Mylan being sued over sorafenib generic

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Mylan being sued over sorafenib generic

Genéricos/Novedades | Posted 20/02/2015 0 Post your comment

US-based Mylan is coming under fire from German pharma giant Bayer, as the generics maker is sued for violating patents on Bayer’s liver and kidney cancer drug Nexavar (sorafenib).

Mylan announced on 9 February 2015 that Bayer had filed a lawsuit against the company in the United States District Court of Delaware. The lawsuit comes as a result of Mylan’s filing of an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) for generic sorafenib tablets, 200 mg.

Nexavar is an anticancer medicine for the treatment of primary kidney and advanced primary liver cancer known as hepatocellular carcinoma that cannot be removed by surgery. The drug can extend the life of kidney cancer patients by 4−5 years and in liver cancer patients by 6−8 months.

Nexavar has already caused controversy, being rejected in the UK on the grounds that the cost of the medicine does not justify the benefit [1]. The drug is also the subject of a compulsory licence in India, allowing Natco to sell a generic version at a significantly lower cost than the brand-name version, despite any existing patents on the drug [2].

Mylan believes that it is the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity upon receiving final FDA approval.

Nexavar had US sales for 2014 of approximately US$48 million, according to IMS Health. The US patents on Nexavar expire in January 2020.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Bayer opposes sorafenib compulsory licence in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 20]. Available from: www.gabionline.net/Biosimilars/News/Bayer-opposes-sorafenib-compulsory-licence-in-India
2. GaBI Online - Generics and Biosimilars Initiative. India issues more compulsory licences [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 20]. Available from: www.gabionline.net/Policies-Legislation/India-issues-more-compulsory-licences

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Source: Mylan