Even as US-based Amgen Inc mounts a legal challenge, Piramal Enterprises said its US partner Slate Run Pharmaceuticals has launched the generic equivalent of Amgen’s hyperthyroidism drug Sensipar.
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.
Amgen has filed an appeal which is currently pending in the U.S. Court of Appeals for the Federal Circuit.
Now, Piramal has gone ahead with the launch, with the help of its US partner Slate Run.
Piramal’s launch is close on the heels of a similar move by India-based competitor Cipla, which too launched its generic version of Sensipar earlier this month.
The move is likely to bring down cost of treatment for US citizens suffering from kidney disease and
Cinacalcet hydrochloride is used in the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease on dialysis.
Piramal Group is a diversified business conglomerate which has presence in various areas such as financial services, pharmaceuticals, specialty glass packaging and real estate.