Among all of the fallout from the well-publicized manufacturing mess at Ranbaxy Laboratories has been its inability to get a generic of Novartis' ($NVS) blockbuster hypertension fighter Diovan to market. Ranbaxy has a 6-month exclusivity for the drug and was going to make it at its plant in Mohali, India, but the FDA last year banned that plant from shipping to the U.S. until problems there were fixed. Reports have now surfaced that indicate the Indian drugmaker wants to make the drug in the U.S., using an API supplied by another company.
India's Business Standard, citing unnamed sources, says that Ranbaxy has applied to the FDA to make the drug at its Ohm Laboratories plant in New Jersey. That is the only Ranbaxy FDA-approved plant that the agency has not banned from selling in the U.S. Mohali and two other Indian plants have been cut off over poor manufacturing practices. The publication was unable to get Ranbaxy to say anything about the report.
Ranbaxy this week announced the FDA has issued a Form 483 for its active pharmaceutical plant (API) in Toansa, a facility that supplies about 70% of the raw ingredients for U.S. production. It is unknown whether the Toansa plant was expected to manufacture the API for Diovan, but sources told the Business Standard Ranbaxy will buy it from another "multinational" company.
The patent for Diovan fell off in September 2012. The Indian generics maker was initially forecast to generate $187 million during its 6-month exclusivity but the delay may affect that. Mylan ($MYL) tried a couple of times to get the FDA to cancel the exclusivity since Ranbaxy's drug had yet to be approved, but it was turned back in those efforts. Other generics won't come to the market until after Ranbaxy exercises its exclusivity. That has been a boon for Novartis ($NVS), which has reported an earnings boost from strong sales of the drug.
- here's the Business Standard story