The US Court of Appeals for the Federal Circuit has affirmed judgement holding that Zydus Cadila’s proposed generic version of Lialda does not infringe a US Patent
Drug firm Zydus Cadila has received a favourable judgement from a US federal court in a patent infringement case paving the way for company to launch its generic product in the American market.
The US Court of Appeals for the Federal Circuit has affirmed judgement in favour of Zydus Pharmaceuticals (USA), holding that its proposed generic version of Lialda does not infringe a US Patent, the company said in a statement.
“We welcome this decision which is a positive step and will help us further our mission of making available high- quality, affordable generic products to our customers and their patients,” said Pankaj R Patel, CMD, Zydus Cadila.
Zydus was the first pharmaceutical company to file an abbreviated new drug application (ANDA) for a generic version of Lialda.
The Court of Appeals’ decision is a major step toward Zydus providing a generic version of Lialda (mesalamine) in the US. Shire has reported annual sales of $714 million for this product in 2016 in the US.
Lialda is indicated for the induction of remission of active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis.
Ulcerative colitis is a chronic inflammatory bowel disease that affects around 7 lakh people in the US.