Mylan Inc. (MYL) announced that it is looking to bring its generic version of Bayer’s (BAYRY) cancer drug, Nexavar (sorafenib) to market. Mylan confirmed that Bayer Healthcare, Bayer Healthcare Pharmaceuticals Inc., and Onyx Pharmaceuticals Inc. have filed a patent infringement lawsuit against Mylan in the United States District Court in the District of Delaware.
Nexavar is approved for the treatment of certain types of cancers including unresectable hepatocellular carcinoma and advanced renal cell carcinoma.
Mylan believes it was first to file, which means it would be entitled to 180 days of marketing exclusivity, once it gains final approval.
According to IMS Health, annual U.S. sales of Nexavar were about $48 million in 2014.
Currently, Mylan has 283 abbreviated new drug applications (ANDAs) pending with the FDA representing branded annual sales of $107.1 billion, according to IMS Health. Mylan believes that 43 of these pending ANDAs are potential first-to-file opportunities representing annual branded sales of $27.2 billion (according to IMS Health) for the 12 months ending Jun 30, 2014.
Mylan is one of the leading players in the global generics market and boasts of a deep generic pipeline. The company was among the first to launch a generic version of Celebrex in Dec 2014.
Earlier this year, Mylan launched its generic versions of Epivir-HBV and Diovan. Meanwhile, we remain positive on Mylan’s deal with Abbott Laboratories (ABT) to buy the latter’s branded specialty and generics business in the developed ex-U.S. markets.
Mylan currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Impax Laboratories (IPXL), sporting a Zacks Rank #1 (Strong Buy).
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