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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.

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

International Patents:	88
US Patents:	3
Tradenames:	2
Applicants:	16
NDAs:	16
Drug Master File Entries:	39
Suppliers / Packagers:	23
Bulk Api Vendors:	106
Clinical Trials:	235
Patent Applications:	6,322
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for telmisartan
Drug Sales Revenues:	Drug sales revenues 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-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

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
Sandoz Inc	TELMISARTAN	telmisartan	TABLET;ORAL	203867-002	Nov 3, 2014	AB	RX	No	No
Jubilant Generics	TELMISARTAN	telmisartan	TABLET;ORAL	204164-002	Aug 22, 2016	AB	RX	No	No
Zydus Pharms Usa Inc	TELMISARTAN	telmisartan	TABLET;ORAL	203325-001	Aug 26, 2014	AB	RX	No	No
Amneal Pharms	TELMISARTAN	telmisartan	TABLET;ORAL	204415-002	Sep 8, 2015	AB	RX	No	No
Amneal Pharms	TELMISARTAN	telmisartan	TABLET;ORAL	204415-001	Sep 8, 2015	AB	RX	No	No
Hetero Labs Ltd V	TELMISARTAN	telmisartan	TABLET;ORAL	205901-001	Apr 22, 2016	AB	RX	No	No
Alembic Pharms Ltd	TELMISARTAN	telmisartan	TABLET;ORAL	202130-003	Jul 7, 2014	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	020850-001	Nov 10, 1998
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-002	Nov 10, 1998

International Patents for telmisartan

Country	Patent Number	Estimated Expiration
Canada	2677910
Japan	2009242426
Norway	20001979
Uruguay	25971
Peru	13622000
South Korea	100572080
Spain	2287617

Supplementary Protection Certificates for telmisartan

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0502314	99C0014	Belgium		PRODUCT NAME: TELMISARTAN REGISTRATION NO/DATE: EU/1/98/089/001 / 19981211
0502314	SPC/GB99/014	United Kingdom		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	C00502314/03	Switzerland		PRODUCT NAME: TELMISARTAN + AMLODIPIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 61270 08.11.2010
0502314	23/1999	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	SPC/GB02/037	United Kingdom		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	24/2002	Austria		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		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