PatentJun 2, 2026, 08:06 AM
Scienture Holdings Secures Patent for REZENOPY Nasal Spray 10 mg
AI Summary
Scienture Holdings announced the U.S. Patent and Trademark Office granted U.S. Patent No. 12,622,903 B2 for REZENOPY (naloxone HCl) Nasal Spray 10 mg, effective May 12, 2026, and expiring February 5, 2041. Scienture, through its subsidiary, holds exclusive U.S. commercialization rights for REZENOPY , which received FDA approval on April 19, 2024. The product is the highest FDA-approved dose per nasal spray for naloxone in the U.S. market, addressing a critical public health need in the approximately $141 million annual U.S. naloxone market. The company plans a commercial launch in mid-July.
Key Highlights
- U.S. Patent No. 12,622,903 B2 granted for REZENOPY (naloxone HCl) Nasal Spray 10 mg.
- Patent is effective May 12, 2026, with an expiry date of February 5, 2041.
- REZENOPY received FDA approval on April 19, 2024, as the highest FDA-approved dose (10 mg) for naloxone nasal spray.
- Scienture has exclusive U.S. commercialization rights for REZENOPY through an agreement with Summit Biosciences Inc.
- U.S. naloxone market reached approximately $141 million in annual sales and 9.4 million units annually (IQVIA, Jan 2026).
- Commercial launch of REZENOPY is planned for mid-July.
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