Glenmark and Mylan plan to sell generic versions of the drug Malarone, the most successful anti-malarial medication in the UK. With a UK court revoking Glaxo’s patent on the drug, Glenmark Generics was able to launch the first generic version of the drug, Atovaquone proguanil, in the UK in early February.
Glenmark Generics (Europe) and Mylan had filed a suit against The Wellcome Foundation and Glaxo Group, calling for the revocation of Glaxo’s patent for its anti-malarial product, Malarone.
The drug is indicated for the treatment of acute, uncomplicated falciparum malaria. Based on IMS Health sales data for the 12-month period ending September 2012, the drug had garnered sales of €20.69 million in the UK.
Glenmark Generics is a subsidiary of Glenmark Pharmaceuticals. The company has more than 300 marketing authorisations approved in Europe.
A company spokesperson said though the anti-malarial drug is taken by Europeans and Americans when they visit emerging markets including India, the drug is not available in India. In 2009, GlaxoSmithKline had filed a patent infringement lawsuit against Glenmark in the US after the FDA accepted its request to market a generic version of the malaria drug.
In April 2010, Glenmark settled the patent litigation with GlaxoSmithKline. The former was allowed to sell the generic tablets under a royalty bearing licence from GlaxoSmithKline in the third quarter of 2011, or earlier under certain circumstances.
Glenmark was the first to seek approval of a generic version of the product and was granted 180 days of exclusivity on it.