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MICARDIS HCT Drug Profile

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

This drug has forty-two patent family members in thirty-four countries.

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

Summary for Tradename: MICARDIS HCT

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Formulation / Manufacturing:see details

Pharmacology for Tradename: MICARDIS HCT

Clinical Trials for: MICARDIS HCT

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;ORAL021162-001Nov 17, 2000RXNo6,358,986<disabled> <disabled>
Boehringer Ingelheim
MICARDIS HCT
hydrochlorothiazide; telmisartan
TABLET;ORAL021162-002Nov 17, 2000RXNo6,358,986<disabled> <disabled>
Boehringer Ingelheim
MICARDIS HCT
hydrochlorothiazide; telmisartan
TABLET;ORAL021162-003Apr 19, 2004RXYes<disabled><disabled>
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Expired Patents for Tradename: MICARDIS HCT

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
MICARDIS HCT
hydrochlorothiazide; telmisartan
TABLET;ORAL021162-001Nov 17, 20005,591,762<disabled>
Boehringer Ingelheim
MICARDIS HCT
hydrochlorothiazide; telmisartan
TABLET;ORAL021162-003Apr 19, 20045,591,762<disabled>
Boehringer Ingelheim
MICARDIS HCT
hydrochlorothiazide; telmisartan
TABLET;ORAL021162-002Nov 17, 20005,591,762<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

Non-Orange Book Patents for Tradename: 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<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: MICARDIS HCT

Country Document Number Estimated Expiration
Australia765081<disabled in preview>
Serbia50044<disabled in preview>
Colombia5150238<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: MICARDIS HCT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2011 00026Denmark<disabled>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
C0025Belgium<disabled>PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
C/GB02/037United Kingdom<disabled>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
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