According to Orexo, the United States Patent and Trademark Office (USPTO) has granted US Patent No. 11,957,647 (“Pharmaceutical composition comprising adrenaline”), which covers Orexo’s OX640 epinephrine nasal powder product. The USPTO previously issued US patent No. 11,737,980, which also provides protection for OX640, in August 2023.
The FDA is currently reviewing Orexo’s NDA for the nasal powder and is expected to complete that review by July 15, 2024. Orexo resubmitted the NDA in September 2023 after the FDA rejected the company’s initial application.
Orexo President and CEO Nikolaj Sørensen commented, “Once again, I am pleased with the USPTO recognizing the inventiveness of our OX640 product and the AmorphOX technology. This is the eighth patent based on the technology, underscoring its uniqueness and value. In parallel, we continue to broaden the applications of AmorphOX by testing the technology with new substances, which is expected to lead to more patents. The extended exclusivity for OX640 build additional long-term value and improves the attractiveness for potential partners for commercialization in the US market.”
Read the Orexo press release.
