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Last Updated: November 22, 2019

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GLIPIZIDE Drug Profile

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When do Glipizide patents expire, and when can generic versions of Glipizide launch?

Glipizide is a drug marketed by Aurobindo Pharma Ltd, Mylan, Par Pharm, Unique Pharm Labs, Watson Labs, Zydus Pharms, Accord Hlthcare, Ani Pharms Inc, Apotex, Barr Labs Inc, Beximco Pharms Usa, Oxford Pharms, Sandoz, Sun Pharm Inds Inc, Watson Labs Teva, Epic Pharma Llc, Heritage Pharms Inc, Teva Pharms, and Zydus Pharms Usa Inc. and is included in twenty-five NDAs.

The generic ingredient in GLIPIZIDE is glipizide; metformin hydrochloride. There are eighteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the glipizide; metformin hydrochloride profile page.

Drug patent expirations by year for GLIPIZIDE
Drug Prices for GLIPIZIDE

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Drug Sales Revenue Trends for GLIPIZIDE

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Recent Clinical Trials for GLIPIZIDE

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

SponsorPhase
AbbottN/A
University of WashingtonN/A
American Diabetes AssociationN/A

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Recent Litigation for GLIPIZIDE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Endo Pharmaceuticals Inc., and Grunenthal GbmH v. Teva Pharmaceuticals USA, Inc., and Barr Laboratories, Inc.2012-11-05
Purdue Pharma LP v. Sandoz Inc.2012-10-10
Purdue Pharma L.P. v. PAR Pharmaceutical, Inc.2012-07-20

