In a relief to Natco Pharma, the US court of appeals has invalidated Teva’s Copaxone patent. This may help generic pharma companies to launch one of the top-selling multiple sclerosis drugs, Copaxone.
“The US Court of Appeals for Federal Circuit has again found Teva’s US 808 patent for Copaxone to be invalid as indefinite. The company awaits approval from the US Food and Drug Administration (USFDA) to launch the product,” said Natco in a filing to the exchanges.
Natco is awaiting the USFDA nod to launch the product in the US. Last year, the US Supreme Court had denied Teva’s application for an injunction seeking to prevent the launch of a generic version of Copaxone.
The pharma companies involved in the generic forms of Copaxone are Novartis’ Sandoz, Momenta Pharmaceuticals, Mylan and Natco Pharma.
As per available estimates, the annual sales of Copaxone is about $4.3 billion worldwide and account for more than half of Teva’s profit. In 2003, Natco began research to develop a generic version of Copaxone in order to make a cost-effective version of the drug available to patients in India. Later, Natco developed a novel process for producing copolymer-1 and filed patent applications covering its process. Presently, Natco’s copolymer-1 product is sold in India under the brand Glatimer.
