Indian Generics Dominate US Market

Glenmark Pharmaceuticals, an Indian generics company, recently launched its malaria treatment drug in the US. Glenmark's anti-malarial atovaquone and proguanil hydrochloride tablets are the generic equivalent of GlaxoSmithKline's brand Malarone. The Indian pharmaceutical company settled a patent litigation with GlaxoSmithKline in April 2010, which allows Glenmark to launch the generic tablets in the US in  2011.

With Pfizer's cholesterol-lowering blockbuster Lipitor going off patent on December 1, another Indian generics company, Ranxbury, is hoping to corner that market with their generics version of Lipitor (currently the largest-selling drug in the world). Ranxbury has put a tremendous effort, as well as investment, into preparing their generic version of the drug.  However, Pfizer may not let it go so easily.  Since 2008, Ranxbury and Pfizer have been involved in patent litigation procedures which delayed the release of a Lipitor generic through November 30 of this year. During this time the rules to the game have changed. Last year Pfiizer sold rights for Lipitor to Watson Pharma (a New Jersey-based company) allowing it to sell the generic version of the drug, as long as 70% of drug revenues go to Pfizer over the next five years.

Ranbaxy was given first rights on selling a generics version of Lipitor in 2002 because it was the first to apply for FDA approval. In 2008, the two companies reached an agreement that the generic would be released on November 30, 2011. However, whether the FDA would grant approval,  given the manufacturing problems that the agency reported at Ranxbury (the FDA accused a Ranbaxy plant in India of submitting false and unreliable data) remained unclear. As a result, in 2009 the FDA invoked an 'application integrity policy' against Ranbaxy, which placed its drug applications under greater scrutiny and required certain corrective actions. In the meantime, Pfizer made an agreement with Watson Pharmaceuticals. The issue is yet to be completely resolved.

Indian generics dominating the market, however, is not news if we look at the US generics market today. In fact, as of this year, Indian companies account for 35 % of all abbreviated new drug application approvals in the United States. Despite isolated problems associated with one of India's largest generics producers mentioned above, i.e. Ranxbury, other top Indian generics companies in the US market are either maintaining or improving their approval rates this year. Along with Glenmark, two other companies, Aurobindo and Sun Pharma, have risen to the number one position as leading generics-selling companies in the US in just the last few years. This trend is likely to continue with the opening of FDA offices in New Delhi and Mumbai this year. However, US and other multinational pharmaceutical companies are preparing to fight back, and, like Pfizer, are joining the major players in the generics market. The race has begun, will there be a tie?

References
http://www.fiercepharma.com/story/indian-drugmakers-push-us-market/2009-03-06
http://www.business-standard.com/india/news/indian-pharma-remains-top-in-us-generics/420523/
http://articles.economictimes.indiatimes.com/2011-11-30/news/30458695_1_generic-version-arun-sawhney-ranbaxy-laboratories