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Last Updated: December 12, 2019

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Telmisartan - Generic Drug Details

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

Telmisartan is the generic ingredient in two branded drugs marketed by Boehringer Ingelheim, Alembic Pharms Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Cadila Pharms Ltd, Cipla, Glenmark Pharms Ltd, Hetero Labs Ltd V, Hisun Pharm Hangzhou, Inventia, Jubilant Generics, Micro Labs, Mylan, Prinston Inc, Sandoz Inc, Torrent, and Zydus Pharms, and is included in seventeen NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Telmisartan has eighty-eight patent family members in thirty-eight countries.

There are thirty-nine drug master file entries for telmisartan. Twenty-four suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for telmisartan

See drug prices for telmisartan

Drug Sales Revenue Trends for telmisartan

See drug sales revenues for telmisartan

Recent Clinical Trials for telmisartan

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

SponsorPhase
University of British ColumbiaEarly Phase 1
Heart and Stroke Foundation of CanadaEarly Phase 1
Michael Smith Foundation for Health ResearchEarly Phase 1

See all telmisartan clinical trials

Generic filers with tentative approvals for TELMISARTAN
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial80MG; 25MGTABLET; ORAL
  Start Trial  Start Trial80MG; 12.5MGTABLET; ORAL
  Start Trial  Start Trial40MG; 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.

