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Teva, Amgen settle patent dispute over generic drug for thyroid disorder

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Teva, Amgen settle patent dispute over generic drug for thyroid disorder

Teva Pharmaceutical Industries Ltd. and Amgen Inc. agreed to settle an ongoing patent dispute over Teva's generic version of the drug cinacalcet hydrochloride.

Israel-based Teva will pay Amgen an undisclosed amount and halt distribution of its generic product until its license date in mid-year of 2021 or earlier under certain circumstances. The U.S. Food and Drug Administration approved Teva's generic copy of cinacalcet in December 2018.

Cinacalcet, marketed by Amgen as Mimpara, is used to treat secondary hyperparathyroidism — a condition in which the parathyroid glands produce too much parathyroid hormone, causing hypercalcaemia or high levels of calcium in the blood — in adult patients with chronic kidney disease on dialysis.

The drug is also indicated to treat hypercalcemia in adult patients with parathyroid carcinoma, as well as severe hypercalcemia in adult patients with primary hyperparathyroidism who are unable to undergo parathyroidectomy, a surgical procedure to remove the parathyroid glands.

The settlement agreement will end the litigation process between Teva and Amgen.