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micardis Drug Profile

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Micardis is a drug marketed by Boehringer Ingelheim and is included in two NDAs. It is available from three 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. Ten 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 list3

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>
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Expired Patents for Tradename: MICARDIS

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
MICARDIS
telmisartan
TABLET;ORAL020850-001Nov 10, 19985,591,762<disabled>
Boehringer Ingelheim
MICARDIS
telmisartan
TABLET;ORAL020850-003Apr 4, 20005,591,762<disabled>
Boehringer Ingelheim
MICARDIS
telmisartan
TABLET;ORAL020850-002Nov 10, 19985,591,762<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
6,410,742 Polymorphs of telmisartan<disabled in preview>
8,604,070Use of inhibitors of the renin-angiotensin system<disabled in preview>
RE38676 Thermally initiated polymerization of olefins using ruthenium or osmium vinylidene complexes<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

Country Document Number Estimated Expiration
Japan2009242426<disabled in preview>
TaiwanI280241<disabled in preview>
Hungary0105148<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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90006-5.LSweden<disabled>PRODUCT NAME: TELMISARTAN, VALFRITT I FORM AV FARMACEUTISKT GODTAGBARA SALT, OCH AMLODIPIN, VALFRITT I FORM AV FARMACEUTISKT GODTAGBARA SALT SAERSKILT AMOLODIPINBESILAT; REG. NO/DATE: EU/1/10/648/001-028 " EESGODKLANDKOD="EG" EESGODKDATUM="2010-10-07" SEGODKNR="EU/1/10/648/001-028 " SEGODKLANDKOD="EG" SEGODKDATUM="2010-10-07" FLAG="L" SPCNR="1190006-5" 20101007
/1999Austria<disabled>PRODUCT NAME: TELMISARTAN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; NAT. REGISTRATION NO/DATE: EU/1/98/089/001-010 19981211; FIRST REGISTRATION: BE K (1998) 4288-DE 19981211
2011Austria<disabled>PRODUCT NAME: TELMISARTAN, GGF. IN FORM SEINER PHARMAZEUTISCH ANNEHMBAREN SALZE UND AMLODIPIN, GGF. IN FORM SEINER PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE AMLODIPINBESILAT; REGISTRATION NO/DATE: EU/1/10/648/001 - EU/1/10/648/028 20101007
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