Generics
Teva and Amgen Resolve Ongoing Dispute Over Teva's Generic Cinacalet HCl Product
3 January 2019 - - Israeli generic drug specialist Teva Pharmaceutical Industries Ltd., (NYSE: TEVA) (TASE: TEVA) has resolved its ongoing dispute with US-based Amgen over Teva's generic cinacalcet HCl product, the company said.

Teva and Amgen have been involved in patent infringement litigation, and Teva recently received approval for, and launched its generic product in the US.

By virtue of the settlement, the litigation between the parties will be ended and Teva has agreed to stop selling its generic product until its license date in mid-year 2021, or earlier under certain circumstances.

Teva will pay Amgen an undisclosed amount as part of the settlement.

That amount and other terms of the settlement remain confidential.

Cinacalcet is a calcium-sensing receptor agonist indicated for secondary hyperparathyroidism in adult patients with chronic kidney disease on dialysis.

It is also used for the treatment of hypercalcemia in adult patients with parathyroid carcinoma and severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy.

Cinacalcet hydrochloride tablets are indicated for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on dialysis. Important Limitations of Use: cinacalcet hydrochloride tablets are NOT indicated for use in patients with CKD who are not on dialysis because of an increased risk of hypocalcemia.

Cinacalcet hydrochloride tablets are indicated for the treatment of hypercalcemia in adult patients with Parathyroid Carcinoma.

Cinacalcet hydrochloride tablets are indicated for the treatment of severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy.

Contraindications: Cinacalcet treatment initiation is contraindicated if serum calcium is less than the lower limit of the normal range.

Hypocalcemia: Cinacalcet lowers serum calcium and can lead to hypocalcemia. Significant lowering of serum calcium can cause paresthesias, myalgias, muscle spasms, tetany, seizures, QT interval prolongation and ventricular arrhythmia. Life threatening events and fatal outcomes associated with hypocalcemia have been reported in patients treated with cinacalcet, including in pediatric patients.

The safety and effectiveness of cinacalcet have not been established in pediatric patients.
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