Prucalopride Succinate

Treats chronic idiopathic constipation (CIC). Sold as Motegrity. Every FDA application for this active ingredient: 1 branded and 19 generic.

As of Nov 15, 2026, FDA lists 20 applications for Prucalopride Succinate (sold as Motegrity), first approved Dec 14, 2018, with 1 new use approved and 0 published complete response letters.

First approved: Dec 14, 2018
Applications: 20
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $66.1M
First approved in the EU: Oct 14, 2009

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Motegrity	Part D	$45.9M	-35%	15,265
Prucalopride	Part D	$20.2M	New	16,658

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

PRUCALOPRIDE 1 MG TABLET: $0.634 per unitGeneric · -23% in a year
PRUCALOPRIDE 2 MG TABLET: $0.615 per unitGeneric · -19% in a year
MOTEGRITY 1 MG TABLET: $17.72 per unitBrand · 0% in a year
MOTEGRITY 2 MG TABLET: $17.75 per unitBrand · 0% in a year

Approvals in the EU (EMA)

First approved in the EU 110 months before the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Resolor, new substanceTakeda Pharmaceuticals International AG Ireland · Oct 14, 2009

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Dec 14, 2018	MotegrityNDA 210166 · New molecular entity	Takeda Pharms USA	2	Marketed
Dec 26, 2024	Prucalopride SuccinateANDA 218492	Novitium Pharma	1	Marketed
Jun 24, 2025	Prucalopride SuccinateANDA 217662	Hikma	0	Marketed
Jun 24, 2025	Prucalopride SuccinateANDA 218177	Msn	0	Marketed
Jun 24, 2025	Prucalopride SuccinateANDA 218295	Alkem Labs Ltd	0	Marketed
Jun 24, 2025	Prucalopride SuccinateANDA 218778	Torrent	0	Discontinued
Jun 24, 2025	Prucalopride SuccinateANDA 218795	Zenara	0	Marketed
Jun 24, 2025	Prucalopride SuccinateANDA 218812	Amneal	0	Marketed
Jun 24, 2025	Prucalopride SuccinateANDA 218847	Lupin	0	Marketed
Jun 24, 2025	Prucalopride SuccinateANDA 218963	Appco	0	Marketed
Jun 24, 2025	Prucalopride SuccinateANDA 218977	Apotex	0	Marketed
Jun 24, 2025	Prucalopride SuccinateANDA 219078	Somerset Therap	0	Marketed
Jun 24, 2025	Prucalopride SuccinateANDA 219160	Annora Pharma	0	Marketed
Jun 24, 2025	Prucalopride SuccinateANDA 219193	Specgx LLC	0	Marketed
Jun 24, 2025	Prucalopride SuccinateANDA 219216	Bionpharma	0	Marketed
Aug 7, 2025	Prucalopride SuccinateANDA 218056	Zydus Lifesciences	1	Marketed
Jan 16, 2026	Prucalopride SuccinateANDA 219220	Ajanta Pharma Ltd	0	Marketed
Feb 5, 2026	Prucalopride SuccinateANDA 219071	Teva Pharms Inc	0	Discontinued
Jun 29, 2026	Prucalopride SuccinateANDA 219180	Micro Labs	0	Marketed
Jul 27, 2026	Prucalopride SuccinateANDA 219234	Alembic	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA