Natco Pharma today said it was awaiting the US Food and Drug Administration (USFDA) approval for the launch of its generic version of block buster multiple sclerosis drug, Copaxone.
The US Court of Appeals for Federal Circuit yesterday ruled Teva Pharmaceuticals Limited's patent invalid, again, clearing the way for marketing the generic versions of the drug in the US.
In January the US Supreme Court had remanded back a similar ruling of the appeals court for further review. The latest ruling ends a long wait of Natco for the launch of its generic Copaxone in the US if the US regulator approves the application.
However, Teva was likely to pursue all legal pathways including seeking further appellate review, according to the reports.
The patent on Copaxone was to expire by May end in 2014 while Teva Pharmaceuticals sought its extension until September 1, 2015. Several generic drug firms including Natco had challenged the move in the US courts.
Natco had filed an application with the US Food and Drug Administration (US FDA) for the launch of the generic version of Copaxone over five years ago. The application is pending before the US drug regulator since then. The other generic filers include Momenta Pharmaceuticals Inc and Sandoz, Inc.
However in April, the US drug regulator had approved Copaxone generic versions of Momenta Pharmaceuticals and the Sandoz unit of Novartis AG , who were collaborating on the drug . Soon after the yesterday's ruling Sandoz announced the launch of its generic version of Copaxone, Glatopa, in the US.
While continuing to sell the original version, Teva had also launched a longer acting Copaxone and was able to shift a sizeable number of existing patients to the newer version in the US. In August 2014, Natco's marketing partner Mylan had filed an ANDA for this three-times-a-week generic Copaxone (glatiramer acetate injection, 40 mg/ml) and expects to be eligible for 180 days of marketing exclusivity in the US upon final FDA approval.
On Friday Natco Pharma scrip rose 5.58 per cent or Rs 115.85 to close at Rs 2,192.30 per share on Bombay Stock Exchange(BSE) following the news of Copaxone ruling.
