Piramal Enterprises on March 12 said it has launched generic cinacalcet hydrochloride tablets in the US, through its partner Slate Run Pharmaceuticals.
Piramal has partnered with Slate to develop a non-infringing formulation of cinacalcet hydrochloride tablets used in reducing levels of parathyroid hormone (PTH), calcium, and phosphorous in people who are on long-term dialysis for chronic kidney disease.
Piramal received the final Abbreviated New Drug Application (ANDA) approval for its generic version of Amgen’s Sensipar (cinacalcet hydrochloride) tablets on August 1, 2018.
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.
Amgen’s Sensipar generated US sales of $1.43 billion in 2018.
Amgen has filed an appeal which is currently pending in the US Court of Appeals for the Federal Circuit.
Teva received final ANDA approval for cinacalcet, but reached a patent settlement with Amgen, to enter the market in mid-2021. Cipla launched the generic Sensipar early this month, but the product is still pending for litigation.
Shares of Piramal closed at Rs 2,629.50, down 0.75 percent on BSE on March 12, while the benchmark Sensex gained 1.30 percent to end at 37,535.66 points.