Teva Pharmaceuticals Inc, a US affiliate of Israel-based pharmaceutical company Teva Pharmaceutical Industries Ltd (NYSE:TEVA) (TASE:TEVA), announced on Friday the regulatory approval of its generic version of Forteo (teriparatide injection) in the United States.
This approval is set to enhance patient access to a crucial osteoporosis treatment. Market availability of the generic Forteo in the US is anticipated in the coming weeks.
Teriparatide injection is prescribed to address osteoporosis in specific demographics, including postmenopausal women at high fracture risk and men with primary or hypogonadal osteoporosis. It also caters to individuals with glucocorticoid-induced osteoporosis.
Forteo generated annual sales of USD609m as of July 2023, according to IQVIA data.
Teva has nearly 500 FDA-approved generic products, and 1 in 12 generic prescriptions dispensed in the United States is filled with a Teva generic product.
Its generic equivalent of Forteo employs the Antares Pharma Inc multi-dose pen device, part of an exclusive licence, development and supply agreement with Antares, a wholly owned subsidiary of Halozyme Therapeutics Inc (Nasdaq:HALO). This agreement encompasses the marketing of Teriparatide auto injector products in the EU and the forthcoming US market.
ScinoPharm Taiwan secures first US FDA approval for complex multiple sclerosis generic
ScinoPharm Taiwan's Glatiramer Acetate Injection approved by US FDA
International Isotopes Inc to change name to Radnostix Inc
Galmed Pharmaceuticals reports topline results for combination of Aramchol, Stivarga and metformin
Ingenus Pharmaceuticals' generic equivalent to Premarin receives US FDA approval
EirGenix signs second global exclusive licensing deal with Sandoz
Padagis invests USD36m to expand manufacturing in Minneapolis
Newbury Pharmaceuticals gains Danish approval for generic ivermectin cream