Cipla, Amgen settle case involving generic cinacalcet hydrochloride tablets

Drug major Cipla on Monday said it has reached a settlement with Amgen Inc on pending litigation involving generic cinacalcet hydrochloride tablets, used in treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease.

“The civil action filed by Cipla Ltd and Cipla USA Inc, wholly owned step-down subsidiary of Cipla Ltd (hereinafter together referred to as Cipla), in the US District Court for the District of Delaware in January 2019 has been resolved as between Cipla and Amgen Inc,” Cipla said in a regulatory filing.

A formal stipulation of dismissal has been filed with the court and is awaiting signature by the presiding Judge, the filing added.

It further said “the resolution entitles Cipla and its affiliates to continue importing, marketing, and selling its generic cinacalcet hydrochloride tablets in the United States”.

Cipla’s cinacalcet hydrochloride tablets, in the strengths of 30mg, 60mg and 90mg, are generic versions of Sensipar, a branded drug marketed by Amgen Inc.

Cinacalcet tablets are indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease on dialysis, for the treatment of hypercalcemia in adult patients with Parathyroid Carcinoma, and for treatment of severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy.

Shares of Cipla were trading 1.43% lower at ₹679.75 apiece on the BSE.