Amgen takes on Emcure over Sensipar generic

Amgen has accused India-based Emcure Pharmaceuticals of patent infringement, in a bid to protect its drug Sensipar (cinacalcet hydrochloride).

Amgen filed its complaint on Friday, September 7 against Emcure and its US subsidiaries (Heritage Pharmaceuticals and Heritage Pharma) at the US District Court for the District of Delaware, accusing the companies of infringing US patent number 9,375,405.

The patent, called “Rapid dissolution formulation of a calcium receptor-active compound”, covers Sensipar, which is used to treat secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.

Emcure reportedly notified Amgen in July of the filing of an Abbreviated New Drug Application with the Food and Drug Administration that was seeking approval to market a generic version of Sensipar.

The notification alleged that the ‘405 patent is invalid, unenforceable, and/or would not be infringed by Emcure’s manufacture of a generic.

“Upon information and belief, defendants actively review pharmaceutical patents and seek opportunities to challenge those patents,” claimed the suit.

Amgen is seeking a judgment that the patent is infringed by Emcure and an order stopping the India-based company from selling the ANDA products in the US.

Amgen has undertaken numerous attempts to protect Sensipar, a drug which produced $1.7 billion in revenues last year.

Back in October 2016, Amgen filed complaints against Indian pharmaceutical companies Dr Reddy’s and Ajanta Pharma for allegedly infringing the ‘405 patent.

In the same month, Amgen took Apotex to court over the same patent. This was one month after Amgen filed a complaint against Indian drug company Micro Labs for infringement.

Last month, generic drug maker Amneal secured a finding of non-infringement in a Hatch-Waxman case over Sensipar.

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