Pharmacology for telmisartan
Synonyms for telmisartan
(1,1'-Biphenyl)-2-carboxylic acid, 4'-((1,4'-dimethyl-2'-propyl(2,6'-bi-1H-benzimidazol)-1'-yl)methyl)-
[1,1'-Biphenyl]-2-carboxylic acid, 4'-[(1,4'-dimethyl-2'-propyl[2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-
144701-48-4
2-(4-{[4-methyl-6-(1-methyl-1H-1,3-benzodiazol-2-yl)-2-propyl-1H-1,3-benzodiazol-1-yl]methyl}phenyl)benzoic acid
2-[4-[[4-methyl-6-(1-methyl-2-benzimidazolyl)-2-propyl-1-benzimidazolyl]methyl]phenyl]benzoic acid
2-[4-[[4-methyl-6-(1-methylbenzimidazol-2-yl)-2-propyl-benzimidazol-1-yl]methyl]phenyl]benzoic acid
2-[4-[[4-methyl-6-(1-methylbenzimidazol-2-yl)-2-propylbenzimidazol-1-yl]methyl]phenyl]benzoic acid
2-[4-[[4-methyl-6-(1-methylbenzimidazol-2-yl)-2-propylbenzimidazol-1-yl]methyl]phenyl]benzoic acid.
4'-((1,4'-dimethyl-2'-propyl(2,6'-bi-1H-benzimidazol)-1'-yl)methyl)-(1,1'-biphenyl)-2-carboxylic acid
4'-((1,7'-Dimethyl-2'-propyl-1H,3'H-[2,5'-bibenzo[d]imidazol]-3'-yl)methyl)-[1,1'-biphenyl]-2-carbox
4'-((1,7'-Dimethyl-2'-propyl-1H,3'H-[2,5'-bibenzo[d]imidazol]-3'-yl)methyl)-[1,1'-biphenyl]-2-carboxylic acid
4'-((1,7'-DIMETHYL-2'-PROPYL-1H,3'H-2,5'-BIBENZO[D]IMIDAZOL-3'-YL)METHYL)BIPHENYL-2-CARBOXYLIC ACID
4'-((4-mehtyl-6-(1-methyl-2-benzimidazolyl)-2-propyl-1-benzimmidazolyl)methyl)-2-biphenylcarboxylic acid
4'-((4-Methyl-6-(1-methyl-2-benzimidazolyl)-2-propyl-1-benzimidazolyl)methyl)-2-biphenylcarboxylic acid
4'-[(1,4'-dimethyl-2'-propyl[2,6'-bi-1h-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid
4'-[(1,4'-dimethyl-2'propyl[2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid
4'-[(1,7'-dimethyl-2'-propyl-1H,3'H-2,5'-bibenzimidazol-3'-yl)methyl][1,1'-biphenyl]-2-carboxylic acid
4'-[(1,7'-dimethyl-2'-propyl-1H,3'H-2,5'-bibenzimidazol-3'-yl)methyl]biphenyl-2-carboxylic acid
4'-[[2-n-Propyl-4-methyl-6-(1-methylbenzimidazol-2-yl)-benzimidazol-1-yl]-methyl]-biphenyl-2-carboxylic acid
4'-[[4-Methyl-6-(1-methyl-1H-benzimidazol-2-yl)-2-propyl-1H-benzimidazol-1-yl]methyl]biphenyl-2-carboxylic Acid
4'-[[4-METHYL-6-(1-METHYL-2-BENZIMIDAZOLYL)-2-PROPYL-1-BENZIMIDAZOLYL]METHYL]-2-BIPHENYLCARBOXYLIC ACID
4'-[2-n-propyl-4-methyl-6-(1-methyl benzimidazol-2-yl)benzimidazol-1-yl methyl]biphenyl-2-carboxylic acid
4'-{[4-methyl-6-(1-methyl-1H-1,3-benzodiazol-2-yl)-2-propyl-1H-1,3-benzodiazol-1-yl]methyl}-[1,1'-biphenyl]-2-carboxylic acid
4''-((1,4''-dimethyl-2''-propyl(2,6''-bi-1H-benzimidazol)-1''-yl)methyl)-(1,1''-biphenyl)-2-carboxylic acid
4''-((4-methyl-6-(1-methyl-2-benzimidazolyl)-2-propyl-1-benzimidazolyl)methyl)-2-biphenylcarboxylic acid
4''-[(1,4''-dimethyl-2''propyl[2,6''-bi-1H-benzimidazol]-1''-yl)methyl]-[1,1''-biphenyl]-2-carboxylic acid
4''-[(1,7''-dimethyl-2''-propyl-1H,3''H-2,5''-bibenzimidazol-3''-yl)methyl][1,1''-biphenyl]-2-carboxylic acid
4''-[(1,7''-dimethyl-2''-propyl-1H,3''H-2,5''-bibenzimidazol-3''-yl)methyl]biphenyl-2-carboxylic acid
4'[(1,4'-DIMETHYL-2'-PROPYL[2,6'-BI-1H-BENZIMIDAZOL]-1'-YL)METHYL][1,1'-BIPHENYL]-2-CARBOXYLIC ACID
4CA-1224
66930-EP2270011A1
66930-EP2272841A1
66930-EP2277866A1
66930-EP2277879A1
66930-EP2295406A1
66930-EP2295422A2
66930-EP2298772A1
66930-EP2298779A1
66930-EP2301923A1
66930-EP2301931A1
66930-EP2301936A1
66930-EP2305219A1
66930-EP2305650A1
66930-EP2308839A1
701T484
A808270
AB0012010
AB00639941_08
AB00639941_09
AB00639941-06
AB00639941-07
AB07687
AB2000262
AC-2013
AC1L24EB
AC1Q5U7O
AJ-26708
AK-72892
AKOS005557501
ALBB-028954
AM90292
AN-14373
API0004337
AX8018372
Bay 68-9291
BAY-68-9291
BAY68-9291
BBL029085
BCP04513
BCP0726000055
BDBM50043280
BG0644
BIBR 277
BIBR 277 SE
BIBR 277SE
BIBR-277
BIBR-277-SE
BIBR-277SE
BIBR277
BIDD:GT0365
BR-72892
BRD-K73999723-001-02-2
BSPBio_002738
C-23026
C07710
C33H30N4O2
CAS-144701-48-4
CC-34667
CCG-39514
CHEBI:9434
CHEMBL1017
CPD000466326
CS-1699
D00627
DB00966
DL-511
DSSTox_CID_3636
DSSTox_GSID_23636
DSSTox_RID_77121
DTXSID8023636
FT-0631170
GP9498
GTPL592
HMS1922P07
HMS2051P16
HMS2090P17
HMS2093M22
HMS2231P07
HMS3393P16
HMS3655C08
HMS3715L17
HSDB 7590
HY-13955
I06-0281
J10282
KB-60708
KBio3_001958
KBioGR_001842
Kinzal
Kinzal/Pritor
Kinzalmono
KS-00000D1K
KS-1215
L001035
LS-44263
MCULE-8479555254
MFCD00918125
MFCD00918125 (98%)
Micardis
Micardis (TN)
MLS000759432
MLS001076687
MLS001424174
MLS006011851
MolPort-003-666-621
NC00296
NCGC00095150-01
NCGC00095150-02
NCGC00095150-03
NCGC00095150-04
NCGC00095150-06
NCGC00095150-07
NCGC00095150-08
NSC-759811
NSC759811
Pharmakon1600-01505261
Pritor
PubChem14979
Q-101933
RMMXLENWKUUMAY-UHFFFAOYSA-N
S-2837
s1738
SAM001246602
SBI-0206733.P001
SC-12741
SCHEMBL4464
SMR000466326
SPBio_002131
SPECTRUM1505261
Spectrum2_001976
Spectrum3_001089
Spectrum4_001261
Spectrum5_001053
SR-01000759355
SR-01000759355-4
SR-01000759355-5
ST2410854
STK624049
SW197676-3
SY052776
T-170
Targit
Targit;Temax;BIBR277;Micardis
Tazlok
Telmisartan (JP17/USAN/INN)
Telmisartan (Micardis)
Telmisartan [INN]
Telmisartan [USAN:INN]
Telmisartan [USAN:USP:INN:BAN]
Telmisartan for peak identification, European Pharmacopoeia (EP) Reference Standard
Telmisartan for system suitability, European Pharmacopoeia (EP) Reference Standard
Telmisartan tablets (JP17)
Telmisartan, >=98% (HPLC), solid
Telmisartan, European Pharmacopoeia (EP) Reference Standard
Telmisartan, Pharmaceutical Secondary Standard; Certified Reference Material
Telmisartan, United States Pharmacopeia (USP) Reference Standard
Telmisattan
Temax
TL8000991
TLS
Tox21_111452
Tox21_111452_1
U5SYW473RQ
UNII-U5SYW473RQ
YM-086
Z2210710360
ZINC1530886
ZX-AN079767
Paragraph IV (Patent) Challenges for TELMISARTAN
Tradename Dosage Ingredient NDA Submissiondate
MICARDIS TABLET;ORAL telmisartan 020850 2006-12-26

