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Last Updated: August 8, 2022

MICARDIS Drug Patent Profile


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When do Micardis patents expire, and what generic alternatives are available?

Micardis is a drug marketed by Boehringer Ingelheim and is included in two NDAs. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has forty-one patent family members in eighteen countries.

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

DrugPatentWatch® Generic Entry Outlook for Micardis

Micardis was eligible for patent challenges on November 10, 2002.

Annual sales in 2019 were $20mm indicating the motivation for generic entry (peak sales were $430mm in 2011).

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Drug patent expirations by year for MICARDIS
Drug Prices for MICARDIS

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Drug Sales Revenue Trends for MICARDIS

See drug sales revenues for MICARDIS

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

MICARDIS is protected by one US patents.

Patents protecting MICARDIS

Use of inhibitors of the renin-angiotensin system
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OR PREVENTION OF STROKE

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim MICARDIS HCT hydrochlorothiazide; telmisartan TABLET;ORAL 021162-001 Nov 17, 2000 AB RX Yes 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
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-002 Nov 10, 1998 AB RX Yes Yes 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 MICARDIS

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-002 Nov 10, 1998 See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-003 Apr 4, 2000 See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-001 Nov 10, 1998 See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-002 Nov 10, 1998 See Plans and Pricing See Plans and Pricing
>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
>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
Finland 920486 See Plans and Pricing
Germany 59209330 Benzimidazole, diese Verbindungen enthaltende Arzneimittel und Verfahren zu ihrer Herstellung See Plans and Pricing
Canada 2093785 See Plans and Pricing
Israel 104485 Benzimidazole derivatives their preparation and pharmaceutical compositions containing them See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for MICARDIS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0502314 CA 2011 00008 Denmark See Plans and Pricing
0502314 C300095 Netherlands See Plans and Pricing 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 See Plans and Pricing 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 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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