FDA Orange Book · active-ingredient family
Bimatoprost
Bimatoprost is approved as 5 brand and 15 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ZOLYMBUS · NDA 217307
5
Brand (NDA)
15
Generics (ANDA)
9
Listed patents
1
Exclusivity periods
Brand (NDA) products · gel, implant, solution/drops
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ZOLYMBUSRLD | THEA PHARMA | NDA 217307 | — | Sep 09, 2025 | |
| DURYSTARLD | ABBVIE | NDA 211911 | — | Mar 04, 2020 | |
| LUMIGANRLD | ABBVIE | NDA 022184 | AB | Aug 31, 2010 | |
| LATISSERLD | ABBVIE | NDA 022369 | AT | Dec 24, 2008 | |
| LUMIGANRLD | ABBVIE | NDA 021275 | — | Mar 16, 2001 |
Generic (ANDA) products (15)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BIMATOPROST | AMNEAL | ANDA 217289 | AB | Sep 22, 2025 | |
| BIMATOPROST | MANKIND PHARMA | ANDA 218196 | AB | Mar 17, 2025 | |
| BIMATOPROST | EUGIA PHARMA | ANDA 205537 | AT | Oct 06, 2022 | |
| BIMATOPROST | MICRO LABS | ANDA 202505 | AT | Sep 08, 2020 | |
| BIMATOPROST | ALEMBIC | ANDA 210515 | AT | Jan 21, 2020 | |
| BIMATOPROST | SOMERSET THERAPS LLC | ANDA 207601 | AT | Jun 19, 2019 | |
| BIMATOPROST | ALEMBIC | ANDA 210263 | AT | Apr 12, 2019 | |
| BIMATOPROST | GLAND | ANDA 210126 | AT | Mar 22, 2019 | |
| BIMATOPROST | HIKMA | ANDA 203299 | — | Nov 08, 2018 | |
| BIMATOPROST | HIKMA | ANDA 203051 | — | Oct 09, 2018 | |
| BIMATOPROST | SANDOZ | ANDA 202719 | AT | Apr 19, 2016 | |
| BIMATOPROST | APOTEX | ANDA 090449 | AT | Jul 20, 2015 | |
| BIMATOPROST | SANDOZ | ANDA 202565 | AT | May 05, 2015 | |
| BIMATOPROST | LUPIN | ANDA 203991 | — | Feb 20, 2015 | |
| BIMATOPROST | APOTEX | ANDA 201894 | — | Dec 01, 2014 |
Marketing exclusivity (1)
- NDFNew dosage form exclusivity (3 years)
Sep 09, 2028
in 2 yr 3 mo
Listed patents (9)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10441543 | Dec 19, 2026 | in 6 mo | Product |
| 9149428 | Dec 19, 2026 | in 6 mo | Product |
| 8206737 | Apr 07, 2027 | in 10 mo | U-2759 |
| 7851504 | Jun 13, 2027 | in 1 yr | SubstanceProduct |
| 7799336 | Apr 24, 2029 | in 2 yr 11 mo | Product |
| 8629185 | Jul 15, 2031 | in 5 yr 2 mo | SubstanceProduct |
| 9980974 | Oct 31, 2034 | in 8 yr 6 mo | U-2759 |
| 9492316 | Oct 31, 2034 | in 8 yr 6 mo | Product |
| 10314780 | Jun 08, 2036 | in 10 yr 1 mo | ProductU-1295 |
Bimatoprost — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
