FDA Orange Book · active-ingredient family
Brimonidine tartrate
Brimonidine tartrate is approved as 8 brand and 22 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LUMIFY PRESERVATIVE FREE · NDA 218424
8
Brand (NDA)
22
Generics (ANDA)
11
Listed patents
0
Exclusivity periods
Brand (NDA) products · gel, solution/drops
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LUMIFY PRESERVATIVE FREERLD | BAUSCH AND LOMB INC | NDA 218424 | — | Apr 19, 2024 | |
| LUMIFYRLD | BAUSCH AND LOMB INC | NDA 208144 | — | Dec 22, 2017 | |
| MIRVASORLD | GALDERMA LABS LP | NDA 204708 | AB | Aug 23, 2013 | |
| QOLIANARLD | SANDOZ | NDA 021764 | AT | May 22, 2006 | |
| ALPHAGAN PRLD | ABBVIE | NDA 021770 | AB | Aug 19, 2005 | |
| ALPHAGAN PRLD | ABBVIE | NDA 021262 | AT | Mar 16, 2001 | |
| ALPHAGANRLD | ALLERGAN | NDA 020613 | — | Sep 06, 1996 | |
| ALPHAGAN | ALLERGAN | NDA 020490 | — | Mar 13, 1997 |
Generic (ANDA) products (22)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BRIMONIDINE TARTRATE | MICRO LABS | ANDA 218558 | AB | May 07, 2026 | |
| BRIMONIDINE TARTRATE | MANKIND PHARMA | ANDA 220398 | AB | Apr 16, 2026 | |
| BRIMONIDINE TARTRATE | GLAND | ANDA 219219 | AB | Mar 11, 2026 | |
| BRIMONIDINE TARTRATE | UPSHER SMITH LABS | ANDA 217599 | — | Jul 30, 2025 | |
| BRIMONIDINE TARTRATE | LUPIN | ANDA 213215 | AB | Aug 26, 2024 | |
| BRIMONIDINE TARTRATE | SOMERSET THERAPS LLC | ANDA 216906 | AB | Aug 09, 2024 | |
| BRIMONIDINE TARTRATE | UPSHER SMITH LABS | ANDA 216772 | — | Jun 12, 2024 | |
| BRIMONIDINE TARTRATE | SANDOZ | ANDA 203172 | AB | Mar 04, 2024 | |
| BRIMONIDINE TARTRATE | DR REDDYS LABS SA | ANDA 216361 | — | Feb 16, 2024 | |
| BRIMONIDINE TARTRATE | MICRO LABS | ANDA 217846 | AT | Nov 22, 2023 | |
| BRIMONIDINE TARTRATE | ALEMBIC | ANDA 216909 | AB | Aug 01, 2023 | |
| BRIMONIDINE TARTRATE | ALEMBIC | ANDA 215225 | AT | Mar 29, 2023 | |
| BRIMONIDINE TARTRATE | APOTEX | ANDA 078480 | AB | Dec 21, 2022 | |
| BRIMONIDINE TARTRATE | APOTEX | ANDA 078479 | AT | Jan 31, 2022 | |
| BRIMONIDINE TARTRATE | PADAGIS ISRAEL | ANDA 209158 | AB | Sep 23, 2021 | |
| BRIMONIDINE TARTRATE | SOMERSET THERAPS LLC | ANDA 208992 | AT | Mar 11, 2019 | |
| BRIMONIDINE TARTRATE | REGCON HOLDINGS | ANDA 091691 | AT | Nov 18, 2014 | |
| BRIMONIDINE TARTRATE | SANDOZ | ANDA 078075 | AT | Jan 30, 2008 | |
| BRIMONIDINE TARTRATE | RISING | ANDA 076439 | AT | Mar 14, 2006 | |
| BRIMONIDINE TARTRATE | TEVA PARENTERAL | ANDA 076372 | — | Sep 10, 2004 | |
| BRIMONIDINE TARTRATE | SANDOZ | ANDA 076254 | AT | Sep 16, 2003 | |
| BRIMONIDINE TARTRATE | BAUSCH AND LOMB INC | ANDA 076260 | AT | May 28, 2003 |
Listed patents (11)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11596600 | Jul 27, 2029 | in 3 yr 2 mo | U-2222 |
| 11833245 | Jul 27, 2029 | in 3 yr 2 mo | U-2222 |
| 8293742 | Jul 14, 2030 | in 4 yr 2 mo | U-2222 |
| 9259425 | Jul 14, 2030 | in 4 yr 2 mo | U-2222 |
| 8513247 | Mar 25, 2031 | in 4 yr 10 mo | ProductU-1428 |
| 8513249 | Mar 25, 2031 | in 4 yr 10 mo | ProductU-1428 |
| 9861631 | Mar 25, 2031 | in 4 yr 10 mo | U-1428 |
| 9861632 | Mar 25, 2031 | in 4 yr 10 mo | U-1428 |
| 8053427 | Jun 13, 2031 | in 5 yr 1 mo | ProductU-1428 |
| 8163725 | Jun 13, 2031 | in 5 yr 1 mo | Product |
| 10201517 | Jun 13, 2031 | in 5 yr 1 mo | Product |
Brimonidine tartrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
