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Last Updated: January 23, 2020

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GLYBURIDE - Generic Drug Details

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What are the generic sources for glyburide and what is the scope of patent protection?

Glyburide is the generic ingredient in seven branded drugs marketed by Sanofi Aventis Us, Actavis Elizabeth, Aurobindo Pharma, Cadila Pharms Ltd, Epic Pharma Llc, Heritage Pharms Inc, Impax Labs Inc, Orient Pharma Co Ltd, Pharmadax Inc, Teva, Zydus Pharms, Dava Pharms Inc, Hikma, Mylan, Yaopharma Co Ltd, Pharmacia And Upjohn, and Bristol Myers Squibb, and is included in twenty-seven NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for glyburide. Twenty-nine suppliers are listed for this compound.

Drug Prices for GLYBURIDE

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Drug Sales Revenue Trends for GLYBURIDE

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Recent Clinical Trials for GLYBURIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Ironwood Pharmaceuticals, Inc.Phase 1
Medical College of WisconsinPhase 4
The University of Texas Health Science Center, HoustonPhase 4

See all GLYBURIDE clinical trials

Recent Litigation for GLYBURIDE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Upjohn Company v. Mova Pharmaceutical1995-03-27

See all GLYBURIDE litigation

Pharmacology for GLYBURIDE
Drug ClassSulfonylurea
Medical Subject Heading (MeSH) Categories for GLYBURIDE
Synonyms for GLYBURIDE
(5-chloro-2-methoxyphenyl)-N-[2-(4-{[(cyclohexylamino)carbonylamino]sulfonyl}p henyl)ethyl]carboxamide
1-((p-(2-(5-Chloro-o-anisamido)ethyl)phenyl)sulfonyl)-3-cyclohexyl urea
1-((p-(2-(5-Chloro-o-anisamido)ethyl)phenyl)sulfonyl)-3-cyclohexylurea
1-(p-(2-(5-Chloro-2-methoxybenzamido)ethyl)benzenesulfonyl)-3-cyclohexylurea
1-[[p-[2-(5-Chloro-o-anisamido)ethyl]phenyl]sulfonyl]-3-cyclohexylurea
1-{4-[2-(5-chloro-2-methoxybenzamido)ethyl]benzenesulfonyl}-3-cyclohexylurea;1-{4-[2-(5-chloro-2-methoxybenzamido)ethyl]benzenesulfonyl}-3-cyclohexylurea
10238-21-8
5-Chloro-N-(2-(4-((((cyclohexylamino)carbonyl)amino)sulfonyl)phenyl)ethyl)-2-methoxybenzamide
5-Chloro-N-(2-[4-(([(cyclohexylamino)carbonyl]amino)sulfonyl)phenyl]ethyl)-2-methoxybenzamide #
5-chloro-N-(2-{4-[(cyclohexylcarbamoyl)sulfamoyl]phenyl}ethyl)-2-methoxybenzamide
5-chloro-N-(2-{4-[N-(N-cyclohexylcarbamoyl)sulfamoyl]phenyl}ethyl)-2-methoxybenzamide
5-Chloro-N-(4-(N-(cyclohexylcarbamoyl)sulfamoyl)-phenethyl)-2-methoxybenzamide
5-Chloro-N-(4-(N-(cyclohexylcarbamoyl)sulfamoyl)phenethyl)-2-methoxybenzamide
5-chloro-N-[2-(4-{[(cyclohexylcarbamoyl)amino]sulfonyl}phenyl)ethyl]-2-methoxybenzamide
5-chloro-N-[2-[4-(cyclohexylcarbamoylsulfamoyl)phenyl]ethyl]-2-methoxy-benzamide
5-chloro-N-[2-[4-(cyclohexylcarbamoylsulfamoyl)phenyl]ethyl]-2-methoxybenzamide
5-chloro-N-[2-[4-(cyclohexylcarbamoylsulfamoyl)phenyl]ethyl]-2-methoxybenzamide.
5-Chloro-N-[2-[4-[[[(cyclohexylamino)carbonyl]-amino]sulfonyl]phenyl]-ethyl]-2-methoxybenzamide
5-Chloro-N-[2-[4-[[[(cyclohexylamino)carbonyl]amino]sulfonyl]phenyl]ethyl]-2-methoxybenzamide
