Zydus wins patent battle, can now launch ulcerative colitis drug in US

American court says proposed generic version of Lialda (mesalamine) is not a case of infringement

Ahmedabad-based pharma major Cadila Healthcare on Wednesday said it has received a favourable judgement from a US federal court in a patent infringement case in favour of its US subsidiary, Zydus Pharmaceuticals (USA) Inc. This basically paves the way for the company to launch a generic drug to treat ulcerative colitis in the US market.

Zydus, however, did not comment on when it planned to launch the product in the US. It was the first pharmaceutical company to file an abbreviated new drug application (ANDA) for a generic version of Lialda. Shire has reported annual sales of $714 million for this product in 2016 in the United States, and therefore this presents a major opportunity for the company in the US.

The United States Court of Appeals for the Federal Circuit has affirmed the judgment in favour of its US subsidiary, Zydus Pharmaceuticals, holding that its proposed generic version of Lialda (mesalamine) does not infringe US Patent No. 6,773,720, the company said in its 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 Cadila Healthcare chairman and managing director Pankaj Patel.

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 700,000 people in the US.