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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Julphar
Johnson and Johnson
Merck
QuintilesIMS
Mallinckrodt
Express Scripts
Citi
Deloitte

Generated: April 20, 2018

DrugPatentWatch Database Preview

MICARDIS Drug Profile

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Which patents cover Micardis, and when can generic versions of Micardis launch?

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

This drug has eighty-eight patent family members in thirty-eight countries.

The generic ingredient in MICARDIS is hydrochlorothiazide; telmisartan. There are thirty-two drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; telmisartan profile page.
Summary for MICARDIS
Drug patent expirations by year for MICARDIS
Pharmacology for MICARDIS

US Patents and Regulatory Information for MICARDIS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-003 Apr 4, 2000 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim MICARDIS HCT hydrochlorothiazide; telmisartan TABLET;ORAL 021162-002 Nov 17, 2000 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-002 Nov 10, 1998 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim MICARDIS HCT hydrochlorothiazide; telmisartan TABLET;ORAL 021162-003 Apr 19, 2004 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for MICARDIS

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-002 Nov 10, 1998 ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-003 Apr 4, 2000 ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-001 Nov 10, 1998 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for MICARDIS
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 80 mg/25 mg ➤ Subscribe 2009-02-27
➤ Subscribe Tablets 80 mg/12.5 mg and 40 mg/12.5 mg ➤ Subscribe 2008-12-31
➤ Subscribe Tablets 20 mg, 40 mg and 80 mg ➤ Subscribe 2006-12-26

Non-Orange Book US Patents for 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
8,604,070 Use of inhibitors of the renin-angiotensin system ➤ Sign Up
6,410,742 Polymorphs of telmisartan ➤ Sign Up
7,071,183 Use of inhibitors of the renin-angiotensin system ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for MICARDIS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/1999 Austria ➤ Sign Up 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
00095 Netherlands ➤ Sign Up PRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419
/2002 Austria ➤ Sign Up PRODUCT NAME: TELMISARTAN, GEGEBENENFALLS IN FORM SEINER PHARMAZEUTISCH ANNEHMBAREN SALZE, UND HYDROCHLOROTHIAZID; REGISTRATION NO/DATE: EU/1/02/213/001- EU/1/02/213/010 20020419
2011 Austria ➤ Sign Up 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Healthtrust
Cerilliant
Merck
Fish and Richardson
Queensland Health
Chinese Patent Office
Cantor Fitzgerald
Moodys

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