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Generated: September 19, 2019

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Irbesartan - Generic Drug Details

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

Irbesartan is the generic ingredient in two branded drugs marketed by Sanofi Aventis Us, Ajanta Pharma Ltd, Alembic Pharms Ltd, Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Molecular, Hetero Labs Ltd V, Hisun Pharm Hangzhou, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Neopharma, Prinston Inc, Sandoz, Sciegen Pharms Inc, Teva Pharms, Unichem Labs Ltd, Watson Labs Inc, West-ward Pharms Int, and Zydus Pharms Usa Inc, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-eight drug master file entries for irbesartan. Thirty suppliers are listed for this compound. There are three tentative approvals for this compound.

Pharmacology for irbesartan
Synonyms for irbesartan
(-)-Styrene glycol; (R)-(-)-Phenylethylene glycol
[3H]irbesartan
1,3-Diazaspiro(4.4)non-1-en-4-one, 2-butyl-3-((2'-(1H-tetrazol-5-yl)(1,1'-biphenyl)-4-yl)methyl)-
1,3-Diazaspiro[4.4]non-1-en-4-one, 2-butyl-3-[[2'-(2H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-
138402-11-6
2-(n-butyl)-3-[[2'-(tetrazol-5-yl)biphenyl-4-yl]methyl]-1,3-diazaspiro[4.4]non-1-en-4-one
2-butyl-3-({4-[2-(1H-1,2,3,4-tetrazol-5-yl)phenyl]phenyl}methyl)-1,3-diazaspiro[4.4]non-1-en-4-one
2-butyl-3-({4-[2-(2H-1,2,3,4-tetrazol-5-yl)phenyl]phenyl}methyl)-1,3-diazaspiro[4.4]non-1-en-4-one
2-Butyl-3-(p-(o-1H-tetrazol-5-ylphenyl)benzyl)-1,3-diazaspiro(4.4)non-1-en-4-one
2-butyl-3-[ p -( o -1 H -tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4,4]non-1-en-4-one
2-BUTYL-3-[[2'-(2H-TETRAZOL-5-YL)[1,1'-BIPHENYL]-4-YL]METHYL]-1,3-DIAZASPIRO[4.4]NON-1-EN-4-ONE
2-butyl-3-[[4-[2-(1H-tetrazol-5-yl)phenyl]phenyl]methyl]-1,3-diazaspiro[4.4]non-1-en-4-one
2-butyl-3-[[4-[2-(2H-tetrazol-5-yl)phenyl]phenyl]methyl]-1,3-diazaspiro[4.4]non-1-en-4-one
2-butyl-3-[2'-(1h-tetrazol-5-yl)-biphenyl-4-ylmethyl]-1,3-diaza-spiro[
2-butyl-3-[2'-(1h-tetrazol-5-yl)biphenyl-4-ylmethyl]1,3-diaza-spiro[
2-Butyl-3-[2'-(1H-tetrazol-5-yl)biphenyl-4-ylmethyl]1,3-diaza-spiro[4.4]non-1-en-4-one
2-butyl-3-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one
2-butyl-3-{[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl}-1,3-diazaspiro[4.4]non-1-en-4-one
2-butyl-3-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl}-1,3-diazaspiro[4.4]non-1-en-4-one
2-butyl-3-{[2''-(1H-tetrazol-5-yl)[1,1''-biphenyl]-4-yl]methyl}-1,3-diazaspiro[4.4]non-1-en-4-one
2-butyl-3-{[2''-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl}-1,3-diazaspiro[4.4]non-1-en-4-one
2-n-butyl-3-((2'-(1H-tetrazol-5-yl)biphenyl-4-yl)methyl)-1,3-diazaspiro(4,4)non-1-en-4-one
2-n-butyl-3-<<2'-(1H-tetrazol-5-yl)biphenyl-4-yl>methyl>-1,3-diazaspiro<4.4>non-1-en-4-one;
3-((2'-(1H-Tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-2-butyl-1,3-diazaspiro[4.4]non-1-en-4-one
3-((2'-(1H-tetrazol-5-yl)biphenyl-4-yl)methyl)-2-butyl-1,3-diazaspiro[4.4]non-1-en-4-one
3-((2'-(2H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-2-butyl-1,3-diazaspiro[4.4]non-1-en-4-one
3-((2'-(2H-tetrazol-5-yl)biphenyl-4-yl)methyl)-2-butyl-1,3-diazaspiro[4.4]non-1-en-4-one
402I116
4CA-0654
54246-EP2270011A1
54246-EP2295406A1
54246-EP2295422A2
54246-EP2298772A1
54246-EP2298776A1
54246-EP2298779A1
54246-EP2301923A1
54246-EP2301931A1
54246-EP2305219A1
54246-EP2308562A2
54246-EP2308839A1
8-butyl-7-[[4-[2-(2H-1,2,3,4-tetrazol-5-yl)phenyl]phenyl]methyl]-7,9-diazaspiro[4.4]non-8-en-6-one
8-butyl-7-[[4-[2-(2H-tetrazol-5-yl)phenyl]phenyl]methyl]-7,9-diazaspiro[4.4]non-8-en-6-one
A807387
AB0013366
AB00639954_07
AB00639954_08
AB00639954-06
AB07472
AB1009632
ABP000523
AC-537
AC1L1GMK
AK-57149
AKOS005576396
AKOS015895353
AM90289
AN-15743
Aprovel
Avapro
Avapro (TN)
BC207567
BCP02004
BCP9000792
BCPP000202
BDBM50042235
BIDD:GT0347
BMS 186295
BMS-186295
BR-57149
BRD-K60038276-001-02-5
BRD-K60038276-001-03-3
BSPBio_002687
C07469
C25H28N6O
CAS-138402-11-6
CCG-101012
CCG-39091
CHEBI:5959
CHEMBL1513
CPD000466306
CS-2140
D00523
DB01029
DSSTox_CID_3169
DSSTox_GSID_23169
DSSTox_RID_76900
DTXSID0023169
EBD8758
FT-0601598
GTPL589
GTPL6908
H931
HMS1922J05
HMS2051L08
HMS2093E16
HMS2232F23
HMS3370B06
HMS3393L08
HMS3715L04
HSDB 8215
HY-B0202
I06-0690
I0859
Irbesarran
Irbesartan ,(S)
Irbesartan (Avapro)
Irbesartan (JP17/USAN/INN)
Irbesartan [USAN:INN]
Irbesartan [USAN:USP:INN:BAN]
Irbesartan BMS
Irbesartan Krka
Irbesartan Winthrop
Irbesartan, >=98% (HPLC), powder
Irbesartan, European Pharmacopoeia (EP) Reference Standard
Irbesartan, Pharmaceutical Secondary Standard; Certified Reference Material
Irbesartan, United States Pharmacopeia (USP) Reference Standard
Irbesartan(Avapro)/
Irbetan
J0E2756Z7N
J10394
Jsp002315
Karvea
KB-52707
KBio2_002231
KBio2_004799
KBio2_007367
KBio3_001907
KBioGR_001603
KBioSS_002231
KS-00000ISW
KS-1151
L000319
Lrbesartan
LS-60064
MCULE-9617953373
MFCD00864464
MLS000759408
MLS001424099
MolPort-003-666-550
MolPort-006-167-687
NC00262
NCGC00095122-01
NCGC00095122-02
NCGC00095122-03
NCGC00095122-05
NSC-758696
NSC758696
Pharmakon1600-01504259
PubChem21382
Q-201249
S-1797
S1507
SAM001246548
SBI-0206769.P001
SC-08814
SCHEMBL4246
SMR000466306
SPBio_001889
Spectrum_001751
SPECTRUM1504259
Spectrum2_001675
Spectrum3_000994
Spectrum4_001122
Spectrum5_001288
SR 47436
SR-05000001997
SR-05000001997-1
SR-47436
ST24028252
STK645362
TL8000875
Tox21_111433
Tox21_111433_1
UNII-J0E2756Z7N
YOSHYTLCDANDAN-UHFFFAOYSA-N
ZINC3872931
Generic filers with tentative approvals for IRBESARTAN
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up300MG; 25MGTABLET; ORAL
➤ Sign Up➤ Sign Up300MG; 12.5MGTABLET; ORAL
➤ Sign Up➤ Sign Up150MG; 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.

