Apotex Sues FDA Over Generic Forms of Glaxo's Zofran (Update1)
By Susan Decker
Nov. 8 (Bloomberg) -- Apotex Inc., a Canadian generic-drug maker, sued U.S. regulators to block any rival from getting exclusive rights to sell lower-cost versions of GlaxoSmithKline Plc's nausea medicine Zofran.
The U.S. Food and Drug Administration plans to grant one company, believed to be India's Dr. Reddy's Laboratories Ltd., the right to have the only approved generic copy of Zofran on the market for six months beginning in December, according to the suit, filed Nov. 7 in Washington.
Zofran, used to treat chemotherapy-related nausea, generated U.S. sales of 549 million pounds ($1.05 billion) in the year's first nine months for London-based Glaxo. Apotex claims it has a valid application and should be allowed to enter the market when a patent expires Dec. 24 on the use of ondansetron, the drug's key ingredient, to prevent vomiting.
``If another applicant is permitted to launch its ondansetron tables with exclusivity on Dec. 24, 2006, Apotex will suffer severe and immediate irreparable harm,'' the Weston, Ontario-based company said in the suit.
The FDA hasn't said which company would get six months of exclusive sales. Hyderabad, India-based Dr. Reddy's has said it expects to become the only generic rival in the Zofran market in December.
The FDA rewards the first company to challenge patents on brand medicines with six months of exclusive sales. Generic-drug makers can charge prices only slightly lower than the brand medicine, so covet the six-month period as a way to boost profits.
One trigger for the exclusivity period is a court decision in a civil lawsuit. Apotex contends that the May 2005 dismissal of Glaxo's patent-infringement suit qualifies, so the six-month period has expired. The suit was dismissed after Glaxo agreed that Apotex's version of Zofran wouldn't infringe another patent on the drug that expires in 2011.
Apotex is asking U.S. District Court Judge Rosemary Collyer to bar the FDA from approving any applications until the issue is resolved. The request may be heard in early December, said Apotex lawyer Arthur Tsien, of Olsson, Frank & Weeda in Washington.
FDA spokeswoman Laura Alvey said the agency doesn't comment on pending litigation. Dr. Reddy's General Counsel Andrew Miller didn't immediately return messages seeking comment.
Dr. Reddy's American depositary receipts, each representing one ordinary share, fell 25 cents to $17.32 today in New York Stock Exchange composite trading. They have risen 60 percent this year.
The case is Apotex Inc. v. Food and Drug Administration, 06cv1890, U.S. District Court for the District of Columbia.
To contact the reporter on this story: Susan Decker in Washington at firstname.lastname@example.org
Last Updated: November 8, 2006 17:19 EST