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New Delhi: US-based speciality pharma company Medicis Pharma Corporation has filed a suit against Delaware-based Ranbaxy Inc, a wholly-owned subsidiary of Ranbaxy Laboratories Ltd, in the district court of Delaware, alleging patent infringement of its acne product-solodyn tablets.
The annual sales of this product stood at approximately $365 million in the US market for the 12 months that ended January 31 this year, as per IMS sales data. Medicis Pharma, which specialises in dermatological products, has accused Ranbaxy of infringing patent claims of the company by attempting to obtain approval from the United States Food and Drug Administration (USFDA) to commercially manufacture and sell the generic version of the said acne product.
“Medicis received a letter dated May 6 from Ranbaxy Inc, stating that Ranbaxy Labs had filed the Ranbaxy abbreviated new drug application (Anda), seeking approval to manufacture, use, offer for sale and sell a generic version of solodyn extended release tablets for the treatment of acne before the expiration of the patent,” Jack Blumenfeld, counsel for Medicis, has told the court.
In its suit, Medicis has sought a permanent injunction against Ranbaxy so that the drug maker is prevented from manufacturing, using, selling the generic version of solodyn and has pleaded with the court to bar Ranbaxy from selling and marketing the drug till the patent litigation is resolved conclusively. A Ranbaxy spokesperson refused to comment on the issue.
In March this year, Israel-based Teva Pharma became one of the first companies to receive final approval from the US FDA for the Anda to market its generic version of solodyn.
The other high-profile patent litigation involving Ranbaxy include an agreement with Pfizer Inc to settle worldwide patent litigation involving Pfizer’s cholesterol-lowering medication, lipitor, which generated $12.7 billion in sales in 2007. The agreement allowed Ranbaxy to introduce a generic version of the drug in November 2011, with 180 days of exclusivity, which implies that no other manufacturers can start selling the drug until 180 days after that in the US. Ranbaxy also settled a patent infringement lawsuit with AstraZeneca in April 2008, which allowed the company to distribute the only generic version of esomeprazole magnesium product in the US.
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