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MOTEGRITY

NDA

PRUCALOPRIDE SUCCINATE | N210166 | TAKEDA PHARMACEUTICALS USA INC

2 strengths0 unique patents1 unique exclusivity

Patent Timeline

0 unique patents, 1 exclusivity by expiration date

TodayExclusivity

2027

2028

Today

M-14

Jul. 10, 2028

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Pilnova Pharma Inc. FDA-2026-P-4391 · 8 docket documents Pilnova Pharma Inc. filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to submit an Abbreviated New Drug Application for Prucalopride Orodispersible Films in 1 mg and 2 mg strengths, which would change the dosage form from M	Suitability	2026-04-21	Open	Pilnova Pharma Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

10 trials from ClinicalTrials.gov, 9 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Absorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled Prucalopride Succinate in Volunteers NCT01807000	Phase 1	Completed	Shire	6	2013-03-18 → 2013-04-28
Comparator Study of PEG 3350 Versus Prucalopride in Females With Chronic Constipation NCT01251822	Phase 3	Completed	Norgine	240	2010-11 → 2011-12
M0001 Effects on Oral Contraceptive Plasma Levels NCT01036893	Phase 1	Completed	Movetis	16	2009-12 → 2010-05
Effect Comparison of Electro-acupuncture and Prucalopride for Severe Chronic Constipation: a Randomized Controlled Trial NCT02047045	N/A	Completed	Guang'anmen Hospital of China Academy of Chinese Medical Sciences	560	2014-04 → 2017-05
Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of YH12852 After Oral Administration in Healthy Male Subjects NCT01870674	Phase 1	Completed	Yuhan Corporation	127	2013-08 → 2015-04
Study to Investigate Prucalopride vs. Polyethylene Glycol 3350 on Colon Activity NCT01707667	Phase 4	Completed	Shire	13	2013-02-27 → 2013-11-27
Thorough Corrected QT Interval (QTc) Study To Evaluate Possible Effects of Prucalopride on ECG Parameters NCT00903747	Phase 1	Completed	Movetis	120	2009-01 → 2009-05
Efficacy and Safety of Prucalopride in Combination With Polyethylene Glycol or Lactulose in Women With Chronic Constipation NCT02228616	Phase 4	Completed	Xian-Janssen Pharmaceutical Ltd.	280	2014-10-14 → 2016-09-28
Effect of PEG, Bisacodyl and Prucalopride on Colonic Motility in Healthy Subjects NCT03279341	Phase 4	Completed	University Hospital, Gasthuisberg	10	2012-12-03 → 2016-03
Efficacy of Prucalopride Plus Polyethylene Glycol in Bowel Preparation for Colonoscopy NCT02781493	Phase 4	UNKNOWN	Shandong University	600	2016-06 → 2017-03

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$17.79

per ea

Lowest NADAC/Unit

$17.73

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
54092054701MOTEGRITY 2 MG TABLET	$17.79	EA	Brand	$0.6807	2026-06-17
54092054601MOTEGRITY 1 MG TABLET	$17.73	EA	Brand	$0.6735	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (2 FSS)

Lowest Price

$381.09

Highest Price

$382.50

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
54092-0546-01MOTEGRITY 1MG TAB	$381.09	FSS	Takeda Pharmaceuticals America, Inc.	08/14/2026
54092-0547-01MOTEGRITY 2MG TAB	$382.50	FSS	Takeda Pharmaceuticals America, Inc.	08/14/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Motegrity (2024)

Total Spending

$70.7M

Total Claims

91,612

Beneficiaries

21,866

Avg Cost/Unit

$17.43

Spending Trend

$6.0M(2019)→$22.6M(2020)→$33.4M(2021)→$48.7M(2022)→$61.9M(2023)→$70.7M(2024)

YoY Change:-1.4%

5yr CAGR:+4.3%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain13 active DMFs

12 active API suppliers hold Drug Master Files for this ingredient.

SYMED LABS LTDPRUCALOPRIDE SUCCINATE

DMF 348622020

METROCHEM API PRIVATE LTDPRUCALOPRIDE SUCCINATE

DMF 349702020

SHILPA PHARMA LIFESCIENCES LTDPRUCALOPRIDE SUCCINATE

DMF 350382020

SS PHARMA LLCPRUCALOPRIDE SUCCINATE

DMF 367652022

MEDICHEM MANUFACTURING (MALTA) LTDPRUCALOPRIDE SUCCINATE

DMF 371812022

MSN LABORATORIES PRIVATE LTDPRUCALOPRIDE SUCCINATE

DMF 373012022

BIOPHORE INDIA PHARMACEUTICALS PVT LTDPRUCALOPRIDE SUCCINATE

DMF 375762022

ALEMBIC PHARMACEUTICALS LTDPRUCALOPRIDE SUCCINATE

DMF 379112023

TORRENT PHARMACEUTICALS LTDPRUCALOPRIDE SUCCINATE

DMF 380842023

SUN PHARMACEUTICAL INDUSTRIES LTDPRUCALOPRIDE SUCCINATE

DMF 388932023

ERYTHRO PHARMA PRIVATE LTDPRUCALOPRIDE SUCCINATE ACID INTERMIDIATE

DMF 391882024

APITORIA PHARMA PRIVATE LTDPRUCALOPRIDE SUCCINATE

DMF 408602025

ERYTHRO PHARMA PRIVATE LTDPRUCALOPRIDE SUCCINATE

DMF 426092026

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Jul 11, 2025	SUPPL -4	View Letter (PDF)
Nov 10, 2020	SUPPL -2	View Letter (PDF)
Dec 20, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 1MG BASE

RLDAB

0 patents1 exclusivity▴

TABLET;ORAL | Approved: Dec 14, 2018

Exclusivities (1)

Code	Date	Status
M-14	Jul 10, 2028	Active

#002 — EQ 2MG BASE

RLDAB

0 patents1 exclusivity▾

TABLET;ORAL | Approved: Dec 14, 2018