Diovan image

Ranbaxy’s Diovan copycat approved in US

pharmafile | June 27, 2014 | News story | Manufacturing and Production, Sales and Marketing Diovan, FDA, Novartis, Ranbaxy, blood pressure, sun pharmaceuticals, valsartan 

Ranbaxy has won approval for its copycat form of Novartis’ blockbuster blood pressure drug Diovan, as the Swiss firm finally braces itself for generic erosion in the US.

Novartis actually lost its patent rights to Diovan (valsartan) in the US more than a year and a half ago, but has avoided generic competition because of multiple production quality control problems at Ranbaxy.

The Indian firm, which is in the process of being acquired by fellow native drugmaker Sun Pharmaceuticals for around $4 billion, will be the first company to launch a copy of Diovan in the US.

As an added bonus, the firm will be entitled to six months of exclusivity to sell it as it was the first to file its treatment, meaning no other generic firm can sell their copycat versions until early next year.

The sales of valsartan should add about $200 million to Ranbaxy’s sales, and $100 million to its profit after tax during the exclusive sale period according to analysts.

Ranbaxy has for over a year been the subject of scrutiny by the FDA for numerous quality issues at its Indian plants.

This has been a serious issue as firms in the country produce around 40% of all generic medicines in the US, with around 80% of all of its medicines being copycat versions of once patented drugs.

Ranbaxy had planned to produce generic Diovan at its plant in Mohali, Punjab but the FDA banned the facility from selling products in the US in September 2013.

Three more Ranbaxy plants in India are prohibited from US sales dating back to 2009. The Gurgaon, India-based company has been cited for ‘unsanitary conditions’ and ‘manipulating quality test’s.

The Ranbaxy statement does not say when the generic version of Diovan, which had global sales of $3.5 billion in 2013, will be launched.

Ben Adams 

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