The Medicines Company (MDCO) has settled its litigation with Sun Pharmaceutical Industries (Sun Pharma) and certain of its subsidiaries relating to MDCO’s Angiomax (bivalirudin). The patents are listed in the Orange Book and expire on July 27, 2028.
As a result of the settlement, MDCO will permit a Sun Pharma subsidiary to market a generic bivalirudin product in the United States on June 30, 2019, or earlier in certain limited circumstances. This settlement validates MDCO’s patents while allowing a Sun Pharma subsidiary to enter the market with its generic product.
Glenn Sblendorio, president and CFO of The Medicines Company stated, “This settlement further confirms the strength of our Angiomax patents and, we believe, is a common sense approach to resolving this litigation.”
The other terms of the agreement are confidential. The agreement will be submitted to the applicable governmental agencies for review.
In October 2011, MDCO received a Paragraph IV Certification Notice Letter from a subsidiary of Sun Pharma notifying MDCO that the subsidiary had submitted an ANDA to the US Food and Drug Administration for approval to market a generic version of Angiomax. In November 2011, MDCO filed a patent infringement lawsuit against Sun. The complaint, filed in the US District Court for the District of New Jersey, alleged infringement of above patent Nos.
MDCO remains in infringement litigation involving US Patent Nos. 7,582,727 and 7,598,343 with Hospira, Inc., Mylan Pharmaceuticals, Dr Reddy’s Laboratories, Apotex Inc., Accord Healthcare Inc. USA, Aurobindo Pharma Ltd. and Exela Pharma Sciences, LLC.
The Medicines Company's operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, New Jersey, USA and Zurich, Switzerland.