Belgian healthcare group UCB S.A. has filed a legal action against Dutch group Synthon for allegedly infringing the patent on its antihistamine drug Xyzal in the federal court of Delaware.
UCB said the company has filed a lawsuit in the U.S., together with American partner Sepracor, claiming Synthon used the active Xyzal ingredient levocetirizine in the treatment of allergic rhinitis.
UCB said the move is a response to Synthon's statement at the end of March that it believes itself to be the 'single first filer' of an Abbreviated New Drug Application for the Xyzal drug product.
As a result (of the filing) Synthon expects to be eligible for 180 days exclusivity upon the first commercial marketing of the generic drug product.
The Hatch-Waxman Act allows generics to win USFDA approval on the submission of bioequivalence studies and grants a period of additional marketing exclusivity to make up for the time a patented pipeline drug remains in development.
Synthon declined to comment on the action by UCB.
Xyzal is the successor to blockbuster drug Zyrtec, whose patent has expired.
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