Protein Sciences gains extensive patent protection for Flublok vaccine

MERIDEN, Conn. — Protein Sciences announced Wednesday that in a rare move, the Food and Drug Administration is granting exclusivity to Flublok for a period of 12 years. The U.S. FDA determination of regulatory exclusivity means that no product similar to Flublok can be approved by FDA before Jan. 16, 2025.

 

"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," said Manon Cox, president and CEO of Protein Sciences Corporation. 

 

Flublok, the world's first recombinant protein-based vaccine for the prevention of seasonal influenza disease, was approved by FDA in January 2013.  Flublok is the only flu vaccine made in a 100% egg-free system using modern cell culture technology, making it unnecessary to use an infectious influenza virus or antibiotics in manufacturing.

 

According to the company, Flublok contains three times more antigen than traditional flu vaccines.