Zydus Cadila, a global pharmaceutical company, announced that the United States Court of Appeals for the Federal Circuit has affirmed judgment in favour of its US subsidiary, Zydus Pharmaceuticals (USA) Inc., holding that its proposed generic version of Lialda (mesalamine) does not infringe US Patent No. 6,773,720.
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 approximately 700,000 people in the United States.
Speaking on the development, Pankaj R Patel, chairman and managing director, Zydus Cadila said, “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.”
Zydus was the first pharmaceutical company to file an Abbreviated New Drug Application for a generic version of Lialda (mesalamine). The Court of Appeals’ decision is a major step toward Zydus providing a generic version of Lialda (mesalamine) in the United States. Shire has reported annual sales of $714 million for this product in 2016 in the United States.