Protein Sciences Corporation announced that in a rare move, the FDA is granting exclusivity to Flublok for a period of 12 years. Flublok is the first vaccine awarded this very important status, demonstrating Flublok as a unique and game changing influenza vaccine.
The US FDA determination of regulatory exclusivity means that no product similar to Flublok can be approved by US FDA before January 16, 2025.
"The FDA's designation prevents a generic product maker from capitalizing on the hard work of our team," said Manon Cox, President and CEO of Protein Sciences Corporation. "We are delighted that the FDA recognizes Flublok as a singular innovation in the prevention of an important and often deadly disease caused by the influenza virus."
"I am honored to be representing Protein Sciences Corporation for nearly twenty years on matters of legal exclusivity," said Tom Kowalski, Esq., Shareholder with Vedder Price, P.C. "This biologics regulatory exclusivity is only the third of such exclusivities granted by the US FDA under the Affordable Care Act, and the only one for an influenza vaccine."