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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Julphar
Harvard Business School
Merck
Boehringer Ingelheim
Cantor Fitzgerald
Chinese Patent Office
UBS
Citi

Generated: May 26, 2018

DrugPatentWatch Database Preview

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. Twelve suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; telmisartan profile page.
Summary for MICARDIS HCT
International Patents:47
US Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: 3
Clinical Trials: 57
Formulation / Manufacturing:see details
DailyMed Link:MICARDIS HCT at DailyMed
Drug patent expirations by year for MICARDIS HCT
Pharmacology for MICARDIS HCT

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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim MICARDIS HCT hydrochlorothiazide; telmisartan TABLET;ORAL 021162-002 Nov 17, 2000 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim MICARDIS HCT hydrochlorothiazide; telmisartan TABLET;ORAL 021162-003 Apr 19, 2004 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 021162-003 Apr 19, 2004 ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim MICARDIS HCT hydrochlorothiazide; telmisartan TABLET;ORAL 021162-001 Nov 17, 2000 ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim MICARDIS HCT hydrochlorothiazide; telmisartan TABLET;ORAL 021162-002 Nov 17, 2000 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for MICARDIS HCT
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 80 mg/25 mg ➤ Subscribe 2009-02-27
➤ Subscribe Tablets 80 mg/12.5 mg and 40 mg/12.5 mg ➤ Subscribe 2008-12-31

Non-Orange Book US Patents for MICARDIS HCT

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,410,742 Polymorphs of telmisartan ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for MICARDIS HCT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2011 00026 Denmark ➤ Sign Up PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216
C/GB99/008 United Kingdom ➤ Sign Up 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
0443983/03 Switzerland ➤ Sign Up PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
C0009 Belgium ➤ Sign Up PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Merck
Chubb
Deloitte
Mallinckrodt
Chinese Patent Office
Healthtrust
Cerilliant
Colorcon

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