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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:	105
Clinical Trials:	227
Patent Applications:	6,253
Formulation / Manufacturing:	see details
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
		40MG; 12.5MG	TABLET; ORAL
		80MG; 25MG	TABLET; ORAL
		80MG; 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
Mylan Pharms Inc	TELMISARTAN	telmisartan	TABLET;ORAL	202397-002	Jul 7, 2014	AB	RX	No	No
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-001	Nov 10, 1998	AB	RX	Yes	No
Glenmark Pharms Ltd	TELMISARTAN	telmisartan	TABLET;ORAL	090032-001	Jul 7, 2014	AB	RX	No	No
Mylan Pharms Inc	TELMISARTAN	telmisartan	TABLET;ORAL	202397-003	Jul 7, 2014	AB	RX	No	No

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

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
7,071,183	Use of inhibitors of the renin-angiotensin system
8,604,070	Use of inhibitors of the renin-angiotensin system

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International Patents for telmisartan

Country	Document Number	Estimated Expiration
Japan	2002535315
Austria	252564
Poland	197164
Spain	2287617

Supplementary Protection Certificates for telmisartan

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/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
/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
0502314/03	Switzerland		PRODUCT NAME: TELMISARTAN + AMLODIPIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 61270 08.11.2010
90006-5.L	Sweden		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