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Last Updated: July 21, 2024

Telmisartan - Generic Drug Details


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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, Amneal Pharms, Aurobindo Pharma, Cadila Pharms Ltd, Chartwell Rx, Glenmark Pharms Ltd, Hetero Labs Ltd V, Hisun Pharm Hangzhou, Inventia, Jubilant Generics, Micro Labs, Mylan, Prinston Inc, Sandoz, Torrent, and Zydus Pharms, and is included in seventeen NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-nine drug master file entries for telmisartan. Twenty-six 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
THPharm Corp.Phase 1
HK inno.N CorporationPhase 1
Michael Smith Foundation for Health ResearchEarly Phase 1

See all telmisartan clinical trials

Generic filers with tentative approvals for TELMISARTAN
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up80MG; 25MGTABLET; ORAL
⤷  Sign Up⤷  Sign Up80MG; 12.5MGTABLET; ORAL
⤷  Sign Up⤷  Sign Up40MG; 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
Amneal Pharms TELMISARTAN telmisartan TABLET;ORAL 204415-002 Sep 8, 2015 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Torrent TELMISARTAN telmisartan TABLET;ORAL 203171-002 Jul 7, 2014 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz TELMISARTAN telmisartan TABLET;ORAL 203867-001 Nov 3, 2014 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hisun Pharm Hangzhou TELMISARTAN telmisartan TABLET;ORAL 207843-003 Feb 19, 2019 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-002 Nov 10, 1998 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-002 Nov 10, 1998 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-003 Apr 4, 2000 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-002 Nov 10, 1998 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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