PRINCETON, N.J., June 27, 2019 (GLOBE NEWSWIRE) -- SunGen Pharma, a privately held specialty pharmaceutical company which develops, contract manufactures, and sells pharmaceutical finished products, today announced to launch Bivalirudin for Injection in the near future through their joint venture Peterson Athenex with Athenex Pharmaceuticals (Nasdaq:ATNX). This tentatively approved US ANDA is exclusively licensed from the current ANDA holder, Hainan Shuangcheng Pharmaceuticals.
US Market Sales of Bivalirudin for Injection were $81.8M for the year ending December 2018 according to IQVIA data. Bivalirudin is an anticoagulant (thrombin inhibitor) that helps prevent the formation of blood clots.
Dr. Isaac Liu, Co-CEO and President of SunGen Pharma, stated, “We are proud to add Bivalirudin for Injection to our growing portfolio of specialty injectable products, as well as announce our third injectable product launch. We will continue to look for opportunities to launch products to fill marketplace needs. The launch of Bivalirudin demonstrates a strong development to our partnership with companies around the world. We look forward to collaborating further to bring specialty pharmaceutical drugs to the market.”
Bivalirudin ANDA was originally submitted to the US FDA in December 2016 and was tentatively approved in May 2018. In May 2019, ANDA holder submitted their PIV challenge application to US FDA and notified the RLD holder at the same time. Within 45 days of the notice, the RLD holder has not filed any lawsuit against the ANDA holder, which indicates success of the PIV challenge. Bivalirudin ANDA is currently waiting for US FDA’s final approval.
SunGen Pharma started its oral and topical research and development center in January 2016.
In August 2016, it entered into a Development and License Agreement with Elite Pharmaceuticals, Inc. to develop and commercialize four generic pharmaceutical products.
SunGen formed a sales and marketing joint venture with Athenex Pharmaceuticals in September 2016 named Peterson Athenex Pharmaceuticals, to market seven pharmaceutical products.
SunGen established its injectable division in October 2017 through the acquisition of a privately held pharmaceutical company based in Monmouth Junction, New Jersey. The company launched its first injectable product Terbutaline Sulfate as a prefilled liquid vial with a strength of 1mg/1ml. The product was launched on July 10th, 2017.
In August 2018, SunGen announced it has entered into a strategic manufacturing partnership with Grand River Aseptic Manufacturing to collaborate in the manufacturing and commercialization of generic injectable pharmaceutical products.
In March 2019, SunGen launched Busulfan injection through the acquisition of the ANDA from Sandoz.
SunGen and its partners have filed over 13 ANDAs by the end of Q1 2019, and have received 5 approvals from US FDA. The shortest ANDA approval time was ten months.
About SunGen Pharma LLC
SunGen Pharma, LLC is a privately held specialty pharmaceutical company which develops, contract manufactures, and sells pharmaceutical finished products. SunGen specializes in the development of oral solid extended release, topical and complex injectable products. SunGen has business partnerships with many North American, European and Asian-based generic pharmaceutical companies to develop, manufacture, and sell several pharmaceutical products around the world.
Contact:
SunGen Pharma LLC
Office: (609) 606-1070
www.sungenpharm.com