bimatoprost Topical Solution

Brand(s)
Latisse
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Allergan, Inc. (2015-02-13)
Oldest Current Product
2009-01-26
License(s)
NDA
RxNORM
TOPICAL SOLUTION\BIMATOPROST
FDAOB
TOPICAL\SOLUTION_DROPS\BIMATOPROST
SPL Active
OPHTHALMIC\SOLUTION/DROPS\BIMATOPROST
SPL Moiety
OPHTHALMIC\SOLUTION/DROPS\BIMATOPROST

product(s) by strength(s)

bimatoprost 0.3 mg/ml topical solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000233616LatisseNDAAllergan, Inc.2009-01-26BIMATOPROSTOPHTHALMICSOLUTION/DROPSNDA02236934f83d9d-2c64-463e-8a90-9a460fedfead

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1ANDA201894BIMATOPROSTAPOTEX INC2014-12-01ANDA201894_001
2NDA022369LATISSEALLERGAN INC2008-12-24p7351404, TREATMENT OF HYPOTRICHOSIS OF THE EYELASHES BY INCREASING AND STIMULATING THEIR GROWTH INCLUDING LENGTH
p8632760, METHOD OF INCREASING EYELASH GROWTH
p8986715, METHOD OF INCREASING HAIR GROWTH
p7388029, TREATMENT OF HAIR LOSS AND HYPOTRICHOSIS OF THE EYELASHES BY INCREASING THEIR GROWTH INCLUDING LENGTH
p8926953, METHOD OF INCREASING HAIR GROWTH
p8906962, METHOD OF INCREASING HAIR GROWTH
p8758733, METHOD OF INCREASING EYELASH GROWTH
p8038988, TREATMENT OF HYPOTRICHOSIS OF THE EYELASHES BY INCREASING THEIR GROWTH INCLUDING LENGTH, SUBSTANCE
p8541466, METHOD OF INCREASING HAIR GROWTH
p8101161, METHOD OF INCREASING HAIR GROWTH/ METHOD OF STIMULATING HAIR GROWTH
p8263054, METHOD OF INCREASING EYELASH GROWTH INCLUDING LENGTH
INFORMATION ADDED TO THE PEDIATRIC USE SECTION OF THE LABELING REGARDING USE OF LATISSE IN PATIENTS WHO WERE POST-CHEMOTHERAPY OR HAD ALOPECIA AREATA [2017-09-04]NDA022369_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA201894_001RXBIMATOPROST (0.03%)TOPICALSOLUTION/DROPSFalseAT2014-12-01BIMATOPROST
2NDA022369_001RXBIMATOPROST (0.03%)TOPICALSOLUTION/DROPSTrueAT2008-12-24LATISSE

patent(s)

#idexpiration dateapplication(s)
1p7351404 (view patent)2024-05-25NDA022369
2p7388029 (view patent)2022-01-21NDA022369
3p8038988 (view patent)2023-08-25NDA022369
4p8101161 (view patent)2024-05-25NDA022369
5p8263054 (view patent)2023-01-15NDA022369
6p8541466 (view patent)2021-01-31NDA022369
7p8632760 (view patent)2023-01-15NDA022369
8p8758733 (view patent)2023-01-15NDA022369
9p8906962 (view patent)2021-01-31NDA022369
10p8926953 (view patent)2023-01-15NDA022369
11p8986715 (view patent)2023-01-15NDA022369

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
134f83d9d-2c64-463e-8a90-9a460fedfead (view SPL)These highlights do not include all the information needed to use LATISSE safely and effectively. See full prescribing information for LATISSE. LATISSE (bimatoprost ophthalmic solution) 0.03%Initial U.S. Approval: 2001prescriptionHuman PrescriptionAllergan, Inc.MANUFACTURE2015-02-1311000233616

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII