MUMBAI (Reuters) - Ranbaxy Laboratories still has exclusive rights to the launch of AstraZeneca's heartburn drug Nexium in the United States, it said on Tuesday, despite regulatory concern over the manufacturing process.
Ranbaxy was the first to seek approval from the U.S. Food and Drug Administration (FDA) to sell a cheaper copy of Nexium, gaining exclusive rights to sell it for six months after patent expiry.
However, doubts about Ranbaxy's ability to launch the drug grew after the FDA in January prohibited it from shipping to the United States any pharmaceutical ingredient made at its Toansa plant in India, citing quality control issues.
"We believe we have the (Nexium) exclusivity and we will launch the product upon approval," Ranbaxy chief executive Arun Sawhney said on a post-earnings call with analysts on Tuesday, though he refused to elaborate on when that might be when pressed for more detail.
Sources told Reuters in March that Ranbaxy was in talks with at least two other companies on sourcing the drug ingredient required to manufacture the Nexium copy.
Nexium achieved global sales of $3.87 billion last year, $2.12 billion of which came from the United States, and analysts have said that any delay in the launch of a generic copy would be hugely beneficial for Britain's AstraZeneca.
(Reporting by Zeba Siddiqui in Mumbai; Editing by David Goodman)