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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 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.

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

Summary for telmisartan

US Patents:	3
Tradenames:	2
Applicants:	16
NDAs:	16
Drug Master File Entries:	39
Suppliers / Packagers:	22
Bulk Api Vendors:	101
Clinical Trials:	231
Patent Applications:	6,282
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for telmisartan
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
		80MG; 25MG	TABLET; ORAL
		80MG; 12.5MG	TABLET; ORAL
		40MG; 12.5MG	TABLET; 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
Prinston Inc	TELMISARTAN	telmisartan	TABLET;ORAL	207882-001	May 3, 2017	AB	RX	No	No
Hetero Labs Ltd V	TELMISARTAN	telmisartan	TABLET;ORAL	205901-002	Apr 22, 2016	AB	RX	No	No
Inventia Hlthcare	TELMISARTAN	telmisartan	TABLET;ORAL	205150-002	Oct 30, 2015	AB	RX	No	No
Alembic Pharms Ltd	TELMISARTAN	telmisartan	TABLET;ORAL	202130-002	Jul 7, 2014	AB	RX	No	No
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-002	Nov 10, 1998	AB	RX	Yes	Yes
Prinston Inc	TELMISARTAN	telmisartan	TABLET;ORAL	207882-002	May 3, 2017	AB	RX	No	No

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
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-002	Nov 10, 1998
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-001	Nov 10, 1998

International Patents for telmisartan

Country	Document Number	Estimated Expiration
Norway	20013560
Estonia	200100375
United Kingdom	9810855
Spain	2208265
Brazil	0007584
European Patent Office	1559424

Supplementary Protection Certificates for telmisartan

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/GB11/010	United Kingdom		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
00478	Netherlands		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
/1999	Austria		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
0502314/03	Switzerland		PRODUCT NAME: TELMISARTAN + AMLODIPIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 61270 08.11.2010
00095	Netherlands		PRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419
90007	Netherlands		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