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Teva launches generic testosterone Posted 08/09/2017

Teva Pharmaceutical Industries (Teva) has announced the exclusive launch of generic testosterone, previously marketed as Axiron by Eli Lilly and Co, on the US market.

A naturally occurring hormone, testosterone is also used medically to treat hormone deficiencies and breast cancer, as well as part of hormone therapy for transgender men. Due to its multiple uses, it has a large market and is sold under many brand names worldwide. In the US, testosterone is available in a range of forms including topical gels, solutions, skin patches and intranasal gels.

On 18 August 2017, Teva announced the launch of generic testosterone topical solution CIII (30 mg/1.5 mL) in the US, which is a prescription medicine used to treat men with testosterone deficiency.

Several conditions can lead to a lack (or even a total absence) of testosterone, including hypogonadism, as well as chemotherapy or even toxic damage caused by alcohol. Teva’s medicine is administered under the arm using a metered dose pump.

Generic testosterone could bring in significant sales for the company, as Eli Lilly’s branded equivalent Axiron had sales of over US$240 million in the US last year alone.

Teva’s President and CEO for Global Generic Medicines, North America Andy Boyer said the launch will help Teva to continue to ‘lead the industry’ in terms of generic products, adding: ‘We are pleased with the result in the district court, which has helped Teva add yet another product to our industry-leading generic [drug] portfolio, providing savings to our customers and to patients’.

The Israeli generics giant markets almost 600 generic medicines, which is the largest portfolio of US Food and Drug Administration (FDA)-approved generic products on the market. This means one in six generic drug prescriptions dispensed in the US is filled by Teva.

The company previously had a generic testosterone gel partnership with ANI Pharmaceuticals, which acquired 31 generics from Teva in 2013 [1]. Endo International (Endo) was the first pharmaceutical company to introduce a generic testosterone gel, which can be applied to the skin to treat men with hypogonadism [2].

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References
1. GaBI Online - Generics and Biosimilars Initiative. ANI Pharmaceuticals acquires 31 generics from Teva [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 8]. Available from: www.gabionline.net/Generics/News/ANI-Pharmaceuticals-acquires-31-generics-from-Teva
2. GaBI Online - Generics and Biosimilars Initiative. FDA approvals for generic AIDs and testosterone drugs [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 8]. Available from: www.gabionline.net/Generics/News/FDA-approvals-for-generic-AIDs-and-testosterone-drugs

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Source: Teva

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