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.

Related articles
Roche abandons Herceptin patent in India

India may move away from compulsory licensing

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 

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2015 Pro Pharma Communications International. All Rights Reserved.