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Last Updated: March 29, 2020

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Candesartan cilexetil - Generic Drug Details

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What are the generic sources for candesartan cilexetil and what is the scope of freedom to operate?

Candesartan cilexetil is the generic ingredient in four branded drugs marketed by Ani Pharms Inc, Alembic Pharms Ltd, Apotex Inc, Macleods Pharms Ltd, Mylan, Zydus Pharms, Dr Reddys Labs Ltd, and Prinston Inc, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-two drug master file entries for candesartan cilexetil. There is one tentative approval for this compound.

Drug Prices for candesartan cilexetil

See drug prices for candesartan cilexetil

Recent Clinical Trials for candesartan cilexetil

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

SponsorPhase
Altasciences Company Inc.Phase 1
Pharmtechnology LLCPhase 1
CJ HealthCare CorporationPhase 4

See all candesartan cilexetil clinical trials

Generic filers with tentative approvals for CANDESARTAN CILEXETIL
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial32MG; 25MGTABLET; ORAL
  Start Trial  Start Trial32MG; 12.5MGTABLET; ORAL
  Start Trial  Start Trial16MG; 12.5MGTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Synonyms for candesartan cilexetil
(+-)-1-Hydroxyethyl 2-ethoxy-1-(p-(o-1H-tetrazol-5-ylphenyl)benzyl)-7-benzimidazolecarboxylate, cyclohexyl carbonate (ester)
(+/-)-1-(cyclohexyloxycarbonyloxy)ethyl 2-ethoxy-1-[2'-(1H-tetrazol-5-yl) biphenyl-4-yl]methylbenzimidazole-7-carboxylate
(+/-)-1-(cyclohexyloxycarbonyloxy)ethyl 2-ethoxy-1-[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methylbenzimidazole-7-carboxylate
040C375
1-(((cyclohexyloxy)carbonyl)oxy)ethyl 1-((2'-(1H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-2-ethoxy-1H-benzo[d]imidazole-7-carboxylate
1-(((Cyclohexyloxy)carbonyl)oxy)ethyl 1-((2'-(2H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-2-ethox
1-(((Cyclohexyloxy)carbonyl)oxy)ethyl 1-((2'-(2H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-2-ethoxy-1H-benzo[d]imidazole-7-carboxylate
1-(cyclohexylocarbonyloxy)ethyl-2-ethoxy-1-(2'-(1H-tetrazol-5-yl)biphenyl-4-yl)-1H-benzimidazole-7-carboxylate
1-(cyclohexyloxycarbonyloxy)ethyl 1-((2'-(1H-tetrazol-5-yl)biphenyl-4-yl)methyl)-2-ethoxy-1H-benzo[d]imidazole-7-carboxylate
1-(Cyclohexyloxycarbonyloxy)ethyl-2-ethoxy-1-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]benzimidazol-7-carboxylate
1-[[(cyclohexyloxy)carbonyl]oxy]ethyl 2-ethoxy-1-[[2'-(1h-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1h-benzimidazole-7-carboxylate
1-{[(cyclohexyloxy)carbonyl]oxy}ethyl 2-(ethyloxy)-1-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl}-1H-benzimidazole-7-carboxylate
1-{[(Cyclohexyloxy)carbonyl]oxy}ethyl 2-ethoxy-1-{[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl}-1H-benzimidazole-7-carboxylate
1-{[(cyclohexyloxy)carbonyl]oxy}ethyl 2-ethoxy-1-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl}-1H-benzimidazole-7-carboxylate
1-cyclohexyloxycarbonyloxyethyl 2-ethoxy-3-[[4-[2-(1H-tetrazol-5-yl)phenyl]phenyl]methyl]benzimidazole-4-carboxylate
1-cyclohexyloxycarbonyloxyethyl 2-ethoxy-3-[[4-[2-(2h-tetrazol-5-yl)phenyl]phenyl] methyl]benzimidazole-4-carboxylate
1-cyclohexyloxycarbonyloxyethyl 2-ethoxy-3-[[4-[2-(2H-tetrazol-5-yl)phenyl]phenyl]methyl]benzimidazole-4-carboxylate
1-cyclohexyloxycarbonyloxyethyl 2-ethoxy-3-[[4-[2-(2H-tetrazol-5-yl)phenyl]phenyl]methyl]benzimidazole-4-carboxylate.
