FDA Orange Book · active-ingredient family
Brimonidine tartrate; timolol maleate
Brimonidine tartrate; timolol maleate is approved as 1 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:COMBIGAN · NDA 021398
1
Brand (NDA)
10
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution/drops
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| COMBIGANRLD | ABBVIE | NDA 021398 | AB | Oct 30, 2007 |
Generic (ANDA) products (10)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | CAPLIN | ANDA 219093 | AB | Feb 25, 2025 | |
| BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | AMNEAL | ANDA 217288 | — | Dec 30, 2024 | |
| BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | SOMERSET | ANDA 216114 | AB | Sep 10, 2024 | |
| BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | GLENMARK PHARMS LTD | ANDA 214987 | AB | May 16, 2024 | |
| BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | ALEMBIC | ANDA 215230 | AB | Aug 25, 2023 | |
| BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | UPSHER SMITH LABS | ANDA 215598 | AB | Dec 12, 2022 | |
| BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | SENTISS | ANDA 091086 | AB | Oct 31, 2022 | |
| BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | REGCON HOLDINGS | ANDA 201949 | AB | Oct 04, 2022 | |
| BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | APOTEX | ANDA 091442 | AB | Apr 20, 2022 | |
| BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | SANDOZ | ANDA 091087 | AB | Apr 04, 2022 |
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.
Brimonidine tartrate; timolol maleate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
