Klaria Pharma announces approval by the United Stated Patent and Trademark Office of a new patent application covering Naloxone Alginate Film.
With this approval of a new patent, Naloxone Alginate Film will enjoy patent-protected market exclusivity in the United States until 2038. The approval marks the second time the United States Patent Office (USPTO) has approved a compound/Alginate Film combination patent that protects an individual compound formulated in Klaria’s proprietary Alginate Film. Thus, the approval of the Naloxone Alginate Film combination patent validates Klaria’s patent strategy in the United States, the world’s most valuable market for pharmaceuticals.
Jesper Wiklund, CEO of Klaria said “This approval gives us market exclusivity until 2038 in the US for Naloxone Alginate Film. There is a high need in the United States for treatment of opioid overdoses and also for the co-prescription of Naloxone Alginate Film with Opioids. Securing such a long period of market exclusivity for Naloxone Alginate Film represents a meaningful increase in the value of this exciting program.”
The approval is further confirmation of Klaria’s ability to successfully develop unique, patent-protected products in the United States. The filing and approval of combination patents is key to Klaria’s intellectual property strategy and extends the patent life of the individual products through compound/Alginate Film combination patents.
Dr. Scott Boyer, CSO of Klaria added “Today’s news is a confirmation of Klaria’s technical and intellectual property strategy. Moreover, the granting of the patent is a demonstration of the truly unique performance of the alginate film technology for drug delivery. This ensures that Naloxone Alginate Film will remain a unique product in acute opioid overdose treatment well beyond 2038. It is a testament to the diligent, creative and innovative work within our laboratories and the wealth of data on this product that has formed the basis for this patent.”
About Naloxone Alginate Film (KL-00514)
KL-00514 is an alginate-based oral trans-mucosal film. KL-00514 is the first oral trans-mucosal opiate overdose product and is designed to be a significant improvement to all available acute nasal spray treatments available to patients today, particularly in the co-prescription market. KL-00514 is a unique molecular dispersion of naloxone. The KL-00514 film presents naloxone to the oral mucosal surface in a unique way to allow rapid, consistent absorption superior to that of present nasal spray-based products. The base film-forming alginate and the naloxone-containing films have been the subject of comprehensive intellectual property protection, thus ensuring prolonged market exclusivity.