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Generated: June 25, 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, Watson Labs, Aurobindo Pharma Ltd, Amneal Pharms, 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 fourteen NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Telmisartan has seventy-nine patent family members in thirty-eight countries.

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

Summary for Generic Name: telmisartan

Tradenames:2
Patents:4
Applicants:14
NDAs:14
Drug Master File Entries: see list36
Suppliers / Packagers: see list19
Bulk Api Vendors: see list86
Clinical Trials: see list225
Patent Applications: see list5,337
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
► Subscribe► Subscribe40MG; 12.5MGTABLET; ORAL
► Subscribe► Subscribe80MG; 25MGTABLET; ORAL
► Subscribe► 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
Alembic Pharms Ltd
TELMISARTAN
telmisartan
TABLET;ORAL202130-001Jul 7, 2014ABRXNoNo► Subscribe► Subscribe
Prinston Inc
TELMISARTAN
telmisartan
TABLET;ORAL207882-002May 3, 2017ABRXNoNo► Subscribe► Subscribe
Alembic Pharms Ltd
TELMISARTAN
telmisartan
TABLET;ORAL202130-003Jul 7, 2014ABRXNoNo► Subscribe► Subscribe
Boehringer Ingelheim
MICARDIS
telmisartan
TABLET;ORAL020850-001Nov 10, 1998ABRXYesNo6,358,986► Subscribe ► Subscribe
Torrent Pharms Ltd
TELMISARTAN
telmisartan
TABLET;ORAL203171-002Jul 7, 2014ABRXNoNo► 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, 20005,591,762► Subscribe
Boehringer Ingelheim
MICARDIS
telmisartan
TABLET;ORAL020850-002Nov 10, 19985,591,762► Subscribe
Boehringer Ingelheim
MICARDIS
telmisartan
TABLET;ORAL020850-001Nov 10, 19985,591,762► 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
7,071,183Use of inhibitors of the renin-angiotensin system► Subscribe
6,410,742 Polymorphs of telmisartan► 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
United Kingdom9810855► Subscribe
Canada2677910► Subscribe
Slovakia10202001► Subscribe
Peru13622000► Subscribe
Denmark1144386► 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
/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
C/GB99/014United Kingdom► SubscribePRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/98/089/001 19981211; UK EU/1/98/089/002 19981211; UK EU/1/98/089/003 19981211; UK EU/1/98/089/004 19981211; UK EU/1/98/089/005 19981211; UK EU/1/98/089/006 19981211; UK EU/1/98/089/007 19981211; UK EU/1/98/089/008 19981211; UK EU/1/98/089/009 19981211; UK EU/1/98/089/010 19981211
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
/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
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
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Serving 500+ biopharmaceutical companies globally:

AstraZeneca
Cipla
Cerilliant
Medtronic
Cantor Fitzgerald
Colorcon
Express Scripts
Argus Health
Merck
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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