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Generated: July 21, 2018

DrugPatentWatch Database Preview

Telmisartan - Generic Drug Details

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What are the generic drug sources for telmisartan and what is the scope of telmisartan 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, Glenmark Pharms Ltd, Hetero Labs Ltd V, Inventia Hlthcare, Jubilant Generics, Micro Labs, Mylan Pharms Inc, Prinston Inc, Sandoz Inc, Torrent Pharms Ltd, Watson Labs, and Zydus Pharms Usa Inc, and is included in sixteen 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-three suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for telmisartan
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-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
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,?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'-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'-(1,7'-DIMETHYL-2'-PROPYL-1H-[2,5']BIBENZOIMIDAZOLYL-3'-YLMETHYL)-BIPHENYL-2-CARBOXYLIC ACID
4'-[(1,4'-DIMETHYL-2'-N-PROPYL[2,6'-BI-1H-BENZIMIDAZOL]-1'-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
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]-2-BIPHENYLCARBOXYLIC 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
Abbott brand of telmisartan
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
BCP0726000055
BDBM50043280
BG0644
BIBR 277
BIBR 277 SE
BIBR 277SE
BIBR-277
BIBR-277-SE
BIBR-277SE
BIBR277
BIDD:GT0365
Bio-0103
Boehringer Ingelheim brand of telmisartan
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
D0N6RF
DB00966
DL-511
DR003120
DSSTox_CID_3636
DSSTox_GSID_23636
DSSTox_RID_77121
DTXSID8023636
FT-0631170
Glaxo Wellcome brand of telmisartan
GlaxoSmithKline brand of telmisartan
GP9498
GTPL592
HE160708
HE311798
HE311799
HMS1922P07
HMS2051P16
HMS2090P17
HMS2093M22
HMS2231P07
HMS3393P16
HMS3655C08
HSDB 7590
HY-13955
I06-0281
IN2170
J10282
KB-60708
KBio3_001958
KBioGR_001842
Kinzal
Kinzal/Pritor
Kinzalmono
KS-00000D1K
KS-1215
L001035
LS-44263
MCULE-8479555254
MFCD00918125
Micardis
Micardis (TN)
Micardis, Targit, Temax, BIBR277, Telmisartan
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
ST2410854
STK624049
Targit
Targit;Temax;BIBR277;Micardis
Tazlok
Telmisartan (JAN/USAN/INN)
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; traceable to USP, PhEur
Telmisartan, United States Pharmacopeia (USP) Reference Standard
Telmisattan
Temax
TL8000991
TLS
tolura
Tox21_111452
Tox21_111452_1
U5SYW473RQ
UNII-U5SYW473RQ
YM-086
Z2210710360
ZINC1530886
ZX-AN079767
Tentative approvals for TELMISARTAN
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up40MG; 12.5MGTABLET; ORAL
➤ Sign Up➤ Sign Up80MG; 25MGTABLET; ORAL
➤ Sign Up➤ Sign Up80MG; 12.5MGTABLET; ORAL

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
Mylan Pharms Inc TELMISARTAN telmisartan TABLET;ORAL 202397-002 Jul 7, 2014 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-001 Nov 10, 1998 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Glenmark Pharms Ltd TELMISARTAN telmisartan TABLET;ORAL 090032-001 Jul 7, 2014 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Pharms Inc TELMISARTAN telmisartan TABLET;ORAL 202397-003 Jul 7, 2014 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 telmisartan

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

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Non-Orange Book US Patents for telmisartan

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,410,742 Polymorphs of telmisartan ➤ Sign Up
7,071,183 Use of inhibitors of the renin-angiotensin system ➤ Sign Up
8,604,070 Use of inhibitors of the renin-angiotensin system ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for telmisartan

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB02/037 United Kingdom ➤ Sign Up 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
/2002 Austria ➤ Sign Up 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
0502314/03 Switzerland ➤ Sign Up PRODUCT NAME: TELMISARTAN + AMLODIPIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 61270 08.11.2010
90006-5.L Sweden ➤ Sign Up 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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