FDA Approves 2 Cinacalcet Hydrochloride Generics for HPT Market Competition

The US Food and Drug Administration (FDA) has approved the Abbreviated New Drug Applications for the first 2 generic versions of cinacalcet hydrochloride (Sensipar) tablets, for the treatment of a thyroid issue experienced by certain patients on dialysis.

The generics, from Cipla Limited and Aurobindo Pharma, have been indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with parathyroid carcinoma (PC), and severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy. They will be available in tablet form base doses of 30 mg, 60 mg, and 90 mg.

Sensipar, from Amgen, was denied a 6-month extension of market exclusivity by the District of Columbia’s District Court last month. The therapy was given FDA approval for HPT in patients with chronic kidney disease on dialysis in 2011. In 2017, the therapy generated $1.72 billion in revenue for Amgen — comprising 7.5% of their total annual earnings.

The approvals, marking the ninth and tenth generics greenlit in 2018, come on the heels of the FDA’s expressed intention to broaden the competitive market of generics.

In June 2017, the administration released a frequently-updated list of off-patent, off-exclusivity branded drugs that lacked generics, and implemented an expedited application process for limited-competition generic drugs.

FDA Commissioner Scott Gottlieb, MD, said at the time the market is in need of more accessible and affordable drug options for patients.

“I am committed to continuing to pursue additional policy steps, under the FDA’s current authority, to help reduce the burden on patients who have a difficult time paying for the medicines they need,” Gottlieb said.

Primary hyperparathyroidism currently affects between 1-4 patients per 1000 people, and is three-fold more likely to be diagnosed in women than men. It is most often diagnosed in older patients (aged 50 years and older).

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