The United States Patent and Trademark Office (USPTO) has issued a notice of allowance for patent application 16/671,649. The resulting U.S. patent, once issued, will extend the patent protection for BioCryst Pharmaceuticals, Inc.‘s berotralstat (BCX7353) in the United States by four years through October 2039.
The allowed patent application covers crystalline salt forms of berotralstat active pharmaceutical ingredient (API).
“The extension of U.S. patent protection for berotralstat, through 2039, adds significant value to BioCryst. We look forward to the U.S. approval and launch of oral, once-daily berotralstat later this year,” said Jon Stonehouse, CEO of BioCryst.
The U.S. Food and Drug Administration is reviewing a new drug application (NDA) for approval of oral, once-daily berotralstat for the prevention of HAE attacks. The Prescription Drug User Fee Act (PDUFA) date for the NDA is December 3, 2020.