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Yasmin generic launched in US Posted 11/09/2015

US generics giant Mylan Pharmaceuticals (Mylan) announced on 8 September 2015 the US launch of its generic version of Bayer’s oral contraceptive pill Yasmin (drospirenone/ethinyl estradiol), following approval by the US Food and Drug Administration (FDA) of its abbreviated new drug applications (ANDA). This marks Mylan’s thirteenth oral contraceptive launch in the US.

Drospirenone/ethinyl estradiol tablets in a dose of 3 mg/0.03 mg, had US sales of approximately US$137.6 million for the 12 months ending 30 June 2015, according to IMS Health.

There has been some controversy over Bayer’s Yaz and Yasmin range in the past with the German pharma giant suing Teva Pharmaceutical Industries for claiming that its generic oral contraceptive, Gianvi, was the same as Yaz [1, 2].

Currently, Mylan has 266 ANDAs pending FDA approval representing US$99.5 billion in annual brand-name drug sales.  Fifty of these pending ANDAs are potential first-to-file opportunities, representing US$33.4 billion in annual brand-name drug sales for 2014, according to IMS Health.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Bayer sues Teva over generic Yaz contraceptive [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 11]. Available from: www.gabionline.net/Generics/News/Bayer-sues-Teva-over-generic-Yaz-contraceptive
2. GaBI Online - Generics and Biosimilars Initiative. Teva changes generic Yaz contraceptive label [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 11]. Available from: www.gabionline.net/Generics/News/Teva-changes-generic-Yaz-contraceptive-label

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Source: Mylan

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