Is there a generic for Prucalopride succinate?

Yes. The FDA Orange Book lists 18 approved generic (ANDA) applications for Prucalopride succinate, referencing the brand MOTEGRITY. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Prucalopride succinate?

MOTEGRITY (NDA 210166, TAKEDA PHARMS USA) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

Does Prucalopride succinate have FDA marketing exclusivity?

Yes. The Orange Book records 2 marketing-exclusivity periods for Prucalopride succinate. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Prucalopride succinate are approved?

Prucalopride succinate is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Prucalopride succinate

Prucalopride succinate: 1 brand, 18 generics; first approved Dec 14, 2018; generic available.

Generic available2 exclusivity periodsHas discontinued products

Generic status & protection

Generic available: 18 ANDA applications approved.

Latest exclusivity ends Jul 10, 2028

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Brand (NDA) products

Originator applications

MOTEGRITYRLD
TAKEDA PHARMS USANDA 21016620182 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1MG BASE TABLET ORAL Rx AB
EQ 2MG BASE TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE	TABLET	ORAL	Rx	AB
EQ 2MG BASE	TABLET	ORAL	Rx	AB

Generic (ANDA) products (18)

Abbreviated applications

PRUCALOPRIDE SUCCINATE
MICRO LABSANDA 21918020262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1MG BASE TABLET ORAL Rx AB
EQ 2MG BASE TABLET ORAL Rx AB
PRUCALOPRIDE SUCCINATE
TEVA PHARMS INCANDA 21907120262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1MG BASE TABLET ORAL Rx AB
EQ 2MG BASE TABLET ORAL Rx AB
PRUCALOPRIDE SUCCINATE
AJANTA PHARMA LTDANDA 21922020262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1MG BASE TABLET ORAL Rx AB
EQ 2MG BASE TABLET ORAL Rx AB
PRUCALOPRIDE SUCCINATE
ZYDUS LIFESCIENCESANDA 21805620252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1MG BASE TABLET ORAL Rx AB
EQ 2MG BASE TABLET ORAL Rx AB
PRUCALOPRIDE SUCCINATE
ALKEM LABS LTDANDA 21829520252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1MG BASE TABLET ORAL Rx AB
EQ 2MG BASE TABLET ORAL Rx AB
PRUCALOPRIDE SUCCINATE
AMNEALANDA 21881220252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1MG BASE TABLET ORAL Rx AB
EQ 2MG BASE TABLET ORAL Rx AB
PRUCALOPRIDE SUCCINATE
ANNORA PHARMAANDA 21916020252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1MG BASE TABLET ORAL Rx AB
EQ 2MG BASE TABLET ORAL Rx AB
PRUCALOPRIDE SUCCINATE
APOTEXANDA 21897720252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1MG BASE TABLET ORAL Rx AB
EQ 2MG BASE TABLET ORAL Rx AB
PRUCALOPRIDE SUCCINATE
APPCOANDA 21896320252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1MG BASE TABLET ORAL Rx AB
EQ 2MG BASE TABLET ORAL Rx AB
PRUCALOPRIDE SUCCINATE
H2-PHARMAANDA 21921620252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1MG BASE TABLET ORAL Rx AB
EQ 2MG BASE TABLET ORAL Rx AB
PRUCALOPRIDE SUCCINATE
HIKMAANDA 21766220252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1MG BASE TABLET ORAL Rx AB
EQ 2MG BASE TABLET ORAL Rx AB
PRUCALOPRIDE SUCCINATE
LUPINANDA 21884720252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1MG BASE TABLET ORAL Rx AB
EQ 2MG BASE TABLET ORAL Rx AB
PRUCALOPRIDE SUCCINATE
MSNANDA 21817720252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1MG BASE TABLET ORAL Rx AB
EQ 2MG BASE TABLET ORAL Rx AB
PRUCALOPRIDE SUCCINATE
SOMERSET THERAPANDA 21907820252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1MG BASE TABLET ORAL Rx AB
EQ 2MG BASE TABLET ORAL Rx AB
PRUCALOPRIDE SUCCINATE
SPECGX LLCANDA 21919320252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1MG BASE TABLET ORAL Rx AB
EQ 2MG BASE TABLET ORAL Rx AB
PRUCALOPRIDE SUCCINATE
TORRENTANDA 21877820252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1MG BASE TABLET ORAL Discontinued —
EQ 2MG BASE TABLET ORAL Discontinued —
PRUCALOPRIDE SUCCINATE
ZENARAANDA 21879520252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1MG BASE TABLET ORAL Rx AB
EQ 2MG BASE TABLET ORAL Rx AB
PRUCALOPRIDE SUCCINATE
NOVITIUM PHARMAANDA 21849220242 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1MG BASE TABLET ORAL Rx AB
EQ 2MG BASE TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE	TABLET	ORAL	Rx	AB
EQ 2MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE	TABLET	ORAL	Rx	AB
EQ 2MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE	TABLET	ORAL	Rx	AB
EQ 2MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE	TABLET	ORAL	Rx	AB
EQ 2MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE	TABLET	ORAL	Rx	AB
EQ 2MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE	TABLET	ORAL	Rx	AB
EQ 2MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE	TABLET	ORAL	Rx	AB
EQ 2MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE	TABLET	ORAL	Rx	AB
EQ 2MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE	TABLET	ORAL	Rx	AB
EQ 2MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE	TABLET	ORAL	Rx	AB
EQ 2MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE	TABLET	ORAL	Rx	AB
EQ 2MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE	TABLET	ORAL	Rx	AB
EQ 2MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE	TABLET	ORAL	Rx	AB
EQ 2MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE	TABLET	ORAL	Rx	AB
EQ 2MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE	TABLET	ORAL	Rx	AB
EQ 2MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE	TABLET	ORAL	Discontinued	—
EQ 2MG BASE	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE	TABLET	ORAL	Rx	AB
EQ 2MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE	TABLET	ORAL	Rx	AB
EQ 2MG BASE	TABLET	ORAL	Rx	AB

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

M-14New use / labeling-change exclusivity (3 years)
Jul 10, 2028
in 2 yr
M-14New use / labeling-change exclusivity (3 years)
Jul 10, 2028
in 2 yr

Listed patents

Orange Book patent file

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Approval history

FDA approval span

First approval

Dec 14, 2018

7 yr 9 mo ago

Most recent approval

Jun 29, 2026

1 mo ago

Approvals span 2018–2026 across 19 FDA applications.

Brand (NDA) 15%

Generic (ANDA) 1895%

Prucalopride succinate: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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