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Generic challenge over chewable Pill


A drug company is facing a challenge over its chewable contraceptive pill.

US firm Warner Chilcott has received a paragraph IV certification notice from another US company, Barr Laboratories.

Barr filed an abbreviated new drug application (ANDA) for a generic version of Femcon Fe® (norethindrone), the patent for which expires in 2019.

Warner Chilcott, based in New Jersey, is a speciality company focused on manufacturing, marketing and selling branded prescription products in women’s healthcare and dermatology in the US.

Barr, based in New York, is a global firm engaged in developing both generic and proprietary pharmaceuticals.

Paragraph IV certification begins a process in which the question of whether a patent is valid or will be infringed by the proposed generic product may be studied by the courts prior to the patent’s expiry.

When an ANDA applicant files a paragraph IV for a listed patent, the applicant must also notify the patent owner.

The notice must include a statement of the factual and legal basis for the ANDA applicant’s opinion that the patent is not valid, or will not be infringed by the generic.

A statement from Warner Chilcott said: “The company is reviewing the detail of the paragraph IV notice from Barr, and continues to have full confidence in its intellectual property protecting Femcon Fe.”

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