tumsasedgars
tumsasedgars / iStockphoto.com
10 September 2018Americas

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.

Did you enjoy reading this story?  Sign up to our free daily newsletters and get stories sent like this straight to our inbox.

Already registered?

Login to your account

To request a FREE 2-week trial subscription, please signup.
NOTE - this can take up to 48hrs to be approved.

Two Weeks Free Trial

For multi-user price options, or to check if your company has an existing subscription that we can add you to for FREE, please email Adrian Tapping at atapping@newtonmedia.co.uk


More on this story

Americas
1 August 2018   Generic drug maker Amneal has secured a finding of non-infringement in a Hatch-Waxman case over kidney disease drug Sensipar (cinacalcet hydrochloride).
Americas
22 March 2022   US pharma company HDT Bio has accused Emcure Pharmaceuticals of the “blatant theft” of its COVID-19 vaccine technology in a new lawsuit.
Big Pharma
17 May 2022   Indian pharmaceutical company Emcure has asked a Washington court to toss a lawsuit accusing the company of stealing trade secrets related to a COVID-19 vaccine.

More on this story

Americas
1 August 2018   Generic drug maker Amneal has secured a finding of non-infringement in a Hatch-Waxman case over kidney disease drug Sensipar (cinacalcet hydrochloride).
Americas
22 March 2022   US pharma company HDT Bio has accused Emcure Pharmaceuticals of the “blatant theft” of its COVID-19 vaccine technology in a new lawsuit.
Big Pharma
17 May 2022   Indian pharmaceutical company Emcure has asked a Washington court to toss a lawsuit accusing the company of stealing trade secrets related to a COVID-19 vaccine.

More on this story

Americas
1 August 2018   Generic drug maker Amneal has secured a finding of non-infringement in a Hatch-Waxman case over kidney disease drug Sensipar (cinacalcet hydrochloride).
Americas
22 March 2022   US pharma company HDT Bio has accused Emcure Pharmaceuticals of the “blatant theft” of its COVID-19 vaccine technology in a new lawsuit.
Big Pharma
17 May 2022   Indian pharmaceutical company Emcure has asked a Washington court to toss a lawsuit accusing the company of stealing trade secrets related to a COVID-19 vaccine.