Watson files ANDA for generic Beyaz

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Watson files ANDA for generic Beyaz

Genéricos/Novedades | Posted 17/02/2012 0 Post your comment

Watson Pharmaceuticals (Watson) announced on 10 February 2012 that it had filed an Abbreviated New Drug Application (ANDA) with FDA for a generic version of Bayer HealthCare’s (Bayer) leading oral contraceptive Beyaz (drospirenone/ethinyl estradiol/levomefolate).

Beyaz is indicated for use by women to prevent pregnancy, as well as to treat symptoms of premenstrual dysphoric disorder, to treat moderate acne in women at least 14 years old and to raise folate (vitamin B) levels in women who choose to use an oral contraceptive for contraception.

Bayer responded to Watson’s ANDA by filing a lawsuit against Watson in the United States District Court for the District of Delaware, seeking to prevent Watson from commercialising the product prior to the expiration in April 2020 of US patent no. 6,441,168 on Beyaz, which covers stable crystalline salts of 5-methyltetrahydrofolic acid. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval for Watson’s ANDA of up to 30 months from the date the plaintiffs received notice of Watson’s ANDA filing, or until final resolution of the matter before the court, whichever occurs sooner.

Watson believes it may be a first applicant to file an ANDA for the generic version of Beyaz and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.

Bayer’s Beyaz is a second generation version of the company’s best-selling Yaz (drospirenone/ethinyl estradiol) oral contraceptive. The only difference is that Yaz does not contain the folate supplement.

For the twelve months ending 31 December 2011, Beyaz had total US sales of approximately US$97 million, according to IMS Health data.

Barr Pharmaceuticals, Bayer’s authorised generics dealer and Sandoz also market generic Yaz. Mylan has also sought approval for its generic version. Teva also sells a generic version of Yaz, called Gianvi, although this does not contain Bayer’s patented ‘betadex as a clathrate’ stabilisation formulation [1].

Reference

1. GaBI Online - Generics and Biosimilars Initiative. Teva changes generic Yaz contraceptive label [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 17]. Available from: www.gabionline.net/Generics/News/Teva-changes-generic-Yaz-contraceptive-label

Source: Watson