Orange Book product · Brand (NDA)
LUMIGAN
BIMATOPROST
At a glance
Mar 16, 2001
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 16, 2001
25 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
BIMATOPROST
Strength
0.03% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
Not listed
Application
NDA 021275
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 2025ZOLYMBUSBrand (NDA)
NDA 217307 · THEA PHARMA
- 2020DURYSTABrand (NDA)
NDA 211911 · ABBVIE
- 2010LUMIGANBrand (NDA)
NDA 022184 · ABBVIE
- 2008LATISSEBrand (NDA)
NDA 022369 · 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
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.
