FDA Orange Book · active-ingredient family
Sucralfate
Sucralfate is approved as 2 brand and 14 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CARAFATE · NDA 019183
2
Brand (NDA)
14
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · suspension, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CARAFATERLD | ABBVIE | NDA 019183 | AB | Dec 16, 1993 | |
| CARAFATERLD | ABBVIE | NDA 018333 | AB | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (14)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SUCRALFATE | GLENMARK PHARMS LTD | ANDA 212141 | AB | Jan 05, 2026 | |
| SUCRALFATE | PADAGIS US | ANDA 211780 | AB | Apr 14, 2025 | |
| SUCRALFATE | COSETTE PHARMS NC | ANDA 217126 | AB | Nov 13, 2024 | |
| SUCRALFATE | HIKMA | ANDA 212769 | — | Jul 23, 2024 | |
| SUCRALFATE | STRIDES PHARMA | ANDA 216474 | AB | May 21, 2024 | |
| SUCRALFATE | ABON PHARMS LLC | ANDA 216726 | AB | Mar 21, 2024 | |
| SUCRALFATE | PD PARTNERS | ANDA 213549 | AB | Jan 17, 2024 | |
| SUCRALFATE | ZYDUS LIFESCIENCES | ANDA 215705 | AB | May 03, 2023 | |
| SUCRALFATE | MYLAN | ANDA 212913 | AB | Sep 12, 2022 | |
| SUCRALFATE | AMNEAL PHARMS | ANDA 215576 | AB | Apr 15, 2022 | |
| SUCRALFATE | VISTAPHARM LLC | ANDA 211884 | AB | Mar 15, 2022 | |
| SUCRALFATE | AMNEAL | ANDA 209356 | AB | Dec 02, 2019 | |
| SUCRALFATE | CHARTWELL RX | ANDA 074415 | AB | Jun 08, 1998 | |
| SUCRALFATE | TEVA | ANDA 070848 | AB | Mar 29, 1996 |
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.
Sucralfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