145040-37-5
1H-Benzimidazole-7-carboxylic acid, 2-ethoxy-1-((2'-(1H-tetrazol-5-yl)(1,1'-biphenyl)-4-yl)methyl)-, 1-(((cyclohexyloxy)carbonyl)oxy)ethyl ester, ( -)-
1H-Benzimidazole-7-carboxylic acid, 2-ethoxy-1-((2'-(1H-tetrazol-5-yl)(1,1'-biphenyl)-4-yl)methyl)-, 1-(((cyclohexyloxy)carbonyl)oxy)ethyl ester, (+-)-
1H-Benzimidazole-7-carboxylic acid, 2-ethoxy-1-[[2'-(2H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-, 1-[[(cyclohexyloxy)carbonyl]oxy]ethyl ester
1H-Benzimidazolium, 7-carboxy-1-(2-((cyclohexylcarbonyl)oxy)ethyl)-2-ethoxy-1-(2'-(1H-tetrazol-5-yl)(1,1'-biphenyl)-4-yl)-, hydroxide, inner salt, (+-)-
2-ETHOXY-1-[[2'-(2H-TETRAZOL-5-YL)[1,1'-BIPHENYL]-4-YL]METHYL]-1H-BENZIMIDAZOLE-7-CARBOXYLIC ACID 1-[[(CYCLOHEXYLOXY)CARBONYL]OXY]ETHYL ESTER
2-Ethoxy-1-[2'-(1H-tetrazole-5-yl)-4-biphenylylmethyl]-1H-benzimidazole-7-carboxylic acid 1-(cyclohexyloxycarbonyloxy)ethyl ester
2-ethoxy-3-[2'-(1h-tetrazol-5-yl)-biphenyl-4-ylmethyl]-3h-benzoimidazole-4-carboxylic acid 1-cyclohe
2-Ethoxy-3-[2'-(1H-tetrazol-5-yl)-biphenyl-4-ylmethyl]-3H-benzoimidazole-4-carboxylic acid 1-cyclohexyloxycarbonyloxy-ethyl ester
2-Ethoxy-3-[2''-(1H-tetrazol-5-yl)-biphenyl-4-ylmethyl]-3H-benzoimidazole-4-carboxylic acid 1-cyclohexyloxycarbonyloxy-ethyl ester
2-Ethoxy-3-[2''-(2H-tetrazol-5-yl)-biphenyl-4-ylmethyl]-3H-benzoimidazole-4-carboxylic acid 1-cyclohexyloxycarbonyloxy-ethyl ester
4CH-009595
A-2005
AB0012012
AB01274805_02
AB01274805_03
AB01274805-01
AB07617
AB2000442
AC-204
AK-75900
AKOS015894954
AKOS015920180
AM90293
Amias
Atacand
Atacand (TN)
Atacand;Amias;Blopress;Ratacand;TCV 116;TCY 116
BCP22050
BCP9000480
BDBM50318907
BG0573
BR-75900
BRD-A65671304-001-02-6
BRD-A65671304-001-03-4
BSPBio_002691
C-265
C07709
C33H34N6O6
Camptothecine, Antibiotic for Culture Media Use Only
Candesartan (Cilexetil)
Candesartan cilexetil (Atacand)
Candesartan cilexetil (JP17/USAN)
Candesartan cilexetil [USAN]
Candesartan cilexetil for peak identification, European Pharmacopoeia (EP) Reference Standard
Candesartan cilexetil for system suitability, European Pharmacopoeia (EP) Reference Standard
Candesartan cilexetil, >=98% (HPLC)
Candesartan cilexetil, European Pharmacopoeia (EP) Reference Standard
Candesartan Cilexetil, Pharmaceutical Secondary Standard; Certified Reference Material
Candesartan cilexetil, United States Pharmacopeia (USP) Reference Standard
candesartan cilexitil
CANDESARTAN CILEXTIL
Candesartan hexetil
Candesartan-cilexetil-Atacand
candesartancilexetil
CAS-145040-37-5
CCG-222334
CCG-39530
CHEBI:3348
CHEMBL1014
CS-2893
D00626
DB00796
DS-1302
DSSTox_CID_239
DSSTox_GSID_20239
DSSTox_RID_85567
DTXSID5020239
EBD4212
FT-0082579
FT-0602914
GHOSNRCGJFBJIB-UHFFFAOYSA-N
GTPL8352
H212/91
HMS1922J09
HMS2093E20
HMS3651I08
HY-17505
J10436
KBio2_002187
KBio2_004755
KBio2_007323
KBio3_001911
KBioGR_001607
KBioSS_002187
Kenzen
KS-00000IVU
KS-1147
L006257
LS-32741
MFCD00871371
MLS004774127
NCGC00095123-01
NCGC00095123-02
NCGC00095123-03
NCGC00255218-01
NSC-758697
NSC758697
Parapres
Pharmakon1600-01504261
Q-200786
Q27075664
Racanda
s2037
SBI-0206767.P001
SC-12740
SCHEMBL40831
SMR003500784
SPBio_000349
Spectrum_001707
SPECTRUM1504261
Spectrum2_000485
Spectrum3_000996
Spectrum4_001124
Spectrum5_001462
SR-05000001976
SR-05000001976-1
ST24030238
STL451065
SW220041-1
TCV 116
TCV-116
TCY 116
Tox21_302202
VA10473
Paragraph IV (Patent) Challenges for CANDESARTAN CILEXETIL
Tradename Dosage Ingredient NDA Submissiondate
ATACAND TABLET;ORAL candesartan cilexetil 020838 2006-12-22