US Patents and Regulatory Information for telmisartan

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zydus Pharms TELMISARTAN telmisartan TABLET;ORAL 203325-001 Aug 26, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Alembic Pharms Ltd TELMISARTAN telmisartan TABLET;ORAL 202130-001 Jul 7, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Glenmark Pharms Ltd TELMISARTAN telmisartan TABLET;ORAL 090032-003 Jul 7, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Sandoz Inc TELMISARTAN telmisartan TABLET;ORAL 203867-002 Nov 3, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Jubilant Generics TELMISARTAN telmisartan TABLET;ORAL 204164-002 Aug 22, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-001 Nov 10, 1998 AB RX Yes No   Start Trial   Start Trial   Start Trial
Prinston Inc TELMISARTAN telmisartan TABLET;ORAL 207882-003 May 3, 2017 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 telmisartan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-003 Apr 4, 2000   Start Trial   Start Trial
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-002 Nov 10, 1998   Start Trial   Start Trial
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-001 Nov 10, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for telmisartan

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0502314 1190006-5.L Sweden   Start Trial PRODUCT NAME: TELMISARTAN, VALFRITT I FORM AV FARMACEUTISKT GODTAGBARA SALT, OCH AMLODIPIN, VALFRITT I FORM AV FARMACEUTISKT GODTAGBARA SALT SAERSKILT AMOLODIPINBESILAT; REG. NO/DATE: EU/1/10/648/001-028 " EESGODKLANDKOD="EG" EESGODKDATUM="2010-10-07" SEGODKNR="EU/1/10/648/001-028 " SEGODKLANDKOD="EG" SEGODKDATUM="2010-10-07" FLAG="L" SPCNR="1190006-5" 20101007
0502314 SPC/GB02/037 United Kingdom   Start Trial PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419
0502314 SPC/GB99/014 United Kingdom   Start Trial PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/98/089/001 19981211; UK EU/1/98/089/002 19981211; UK EU/1/98/089/003 19981211; UK EU/1/98/089/004 19981211; UK EU/1/98/089/005 19981211; UK EU/1/98/089/006 19981211; UK EU/1/98/089/007 19981211; UK EU/1/98/089/008 19981211; UK EU/1/98/089/009 19981211; UK EU/1/98/089/010 19981211
0502314 C300478 Netherlands   Start Trial PRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN AMLODIPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER AMLODIPINEBESILAAT; REGISTRATION NO/DATE: EU/1/10/648/001-028 20101007
0502314 24/2002 Austria   Start Trial PRODUCT NAME: TELMISARTAN, GEGEBENENFALLS IN FORM SEINER PHARMAZEUTISCH ANNEHMBAREN SALZE, UND HYDROCHLOROTHIAZID; REGISTRATION NO/DATE: EU/1/02/213/001- EU/1/02/213/010 20020419
0502314 3/2011 Austria   Start Trial PRODUCT NAME: TELMISARTAN, GGF. IN FORM SEINER PHARMAZEUTISCH ANNEHMBAREN SALZE UND AMLODIPIN, GGF. IN FORM SEINER PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE AMLODIPINBESILAT; REGISTRATION NO/DATE: EU/1/10/648/001 - EU/1/10/648/028 20101007
0502314 C990007 Netherlands   Start Trial PRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT; REGISTRATION NO/DATE: EU/1/98/089/001-EU/1/98/089/010 19981211
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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