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Last Updated: January 20, 2020

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MICARDIS HCT Drug Profile

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

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

This drug has forty-seven patent family members in thirty-five countries.

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

US ANDA Litigation and Generic Entry Outlook for Micardis Hct

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Micardis Hct was eligible for patent challenges on December 31st, 1968.

There are two Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.

Drug patent expirations by year for MICARDIS HCT
Drug Prices for MICARDIS HCT

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Drug Sales Revenue Trends for MICARDIS HCT

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Recent Clinical Trials for MICARDIS HCT

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

SponsorPhase
Xiaoduo FanPhase 2
Pharmtechnology LLCPhase 1
Algorithme Pharma, An Altasciences CompanyPhase 1

See all MICARDIS HCT clinical trials

Pharmacology for MICARDIS HCT
Paragraph IV (Patent) Challenges for MICARDIS HCT
Tradename Dosage Ingredient NDA Submissiondate
MICARDIS HCT TABLET;ORAL hydrochlorothiazide; telmisartan 021162 2008-12-31

US Patents and Regulatory Information for MICARDIS HCT

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 HCT hydrochlorothiazide; telmisartan TABLET;ORAL 021162-001 Nov 17, 2000 AB RX Yes No   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim MICARDIS HCT hydrochlorothiazide; telmisartan TABLET;ORAL 021162-002 Nov 17, 2000 AB RX Yes No   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim MICARDIS HCT hydrochlorothiazide; telmisartan TABLET;ORAL 021162-003 Apr 19, 2004 AB RX Yes Yes   Start Trial   Start Trial   Start 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 HCT

Supplementary Protection Certificates for MICARDIS HCT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0565634 06C0030 France   Start Trial PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
0502314 C300095 Netherlands   Start 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
0480717 98C0025 Belgium   Start Trial PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
0502314 SPC/GB02/037 United Kingdom   Start 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
0454511 99C0009 Belgium   Start Trial PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
0454511 SPC/GB99/008 United Kingdom   Start Trial PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE)(GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/98/086/001 19981015; UK EU/1/98/086/002 19981015; UK EU/1/98/086/003 19981015; UK EU/1/98/086/004 19981015; UK EU/1/98/086/005 19981015; UK EU/1/98/086/006 19981015
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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AstraZeneca
Medtronic

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