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|February 09, 2018 9:01 a.m.|
|Teva Announces Launch of a Generic Version of Syprine® in the United States|
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
With nearly 600 generic medicines available, Teva has the largest
Trientine hydrochloride had annual sales of approximately
About Trientine Hydrochloride Capsules
Trientine hydrochloride capsules are indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine. Clinical experience with trientine hydrochloride is limited and alternate dosing regimens have not been well-characterized; all endpoints in determining an individual patient's dose have not been well defined. Trientine hydrochloride and penicillamine cannot be considered interchangeable. Trientine hydrochloride should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects.
Unlike penicillamine, trientine hydrochloride is not recommended in cystinuria or rheumatoid arthritis. The absence of a sulfhydryl moiety renders it incapable of binding cystine and, therefore, it is of no use in cystinuria. In 15 patients with rheumatoid arthritis, trientine hydrochloride was reported not to be effective in improving any clinical or biochemical parameter after 12 weeks of treatment. Trientine hydrochloride is not indicated for treatment of biliary cirrhosis.
Important Safety Information
Trientine hydrochloride capsules are contraindicated in patients with hypersensitivity to this product. Patients should be observed closely for signs of possible hypersensitivity. There have been reports of asthma, bronchitis and dermatitis occurring after prolonged environmental exposure with other uses of trientine hydrochloride.
Patient experience with trientine hydrochloride is limited. Patients receiving trientine hydrochloride capsules should remain under regular medical supervision throughout the period of drug administration. Patients (especially women) should be closely monitored for evidence of iron deficiency anemia. Trientine hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
The following adverse reactions have been reported in a clinical study in patients with Wilson's disease who were on therapy with trientine hydrochloride: iron deficiency, systemic lupus erythematosus. In addition, the following adverse reactions have been reported in marketed use: dystonia, muscular spasm, myasthenia gravis. The following adverse reactions have been reported in a clinical study for another use of trientine hydrochloride capsules: heartburn; epigastric pain and tenderness; thickening, fissuring and flaking of the skin; hypochromic microcytic anemia; acute gastritis; aphthoid ulcers; abdominal pain; melena; anorexia; malaise; cramps; muscle pain; weakness; rhabdomyolysis.
For more information, please see accompanying Full Prescribing Information.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the launch and potential benefits of Teva's generic version of Syprine®, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:
and other factors discussed in our Annual Report on Form 20-F for the year ended December 31, 2016 (“Annual Report”) and in our other filings with the U.S. Securities and Exchange Commission (the “SEC”). Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to rely on these forward-looking statements. You are advised to consult any additional disclosures we make in our reports to the SEC on Form 6-K, as well as the cautionary discussion of risks and uncertainties under “Risk Factors” in our Annual Report. These are factors that we believe could cause our actual results to differ materially from expected results. Other factors besides those listed could also materially and adversely affect us. This discussion is provided as permitted by the Private Securities Litigation Reform Act of 1995.
1 Syprine® is a registered trademark of
Teva Pharmaceutical Industries Ltd.