The approval and subsequent launch will enhance access to a critical treatment option for patients while serving to demonstrate Teva’s strategic goal of sustaining a generic powerhouse

mufid-majnun-cM1aU42FnRg-unsplash

Forteo® (teriparatide injection) is indicated to treat osteoporosis among certain women and men. (Credit: Mufid Majnun on Unsplash)

Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries, announced today the approval of a generic version of Forteo, in the United States. Market availability of the product in the US 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 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.

Source: Company Press Release