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Last Updated: March 29, 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-003 Apr 4, 2000 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-002 Nov 10, 1998 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-002 Nov 10, 1998 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-003 Apr 4, 2000 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-002 Nov 10, 1998 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-001 Nov 10, 1998 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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
>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
Germany 4212250 ⤷  Try a Trial
Austria 366110 ⤷  Try a Trial
China 1050122 ⤷  Try a Trial
Australia 765081 ⤷  Try a Trial
Japan H05279341 ⤷  Try a Trial
Singapore 43083 Benzinidaziles pharmaceutical compositions containing these compounds and processes for preparing them ⤷  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 23/1999 Austria ⤷  Try a Trial 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
0502314 C00502314/03 Switzerland ⤷  Try a Trial PRODUCT NAME: TELMISARTAN + AMLODIPIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 61270 08.11.2010
0502314 1190006-5.L Sweden ⤷  Try a Trial 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 3/2011 Austria ⤷  Try a Trial PRODUCT NAME: TELMISARTAN, GGF. IN FORM SEINER PHARMAZEUTISCH ANNEHMBAREN SALZE UND AMLODIPIN, GGF. IN FORM SEINER PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE AMLODIPINBESILAT; REGISTRATION NO/DATE: EU/1/10/648/001 - EU/1/10/648/028 20101007
0502314 24/2002 Austria ⤷  Try a Trial 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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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