Actavis, Inc. (ACT) recently re-launched Vestura (3 mg drospirenone and 0.02 mg ethinyl estradiol), the company’s generic version of Bayer’s (BAYRY) oral contraceptive, Yaz. Actavis decided to re-launch Vestura following a favorable ruling by the US Court of Appeals for the Federal Circuit regarding the RE '564 patent.
Vestura was initially launched in Jan 2012. However, Actavis had to withdraw the product from the market when the US District Court for the District of Nevada found the RE '564 patent to be valid. Actavis had appealed the ruling in the Federal Circuit which found the patent to be invalid.
Vestura is approved for the prevention of pregnancy and the treatment of moderate acne in women at least 14 years old only if the patient is willing to use an oral contraceptive for birth control.
Bayer recorded Yaz/Yasmin/Yasminelle sales of €1,045 million in 2012. Actavis estimates that Yaz sales, branded and generic, for the 12 months ended Feb 28, 2013 were about $347 million in the US.
Indian company Lupin is also looking to launch its generic version of Yaz – the company’s generic version has yet to gain approval from the US Food and Drug Administration (:FDA). Lupin is currently working on its commercialization plan for generic Yaz while awaiting FDA approval.
Actavis currently carries a Zacks Rank #3 (Hold). The favorable court ruling is a positive for the company.
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