FDA Approves First Two Generics of Amgen’s Blockbuster Drug Sensipar
The US Food and Drug Administration (FDA) has approved two generic versions of Amgen’s Sensipar (cinacalcet hydrochloride), a calcium-reducer and one of its top-selling drugs, to Aurobindo Pharma, a Hyderabad, India-headquartered generics and active pharmaceutical ingredients manufacturer, and Cipla, a Mumbai, India-based pharmaceutical company. Sensipar had 2017 global sales of $1.71 billion.
The two generic drugs were approved for treating secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease on dialysis, hypercalcemia in adult patients with parathyroid carcinoma, and severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy.
The approvals follow a court-ruling against Amgen that denied it additional market exclusivity for Sensipar. Amgen suffered a setback in February 2018 in seeking pediatric exclusivity for Sensipar when a federal district court ruled in favor of the FDA, which had denied Amgen’s request for pediatric exclusivity, which would have provided the drug with six additional months of market exclusivity. Sensipar now faces generic-drug competition following the expiration (March 2018) of its composition of matter patent in the US.
The FDA also granted tentative approval for Sensipar generics to Teva Pharmaceutical Industries and Mylan.