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Telmisartan - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for telmisartan?

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, Jubilant Generics, Sandoz Inc, Torrent Pharms Ltd, and Mylan Pharms Inc, and is included in thirteen 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-seven patent family members in thirty-seven 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:13
NDAs:13
Drug Master File Entries: see list36
Suppliers / Packagers: see list19
Bulk Api Vendors: see list86
Clinical Trials: see list46
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. Form Dosage
► Subscribe► SubscribeTABLET; ORAL40MG; 12.5MG
► Subscribe► SubscribeTABLET; ORAL80MG; 12.5MG
► Subscribe► SubscribeTABLET; ORAL80MG; 25MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Jubilant Generics
TELMISARTAN
telmisartan
TABLET;ORAL204164-001Aug 22, 2016RXNoNo► Subscribe► Subscribe
Boehringer Ingelheim
MICARDIS
telmisartan
TABLET;ORAL020850-002Nov 10, 1998RXYesYes6,358,986► Subscribe ► Subscribe
Inventia Hlthcare
TELMISARTAN
telmisartan
TABLET;ORAL205150-002Oct 30, 2015RXNoNo► Subscribe► Subscribe
Glenmark Generics
TELMISARTAN
telmisartan
TABLET;ORAL090032-002Jul 7, 2014RXNoNo► Subscribe► Subscribe
Boehringer Ingelheim
MICARDIS
telmisartan
TABLET;ORAL020850-001Nov 10, 1998RXYesNo6,358,986► 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;ORAL020850-001Nov 10, 19985,591,762► Subscribe
Boehringer Ingelheim
MICARDIS
telmisartan
TABLET;ORAL020850-002Nov 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
6,410,742 Polymorphs of telmisartan► Subscribe
8,604,070Use of inhibitors of the renin-angiotensin system► Subscribe
7,071,183Use 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
South Korea100572080► Subscribe
Hungary227401► Subscribe
European Patent Office1776954► Subscribe
CroatiaP20010514► Subscribe
Japan5187991► 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
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
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
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
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
0502314/03Switzerland► SubscribePRODUCT NAME: TELMISARTAN + AMLODIPIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 61270 08.11.2010
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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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