Therapeutics announced the submission of U.S. Patent No. 11,707,456 for MIPLYFFA® (arimoclomol) to the FDA for Orange Book listing. This patent provides intellectual property protection until November 19, 2041, strengthening the long-term value of MIPLYFFA for Niemann-Pick disease type C. The company also has a pending patent term extension for another patent expiring in 2029.
Key Highlights
- Zevra submitted U.S. Patent No. 11,707,456 for MIPLYFFA to the FDA for Orange Book listing.
- The patent extends intellectual property protection for MIPLYFFA until November 19, 2041.
- MIPLYFFA treats Niemann-Pick disease type C (NPC), an ultra-rare neurodegenerative disease.
- A separate patent term extension for U.S. Patent No. 11,045,460, expiring in 2029, is pending.
- Orange Book listing dictates when generic competitors can enter the market.
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