Orange Book product · Brand (NDA)
ZOLYMBUS
BIMATOPROST
At a glance
Sep 09, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 09, 2025
9 mo ago
Today
Exclusivity ends · NDF
New dosage form exclusivity (3 years)
Sep 09, 2028
in 2 yr 3 mo
Patent 10314780 expires
Listed drug product patent expiration.
Jun 08, 2036
in 10 yr 1 mo
Pharmaceutical detail
Active ingredient
BIMATOPROST
Strength
0.01%
Dosage form
GEL
Route
OPHTHALMIC
TE code
Not listed
Application
NDA 217307
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2020DURYSTABrand (NDA)
NDA 211911 · ABBVIE
- 2010LUMIGANBrand (NDA)
NDA 022184 · ABBVIE
- 2008LATISSEBrand (NDA)
NDA 022369 · ABBVIE
- 2001LUMIGANBrand (NDA)
NDA 021275 · ABBVIE
- 2025BIMATOPROSTGeneric (ANDA)
ANDA 217289 · AMNEAL
- 2025BIMATOPROSTGeneric (ANDA)
ANDA 218196 · MANKIND PHARMA
- 2022BIMATOPROSTGeneric (ANDA)
ANDA 205537 · EUGIA PHARMA
- 2020BIMATOPROSTGeneric (ANDA)
ANDA 202505 · MICRO LABS
- 2020BIMATOPROSTGeneric (ANDA)
ANDA 210515 · ALEMBIC
- 2019BIMATOPROSTGeneric (ANDA)
ANDA 207601 · SOMERSET THERAPS LLC
- 2019BIMATOPROSTGeneric (ANDA)
ANDA 210263 · ALEMBIC
- 2019BIMATOPROSTGeneric (ANDA)
ANDA 210126 · GLAND
Marketing exclusivity (1)
- NDFNew dosage form exclusivity (3 years)
Sep 09, 2028
in 2 yr 3 mo
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10314780 | Jun 08, 2036 | in 10 yr 1 mo | ProductU-1295 |