See all GLIPIZIDE litigation

PTAB Litigation
PetitionerDate
PACK Pharmaceuticals LLC2014-05-30

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Pharmacology for GLIPIZIDE
Drug ClassSulfonylurea
Medical Subject Heading (MeSH) Categories for GLIPIZIDE
Synonyms for GLIPIZIDE
094G619
1-Cyclohexyl-3-((p-(2-(5-methylpyrazinecarboxamido)ethyl)phenyl)sulfonyl)urea
1-cyclohexyl-3-({p-[2-(5-methylpyrazinecarboxamido)ethyl]phenyl}sulfonyl)urea
1-cyclohexyl-3-(4-(2-(2-methylpyrazine-5-carboxamido)ethyl)phenylsulfonyl)urea
1-cyclohexyl-3-[[p-[2-(5-methylpyrazinecarboxamido)ethyl]phenyl]sulfonyl]urea
172964-66-8
29094-61-9
29094-66-4
38777-27-4
AB0012143
AC-15789
AC1L1G0Z
AC1Q2OG0
AKOS005564405
Aldiab
AN-15826
ANW-41980
API0002842
BBL028143
BC209538
BCP09195
BDBM50012956
BG0209
BIDD:GT0476
Bio1_000074
Bio1_000563
Bio1_001052
Bio2_000069
Bio2_000549
BPBio1_000224
BRD-K12219985-001-04-8
BRD-K12219985-001-15-4
BRN 0903495
BSPBio_000202
BSPBio_001349
C-22417
C21H27N5O4S
CAS-29094-61-9
CBiol_001788
CC-28982
CCG-204710
CHEBI:5384
CHEMBL1073
CP 28,720
CP 28720
CP-28,720
CP-28720
CPD000058455
CS-2239
CTK8B3212
D00335
DB01067
Digrin
Dipazide
DSSTox_CID_20676
DSSTox_GSID_40676
DSSTox_RID_79535
DTXSID0040676
EINECS 249-427-6
EU-0100621
FT-0626714
FT-0659737
G-117
G0369
Glibenese
Glibetin
Glican
Glide
Glidiab
Glidiazinamide
Glipid
Glipizibe
Glipizida
Glipizida [INN-Spanish]
Glipizide (Glucotrol)
Glipizide (USP/INN)
Glipizide [USAN:BAN:INN]
Glipizide [USAN:USP:INN:BAN]
Glipizide Extended-Release Tablets
Glipizide, 98+%
Glipizide, European Pharmacopoeia (EP) Reference Standard
Glipizide, Pharmaceutical Secondary Standard; Certified Reference Material
Glipizide, solid
Glipizide, United States Pharmacopeia (USP) Reference Standard
Glipizide,(S)
Glipizidum
Glipizidum [INN-Latin]
Gluco-Rite
Glucolip
Glucotrol
Glucotrol (TN)
Glucotrol XL
Glucozide
Glupitel
Glupizide
Glyde
Glydiazinamide
Glypidizine
GTPL6821
HMS1361D11
HMS1568K04
HMS1791D11
HMS1989D11
HMS2089C21
HMS2093J09
HMS2095K04
HMS2233N11
HMS3259K12
HMS3261N04
HMS3369L12
HMS3402D11
HMS3655G04
HMS3712K04
HY-B0254
I06-0186
I06-1985
IDI1_033819
K 4024
K-4024
KB-52251
KBio2_000069
KBio2_002637
KBio2_005205
KBio3_000137
KBio3_000138
KBioGR_000069
KBioSS_000069
KS-1068
Lopac-G-117
Lopac0_000621
LP00621
LS-159679
MCULE-5142805548
Melizide
Metaglip
Metaglip (Salt/Mix)
MFCD00072159
Mindiab
Minidab
Minidiab
Minodiab
MLS000069386
MLS001148176
MolPort-002-885-830
N-(2-[4-(([(Cyclohexylamino)carbonyl]amino)sulfonyl)phenyl]ethyl)-5-methyl-2-pyrazinecarboxamide
N-(2-{4-[(cyclohexylcarbamoyl)sulfamoyl]phenyl}ethyl)-5-methylpyrazine-2-carboxamide
N-(4-(.beta.-(5-Methylpyrazine-2-carboxamido)ethyl)benzenesulphonyl)-N'-cyclohexylurea
N-(4-(beta-(5-Methylpyrazine-2-carboxamido)ethyl)benzenesulphonyl)-N'-cyclohexylurea
N-(4-(N-(cyclohexylcarbamoyl)sulfamoyl)phenethyl)-5-methylpyrazine-2-carboxamide
N-(4-[N-(cyclohexylcarbamoyl)sulfamoyl]phenethyl)-5-methylpyrazine-2-carboxamide
N-[2-(4-{[(cyclohexylamino)carbonylamino]sulfonyl}phenyl)ethyl](5-methylpyrazi n-2-yl)carboxamide
N-[2-(4-{[(cyclohexylcarbamoyl)amino]sulfonyl}phenyl)ethyl]-5-methylpyrazine-2-carboxamide
N-[2-[4-(cyclohexylcarbamoylsulfamoyl)phenyl]ethyl]-5-methyl-pyrazine-2-carboxamide
N-[2-[4-(cyclohexylcarbamoylsulfamoyl)phenyl]ethyl]-5-methylpyrazine-2-carboxamide
N-[4-(3-Cyclohexylureidosulfonyl)phenethyl]-5-methyl-2-pyrazinecarboxamide
N-{4-[beta-(5-methylpyrazine-2-carboxamido)ethyl]benzenesulphonyl}-N'-cyclohexylurea
Napizide
NC00564
NCGC00015462-01
NCGC00015462-02
NCGC00015462-03
NCGC00015462-04
NCGC00015462-05
NCGC00015462-06
NCGC00015462-07
NCGC00015462-08
NCGC00015462-09
NCGC00015462-10
NCGC00015462-11
NCGC00015462-12
NCGC00015462-14
NCGC00016802-01
NCGC00023748-03
NCGC00023748-04
NCGC00023748-05
NCGC00023748-06
NCGC00023748-07
NCGC00255522-01
NCGC00261306-01
NSC-759120
NSC759120
Opera_ID_1908
Ozidia
Pharmakon1600-01505433
Prestwick_242
Prestwick0_000131
Prestwick1_000131
Prestwick2_000131
Prestwick3_000131
Pyrazinecarboxamide, N-(2-(4-((((cyclohexylamino)carbonyl)amino)sulfonyl)phenyl)ethyl)-5-methyl-
Pyrazinecarboxamide, N-[2-[4-[[[(cyclohexylamino)carbonyl]amino]sulfonyl]phenyl]ethyl]-5-methyl-
s1715
SAM002564210
SBI-0050603.P002
SC-13933
SCHEMBL17094
Semiglynase
SMR000058455
SPBio_002141
SR-01000000010
SR-01000000010-2
SR-01000000010-5
ST50826363
STK631952
Sucrazide
SW196549-3
TC-063559
TK 1320
TL8006447
Tox21_110156
Tox21_110156_1
Tox21_301834
Tox21_500621
UNII-X7WDT95N5C
Urea, 1-cyclohexyl-3-((p-(2-(5-methylpyrazinecarboxamido)ethyl)phenyl)sulfonyl)-
W-107005
X7WDT95N5C
Z1880962274
ZINC537795
ZJJXGWJIGJFDTL-UHFFFAOYSA-N
Paragraph IV (Patent) Challenges for GLIPIZIDE
Tradename Dosage Ingredient NDA Submissiondate
GLUCOTROL XL TABLET, EXTENDED RELEASE;ORAL glipizide 020329

US Patents and Regulatory Information for GLIPIZIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs GLIPIZIDE glipizide TABLET;ORAL 074370-002 Nov 22, 1994 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan GLIPIZIDE glipizide TABLET;ORAL 074226-002 May 10, 1994 AB RX No No   Start Trial   Start Trial   Start Trial
Heritage Pharms Inc GLIPIZIDE AND METFORMIN HYDROCHLORIDE glipizide; metformin hydrochloride TABLET;ORAL 078728-003 Jun 23, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Zydus Pharms Usa Inc GLIPIZIDE AND METFORMIN HYDROCHLORIDE glipizide; metformin hydrochloride TABLET;ORAL 078905-002 Jan 31, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Epic Pharma Llc GLIPIZIDE AND METFORMIN HYDROCHLORIDE glipizide; metformin hydrochloride TABLET;ORAL 077507-002 Oct 27, 2005 AB RX No No   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

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AstraZeneca
Boehringer Ingelheim
Moodys

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