5-Chloro-N-[2-[4-[[[(Cylcohexylamino)carbonyl]amino]sulphonyl]phenyl]ethyl]-2-methoxybenzamide
5-chloro-N-[4-({[(cyclohexylamino)carbonyl]amino}sulfonyl)phenethyl]-2-methoxybenzamide
5-Chloro-N-[4-(3-cyclohexylureidosulfonyl)phenethyl]-2-methoxybenzamide
5-Chloro-N-[4-(cyclohexylureidosulfonyl)phenethyl]-2-methoxybenzamide
78637-EP2270001A1
78637-EP2270011A1
78637-EP2272825A2
78637-EP2272841A1
78637-EP2275414A1
78637-EP2287165A2
78637-EP2287166A2
78637-EP2292620A2
78637-EP2298750A1
78637-EP2298776A1
78637-EP2298779A1
78637-EP2301923A1
78637-EP2301936A1
78637-EP2305648A1
78637-EP2308847A1
A19539
AB00051949
AB00051949_18
AB00051949_19
AB00051949-16
AB00051949-17
AB0012611
AB2000243
Abbenclamide
AC1L1G1Q
AC1Q44V7
ACMC-20a66i
Adiab
AJ-23371
AKOS001487495
Amglidia
AN-20367
ANW-58936
AOB6214
Apo-Glibenclamide
Azuglucon
Bastiverit
BCP05327
BCP9000729
BDBM50012957
Benclamin
Benzamide, 5-chloro-N-(2-(4-((((cyclohexylamino)carbonyl)amino)sulfonyl)phenyl)ethyl)-2-methoxy-
Benzamide, 5-chloro-N-[2-[4-[[[(cyclohexylamino)carbonyl]amino]sulfonyl]phenyl]ethyl]-2-methoxy-
Betanase
Betanese 5
BG0207
BIDD:GT0239
Bio1_000076
Bio1_000565
Bio1_001054
Bio2_000071
Bio2_000551
BPBio1_000344
BRD-K36927236-001-06-0
BRD-K36927236-001-17-7
BRN 2230085
BSPBio_000312
BSPBio_001351
BSPBio_003053
C-22898
C07022
C23H28ClN3O5S
Calabren
CAS-10238-21-8
CBiol_001790
CCG-39618
CHEBI:5441
CHEMBL472
CPD000058229
CS-1075
CTK8B7917
Cytagon
D00336
Daonil
DB01016
Debtan
Delmide
Dia-basan
Diabeta
Diabeta (TN)
Diabiphage
Dibelet
DivK1c_000481
DSSTox_CID_17237
DSSTox_GSID_37237
DSSTox_RID_79313
DTXSID0037237
Duraglucon
EINECS 233-570-6
EU-0100499
Euclamin
Euglucan
Euglucon
Euglucon 5
Euglucon N
Euglykon
FT-0601608
G 0639
G-150
G0382
GBM
GBN 5
Gen-Glybe
Gewaglucon
GIBENCLAMIDE
Gilemal
Glamide
Glibadone
Gliban
Gliben
Gliben-Puren N
Glibenbeta
Glibenclamid AL
Glibenclamid Basics
Glibenclamid Fabra
Glibenclamid Genericon
Glibenclamid Heumann
Glibenclamid Riker M
Glibenclamid Riker M.
Glibenclamid-Cophar
Glibenclamid-Ratiopharm
Glibenclamida
Glibenclamida [INN-Spanish]
Glibenclamide
Glibenclamide (JP17/INN)
Glibenclamide [INN]
Glibenclamide 1.0 mg/ml in Acetonitrile
Glibenclamide B.P.
Glibenclamide for peak identification, European Pharmacopoeia (EP) Reference Standard
Glibenclamide,(S)
Glibenclamidum
Glibenclamidum [INN-Latin]
Glibenil
Glibens
Glibesyn
Glibet
Glibetic
Glibil
Gliboral
Glicem
Glidiabet
Glimel
Glimide
Glimidstata
Glisulin
Glitisol
Glubate
Gluben
Gluco-Tablimen
Glucobene
Glucohexal
Glucolon
Glucomid
Glucoremed
Glucoven
Glyben
Glybenclamide
Glybenclamide, >=99% (HPLC)
Glybenclamide, European Pharmacopoeia (EP) Reference Standard
Glybenzcyclamide
Glyburide (Diabeta)
glyburide (glibenclamide)
Glyburide (Glibenclamide), Pharmaceutical Secondary Standard; Certified Reference Material
Glyburide (micronized)
Glyburide (USP)
Glyburide [USAN:USP]
Glyburide [USAN]
Glyburide, meets USP testing specifications
Glyburide, United States Pharmacopeia (USP) Reference Standard
Glycolande
Glycomin
Glycron
Glynase
Glynase (TN)
GP8701
GTPL2414
HB 419
HB-419
