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A pharmaceutical company has launched legal action against a rival firm alleging it has infringed a patent for an oral contraceptive tablet.
Warner Chilcott has filed a lawsuit against Watson Laboratories in the New Jersey District Court over the chewable birth control pill Femcon Fe® (norethindrone).
The action is in response to Watson’s submission of an abbreviated new drug application (ANDA) to the FDA.
That document requests approval for the firm to be allowed to manufacture and sell a generic version of Femcon Fe before the patent expires in 2019.
But the move by Warner Chilcott means the FDA cannot approve Watson’s ANDA for 30 months, unless the matter is settled out of court in that time.
Warner specialises in developing, manufacturing, marketing and selling branded prescription products in women’s healthcare and dermatology in the USA.
Femcon Fe has been on the market in the USA for almost a year, and is 99% effective in preventing pregnancy.
Warner Chilcott http://www.warnerchilcott.com