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Telmisartan - Generic Drug Details

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Telmisartan is the generic ingredient in two branded drugs marketed by Hetero Labs Ltd V, Watson Labs, Aurobindo Pharma Ltd, Amneal Pharms, Zydus Pharms Usa Inc, Alembic Pharms Ltd, Glenmark Generics, Boehringer Ingelheim, Inventia Hlthcare, Sandoz Inc, Torrent Pharms Ltd, and Mylan Pharms Inc, and is included in twelve NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has seventy-seven patent family members in thirty-seven countries.

There are thirty-six drug master file entries for telmisartan. Sixteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: telmisartan

Tradenames:2
Patents:3
Applicants:12
NDAs:12
Drug Master File Entries: see list36
Suppliers / Packaging: see list16
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: telmisartan

Tentative approvals for TELMISARTAN

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL40MG; 12.5MG
<disabled><disabled>TABLET; ORAL80MG; 12.5MG
<disabled><disabled>TABLET; ORAL80MG; 25MG

Clinical Trials for: telmisartan

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs
TELMISARTAN
telmisartan
TABLET;ORAL078710-002Jan 8, 2014RXNo<disabled><disabled>
Aurobindo Pharma Ltd
TELMISARTAN
telmisartan
TABLET;ORAL206511-001Sep 3, 2015RXNo<disabled><disabled>
Hetero Labs Ltd V
TELMISARTAN
telmisartan
TABLET;ORAL205901-002Apr 22, 2016RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: telmisartan

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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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Non-Orange Book Patents for Generic Ingredient: telmisartan

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
RE38676 Thermally initiated polymerization of olefins using ruthenium or osmium vinylidene complexes<disabled in preview>
7,071,183Use of inhibitors of the renin-angiotensin system<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 Ingredient: telmisartan

Country Document Number Estimated Expiration
Bulgaria105654<disabled in preview>
Brazil0007584<disabled in preview>
Austria252564<disabled in preview>
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Supplementary Protection Certificates for Tradename: TELMISARTAN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00095Netherlands<disabled>PRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419
C/GB11/010United Kingdom<disabled>PRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK
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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