The FDA has approved the first generic versions of Amgen’s Sensipar to treat secondary hyperparathyroidism in patients on dialysis.
The FDA’s Center for Drug Evaluation and Research (CDER) announced the approval for the cinacalcet hydrochloride tables on March 8. The FDA “considers first generics to be important to public health, and prioritizes review of these submissions,” the agency wrote on its website in approving the generic versions.
The approvals are for drug manufacturers Cipla Limited and Aurobindo Pharma Limited. Both generics will be available in 30-mg, 60-mg and 90-mg dosage strengths.
Amgen reported Sensipar sales were flat in the fourth quarter of 2017 compared to the fourth quarter of the previous year ($413 million vs. $411 million), but up 9% overall for the year compared to 2016 ($1.718 billion vs. $1.582 billion). The company first received FDA approval for Sensipar in 2004.
Earlier this year, the District of Columbia’s District Court denied Amgen a 6-month extension of market exclusivity for Sensipar after Amgen had appealed to the FDA for pediatric exclusivity.
The FDA approvals also cover indications of hypercalcemia in adult patients with parathyroid carcinoma and severe hypercalcemia in adult patients with primary hyperparathyroidism who are unable to undergo parathyroidectomy.
It remains unclear when the Sensipar generics will launch in the U.S. market. Despite the approval, Aurobindo remains in litigation with Amgen over selling of the generic.