Cipla launches generic Sensipar amid legal battle with Amgen

Pharmaceutical major Cipla and its subsidiary Cipla USA announced the phased launch of a generic therapeutic equivalent version of Sensipar, a branded drug manufactured by Amgen Inc.

The launch, however, is a subject of ongoing litigation, Cipla said in a regulatory filing.

Amgen’s Sensipar generated US sales of $1.43 billion in 2018.

Cinacalcet hydrochloride tablets in doses of 30 mg, 60 mg and 90 are used for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) 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.

Secondary hyperparathyroidism is the medical condition of excessive secretion of parathyroid hormone (PTH) by the parathyroid glands in response to hypocalcemia (low blood calcium levels). This disorder is primarily seen in patients with chronic kidney failure.

Hypercalcemia is a condition in which the calcium level in blood is above normal. Too much calcium in blood can weaken bones, create kidney stones, and interfere with how heart and brain work. Hypercalcemia is usually a result of overactive parathyroid glands.

Parathyroid carcinoma is a rare cancer resulting in parathyroid adenoma to carcinoma progression. It forms in tissues of one or more of the parathyroid glands.

Meanwhile, the US District Court of Delaware denied Amgen’s request for preliminary injunction to stop Cipla’s continued sale of its generic cinacalcet hydrochloride tablets in the USA.

Both Cipla and Amgen have been engaged in legal battle over the sales of generic Sensipar tablets.

In January, Israel drugmaker Teva received final approval from the USFDA for sales of generic Sensipar tablets, but reached a patent agreement with Amgen to enter the market in mid-2021. Cipla had announced its intention to launch generic Sensipar pills in March.

In its antitrust lawsuit, Cipla alleged that Amgen paid to license Teva products under the companies’ patent settlement, which resulted in Teva pulling its generic off the market shortly after launch.

The move is likely to bring down cost of treatment for US citizens suffering from kidney disease, hypercalcemia and parathyroid carcinoma.

In March, Mumbai-based healthcare firm and Cipla’s competitor, Piramal Enterprises had launched a generic version of Amgen’s Sensipar pills.

Amgen challenged Piramal’s license to manufacture a bio-equivalent version of the drug soon after the Indian company got the regulatory nod in August last year.

However, Piramal received a favourable US district court ruling which holds that Piramal’s generic version does not infringe any of the asserted claims of Amgen’s Patent No. 9,375,405.

Headquartered in Mumbai, Cipla primarily develops medicines to treat respiratory, cardiovascular disease, arthritis, diabetes, weight control, depression and other medical conditions. It has 34 manufacturing units in 8 locations across India and its presence in 100 countries.