Teva Pharma (TEVA) Announces US Approval of a Generic Version of Forteo

Teva Pharmaceuticals Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE: TEVA), announced today the approval of a generic version of Forteo®1, in the United States. Market availability of the product in the U.S. is expected in the coming weeks.

Teriparatide injection is indicated to treat osteoporosis among certain women and men. Please see the below “What is?” section for more information.

“We are thrilled to receive the long-awaited generic approval of this important drug-device combination product,” said Dr. Eric Hughes, Executive Vice President Global R&D and Chief Medical Officer. “This approval showcases Teva’s exceptional strengths in complex generic formulations development and device engineering, which support our ambitions to focus our generics pipeline on medicines that deliver the highest impact to patients. The approval will enhance access to a critical treatment option for patients while serving to demonstrate our strategic goal of sustaining a generic powerhouse.”

With nearly 500 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 approximately 100 pending first-to-files in the U.S. Currently, 1 in 12 generic prescriptions dispensed in the U.S. is filled with a Teva generic product.

Forteo® had annual sales of $609 million as of July 2023, according to IQVIA data.

Teva’s generic equivalent of Forteo® (teriparatide injection) utilizes the Antares Pharma, Inc. multi-dose pen device. Antares, a wholly owned subsidiary of Halozyme Therapeutics, Inc., and Teva are parties to an exclusive license, development and supply agreement for Teriparatide auto injector product that Teva markets in the EU and will market in the U.S.

What is teriparatide injection?

Teriparatide injection is a prescription medicine used to:

• treat postmenopausal women who have osteoporosis who are at high risk for having broken bones (fractures) or who cannot use other osteoporosis treatments. Teriparatide injection can lessen the chance of broken bones (fractures) in the spine and other bones in postmenopausal women with osteoporosis.
• increase the bone mass in men with primary or hypogonadal osteoporosis who are at high risk for having broken bones (fractures) or who cannot use other osteoporosis treatments.
• treat both men and women with osteoporosis due to use of glucocorticoid medicines, such as prednisone, for several months, who are at high risk for having broken bones (fractures) or who cannot use other osteoporosis treatments.

It is not known if Teriparatide injection is safe and effective in children.
Teriparatide injection should not be used in children and young adults whose bones are still growing.

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