Mumbai: Drug firm Glenmark Pharmaceutical Ltd has decided to fight a lawsuit filed by Sanofi-Aventis SA and Abbott Laboratories Inc. against the Mumbai drug maker’s patent challenge of the hypertension drug Tarka in the US. The drug, patented by Sanofi, has been licensed to Abbott in the US and has annual sales of $120 million (Rs472 crore).
Glenmark had filed a so-called abbreviated new drug application for this drug with the US food and drug administration (FDA) early this year.
The firm’s managing director and chief executive Glenn Saldanha said he was confident of winning the case and enjoying a 180-day exclusivity in the US as Glenmark was the first to make the filing there.
“We are ready to launch the drug in the US market any time now if the company wins the case,” he said.
FDA could approve Glenmark’s generic version for the local market if the company wins the court case. It is also possible that there may be an out of court settlement between the innovator and Glenmark, said an industry analyst with a foreign equity research firm, seeking anonymity.
Sanofi-Aventis and Abbott had on Tuesday sued Glenmark alleging infringement of a US patent for this hypertension drug.
The two companies, in a complaint filed on 7 December in the federal court in Newark, New Jersey, are seeking a court order blocking Glenmark from selling the drug until the patent expires in 2015.
Shares of Glenmark shot up 10.61% to close at Rs574.95 on the Bombay Stock Exchange.
‘Bloomberg’ contributed to this story.