FDA Orange Book
Generic for Motegrity
Motegrity contains prucalopride. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Motegrity is prucalopride. 17 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Motegrity and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Motegrity products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 1MG BASE | Marketed (Rx) | AB | 17 | AB |
| tablet, oral | EQ 2MG BASE | Marketed (Rx) | AB | 17 | AB |
NDA 210166, held by TAKEDA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic prucalopride
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| NOVITIUM PHARMA LLC | 218492 | AB (A-rated, therapeutically equivalent) | December 26, 2024 | EQ 1MG BASE, EQ 2MG BASE |
| ALKEM LABORATORIES LTD | 218295 | AB (A-rated, therapeutically equivalent) | June 24, 2025 | EQ 1MG BASE, EQ 2MG BASE |
| AMNEAL PHARMACEUTICALS LLC | 218812 | AB (A-rated, therapeutically equivalent) | June 24, 2025 | EQ 1MG BASE, EQ 2MG BASE |
| ANNORA PHARMA PRIVATE LTD | 219160 | AB (A-rated, therapeutically equivalent) | June 24, 2025 | EQ 1MG BASE, EQ 2MG BASE |
| APOTEX INC | 218977 | AB (A-rated, therapeutically equivalent) | June 24, 2025 | EQ 1MG BASE, EQ 2MG BASE |
| APPCO PHARMA LLC | 218963 | AB (A-rated, therapeutically equivalent) | June 24, 2025 | EQ 1MG BASE, EQ 2MG BASE |
| BIONPHARMA INC | 219216 | AB (A-rated, therapeutically equivalent) | June 24, 2025 | EQ 1MG BASE, EQ 2MG BASE |
| HIKMA PHARMACEUTICALS USA INC | 217662 | AB (A-rated, therapeutically equivalent) | June 24, 2025 | EQ 1MG BASE, EQ 2MG BASE |
| LUPIN LTD | 218847 | AB (A-rated, therapeutically equivalent) | June 24, 2025 | EQ 1MG BASE, EQ 2MG BASE |
| MSN LABORATORIES PRIVATE LTD | 218177 | AB (A-rated, therapeutically equivalent) | June 24, 2025 | EQ 1MG BASE, EQ 2MG BASE |
| SOMERSET THERAPEUTICS LLC | 219078 | AB (A-rated, therapeutically equivalent) | June 24, 2025 | EQ 1MG BASE, EQ 2MG BASE |
| SPECGX LLC | 219193 | AB (A-rated, therapeutically equivalent) | June 24, 2025 | EQ 1MG BASE, EQ 2MG BASE |
| ZENARA PHARMA PRIVATE LTD | 218795 | AB (A-rated, therapeutically equivalent) | June 24, 2025 | EQ 1MG BASE, EQ 2MG BASE |
| ZYDUS LIFESCIENCES LTD | 218056 | AB (A-rated, therapeutically equivalent) | August 7, 2025 | EQ 1MG BASE, EQ 2MG BASE |
| AJANTA PHARMA LTD | 219220 | AB (A-rated, therapeutically equivalent) | January 16, 2026 | EQ 1MG BASE, EQ 2MG BASE |
| MICRO LABS LTD | 219180 | AB (A-rated, therapeutically equivalent) | June 29, 2026 | EQ 1MG BASE, EQ 2MG BASE |
| ALEMBIC PHARMACEUTICALS LTD | 219234 | AB (A-rated, therapeutically equivalent) | July 27, 2026 | EQ 1MG BASE, EQ 2MG BASE |
Motegrity exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| M-14 | Miscellaneous | July 10, 2028 | 210166 |
Motegrity NDC codes
Questions
Is there a generic for Motegrity?
Yes. The generic name for Motegrity is prucalopride. 17 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Motegrity?
The active ingredient in Motegrity is prucalopride, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.