Protein Sciences gets 12-year FDA exclusivity on Flublok flu vaccine

The FDA has granted the Flublok flu vaccine 12 years of exclusivity.
The FDA has granted the Flublok flu vaccine 12 years of exclusivity. | Courtesy of

Protein Sciences Corp. said on Wednesday that the Food and Drug Administration (FDA) has granted exclusivity to Protein Sciences' Flublok influenza vaccine for 12 years.

This exclusivity status means the FDA won't approve any similar product before Jan. 16, 2025.

This is a rare move for the FDA, as Flublok is the first vaccine ever to be awarded this exclusivity status, suggesting that the new influenza vaccine may be the most unique and innovative to date.

"The FDA's designation prevents a generic product maker from capitalizing on the hard work of our team," Manon Cox, president and CEO of Protein Sciences Corp., said. "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 20 years on matters of legal exclusivity," Tom Kowalski, an attorney and partner at Vedder Price, P.C., said. "This biologics regulatory exclusivity is only the third of such exclusivities granted by the U.S. FDA under the Affordable Care Act, and the only one for an influenza vaccine."

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