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Last Updated: March 28, 2024

MICARDIS Drug Patent Profile


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Which patents cover Micardis, and what generic alternatives are available?

Micardis is a drug marketed by Boehringer Ingelheim and is included in two NDAs.

The generic ingredient in MICARDIS is hydrochlorothiazide; telmisartan. There are thirty-two drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; telmisartan profile page.

Drug patent expirations by year for MICARDIS
Drug Prices for MICARDIS

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Drug Sales Revenue Trends for MICARDIS

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Recent Clinical Trials for MICARDIS

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

SponsorPhase
University of HawaiiPhase 2
Queens Medical CenterPhase 2
HK inno.N CorporationPhase 1

See all MICARDIS clinical trials

Pharmacology for MICARDIS
Paragraph IV (Patent) Challenges for MICARDIS
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 MICARDIS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-003 Apr 4, 2000 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim MICARDIS HCT hydrochlorothiazide; telmisartan TABLET;ORAL 021162-001 Nov 17, 2000 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-001 Nov 10, 1998 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-002 Nov 10, 1998 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim MICARDIS HCT hydrochlorothiazide; telmisartan TABLET;ORAL 021162-003 Apr 19, 2004 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim MICARDIS HCT hydrochlorothiazide; telmisartan TABLET;ORAL 021162-002 Nov 17, 2000 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 MICARDIS

EU/EMA Drug Approvals for MICARDIS

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
Bayer AG Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG) telmisartan EMEA/H/C/000211
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
Bayer AG Pritor telmisartan EMEA/H/C/000210
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 1998-12-11
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for MICARDIS

See the table below for patents covering MICARDIS around the world.

Country Patent Number Title Estimated Expiration
Mexico 9302034 BENCIDAZOLES, MEDICAMENTOS QUE CONTIENEN ESTOS COMPUESTOS Y PROCEDIMIENTOS PARA SU PREPARACION. ⤷  Try a Trial
European Patent Office 1559424 ⤷  Try a Trial
Germany 4117121 ⤷  Try a Trial
African Regional IP Organization (ARIPO) 1300 The use of inhibitors of the renin-angiotensin system for the treatment of hypoxia or impaired metabolic function. ⤷  Try a Trial
Israel 106408 Biphenylmethyl-1-benzimidazole derivatives their preparation and pharmaceutical compositions containing them ⤷  Try a Trial
Hungary 0003982 ⤷  Try a Trial
Poland 211829 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for MICARDIS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0502314 91802 Luxembourg ⤷  Try a Trial 91802, EXPIRES: 20170131
0502314 SPC/GB02/037 United Kingdom ⤷  Try a Trial 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 CA 2002 00023 Denmark ⤷  Try a Trial
0502314 CA 2011 00008 Denmark ⤷  Try a Trial
0502314 C300095 Netherlands ⤷  Try a Trial 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 C990007 Netherlands ⤷  Try a Trial PRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT; REGISTRATION NO/DATE: EU/1/98/089/001-EU/1/98/089/010 19981211
0502314 C300478 Netherlands ⤷  Try a Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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