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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 210166


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NDA 210166 describes MOTEGRITY, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from one supplier. Additional details are available on the MOTEGRITY profile page.

The generic ingredient in MOTEGRITY is prucalopride succinate. Seventeen suppliers are listed for this compound. Additional details are available on the prucalopride succinate profile page.
Summary for 210166
Tradename:MOTEGRITY
Applicant:Takeda Pharms Usa
Ingredient:prucalopride succinate
Patents:0
Pharmacology for NDA: 210166
Mechanism of ActionSerotonin 4 Receptor Agonists
Suppliers and Packaging for NDA: 210166
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MOTEGRITY prucalopride succinate TABLET;ORAL 210166 NDA Takeda Pharmaceuticals America, Inc. 54092-546 54092-546-01 30 TABLET, FILM COATED in 1 BOTTLE (54092-546-01)
MOTEGRITY prucalopride succinate TABLET;ORAL 210166 NDA Takeda Pharmaceuticals America, Inc. 54092-547 54092-547-01 30 TABLET, FILM COATED in 1 BOTTLE (54092-547-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:Dec 14, 2018TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Jul 10, 2028
Regulatory Exclusivity Use:ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2MG BASE
Approval Date:Dec 14, 2018TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Jul 10, 2028
Regulatory Exclusivity Use:ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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