Global pharma giant Pfizer Inc has sued city-based Aurobindo Pharma over the generic version of Lipitor, sources close to the development said today.
Aurobindo may opt for out-of-court settlement with Pfizer, which sued the Indian drugmaker on June 27, they said.
However, when contacted a company official declined to comment on the issue, said they were yet to get the details of Pfizer case officially.
According to the US Food and Drug Administration, Lipitor, which is used to lower cholesterol, is one of the best selling medications in the American market, with annual sales of approximately $7 billion.
Pfizer, which has sued numerous generics makers over Lipitor, has argued patents covering the blockbuster drug's brand name grant it exclusive production right until 2017.
Pfizer, which filed a patent infringement case against the Indian firm in the District Court of Delaware, said Aurobindo, in a notice on May 17, notified that it had filed Abbreviated New Drug Application (ANDA) seeking approval to market Atorvastatin in the US market.
The US-based drugmaker requested the court to refrain Aurobindo from manufacturing and marketing of the drug before January 8, 2017, the date of expiration of the patent, including the period of exclusivity granted to Lipitor.
Ranbaxy reached an agreement with Pfizer to settle most of their patent litigations over Lipitor in 2008. The pact allows India's top drugmaker to sell generic versions of Lipitor and Caduet in the US effective November 30, 2011. Caduet, that combines the active ingredients of Lipitor and Norvasc, treats both high blood pressure and high cholesterol.
Dr Reddy's Laboratories is also facing a patent infringement suit from Pfizer over the same drug.
Aurobindo shares lost 1.57% to end at Rs 172.50 on the BSE.
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