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Last Updated: December 8, 2022

Telmisartan - Generic Drug Details


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What are the generic drug 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, 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-two suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for telmisartan

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Drug Sales Revenue Trends for telmisartan

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Recent Clinical Trials for telmisartan

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

SponsorPhase
HK inno.N CorporationPhase 1
Heart and Stroke Foundation of CanadaEarly Phase 1
University of British ColumbiaEarly Phase 1

See all telmisartan clinical trials

Generic filers with tentative approvals for TELMISARTAN
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing80MG; 25MGTABLET; ORAL
See Plans and PricingSee Plans and Pricing80MG; 12.5MGTABLET; ORAL
See Plans and PricingSee Plans and Pricing40MG; 12.5MGTABLET; 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
Paragraph IV (Patent) Challenges for TELMISARTAN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
MICARDIS Tablets telmisartan 20 mg, 40 mg and 80 mg 020850 1 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
Hisun Pharm Hangzhou TELMISARTAN telmisartan TABLET;ORAL 207843-002 Feb 19, 2019 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Micro Labs TELMISARTAN telmisartan TABLET;ORAL 207016-002 Oct 3, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alembic Pharms Ltd TELMISARTAN telmisartan TABLET;ORAL 202130-003 Jul 7, 2014 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Micro Labs TELMISARTAN telmisartan TABLET;ORAL 207016-001 Oct 3, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-001 Nov 10, 1998 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

EU/EMA Drug Approvals for telmisartan

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Boehringer Ingelheim International GmbH Micardis telmisartan EMEA/H/C/000209
HypertensionTreatment of essential hypertension in adults.Cardiovascular preventionReduction of cardiovascular morbidity in patients with:manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or;type-2 diabetes mellitus with documented target-organ damage.
Authorised no no no 1998-12-16
Krka, d.d., Novo mesto  Tolura telmisartan EMEA/H/C/001196
HypertensionTreatment of essential hypertension in adults.Cardiovascular preventionReduction of cardiovascular morbidity in patients with:manifest atherothrombotic cardiovascular disease (history of coronary heart disease or peripheral arterial disease) or;type 2 diabetes mellitus with documented target organ damage.
Authorised yes no no 2010-06-04
Teva B.V. Telmisartan Teva Pharma telmisartan EMEA/H/C/002511
Treatment of essential hypertension in adults.
Authorised yes no no 2011-10-03
Teva B.V. Telmisartan Teva telmisartan EMEA/H/C/001146
Treatment of essential hypertension in adults
Withdrawn yes no no 2010-01-25
Actavis Group PTC ehf Telmisartan Actavis telmisartan EMEA/H/C/001168
HypertensionTreatment of essential hypertension in adults.Cardiovascular preventionReduction of cardiovascular morbidity in patients with:manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or;type 2 diabetes mellitus with documented target organ damage.
Authorised yes no no 2010-09-29
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for telmisartan

Country Patent Number Title Estimated Expiration
United Kingdom 9810855 See Plans and Pricing
Canada 2306216 UTILISATION D'INHIBITEURS DU SYSTEME RENINE-ANGIOTENSINE (THE USE OF INHIBITORS OF THE RENIN-ANGIOTENSIN SYSTEM FOR THE TREATMENT OF CACHEXIA AND WASTING) See Plans and Pricing
United Kingdom 9722026 See Plans and Pricing
Austria 294579 See Plans and Pricing
World Intellectual Property Organization (WIPO) 9920260 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for telmisartan

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0502314 1190006-5.L Sweden See Plans and Pricing 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 SPC/GB02/037 United Kingdom See Plans and Pricing 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 C300478 Netherlands See Plans and Pricing 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
0502314 SPC/GB99/014 United Kingdom See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: TELMISARTAN + AMLODIPIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 61270 08.11.2010
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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