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Ranbaxy Contests Pfizer Mega Drug Patent In US

Sanjay Sardana

New Delhi, August 22: Ranbaxy Laboratories has challenged yet another patent of a blockbuster drug in the US market. This will take the company’s paragraph IV filings in that country to more than half a dozen.

Ranbaxy has now challenged Pfizer’s blockbuster Lipitor –– a cholesterol drug–– which generated an annual revenue of around $7.9 billion for the multinational pharma company.

“Ranbaxy has 7-8 Para IV filings with first-to-file status. The latest patent challenge of a drug in the US is Lipitor,” the company spokesperson told FE.

Among the mega drugs whose patent has been challenged by Ranbaxy Laboratories in the US include Lipitor of Pfizer, Augmentin of Glaxo and Ganciclovir (Cytovene) of Roche.

Although Ranbaxy was the first to file an abbreviated new drug application (ANDA) with a patent challenge, it has not been sued by Roche, the spokesperson added.

Ranbaxy recently received FDA approval for Ganciclovir capsules- 250 & 500 mg dosages.

In a Para IV filing, a generic manufacturer challenges the original patented drug and claims that the generic version proposed to be launched by the manufacturer does not infringe the patent holder’s version. In case the patent challenge is won, it entitles the first to file Para IV generic manufacturer with a 180-day exclusivity, if the company comes up with an equivalent of the innovator’s branded formulation.

Ranbaxy has so far won only one patent Para IV filing case in the US, when two years ago the company successfully challenged Glaxo Smithkline’s Ceftin –– Cefuroxime Axetil. As a result, the company launched its generic version of the drug in the US market in March 2002. Ranbaxy’s generic version generated an annual revenue of around $115 million in the first year of launch and captured a majority of the market for anti-infective drug cefuroxime axetil in the US market.

With Pfizer’s patent for Lipitor now being challenged by Ranbaxy Laboratories, an interesting battle is on the cards. The company in its appeal has contended that Pfizer should not be allowed to enforce patent for its blockbuster drug Lipitor.

The world’s largest drug company, Pfizer in turn will now try to block Ranbaxy’s generic version of the drug being approved by the US Food and Drug Administration (USFDA), said the company official.

Ranbaxy has challenged Lipitor’s patent in the US seeking to either invalidate the drug’s patent or is seeking a ruling that the patent can not be enforced.

“It is a long drawn process and it will take a little while as the original patent for Lipitor is expiring only in 2006,” said a pharma analyst.

The patent for Lipitor was issued in 1987 and was expected to originally expire in 2006. However, Warner-Lambert received an extension of the patent up to 2011. Ranbaxy has now challenged both the original patent and the extension.

Lipitor came under Pfizer’s stable as part of the $120 billion purchase of Warner-Lambert Co in 2000.

URL: http://www.financialexpress.com/fe_full_story.php?content_id=40646

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