Protein Sciences Corporation announced this week that in a rare move, the FDA is granting exclusivity to its influenza vaccine Flublok, for a period of 12 years.
Flublok is the world’s first recombinant protein-based vaccine for the prevention of seasonal influenza, and 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.
The vaccine is highly purified and does not contain any preservatives (e.g., thimerosal, a mercury derivative), egg proteins, gelatin or latex.
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.”
Source: Protein Sciences Corporation press release, adapted.