HB-420
HD 419
Hemi-Daonil
Hexaglucon
HMS1361D13
HMS1568P14
HMS1791D13
HMS1922L08
HMS1989D13
HMS2089L06
HMS2093P04
HMS2095P14
HMS3259O12
HMS3261D19
HMS3267A15
HMS3402D13
HMS3428D15
HMS3651E17
HMS3712P14
HMS501I03
Humedia
HY-15206
I06-0716
IDI1_000481
IDI1_033821
J10021
KB-73471
KBio1_000481
KBio2_000071
KBio2_000730
KBio2_002639
KBio2_003298
KBio2_005207
KBio2_005866
KBio3_000141
KBio3_000142
KBio3_002273
KBioGR_000071
KBioGR_001897
KBioSS_000071
KBioSS_000730
KS-5326
Lederglib
Libanil
Lisaglucon
Lopac-G-0639
Lopac0_000499
LP00499
LS-159295
Maninil
MCULE-2351642942
Med-Glionil
Melix
MFCD00056625
Micronase
Micronase (TN)
Micronized glyburide
Miglucan
MLS000069721
MLS001077262
MolPort-000-784-850
N-(4-(.beta.-(2-Methoxy-5-chlorbenzamido)-aethyl)-benzolsulfonyl)-N'-cyclohexyl-harnstoff
N-(4-(2-(5-Chloro-2-methoxybenzamido)ethyl)phenylsulfonyl)-N'-cyclohexylurea
N-(4-(beta-(2-Methoxy-5-chlorbenzamido)-aethyl)-benzolsulfonyl)-N'-cyclohexyl-harnstoff
N-[(4-{2-[(5-chloro-2-methoxyphenyl)carbonylamino]ethyl}phenyl)sulfonyl](cyclo hexylamino)carboxamide
N-p-[2-(5-Chloro-2-methoxybenzamido)-ethyl]benzene-sulfonyl-N -cyclohexylurea
N-p-[2-(5-Chloro-2-methoxybenzamido)-ethyl]benzene-sulfonyl-N'-cyclohexylurea
N-p-[2-(5-Chloro-2-methoxybenzamido)ethyl]benzenesulfonyl-N'-cyclohexylurea
Nadib
NC00566
NCGC00015467-01
NCGC00015467-02
NCGC00015467-03
NCGC00015467-04
NCGC00015467-05
NCGC00015467-06
NCGC00015467-07
NCGC00015467-08
NCGC00015467-09
NCGC00015467-10
NCGC00015467-11
NCGC00015467-12
NCGC00015467-13
NCGC00015467-14
NCGC00015467-15
NCGC00015467-16
NCGC00015467-17
NCGC00015467-18
NCGC00015467-20
NCGC00015467-36
NCGC00016689-01
NCGC00023447-02
NCGC00023447-04
NCGC00023447-05
NCGC00023447-06
NCGC00023447-07
NCGC00023447-08
NCGC00023447-09
NCGC00023447-10
NCGC00023447-11
NCGC00023447-12
NCGC00254662-01
NCGC00261184-01
Neogluconin
NINDS_000481
Norglicem 5
Normoglucon
Novo-Glyburide
NSC-759618
NSC759618
Opera_ID_801
Oprea1_764617
Orabetic
Pharmakon1600-02300229
Pira
Praeciglucon
PresTab
Prestwick_569
Prestwick0_000316
Prestwick1_000316
Prestwick2_000316
Prestwick3_000316
Probes1_000431
Probes2_000378
Prodiabet
Renabetic
RP-1127
RT-000122
S1716
SAM002564212
SB17414
SBB057426
SBI-0050483.P003
SC-17437
SCHEMBL22009
Semi-daonil
Semi-Euglucon
Semi-Gliben-Puren N
SMR000058229
SPBio_001831
SPBio_002531
Spectrum_000250
Spectrum2_001816
SPECTRUM2300229
Spectrum3_001327
Spectrum4_001199
Spectrum5_001631
SR-01000000196
SR-01000000196-2
SR-01000000196-4
SR-01000000196-5
SR-01000000196-6
SR-01000000196-8
ST024780
STK362992
Sugril
Suraben
SW195828-5
SX6K58TVWC
SYN3026
Tiabet
Tocris-0911
Tox21_110158
Tox21_110158_1
Tox21_300758
Tox21_500499
U 26452
U-26,452
U-26452
UNII-SX6K58TVWC
UPCMLD-DP006
UPCMLD-DP006:001
UR 606
Urea, 1-((p-(2-(chloro-o-anisamido)ethyl)phenyl)sulfonyl)-3-cyclohexyl-
Urea, 1-(p-(2-(5-chloro-2-methoxybenzamido)ethyl)benzenesulfonyl)-3-cyclohexyl-
W-108874
W-5054
Yuglucon
Z277540138
ZINC537805
ZNNLBTZKUZBEKO-UHFFFAOYSA-N
Paragraph IV (Patent) Challenges for GLYBURIDE
Tradename Dosage Ingredient NDA Submissiondate
GLYNASE TABLET;ORAL glyburide 020051

