This landmark decision will help all generic companies prevent brand companies from improperly delaying or preventing the marketing of generic drugs against their products
Sun Pharmaceutical Industries announced that the US Supreme Court has ruled in favour of its subsidiary Caraco Pharmaceutical Laboratories in its’ patent litigation against Novo-Nordisk over Caraco’s generic version of Prandin, repaglinide tablets.
The Supreme Court, in a unanimous opinion, concluded that Caraco can seek correction of Novo Nordisk’s inaccurate use code regarding the combination use of repaglinide and metformin for the treatment of type II diabetes. Sun Pharma is pleased that this landmark decision will 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 from 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. Prandin has annual sales of approximately $230 million in the US.
EP News Bureau — Mumbai
