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Profile for Tradename: MICARDIS

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Micardis is a drug marketed by Boehringer Ingelheim and is included in two NDAs. It is available from four suppliers. There are three patents protecting this drug and three Paragraph IV challenges.

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

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

Summary for Tradename: MICARDIS

Patents:3
Applicants:1
NDAs:2
Suppliers / Packagers: see list13

Pharmacology for Tradename: MICARDIS

Clinical Trials for: MICARDIS

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim
MICARDIS
telmisartan
TABLET;ORAL020850-003Apr 4, 2000RXNo6,358,986<disabled><disabled>
Boehringer Ingelheim
MICARDIS HCT
hydrochlorothiazide; telmisartan
TABLET;ORAL021162-002Nov 17, 2000RXNo6,358,986<disabled><disabled>
Boehringer Ingelheim
MICARDIS
telmisartan
TABLET;ORAL020850-002Nov 10, 1998RXYes8,003,679<disabled><disabled>
Boehringer Ingelheim
MICARDIS HCT
hydrochlorothiazide; telmisartan
TABLET;ORAL021162-003Apr 19, 2004RXYes<disabled><disabled>
Boehringer Ingelheim
MICARDIS
telmisartan
TABLET;ORAL020850-001Nov 10, 1998RXNo6,358,986<disabled><disabled>
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Paragraph IV activity for: MICARDIS

Drugname Dosage Strength RLD Submissiondate
telmisartan and hydrochlorothiazideTablets80 mg/25 mgMicardis HCT2/27/2009
telmisartan and hydrochlorothiazideTablets80 mg/12.5 mg and 40 mg/12.5 mgMicardis HCT12/31/2008
telmisartanTablets20 mg, 40 mg and 80 mgMicardis12/26/2006

Non-Orange Book Patents for Tradename: MICARDIS

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
RE38676 Thermally initiated polymerization of olefins using ruthenium or osmium vinylidene complexes<disabled in preview>
8,604,070Use of inhibitors of the renin-angiotensin system<disabled in preview>
6,410,742 Polymorphs of telmisartan<disabled in preview>
7,071,183Use of inhibitors of the renin-angiotensin system<disabled in preview>
6,107,420 Thermally initiated polymerization of olefins using Ruthenium or osmium vinylidene complexes<disabled in preview>
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International Patent Family for Tradename: MICARDIS

Country Document Number Publication Date
Portugal1144386Mar 31, 2004
CroatiaP20010514Jan 31, 2010
Spain2238770Sep 01, 2005
European Patent Office1498124Aug 17, 2005
Hungary0105148Jan 28, 2003
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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