Sun Pharmaceutical Industries Ltd. announced that the U.S. Supreme Court had ruled in favour of its subsidiary Caraco Pharmaceutical Laboratories Ltd. in its patent litigation against Novo-Nordisk over Caraco's generic version of Prandin, Repaglinide tablets.
The Supreme Court unanimously ruled that Caraco could sue a brand-name drug maker to get it to narrow its patent description with the Food and Drug Administration.
The FDA approved Prandin, known generically as repaglinide, for three separate uses to help patients with Type 2 diabetes to control their blood sugar levels.
The company said this landmark decision would help all generic companies prevent brand companies from improperly delaying or preventing the marketing of generic drugs against their products by misrepresenting their patents to the US FDA.
Caraco's ANDA for generic Prandin is still awaiting approval at the US FDA. Also, a separate appeal concerning the validity of patents for Prandin is currently pending before the Court of Appeals for the Federal Circuit after a lower court ruled in favour of Caraco, the company said.
Prandin has annual sales of around $230 million in the US, it added.
At the BSE, Sun Pharmaceutical Industries shares are currently trading at Rs.596.95, up 2.18 percent from the previous close.
by RTT Staff Writer
For comments and feedback: email@example.com