Ranbaxy files two anti-retrovirals agents with WHO

EPP News Bureau - New Delhi

Pharma major Ranbaxy Laboratories has made two further filings of its anti-retrovirals (ARVs) agents, to the World Health Organisation (WHO) for its approval, taking the total number of filings submitted with the WHO, to five. Besides, Ranbaxy has also filed one more ARV with the US FDA under it’s expedited review process for the US President’s Emergency Programme For Aids Relief (PEPFAR), thus taking the total number of ARV filings with the FDA to four, said a press release.

“Ranbaxy remains committed towards re-filing of its ARVs with the WHO and the US FDA (under the PEPFAR programme). By this summer, we expect most of our range of HIV medicines to be filed with WHO and US FDA,” said Dr Brian W Tempest, CEO and MD, Ranbaxy. This is yet another step in making these quality medicines available widely, in countries that urgently need them.

Ranbaxy is committed to making affordable, bio-equivalent ARVs accessible to HIV/AIDS patients throughout the world, particularly to those, who might not otherwise be able to access therapy.

HIV/AIDS is a serious pandemic that now infects some 40 million people around the globe. More than 20 million individuals have so far succumbed to this devastating disease.

...appeals preliminary injunction against sales of quinapril in US

Ranbaxy Laboratories Limited announced that the US district court for the district of New Jersey hearing the preliminary injunction motion brought by Pfizer against Teva Pharmaceuticals USA, Inc (Teva) and Ranbaxy Pharmaceuticals Inc (RPI) enjoined Teva and RPI from selling RPI’s quinapril tablets (5, 10, 20, and 40 mg).

Pfizer had asserted that RPI’s quinapril tablets, which have been marketed through an exclusivity relinquishment arrangement with Teva, were infringing US Patent No 4,743,450 literally and under the doctrine of equivalents, a Ranbaxy release said.

Jay Deshmukh, Ranbaxy’s vice president, Intellectual Property, stated, that while Teva and RPI will comply with the preliminary injunction they will also immediately file with the US Court of Appeals for the Federal Circuit an appeal to have the injunction lifted and a motion to expedite the appeal.

Jay further stated that RPI is confident that it will, on appeal, be able to make a compelling argument in support of its non-infringement position.