The Hindu Business Line : Opportunity knocks for Sun Pharma?

That Sun Pharmaceuticals has secured 180-day exclusive marketing rights for the generic version of a large anti-ulcer drug in the US market marks the opening up of a significant opportunity for the company.

Though the launch date is as yet unannounced, the marketing exclusivity may give Sun Pharma access to a drug that has estimated annual sales of over $2 billion (Rs 8,000 crore). The USFDA has granted Sun approval to sell 20 and 40 mg, delayed-release tablets of pantoprazole, or generic Protonix.

Sun Pharma, by virtue of being one of the first to file an ANDA (application to market a generic) for the drug, shares this 180-day marketing exclusivity with Israel’s Teva Pharmaceutical Industries.

Actual benefits

However, the actual benefits to Sun Pharma from this development will depend on how and when it decides to launch this product. The company is currently evaluating whether to launch the drug “at risk” (that is, while it is still the subject of litigation).

Launching a drug “at risk” brings significant rewards such as higher prices, but losing the trial would mean substantial penalties.

Wyeth has already charged Sun and Teva with patent infringement in a Federal Court; but a US district judge on September 7 refused to block these companies from selling generic copies of Protonix, before the trial.

Only large pharma companies such as Sun Pharma, Ranbaxy Labs and Dr Reddy’s Labs that have enough financial muscle to bear litigation costs, usually resort to this route.

In the last one month, Sun Pharma has secured regulatory approvals to sell generic versions of blood-pressure drug - Carvedilol and dementia drug - Razadyne, but without marketing exclusivity.