Taking a shot

New Delhi, Dec. 20: Drug manufacturers are eyeing the competitive generic market with the patents of several best-selling medicines expiring in the coming years. The recent reverses in global litigation on patents have failed to deter them.

During the 2006-13 period, the patents of as many as 25 best-selling drugs of leading companies, valued in billions of dollars, will expire. Pharmaceutical companies would then be allowed to introduce generic products, which are bio-equivalent of the original drug.

Recently, a court ruling prevented Ranbaxy from manufacturing a cheaper generic version of Lipitor, Pfizer?s best-selling anti-cholesterol drug, till its patent expires in 2011.

According to an Assocham study, drugs worth $70 billion may go off patent by 2008.

In 2006, the patents of four major drugs will expire, throwing open a generic market of more than $3 billion. These drugs are Glaxo?s Imitrex for treatment of migraine, Merck and Co?s Proscar for benign prostate hypertrophy, Johnson and Johnson?s Risperdai for psychosis and American Home?s Prempro for menopausal syndrome.

Analysts said the cheaper generic versions almost invariably hit the market less than three months after the patent of the original drug expires.

The highly competitive market has triggered several lawsuits, making them an integral part of the global generic drug business due to the high stakes involved. A company like Ranbaxy spent about $20 million on cases of patent challenges last year. Analysts feel that companies would not shy away from litigation because of the size of the gains in case of a win.

They said the patent portfolio of some of the traditional pharmaceutical companies indicate that their in-house technical competence is inadequate to meet the threat from global generic drug manufacturers such as Ranbaxy, which are fiercely targeting the large domain of off-patent drugs.

Analysts said in the new regime, several Indian companies have shown signs of a transition from being generic drug manufacturers to innovators. These firms are also focusing on basic research in search for new molecules.