FDA had cancelled Ranbaxy's approvals to launch generic Nexium, Valcyte
US District Judge Beryl Howell in Minneapolis denied Ranbaxy's request, the court filing showed.
The first petition alleges that Cipla Ltd, India's second largest pharmaceutical company, violated Roche's patent by launching a generic version of Valcyte. The second petition says Cipla violated the Swiss drug maker's trademark by launching the product in a phonetically similar name, 'Valcept'.
The FDA has been tightening its monitoring of Indian pharma majors over compliance issues. Surprise plant inspections and import alerts have been frequent outcomes
The Valcyte case is vital as it bars incremental innovation and recognises the right of patient groups to oppose patents.
Swiss drug multinational Roche AG suffered yet another setback in its ongoing patent fights in India after the Chennai patent office rejected its claim over Valcyte (valganciclovir).
The company has got the approval for the generic version of Roche's anti-viral 'Valcyte', which has a total annual market of around $239 million. Ranbaxy believes that it has First-to-File status on Valganciclovir tablets, thereby, providing a potential of 180-days of marketing exclusivity which offers a significant opportunity in the future, the company said.
First time, an Indian court revisits a patent office order.
Indices reversed all its losses during late trades.
The weakness in the stock was because of inspections by the American drug regulator at its Halol plant in Gujarat which resulted in eight observations, as well as a downward revision of speciality drug payoffs.
The 30-share Sensex ended down 538 points at 26,781 and 50-share Nifty ended down 152 points at 8,067.
In a surprise announcement in April, Sun and Ranbaxy -- at that time owned by Japan's Daiichi -- declared an all-stock deal to create India's largest and world's fifth-largest drugmaker in an over $4 billion deal.
The joint entity will have a market share of nine per cent in India. Analysts tracking the company said one of the key outcomes of the merger would be to create a single brand entity of Sun and the Ranbaxy brand would eventually dissolve.
The Sensex ended below 28,000 for the second straight day at 27,869.
Ranbaxy's US factory, Ohm Laboratories, is learnt to have got a clean chit from the American regulator. This US facility was under surveillance of the Food and Drug Administration (FDA) since the end of 2012.
Import alert on Ranbaxy's Mohali unit; Strides' injectible arm gets warning letter
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