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Last Updated: June 16, 2021

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MICARDIS Drug 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 2018 were $34mm 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

See drug prices for MICARDIS

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
Queens Medical CenterPhase 2
University of HawaiiPhase 2
Programme PACCIPhase 2/Phase 3

See all MICARDIS clinical trials

Pharmacology for MICARDIS
Paragraph IV (Patent) Challenges for MICARDIS
Tradename Dosage Ingredient NDA Submissiondate
MICARDIS TABLET;ORAL telmisartan 020850 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   Get Started Free   Get Started Free   Get Started Free
Boehringer Ingelheim MICARDIS HCT hydrochlorothiazide; telmisartan TABLET;ORAL 021162-001 Nov 17, 2000 AB RX Yes No   Get Started Free   Get Started Free   Get Started Free
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-001 Nov 10, 1998 AB RX Yes No   Get Started Free   Get Started Free   Get Started Free
>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   Get Started Free   Get Started Free
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-002 Nov 10, 1998   Get Started Free   Get Started Free
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-001 Nov 10, 1998   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for MICARDIS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0502314 C300478 Netherlands   Get Started Free 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 C300095 Netherlands   Get Started Free 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 SPC/GB02/037 United Kingdom   Get Started Free 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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