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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. Seventeen 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 list17
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;ORAL078710-001Jan 8, 2014RXNo<disabled><disabled>
Amneal Pharms
TELMISARTAN
telmisartan
TABLET;ORAL204415-003Sep 8, 2015RXNo<disabled><disabled>
Zydus Pharms Usa Inc
TELMISARTAN
telmisartan
TABLET;ORAL203325-002Aug 26, 2014RXNo<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>
6,107,420 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>
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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
European Patent Office1023067<disabled in preview>
Australia765081<disabled in preview>
Denmark1023067<disabled in preview>
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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
90007Netherlands<disabled>PRODUCT 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
/2002Austria<disabled>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
C/GB99/014United Kingdom<disabled>PRODUCT 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
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