Posted from: Thursday, February 07, 2019 - 05:18 PM - Present

Teva Ceases Sales of Sensipar Generic

January 2, 2019 – Teva Pharmaceuticals has announced that it will cease sales of its generic cinacalcet tablets following the resolution of a patent dispute with Amgen, the maker of Sensipar® (cinacalcet).

In 2018, Teva launched its generic for Sensipar at a 25% discount to the brand name product. Under the new settlement, Teva has agreed to end sales of its generic until mid-2021. However, if certain undisclosed conditions are met, sales may resume sooner.

A total of eight generics for Sensipar have received FDA approval. Amgen is currently pursuing patent litigation against Piramal, Amneal, and Zydu in regards to their generics, and has reached settlements with Mylan and Cipla.

Sensipar first received FDA approval in 2004, and is indicated to treat secondary hyperparathyroidism (HPT) or hypercalcemia in patients who meet certain criteria. Although Amgen’s primary patent for the drug has expired, the company holds a formulation patent that is valid until 2026.

 

Last Updated Tuesday, April 16, 2019 - 11:20 PM.