DrugPatentWatch Database Preview

Telmisartan - Generic Drug Details

« Back to Dashboard

What are the generic 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, Celltrion, 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 is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Telmisartan has forty-one patent family members in eighteen 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:	41
US Patents:	1
Tradenames:	2
Applicants:	17
NDAs:	17
Drug Master File Entries:	39
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	129
Clinical Trials:	257
Patent Applications:	5,489
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for telmisartan
Drug Sales Revenues:	Drug sales revenues for telmisartan
What excipients (inactive ingredients) are in telmisartan?	telmisartan excipients list
DailyMed Link:	telmisartan at DailyMed

See drug prices for telmisartan

See drug sales revenues for telmisartan

Recent Clinical Trials for telmisartan

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
PACCI Program	Phase 2/Phase 3
Centre Muraz	Phase 2/Phase 3
University of Bordeaux	Phase 2/Phase 3

See all telmisartan clinical trials

Generic filers with tentative approvals for TELMISARTAN

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

Anatomical Therapeutic Chemical (ATC) Classes for telmisartan

C09CA	Angiotensin II receptor blockers (ARBs), plain
C09C	ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Jubilant Generics	TELMISARTAN	telmisartan	TABLET;ORAL	204164-001	Aug 22, 2016		DISCN	No	No
Glenmark Pharms Ltd	TELMISARTAN	telmisartan	TABLET;ORAL	090032-002	Jul 7, 2014	AB	RX	No	No
Mylan	TELMISARTAN	telmisartan	TABLET;ORAL	202397-001	Jul 7, 2014	AB	RX	No	No
Inventia	TELMISARTAN	telmisartan	TABLET;ORAL	205150-001	Oct 30, 2015	AB	RX	No	No
Inventia	TELMISARTAN	telmisartan	TABLET;ORAL	205150-003	Oct 30, 2015	AB	RX	No	No
Hetero Labs Ltd V	TELMISARTAN	telmisartan	TABLET;ORAL	205901-003	Apr 22, 2016	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	020850-002	Nov 10, 1998
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-001	Nov 10, 1998
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-002	Nov 10, 1998
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-003	Apr 4, 2000

International Patents for telmisartan

Country	Patent Number	Estimated Expiration
Spain	2238770
European Patent Office	1023067
European Patent Office	1498124
Germany	69830069
Denmark	1023067
Uruguay	25972

Supplementary Protection Certificates for telmisartan

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	C300095	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
0502314	99C0014	Belgium		PRODUCT NAME: TELMISARTAN REGISTRATION NO/DATE: EU/1/98/089/001 / 19981211
0502314	1190006-5.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
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