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Last Updated: November 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.

Summary for telmisartan

International Patents:	88
US Patents:	3
Tradenames:	2
Applicants:	17
NDAs:	17
Drug Master File Entries:	39
Suppliers / Packagers:	24
Bulk Api Vendors:	111
Clinical Trials:	241
Patent Applications:	6,371
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for telmisartan
Drug Sales Revenues:	Drug sales revenues for telmisartan
DailyMed Link:	telmisartan at DailyMed

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

Sponsor	Phase
Michael Smith Foundation for Health Research	Early Phase 1
University of British Columbia	Early Phase 1
Heart and Stroke Foundation of Canada	Early Phase 1

See all telmisartan clinical trials

Generic filers with tentative approvals for TELMISARTAN

Applicant	Application No.	Strength	Dosage Form
Start Trial	Start Trial	80MG; 25MG	TABLET; ORAL
Start Trial	Start Trial	80MG; 12.5MG	TABLET; ORAL
Start Trial	Start Trial	40MG; 12.5MG	TABLET; 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

Drug Class	Angiotensin 2 Receptor Blocker
Mechanism of Action	Angiotensin 2 Receptor Antagonists

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal Pharms	TELMISARTAN	telmisartan	TABLET;ORAL	204415-001	Sep 8, 2015	AB	RX	No	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
Amneal Pharms	TELMISARTAN	telmisartan	TABLET;ORAL	204415-003	Sep 8, 2015	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Sandoz Inc	TELMISARTAN	telmisartan	TABLET;ORAL	203867-001	Nov 3, 2014	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-002	Nov 10, 1998	AB	RX	Yes	Yes	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

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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

International Patents for telmisartan

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Country	Patent Number	Estimated Expiration
Serbia	50044	Start Trial
European Patent Office	1559424	Start Trial
China	1336920	Start Trial
European Patent Office	1776954	Start Trial
South Korea	20010031177	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for telmisartan

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	23/1999	Austria	Start Trial	PRODUCT NAME: TELMISARTAN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; NAT. REGISTRATION NO/DATE: EU/1/98/089/001-010 19981211; FIRST REGISTRATION: BE K (1998) 4288-DE 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	SPC/GB11/010	United Kingdom	Start Trial	PRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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