Biotech Values

[DewDiligence]

MYL Sues FDA to Force Hatch-Waxman Decision on Generic Lipitor

[Ranbaxy, the Indian subsidiary of Daiichi Sankyo, has 180-day first-filer exclusivity under Hatch-Waxman but does not have FDA approval to launch, which holds up the launch of other generics that do have FDA approval. Meanwhile, WPI has the right to sell a Lipitor AG (which is not blocked by Ranbaxy’s first-filer status) and could see windfall profits (#msg-58721867).]

http://www.bloomberg.com/news/print/2011-03-21/mylan-sues-fda-seeking-to-block-ranbaxy-s-lipitor-copy-approval.html

›By Susan Decker, Catherine Larkin and Adi Narayan - Mar 21, 2011

Mylan Inc. sued the U.S. Food and Drug Administration, seeking to block India’s Ranbaxy Laboratories Ltd. (RBXY)’s exclusive rights to sell a generic version of Pfizer Inc. (PFE)’s cholesterol pill Lipitor, the world’s best- selling medicine.

In a complaint filed March 18 in federal court in Washington, Mylan said it and other generic-drug makers should be allowed to enter the market as soon as a patent expires. Ranbaxy declined to comment on the lawsuit in an e-mail statement.

Ranbaxy, 64 percent owned by Tokyo-based Daiichi Sankyo Co., fell the most in a month in Mumbai on speculation that Mylan’s move may hamper its plan to start selling the medicine in the world’s largest drug market in November. The company has said it is entitled to 180 days of marketing exclusivity as a reward for being the first to challenge the Lipitor patents.

“It is the first time someone is openly challenging Ranbaxy’s exclusivity for Lipitor,” Bino Pathiparampil, a Mumbai-based analyst at India Infoline Ltd., said. “It is incrementally negative for sure” for Ranbaxy.

Ranbaxy fell 4.2 percent to 449 rupees at 11:15 a.m. in Mumbai trading, the worst performer on the Bombay Stock Exchange 200 Index. It earlier dropped as much as 5.3 percent, the most since Feb. 24.
Agreement With Pfizer

Ranbaxy, based in Gurgaon near New Delhi, reached an agreement with Pfizer in 2008 to sell copies of the medicine beginning in November. It has not yet received the final regulatory approval on its application to sell the drug.

In its complaint, Mylan contends that Ranbaxy isn’t eligible for that marketing exclusivity because of “false and unreliable data” from its manufacturing site in Paonta Sahib, India, where the Lipitor copies would be produced.

Mylan said it wrote to the FDA in January and February, and met with agency officials on Feb. 14 to ask whether Ranbaxy’s claim to the marketing exclusivity or the entire application would be denied because of the improper information. The FDA hasn’t answered those questions, the company said.

“FDA’s indecision is depriving millions of Lipitor patients access to lower-cost generic Lipitor,” Mylan, based in Canonsburg, Pennsylvania, said in its complaint. It’s “costing the public billions of dollars in savings, and costing generic manufacturers billions of dollars in lost sales.”

‘Tainted by Misconduct’

Mylan wants a court to force the FDA to say publicly whether Ranbaxy’s application “is tainted by Ranbaxy’s misconduct” and that therefore the application must be denied and the 180-day reward voided. A victory for Mylan would let it enter the market 11 months earlier than expected.

Ranbaxy is working with regulators to resolve outstanding questions and is confident that it will get the FDA approval for its copy this year, Chuck Caprariello, a company spokesman, said in an interview last month.

Lipitor sales fell 6 percent to $10.7 billion last year as generic competitors arrived in Spain and Canada. New York-based Pfizer’s product has been the world’s biggest-selling medicine for the past 10 years.

The case is Mylan Pharmaceuticals Inc. v. U.S. Food and Drug Administration, 11-566, U.S. District Court for the District of Columbia (Washington).‹