US Patents and Regulatory Information for GLYBURIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zydus Pharms GLYBURIDE glyburide TABLET;ORAL 206749-002 May 10, 2016 AB1 RX No No   Start Trial   Start Trial   Start Trial
Heritage Pharms Inc GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide; metformin hydrochloride TABLET;ORAL 079009-003 Jun 3, 2009 DISCN No No   Start Trial   Start Trial   Start Trial
Sanofi Aventis Us GLYBURIDE (MICRONIZED) glyburide TABLET;ORAL 020055-002 Apr 17, 1992 DISCN No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide; metformin hydrochloride TABLET;ORAL 077870-002 Nov 14, 2007 AB RX No Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for GLYBURIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pharmacia And Upjohn MICRONASE glyburide TABLET;ORAL 017498-003 May 1, 1984   Start Trial   Start Trial
Pharmacia And Upjohn MICRONASE glyburide TABLET;ORAL 017498-001 May 1, 1984   Start Trial   Start Trial
Pharmacia And Upjohn GLYNASE glyburide TABLET;ORAL 020051-002 Mar 4, 1992   Start Trial   Start Trial
Sanofi Aventis Us DIABETA glyburide TABLET;ORAL 017532-003 May 1, 1984   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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McKinsey
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Dow
AstraZeneca

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