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Last Updated: August 13, 2020

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MICARDIS HCT Drug Profile

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Which patents cover Micardis Hct, and when can generic versions of Micardis Hct launch?

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. Twelve 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

There are two Paragraph IV patent challenges 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 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
Programme PACCIPhase 2/Phase 3
Université de BordeauxPhase 2/Phase 3
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)Phase 2/Phase 3

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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim MICARDIS HCT hydrochlorothiazide; telmisartan TABLET;ORAL 021162-001 Nov 17, 2000   Start Trial   Start Trial
Boehringer Ingelheim MICARDIS HCT hydrochlorothiazide; telmisartan TABLET;ORAL 021162-002 Nov 17, 2000   Start Trial   Start Trial
Boehringer Ingelheim MICARDIS HCT hydrochlorothiazide; telmisartan TABLET;ORAL 021162-001 Nov 17, 2000   Start Trial   Start Trial
Boehringer Ingelheim MICARDIS HCT hydrochlorothiazide; telmisartan TABLET;ORAL 021162-002 Nov 17, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for MICARDIS HCT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 3/2011 Austria   Start 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 91802 Luxembourg   Start Trial 91802, EXPIRES: 20170131
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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