Ranbaxy Laboratories has become the second Indian company after Dr Reddy's to explore the authorised generics option. It has entered into a tie-up with the US-based FSC Laboratories as its authorised generic partner for FSC's hypertension medicine Isoptin SR (Verapamil SR) in the US. This marks the company's foray into the authorised generics space.
The generic market for Verapamil SR, a calcium ion antagonist or channel blocker for the management of hypertension and angina, is worth $122.2 million. With limited competition from global generic players such as Ivax and Mylan Labs, the company is expected to garner a fair share of the generic sales during the 180-day market exclusivity period that precedes the expiry of the patent and the entry of other generic players.
Commenting on the development, K Venkatachalam, vice president & regional director, North America, Ranbaxy, said, "The commercialisation of Isoptin SR heralds Ranbaxy's entry into the authorised generics space. Isoptin SR, a niche value added formulation, also enhances our new drug delivery systems capability and our efforts with other molecules to improve patent compliance."
Dr Reddy's is the only other Indian company that has explored the authorised generic opportunity with multinational firms. Dr Reddy's had sealed a deal with Merck for launching the authorised generic versions of Merck's Zocor (simvastatin) and Proscar (finasteride) last year.
Both these products had together contributed Rs 1.6 crore (Rs 16 million) to Dr Reddy's top line last year.
The advantage of being an authorised generic partner is the risk-free nature of revenue generation. While other generic competitors, who are in the fray during the 180-day exclusivity period, risk litigations to gain the right to market, an authorised generic player gets to market the product by partnering the innovator.
"Authorised generics are going to play an important role for Indian drug companies. Unlike the risks involved in fighting long litigations (Ranbaxy's lipitor battle for instance), authorised generics allow them to make risk-free gains. It is a healthy development for Indian companies who need product launches in developed markets to strengthen their revenue flow," Sujay Shetty, associate director, pharmaceutical advisory services, PricewaterhouseCoopers, said.
Ranbaxy stocks at the Bombay Stock Exchange gained 0.48 per cent or Rs 1.8 to close at Rs 376.7 on Monday.
