When the US FDA in 2014 stripped the Indian drug maker Ranbaxy’s generics of its approval for two blockbusters which includes the heartburn medicine Nexium, Ranbaxy fired back with a lawsuit against the FDA. But Ranbaxy is now owned by India’s biggest pharmaceutical company Sun Pharmaceutical. Sun Pharma now sees no benefit in battling it out with the US FDA, and has dropped the lawsuit.
In a filing with the Bombay Stock Exchange recently, Sun Pharmaceutical stated that it had “pulled off its appeal of the lawsuit submitted by Ranbaxy Laboratories” against the US FDA previous year.
Ranbaxy Laboratories submitted the federal action in last year November following the FDA, quoting Ranbaxy’s on-going manufacturing issues to withdraw its previous approvals of Ranbaxy generics for blockbuster Nexium (AstraZeneca’s product) and Valcyte (Roche’s product). The patent for Nexium had expired in May 2015. Ranbaxy had the exclusive rights but since the manufacturing unit where it was to manufacture the drug was sidelined by FDA concerns, Ranbaxy had not been able to bring it to market. The same circumstances had postponed generics of Novartis’ heart drug Diovan by almost two years, keeping customers away from less expensive version of the drug. FDA was under pressure not to let that occur once again.
The US FDA’s action has been a big financial loss to Ranbaxy, which was trying to prevent the FDA from accepting any other versions of the medicines until it had been able to realize its 6 months exclusives for the drugs. A federal judge rapidly swatted the legal action aside, leaving Ranbaxy to appeal. At the same time the FDA permitted other pharma companies to get generics into the market.
Sun Pharmaceuticals in March finished its $4 billion buyout of Ranbaxy. Managing Director Dilip Shanghvi has pledged that it will work closely with the US FDA to get 4 banned Ranbaxy manufacturing units into 100% compliance with FDA specifications. He has stated that “We will do anything it takes to gain back the confidence of the US FDA.”
Adding to above comments Dilip Shanghvi said that,
“I do not think that withdrawing the lawsuit will have any adverse financial effect on the organization.”