Dr Reddy's may launch low-cost copy of Plavix in US

Dr Reddy’s Laboratories may soon launch a low-cost version of blood thinning drug Plavix in the US, the world’s largest drug market.

An antiplatelet agent used to reduce the risk of stroke or heart attack in patients with atherosclerosis, Plavix has a $6-billion market in the US. It is sold by Bristol-Myers Squibb and Sanofi-Aventis.

“It should give a major boost to the company’s revenue, as the drug commands a huge market in the US and Dr Reddy’s is likely to be the only player launching the generic version,” an analyst said.

An e-mail query sent to Dr Reddy’s did not elicit any response. Shares in Dr Reddy’s on Wednesday closed 0.7 per cent higher at Rs 1,666.95 on the Bombay Stock Exchange.

In 2006, Canada’s Apotex launched a generic version of Plavix in the US at a risk being the first to file for a copy and had also earned a right to exclusively market it for 180 days. But Bristol-Myers Squibb and Sanofi-Aventis were successful in blocking the marketing of the generic drug by Apotex. In June 2007, a US district court upheld the validity and enforceability of the Plavix patent till 2011 and prevented Apotex from marketing the generic version till the patent expired. But analysts say Apotex made a killing on the drug in the 10 months it was in the market.

Dr Reddy’s received tentative approval from the US Food and Drug Administration (FDA) for its generic Plavix in February 2011. But it would have to get the drug regulator’s final nod before launching the drug.

The launch of generic Plavix could mark the beginning of the Hyderabad-based drug maker’s big plans for the US market, said a source.

This financial year, Dr Reddy’s plans to launch 15 to 16 products in the US, likely to contribute a third to its revenue. In 2011-12, it sought the USFDA’s approvals for 17 generic drugs.

Dr Reddy’s has 80 abbreviated new drug applications pending with the USFDA for approval. Of these, seven have first-to-file status, which will enable the company to exclusively market generic versions for 180 days. Dr Reddy’s launched 12 products in the US in 2011-12 and recorded around Rs 3,180 crore in revenue. The latest launches included generic versions of Japan-based Eisai Pharma’s Aricept, Wyeth’s anti-depression drug Effexor and Novartis’ Femara, used in the treatment of menopausal disorders.

Dr Reddy’s financials during the last quarter were also led by anti-psychotic Zyprexa (olanzapine) generics, launched on an exclusivity basis in October 2011. It sells products such as lanzaprazole, tacrolimus, fexofinadine and fondaparinux in the US, with limited competition.