FDA Orange Book · active-ingredient family
Prucalopride succinate
Prucalopride succinate is approved as 1 brand and 17 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MOTEGRITY · NDA 210166
1
Brand (NDA)
17
Generics (ANDA)
0
Listed patents
2
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MOTEGRITYRLD×2 | TAKEDA PHARMS USA | NDA 210166 | AB | Dec 14, 2018 |
Generic (ANDA) products (17)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PRUCALOPRIDE SUCCINATE×2 | TEVA PHARMS INC | ANDA 219071 | AB | Feb 05, 2026 | |
| PRUCALOPRIDE SUCCINATE×2 | AJANTA PHARMA LTD | ANDA 219220 | AB | Jan 16, 2026 | |
| PRUCALOPRIDE SUCCINATE×2 | ZYDUS LIFESCIENCES | ANDA 218056 | AB | Aug 07, 2025 | |
| PRUCALOPRIDE SUCCINATE×2 | ALKEM LABS LTD | ANDA 218295 | AB | Jun 24, 2025 | |
| PRUCALOPRIDE SUCCINATE×2 | AMNEAL | ANDA 218812 | AB | Jun 24, 2025 | |
| PRUCALOPRIDE SUCCINATE×2 | ANNORA PHARMA | ANDA 219160 | AB | Jun 24, 2025 | |
| PRUCALOPRIDE SUCCINATE×2 | APOTEX | ANDA 218977 | AB | Jun 24, 2025 | |
| PRUCALOPRIDE SUCCINATE×2 | APPCO | ANDA 218963 | AB | Jun 24, 2025 | |
| PRUCALOPRIDE SUCCINATE×2 | H2-PHARMA | ANDA 219216 | AB | Jun 24, 2025 | |
| PRUCALOPRIDE SUCCINATE×2 | HIKMA | ANDA 217662 | AB | Jun 24, 2025 | |
| PRUCALOPRIDE SUCCINATE×2 | LUPIN | ANDA 218847 | AB | Jun 24, 2025 | |
| PRUCALOPRIDE SUCCINATE×2 | MSN | ANDA 218177 | AB | Jun 24, 2025 | |
| PRUCALOPRIDE SUCCINATE×2 | SOMERSET THERAP | ANDA 219078 | AB | Jun 24, 2025 | |
| PRUCALOPRIDE SUCCINATE×2 | SPECGX LLC | ANDA 219193 | AB | Jun 24, 2025 | |
| PRUCALOPRIDE SUCCINATE×2 | TORRENT | ANDA 218778 | — | Jun 24, 2025 | |
| PRUCALOPRIDE SUCCINATE×2 | ZENARA | ANDA 218795 | AB | Jun 24, 2025 | |
| PRUCALOPRIDE SUCCINATE×2 | NOVITIUM PHARMA | ANDA 218492 | AB | Dec 26, 2024 |
Marketing exclusivity (2)
- M-14New use / labeling-change exclusivity (3 years)
Jul 10, 2028
in 2 yr 1 mo
- M-14New use / labeling-change exclusivity (3 years)
Jul 10, 2028
in 2 yr 1 mo
Listed patents
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.
Prucalopride succinate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
