Request Trial
pills_istock-658027778_vladimirsorokin-
vladimirsorokin / iStockphoto.com
30 May 2017Americas

Amgen sues FDA to get paediatric exclusivity for Sensipar

Amgen has filed a complaint against the US Food and Drug Administration (FDA) for not accepting its study reports and denying six months of paediatric exclusivity for its drug Sensipar (cinacalcet).

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
Teva can pursue monopoly claims over rival’s ‘exclusive pharmacy deal’
7 May 2026   A California judge has denied Corcept’s bid to dismiss the lawsuit over its drug for a rare hormonal disorder, allowing the litigation to proceed on all core counts.
Americas
US judge allows rare patent defence in ‘world’s smallest heart pump’ suit
5 May 2026   J&J’s Abiomed can proceed with its non-infringement defence despite potential future appellate reversal, in a week when both parties in the case were dealt wins and losses in their clash over Impella devices.
Americas
WATCH: Interview with Ben Doranz, president and CEO, Integral Molecular
4 May 2026   LSIPR's senior reporter Marisa Woutersen speaks with Ben Doranz of Integral Molecular, fresh from the stage at LSPN Boston after speaking at a panel session on challenges in antibody patent protection.


Editor's picks

From the courtroom: Hikma v Amarin SCOTUS oral arguments
Americas
From the courtroom: Hikma v Amarin SCOTUS oral arguments
30 April 2026

Editor's picks

Americas
From the courtroom: Hikma v Amarin SCOTUS oral arguments
30 April 2026
Biotechnology
Closing the women's health gap offers ‘benefits for all’
7 April 2026
Europe
European patent offices raise fees
2 April 2026
Americas
Argentina’s patent reset: Why pharma can no longer ignore Latin America's second-largest market
1 April 2026
Europe
WIPR debuts Global In-House Elite 2026
26 March 2026
Biotechnology
mRNA litigation: Who’s winning, who’s filing, and what’s next
25 March 2026

More features

IP in the deal room: The risks that bite before, during and after closing
Teva can pursue monopoly claims over rival’s ‘exclusive pharmacy deal’
Five generations at work: How teams are bridging the gap
Kilpatrick adds tech patent litigator and China expert to Chicago office
US judge allows rare patent defence in ‘world’s smallest heart pump’ suit
WATCH: John Ward, trademarks VP and associate GC of Moderna, at INTA
WATCH: Interview with Ben Doranz, president and CEO, Integral Molecular
Brussels under scrutiny for IP policy as US flags risks to innovation