Bangalore: US biotechnology firm Gilead Sciences Inc said it may take legal action against Lupin Ltd after the Indian firm submitted an abbreviated new drug application (ANDA) to manufacture and market a generic version of its angina drug, Ranexa.
In the notice letter, Lupin alleges that all 10 patents associated with Ranexa are invalid and are unenforceable, Gilead said.
Also, Lupin stated in the letter that the Ranexa patent will not be infringed by Lupin’s manufacture, use or sale of the product described in its ANDA submission.
Gilead said in a statement late on Thursday that it is currently reviewing the notice letter and has 45 days from the date of receipt to commence a patent infringement lawsuit against Lupin.
If a lawsuit is filed then it would restrict the US Food and Drug Administration (FDA) from approving Lupin’s ANDA for up to 30 months, the company said.
Ranexa is currently protected by 10 patents and all those patents would need to be invalidated or expired before a generic version of Ranexa could be approved by FDA.
Ranexa is a prescription medication used to treat adults with chronic angina. Angina is chest pain that is brought on by exercise or stress.