Ranbaxy, you may recall, was the first generic drug maker to win the right to market a copycat version in the U.S., which would have allowed the company to do so for six months without any competition. The arrangement is designed to reward patent challenges to brand-name drugs and lower health-care costs.
But there has been a snag. The FDA banned imports of Ranbaxy products from four different facilities in India due to a raft of regulatory violations. And until manufacturing begins, the six-month market exclusivity remains in place, which means Ranbaxy rivals cannot make their own generic versions.
Last month, however, Ranbaxy executives confidently stated that they expected to be able to proceed with plans to sell generic versions of Nexium, which is marketed by AstraZeneca, and the Valcyte antiviral sold by Roche. Now, though, the FDA has rescinded the tentative approval, although the marketing applications remains under consideration, according to an agency spokeswoman.
What happened? The spokeswoman was unable to provide an immediate explanation, but the drug maker issued a statement saying the FDA decision was made “in error because of the compliance status of the facilities” mentioned in Ranbaxy marketing applications. Although Ranbaxy maintained there were no “data integrity issues,” the drug maker did not offer any further explanation.
We asked a Ranbaxy spokesman for comment and will update you accordingly. [UPDATE: A spokeswoman for Ranbaxy sent us a note saying the drug maker "is disappointed with this development and is actively evaluating all available options to preserve its rights."]
[ANOTHER UPDATE: An FDA spokeswoman says "the FDA is prohibited by law from disclosing information about an unapproved application. However, she adds that applications for selling Valcyte were approved for Endo Laboratories and Dr. Reddy's Laboratories this week."]
The turnabout means that the FDA is likely to face continued pressure over the ongoing delay in the availability of generic Nexium. The reason is simple: consumers are forced to spend more for the brand-name drug and this has riled some politicians.
Two months ago, for instance, Connecticut Attorney General George Jepsen complained about this in a letter to the agency. He calculated that U.S. consumers spend $16.4 million per day, on average, on Nexium and noted that generics typically sell for 20% or less than a brand-name drug within the first year on the market.
He also pointed out that a consent decree that Ranbaxy signed with the FDA in early 2012 set a period of up to three years – through September 2014 – for the drug maker to correct its manufacturing problems. If requirements are not met, Ranbaxy agreed to relinquish exclusivity no later than Sept. 30. A citizen’s petition filed last May by a law firm – on behalf of an unnamed generic drug maker – made the same points.
Perhaps, the alleged error that Ranbaxy cites is an acknowledgement by the FDA hat the agency is now considering whether to allow other generic drug makers to sell Nexium and Valcyte. We also asked the FDA about this stipulation and the status of the consent decree requirements and will pass along any response.
Last July, by the way, Ranbaxy did receive FDA approval to make and sell a generic version of the Diovan heart drug, which was also caught up in the consent decree. In this instance, the drug is being made by a facility in New Jersey, which is the only Ranbaxy plant that is allowed to make drugs for the U.S. market.