US Patents and Regulatory Information for candesartan cilexetil

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Macleods Pharms Ltd CANDESARTAN CILEXETIL candesartan cilexetil TABLET;ORAL 203813-002 Dec 5, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Dr Reddys Labs Ltd CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 202965-003 Jun 3, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan CANDESARTAN CILEXETIL candesartan cilexetil TABLET;ORAL 078702-003 May 3, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc ATACAND HCT candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 021093-003 May 16, 2008 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Apotex Inc CANDESARTAN CILEXETIL candesartan cilexetil TABLET;ORAL 202079-003 Jan 10, 2014 DISCN No No   Start Trial   Start Trial   Start Trial
Prinston Inc CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 207455-001 Apr 11, 2018 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

Expired US Patents for candesartan cilexetil

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ani Pharms Inc ATACAND candesartan cilexetil TABLET;ORAL 020838-003 Jun 4, 1998   Start Trial   Start Trial
Ani Pharms Inc ATACAND candesartan cilexetil TABLET;ORAL 020838-004 Jun 4, 1998   Start Trial   Start Trial
Ani Pharms Inc ATACAND candesartan cilexetil TABLET;ORAL 020838-002 Jun 4, 1998   Start Trial   Start Trial
Ani Pharms Inc ATACAND candesartan cilexetil TABLET;ORAL 020838-001 Jun 4, 1998   Start Trial   Start Trial
Ani Pharms Inc ATACAND candesartan cilexetil TABLET;ORAL 020838-002 Jun 4, 1998   Start Trial   Start Trial
Ani Pharms Inc ATACAND candesartan cilexetil TABLET;ORAL 020838-003 Jun 4, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
McKinsey
Medtronic
Mallinckrodt
AstraZeneca
Dow

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.