Monday, February 12, 2018
Teva Pharmaceutical Industries Ltd., announced the launch of generic version of Syprine®1 (trientine hydrochloride) capsules, 250 mg, in the U.S.
Trientine hydrochloride is used in the treatment of patients with Wilson’s disease who are intolerant of penicillamine.
Wilson’s disease is a genetic disease that prevents the body from removing extra copper. The body needs a small amount of copper from food to stay healthy, but over time, high copper levels can cause life-threatening organ damage. Wilson’s disease is a rare disorder that affects approximately 1 in 30,000 individuals.2
“The launch of trientine hydrochloride capsules illustrates Teva’s commitment to serving patient populations in need—whether it’s a medicine that could be taken by millions of individuals, or one focused on a rare condition disorder like Wilson’s disease,” said Brendan O’Grady, Executive Vice President and Head of North America Commercial at Teva.
“Trientine hydrochloride capsules were included on the FDA’s recent publication of a list of off-patent, off-exclusivity branded drugs without approved generics,” said Hafrun Fridriksdottir, Executive Vice President, Global R&D, Teva. “Teva filed our ANDA more than two years ago and we are pleased that the FDA has now approved our applications and we are able to offer a lower-cost generic alternative to patients. We look forward to working closely with the FDA on their review of our many other generic applications.”
With nearly 600 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market and holds the leading position in first-to-file opportunities, with over 100 pending first-to-files in the U.S. Currently, one in seven generic prescriptions dispensed in the U.S. is filled with a Teva generic product.
Trientine hydrochloride had annual sales of approximately $155 million in the U.S. according to IMS data as of November 2017.