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Telmisartan - Generic Drug Details

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-one 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:	16
NDAs:	16
Drug Master File Entries:	39
Suppliers / Packagers:	21
Bulk Api Vendors:	102
Clinical Trials:	227
Patent Applications:	6,252
Formulation / Manufacturing:	see details
Drug Prices:	see low prices
DailyMed Link:	telmisartan at DailyMed

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-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 Up	40MG; 12.5MG	TABLET; ORAL
➤ Sign Up	➤ Sign Up	80MG; 25MG	TABLET; ORAL
➤ Sign Up	➤ Sign Up	80MG; 12.5MG	TABLET; ORAL

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
Micro Labs	TELMISARTAN	telmisartan	TABLET;ORAL	207016-001	Oct 3, 2017	AB	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Glenmark Pharms Ltd	TELMISARTAN	telmisartan	TABLET;ORAL	090032-003	Jul 7, 2014	AB	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Amneal Pharms	TELMISARTAN	telmisartan	TABLET;ORAL	204415-002	Sep 8, 2015	AB	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Prinston Inc	TELMISARTAN	telmisartan	TABLET;ORAL	207882-001	May 3, 2017	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

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	020850-002	Nov 10, 1998	➤ Sign Up	➤ Sign Up
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-003	Apr 4, 2000	➤ 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

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.

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Patent No.	Title	Estimated Patent Expiration
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
6,410,742	Polymorphs of telmisartan	➤ Sign Up
Patent No.	Title	Estimated Patent Expiration

International Patents for telmisartan

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Country	Document Number	Estimated Expiration
South Korea	20010031179	➤ Sign Up
Eurasian Patent Organization	200100730	➤ Sign Up
China	1144790	➤ Sign Up
Poland	193215	➤ Sign Up
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for telmisartan

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0014	Belgium	➤ Sign Up	PRODUCT NAME: TELMISARTAN REGISTRATION NO/DATE: EU/1/98/089/001 / 19981211
0502314/03	Switzerland	➤ Sign Up	PRODUCT NAME: TELMISARTAN + AMLODIPIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 61270 08.11.2010
C/GB99/014	United Kingdom	➤ Sign Up	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
/1999	Austria	➤ Sign Up	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
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description