Mylan Inc. has sued the Food and Drug Administration to get generic versions of Pfizer Inc.’s Lipitor on the market in late June and block India’s Ranbaxy from receiving 180 days of marketing exclusivity for its version of the medicine.
Ranbaxy is expected to launch its generic Lipitor Nov. 30 under a settlement with Pfizer and remain free of multiple competitors for 180 days, as the first company to apply to sell a cheaper version of the world’s best selling prescription medicine.
Pfizer reported global sales for its cholesterol fighter of $10.73 billion in 2010, with U.S. sales of $5.33 billion. But a branded drug can lose 80 to 90 percent of sales once multiple generics hit the market.
Mylan, whose generic Lipitor has not received FDA approval, contends that generic sales should begin June 28 — the expiration date of certain patents for Lipitor, known chemically as atorvastatin.
It also contends that Ranbaxy should be forced to forfeit its exclusivity for violating the FDA’s application integrity policy.
The FDA in 2009 accused Ranbaxy of falsifying test results and data in applications and halted reviews of products from the company’s Paonta Sahib plant in India. Ranbaxy, which is controlled by Japan’s Daiichi Sankyo, has said it was working to resolve the issues with the U.S. government and planned to manufacture its atorvastatin at a plant in New Jersey.
Mylan would not be the only beneficiary of a green light to sell a cheap version of Lipitor months ahead of the anticipated launch.
In the lawsuit filed Friday in federal court in Washington, Mylan estimated introduction of generic Lipitor would save U.S. consumers, government health plans and third-party payors $10.9 million to $18.6 million per day.
Federal payors such as Medicare, Medicaid and the Department of Veterans Affairs could save $1.3 billion to $2.3 billion in the first year after a generic launch, the lawsuit estimated.
But industry analysts do not believe the case can be resolved in time to see generic Lipitor on the market in June, and expect the Nov. 30 launch by Ranbaxy to go forward.
“It is unlikely the suit will lead to June entry of generics,” Sanford Bernstein analyst Ronny Gal said in a research note. “Court cases take time, and appeal by Ranbaxy and Pfizer and Watson is virtually certain.”
Pfizer also has a patent settlement deal with Watson Pharmaceuticals Inc., granting it the right to begin selling an authorized generic supplied by Pfizer Nov 30. Pfizer would receive payments from those sales.
“We believe the FDA has all the information it needs to decide today on Ranbaxy’s 180-day exclusivity,” Mylan spokeswoman Nina Devlin said in a statement.
In the lawsuit, Mylan said the FDA “arbitrarily, unreasonably and unlawfully failed to decide whether (it) will enforce the terms” of its own AIP against Ranbaxy’s atorvastatin application.
It said such a finding against Ranbaxy would require the FDA to conclude that the Indian company was not eligible for the marketing exclusivity and likely result in approval of other lower-cost Lipitor generics.
FDA’s failure to decide at the earliest possible date will cause plaintiffs’ irreparable harm, the court papers said.
The FDA declined to comment on the lawsuit.
Mylan’s shares gained 0.9 percent on Nasdaq, while Ranbaxy shares closed down 7 percent in India on Monday.
The case is Mylan Pharmaceuticals Inc. and Matrix Laboratories Ltd. vs. United States Food and Drug Administration. United States District Court for the District of Columbia, case No: 1;11-cv-00566.