US Patents and Regulatory Information for irbesartan

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 IRBESARTAN irbesartan TABLET;ORAL 202254-003 Oct 3, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Amneal Pharms IRBESARTAN irbesartan TABLET;ORAL 204740-002 Apr 17, 2018 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Pharms Inc IRBESARTAN irbesartan TABLET;ORAL 200461-002 Sep 27, 2012 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Aurobindo Pharma Ltd IRBESARTAN irbesartan TABLET;ORAL 203081-003 Sep 27, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us AVAPRO irbesartan TABLET;ORAL 020757-002 Sep 30, 1997 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Chartwell Molecular IRBESARTAN irbesartan TABLET;ORAL 077205-003 Nov 14, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
>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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Expired US Patents for irbesartan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us AVAPRO irbesartan TABLET;ORAL 020757-001 Sep 30, 1997 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us AVAPRO irbesartan TABLET;ORAL 020757-003 Sep 30, 1997 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us AVAPRO irbesartan TABLET;ORAL 020757-002 Sep 30, 1997 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us AVAPRO irbesartan TABLET;ORAL 020757-002 Sep 30, 1997 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us AVAPRO irbesartan TABLET;ORAL 020757-001 Sep 30, 1997 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us AVAPRO irbesartan TABLET;ORAL 020757-003 Sep 30, 1997 ➤ Sign Up ➤ Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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