The United States Court of Appeals for the Federal Circuit has affirmed judgment in favour of Zydus Cadila’s US subsidiary, Zydus Pharmaceuticals (USA) Inc., holding that its proposed generic version of Lialda (Mesalamine) does not infringe U.S. 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 around 700,000 people in the United States.
Zydus was the first pharmaceutical company to file an Abbreviated New Drug Application (ANDA) 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.
Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies. It is the only Indian pharma company to launch its own patented NCE - Lipaglyn, the world’s first drug to be approved for the treatment of diabetic dyslipidemia.
Company Name | CMP |
---|---|
Sun Pharma Inds. | 1464.85 |
Dr. Reddys Lab | 5955.65 |
Cipla | 1477.15 |
Zydus Lifesciences | 1050.35 |
Lupin | 1603.55 |
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