On 5 June 2013, US generics maker Actavis (formerly Watson) announced that it had filed an Abbreviated New Drug Application (ANDA) with FDA for approval of a generic version of Bayer’s Safyral (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets), which prevents pregnancy, as well as providing a daily folate supplement. The filing prompted a patent-infringement suit by two subsidiaries of Bayer (Bayer Pharma AG and Bayer Healthcare Pharmaceuticals) and a subsidiary of Germany-based Merck KGaA (Merck & CIE), claiming infringement of their US patent no. 6441168 (the ‘168 patent’).

On 7 June 2013, Actavis announced that it had also filed an ANDA with FDA for approval of a generic version of Fresenius Kabi’s Diprivan (propofol) injection in the 10 mg/mL strength, an intravenous sedative and anaesthetic. The filing also prompted a patent-infringement suit from Fresenius Kabi,

Both lawsuits prevent final FDA approval of Actavis’ ANDA for up to 30 months, or until the companies settle the case.

Safyral had sales of approximately US$19 million during the 12-month period ending 30 April 2013, while Diprivan had sales of about US$212 million for the same period, according to IMS Health data. Actavis believes it may be the first applicant to file an ANDA for the generic version of Safyral, giving the company 180-days generics market exclusivity should its ANDA be approved.

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