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Bayer sues Watson to block generic Beyaz

Lawsuit comes as Watson files generic oral contraceptive for approval in US

Watson Pharmaceuticals has filed for approval in the US to market a generic version of Bayer's oral contraceptive product Beyaz, prompting an immediate lawsuit from Bayer and partner Merck & Cie.

Watson believes it is the first generic drugmaker to file for approval of a generic Beyaz product, so would be entitled to six months' exclusivity on approval.

Beyaz was approved in the US in September 2010, and comprises the hormonal ingredients of Bayer's long-established Yaz oral contraceptive - drospirenone and ethinyl estradiol - with a folate ingredient provided by Merck & Cie, a Swiss subsidiary of Germany's Merck KGaA.

Merck granted Bayer a worldwide licence to use its Metafolin (levomefolate calcium) ingredient in oral contraceptives in 2010.

The premise behind the collaboration was to develop contraceptives that supplement folate ahead of a planned or unplanned pregnancy and so reduce the risk of neural tube defects.

In addition to providing contraception, Beyaz is also indicated in the US for treating moderate acne in women at least 14 years old, and to raise folate levels in women who choose to use an oral contraceptive for contraception.

Beyaz had sales of around $97m in 2011, according to IMS Health data.

The new product has been growing quickly just as Bayer's broader Yaz franchise (which includes other brands such as Yasmin and Yasminelle) has come under pressure from generic competition outside the US and debate about the contraceptives' potential to cause venous thromboembolism.

Bayer reported Yaz franchise sales of €780m ($1.03bn) in the first nine months of 2011, a decline of 4 per cent year on year.

Watson filed for approval of its generic version of Beyaz last week, and Bayer and Merck filed a lawsuit in the US District Court of Delaware on February 10 seeking an injunction on commercialisation ahead of the expiry of US Patent No. 6,441,168.

The lawsuit provides an immediate block on commercialisation for up to 30 months in accordance with US legislation.

14th February 2012

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