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QuintilesIMS
Cerilliant
US Army
Cipla
Express Scripts
Teva
Chinese Patent Office
Baxter
Julphar
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Generated: October 23, 2017

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Telmisartan - Generic Drug Details

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What are the generic drug sources for telmisartan and what is the scope of telmisartan patent protection?

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

Telmisartan has eighty-six patent family members in thirty-eight countries and twelve supplementary protection certificates in six countries.

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

Summary for Generic Name: telmisartan

US Patents:3
Tradenames:2
Applicants:16
NDAs:16
Drug Master File Entries: see list38
Suppliers / Packagers: see list21
Bulk Api Vendors: see list86
Clinical Trials: see list227
Patent Applications: see list5,747
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:telmisartan at DailyMed

Pharmacology for Ingredient: telmisartan

Tentative approvals for TELMISARTAN

Applicant Application No. Strength Dosage Form
u► Subscribe40MG; 12.5MGTABLET; ORAL
u► Subscribe80MG; 25MGTABLET; ORAL
u► Subscribe80MG; 12.5MGTABLET; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Jubilant Generics
TELMISARTAN
telmisartan
TABLET;ORAL204164-001Aug 22, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Alembic Pharms Ltd
TELMISARTAN
telmisartan
TABLET;ORAL202130-001Jul 7, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Glenmark Pharms Ltd
TELMISARTAN
telmisartan
TABLET;ORAL090032-001Jul 7, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Watson Labs
TELMISARTAN
telmisartan
TABLET;ORAL078710-001Jan 8, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Hetero Labs Ltd V
TELMISARTAN
telmisartan
TABLET;ORAL205901-003Apr 22, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Jubilant Generics
TELMISARTAN
telmisartan
TABLET;ORAL204164-002Aug 22, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Inventia Hlthcare
TELMISARTAN
telmisartan
TABLET;ORAL205150-001Oct 30, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Sandoz Inc
TELMISARTAN
telmisartan
TABLET;ORAL203867-003Nov 3, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Zydus Pharms Usa Inc
TELMISARTAN
telmisartan
TABLET;ORAL203325-003Aug 26, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Prinston Inc
TELMISARTAN
telmisartan
TABLET;ORAL207882-002May 3, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: telmisartan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
MICARDIS
telmisartan
TABLET;ORAL020850-003Apr 4, 2000► Subscribe► Subscribe
Boehringer Ingelheim
MICARDIS
telmisartan
TABLET;ORAL020850-002Nov 10, 1998► Subscribe► Subscribe
Boehringer Ingelheim
MICARDIS
telmisartan
TABLET;ORAL020850-001Nov 10, 1998► Subscribe► Subscribe
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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
6,410,742 Polymorphs of telmisartan► Subscribe
7,071,183Use of inhibitors of the renin-angiotensin system► Subscribe
8,604,070Use of inhibitors of the renin-angiotensin system► Subscribe
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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 Ingredient: telmisartan

Country Document Number Estimated Expiration
Czech Republic20012634► Subscribe
European Patent Office1144386► Subscribe
Poland211829► Subscribe
Saudi Arabia584► Subscribe
Hungary0003982► Subscribe
Spain2238770► Subscribe
Colombia5150238► Subscribe
United Kingdom9722026► Subscribe
South Africa200104771► Subscribe
Germany19901921► Subscribe
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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: TELMISARTAN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB11/010United Kingdom► SubscribePRODUCT 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
00478Netherlands► SubscribePRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN AMLODIPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER AMLODIPINEBESILAAT; REGISTRATION NO/DATE: EU/1/10/648/001-028 20101007
/1999Austria► SubscribePRODUCT 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
0502314/03Switzerland► SubscribePRODUCT NAME: TELMISARTAN + AMLODIPIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 61270 08.11.2010
00095Netherlands► SubscribePRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419
90007Netherlands► SubscribePRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT; REGISTRATION NO/DATE: EU/1/98/089/001-EU/1/98/089/010 19981211
C/GB02/037United Kingdom► SubscribePRODUCT 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
/2002Austria► SubscribePRODUCT 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
90006-5.LSweden► SubscribePRODUCT 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
C0014Belgium► SubscribePRODUCT NAME: TELMISARTAN REGISTRATION NO/DATE: EU/1/98/089/001 / 19981211
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Serving leading biopharmaceutical companies globally:

Fuji
Federal Trade Commission
Deloitte
AstraZeneca
Colorcon
Medtronic
Covington
QuintilesIMS
Healthtrust
Cantor Fitzgerald

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