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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: see list4

Pharmacology for Tradename: micardis

Clinical Trials for: micardis

CKD-828 Drug Interaction Study (Telmisartan)
Status: Completed Condition: Healthy Male Volunteers

PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes
Status: Completed Condition: Stroke

Telmisartan (Micardis) and Amlodipine (Norvasc) - Factorial Design Study for the Treatment of Hypertension
Status: Completed Condition: Hypertension

Use of Telmisartan and Captopril in Inflammation of Hemodialysis Patients
Status: Completed Condition: Inflammation; End-stage Renal Disease

CKD-346 DDI Study(Telmisartan/S-Amlodipine, Rosuvastatin)
Status: Completed Condition: Hypertension; Hyperlipidemia

Bioequivalence of BIBR 277 Tablet Compared With Capsule in Healthy Male Volunteers
Status: Completed Condition: Healthy

A Trial Comparing MICARDIS® (Telmisartan) and COZAAR® / LORZAAR® (Losartan) in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring (ABPM)
Status: Completed Condition: Hypertension

CKD-828 (80/5mg) Pharmacokinetic Study
Status: Completed Condition: Hypertension

Study to Investigate the Effect of Atorvastatin on the Pharmacokinetic Properties of Telmisartan/S-amlodipine
Status: Completed Condition: Essential Hypertension; Hyperlipidemia

A Trial Comparing MICARDIS® (Telmisartan) and COZAAR® (Losartan) in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring (ABPM)
Status: Completed Condition: Hypertension

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim
MICARDIS HCT
hydrochlorothiazide; telmisartan
TABLET;ORAL021162-002Nov 17, 2000RXNo6,358,986<disabled><disabled>
Boehringer Ingelheim
MICARDIS
telmisartan
TABLET;ORAL020850-002Nov 10, 1998RXYes7,998,953<disabled><disabled>
Boehringer Ingelheim
MICARDIS
telmisartan
TABLET;ORAL020850-002Nov 10, 1998RXYes8,003,679<disabled><disabled>
Boehringer Ingelheim
MICARDIS
telmisartan
TABLET;ORAL020850-003Apr 4, 2000RXNo6,358,986<disabled><disabled>
Boehringer Ingelheim
MICARDIS HCT
hydrochlorothiazide; telmisartan
TABLET;ORAL021162-003Apr 19, 2004RXYes<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
8,604,070Use of inhibitors of the renin-angiotensin system<disabled in preview>
7,071,183Use of inhibitors of the renin-angiotensin system<disabled in preview>
6,410,742 Polymorphs of telmisartan<disabled in preview>
RE38676 Thermally initiated polymerization of olefins using ruthenium or osmium vinylidene complexes<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
Hungary0003982Nov 28, 2001
Poland197164Mar 31, 2008
Slovakia285429Jan 04, 2007
Czech Republic297412Dec 13, 2006
Czech Republic20012634Oct 17, 2001
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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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