Scienture Holdings, which acquired US rights to Summit Biosciences’s Rezenopy naloxone nasal spray in March 2025, announced that the United States Patent and Trademark Office has granted Summit US Patent No. 12,622,903 B2 covering Rezenopy until February 5, 2041. Summit, which was acquired by Kindeva Drug Delivery in 2024, submitted the NDA for the 10 mg naloxone nasal spray in March 2023, and the FDA approved Rezenopy for the reversal of opiate overdose in April 2024.
Scienture President and co-CEO Narasimhan Mani commented, “The issuance of this patent is a substantial milestone for Scienture and a significant validation of our intellectual patent strategy. With intellectual property protection extending through 2041 and our planned commercial launch of Rezenopy in mid-July, we are entering an exciting new phase for the product. As the highest-dosage naloxone nasal spray approved by the FDA, Rezenopy has the potential to address a critical public health need while creating long-term value for patients, healthcare providers, and our shareholders.”
Executive Chairman and co-CEO Shankar Hariharan said, “This patent enhances the value of Rezenopy as we advance toward commercialization and supports our strategy to establish a meaningful presence in the naloxone market. The opioid epidemic continues to evolve with the widespread presence of highly potent synthetic opioids, underscoring the need for effective overdose reversal tools. We believe Rezenopy offers a differentiated solution, and we look forward to making it available through our commercial and distribution partners in the coming weeks.”
Read the Scienture press release
