 "Glenmark settles Para IV litigation with Forest Labs for generic Savella")
Glenmark Pharmaceuticals has entered into a settlement agreement with Forest Laboratories and Royalty Pharma Collection Trust to settle and dismiss the outstanding patent litigation related to Glenmark’s abbreviated new drug application (ANDA) for milnacipran hydrochloride 12.5 mg, 25 mg, 50 mg, and 100 mg tablets - the generic version of Forest’s Savella.
As per the agreement, Glenmark will have the option to market and distribute its milnacipran hydrochloride tablets or an authorised generic version of Savella tablets. Other terms of the settlement agreement are confidential.
Savella is indicated for the management of fibromyalgia - a rheumatic condition characterised by muscular or musculoskeletal pain with stiffness and localised tenderness at specific points on the body. According to IMS Health sales data for the 12 month period ending October 2015, Savella achieved annual sales of approximately $ 134.7 million.
Glenmark’s current portfolio consists of 103 products authorised for distribution in the US marketplace and 63 ANDA’s pending approval with the US FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
As per the agreement, Glenmark will have the option to market and distribute its milnacipran hydrochloride tablets or an authorised generic version of Savella tablets. Other terms of the settlement agreement are confidential.
Savella is indicated for the management of fibromyalgia - a rheumatic condition characterised by muscular or musculoskeletal pain with stiffness and localised tenderness at specific points on the body. According to IMS Health sales data for the 12 month period ending October 2015, Savella achieved annual sales of approximately $ 134.7 million.
Glenmark’s current portfolio consists of 103 products authorised for distribution in the US marketplace and 63 ANDA’s pending approval with the US FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
You’ve reached your limit of {{free_limit}} free articles this month.
Subscribe now for unlimited access.
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%