 "US Court rules in favour of Zydus in ulcerative colitis drug patent case")
The US Court of Federal Circuit has affirmed judgement in favour of Zydus Pharmaceuticals (USA) Inc, the US-based subsidiary of Zydus Cadila, holding that its proposed generic version of Lialda (mesalamine) does not infringe US Patent (No 6,773,720) of Shire. Zydus was the first pharmaceutical company to file an abbreviated new drug application (ANDA) for a generic version of Lialda.
Lialda is indicated for the induction of remission of active, mild to moderate ulcerative colitis (UC) and for the maintenance of remission of UC. Ulcerative colitis - a chronic inflammatory bowel disease that causes inflammation in the digestive tract - affects approximately 700,000 people in the US.
Earlier, in September 2016, the US District Court for the District of Delaware ruled that a proposed Lialda generic made by Zydus Pharmaceuticals does not infringe US Patent No 6,773,720. Following this ruling, Shire had appealed to the Court of Appeals to the Federal Circuit.
With the Court of Appeals ruling in Zydus flavour, the company has taken a major step towards 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.
Pankaj 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."
One subscription. Two world-class reads.
Already subscribed? Log in
Subscribe to read the full story →*Subscribe to Business Standard digital and get complimentary access to The New York Times
Smart Quarterly
₹900
3 Months
₹300/Month
SAVE 25%
Smart Essential
₹2,700
1 Year
₹225/Month
SAVE 46%
*Complimentary New York Times access for the 2nd year will be given after 12 months
Super Saver
₹3,900
2 Years
₹162/Month
Subscribe
Renews automatically, cancel anytime
Here’s what’s included in our digital subscription plans
Exclusive premium stories online
Over 30 premium stories daily, handpicked by our editors
Complimentary Access to The New York Times
News, Games, Cooking, Audio, Wirecutter & The Athletic
Business Standard Epaper
Digital replica of our daily newspaper — with options to read, save, and share
Curated Newsletters
Insights on markets, finance, politics, tech, and more delivered to your inbox
Market Analysis & Investment Insights
In-depth market analysis & insights with access to The Smart Investor
Archives
Repository of articles and publications dating back to 1997
Ad-free Reading
Uninterrupted reading experience with no advertisements
Seamless Access Across All Devices
Access Business Standard across devices — mobile, tablet, or PC, via web or app
SAVE 25%