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Profile for Tradename: MICARDIS HCT

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

The generic ingredient in MICARDIS HCT 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 HCT

Suppliers: see list4
Formulation / Manufacturing:see details

Pharmacology for Tradename: MICARDIS HCT

Clinical Trials for: MICARDIS HCT

A Randomized, Double-blind, Placebo Controlled Comparison of Telmisartan Hydrochlorothiazide (HCT) and Valsartan HCT in Hypertension (HTN) Stage I/II Patients
Status: Completed Condition: Hypertension

Study to Evaluate the Effect of the Treatment With Micardis® or MicardisPlus® on Blood Pressure
Status: Completed Condition: Hypertension

Study to Evaluate the Effect of Micardis® / MicardisPlus® on Metabolic Parameters in Patients With Essential Hypertension and Diabetes Mellitus
Status: Completed Condition: Hypertension

Micardis® / MicardisPlus® Program for Therapy Optimization With Telmisartan in Cardiovascular Diseases (PROTEKT)
Status: Completed Condition: Hypertension

Post-marketing Surveillance Study With MicardisPlus® in Treatment of Morning Hypertension (Self-monitored by Patient)
Status: Completed Condition: Hypertension

Relative Bioavailability of Telmisartan and HCTZ in Two Experimental Formulations Compared to the Standard Formulation Telmisartan and HCTZ in Healthy Female and Male Subjects
Status: Completed Condition: Healthy

A Study of a Hypertensive Population Under Treatment With Micardis® and Micardis Plus® to Control the Early Morning BP Rise (SURGE II)
Status: Completed Condition: Hypertension

Telmisartan+HCTZ (Hydrochlorothiazide), Hypertension
Status: Completed Condition: Hypertension

Evaluation of Efficacy and Tolerability of Micardis® / MicardisPlus® Under Usual Daily-practice Prescribing in Patients With Hypertension
Status: Completed Condition: Hypertension

Evaluation of the Effect of Telmisartan (Micardis® 80 mg/ MicardisPlus® 80/12.5 mg) on Blood Pressure and Cardiovascular Risk Factor Index in High Risk Hypertensive Patients
Status: Completed Condition: Hypertension; Cardiovascular Diseases

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

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
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Preferred citation:

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

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