FDA lets Endo, Dr. Reddy's make Valcyte copies but stays mum on status of Nexium generic

The FDA says it has approved two companies to make generics of Roche's ($RHHBY) Valcyte but will not give any clarity on plans for a generic of AstraZeneca's ($AZN) blockbuster Nexium after nixing earlier approvals for troubled Ranbaxy Laboratories to make both drugs.

FDA spokeswoman Sandy Walsh said in an email today that the ANDAs from Endo Health Solutions ($ENDP) and Dr. Reddy's Laboratories for valganciclovir (generic Valcyte) have been approved. As far as what the status of a generic of Nexium is concerned, Walsh said only, "We have no additional information to share about the Ranbaxy applications."

Valcyte went off patent last year and Nexium went off patent in May. In a statement Thursday, Ranbaxy said the FDA had withdrawn its tentative approvals for both drugs and its exclusive approval for Valcyte "because of the compliance status of the facilities referenced in the applications." The drugmaker said it was disappointed and evaluating "all available options to preserve its rights." A spokesman for Ranbaxy said today he also had no additional info on the situation with generic Nexium.

Valcyte turned in U.S. sales last year of $368.5 million, Reuters reports. Nexium, well, that is in a different sales league and its delay is significant for maker AstraZeneca and for U.S. consumers and payers, including Medicare and Medicaid.

The British drugmaker Thursday gave an upbeat Q3 earnings report, raising its 2014 forecast for the second time, instead of having to discuss revenue falls from generic competition to its heartburn blockbuster. The copycat drug that Ranbaxy was slated to bring to market is up in the air after the FDA banned the Ranbaxy plant that was supposed to make it from shipping into the U.S. AstraZeneca has earned $2.8 billion this year from the drug, easily eclipsing in three quarters the $2.21 billion it sold in the U.S. last year. It sold about $1 billion just in the third quarter.

The plant where Ranbaxy was expected to produce the drug in India has been banned from shipping products to the U.S. after being caught fudging data on drug testing. Ranbaxy faced the same issue in trying to get a generic of Novartis' ($NVS) heart drug Diovan to market and finally got approval to make it at its U.S. plant. But so far that hasn't happened with Nexium.

A Citizen's petition, filed with the FDA and joined by Connecticut Attorney General George Jepsen, urged the FDA to cancel the exclusive for Nexium. It said the delay has resulted in "higher prices and a dead-stop bottleneck preventing more than a half-dozen generic drug manufacturers lined up behind Ranbaxy from entering the market." Similar attempts were made to force the agency to cancel Ranbaxy's rights to a Diovan generic, which was delayed nearly two years, but a court agreed with the FDA that it was not compelled to cancel the exclusivity.

- here's the Reuters story