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Details for Generic Name: telmisartan

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Telmisartan is the generic ingredient in two branded drugs marketed by Boehringer Ingelheim, Alembic Pharms Ltd, Glenmark Generics, Mylan Pharms Inc, Sandoz Inc, Torrent Pharms Ltd, Watson Labs, and Zydus Pharms Usa Inc, and is included in eight 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. Four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: telmisartan

Drug Master File Entries: see list36
Suppliers / Packaging: see list13
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

CKD-828 Drug Interaction Study (Telmisartan)
Status: Completed Condition: Healthy Male Volunteers

Use of Telmisartan and Captopril in Inflammation of Hemodialysis Patients
Status: Completed Condition: Inflammation; End-stage Renal Disease

CKD-346 DDI Study(Telmisartan/S-Amlodipine, Rosuvastatin)
Status: Completed Condition: Hypertension; Hyperlipidemia

Study to Investigate the Effect of Atorvastatin on the Pharmacokinetic Properties of Telmisartan/S-amlodipine
Status: Completed Condition: Essential Hypertension; Hyperlipidemia

Telmisartan (Micardis) and Amlodipine (Norvasc) - Factorial Design Study for the Treatment of Hypertension
Status: Completed Condition: Hypertension

Telmisartan, Amlodipine and Combination in Healthy Subjects
Status: Completed Condition: Healthy

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim
TABLET;ORAL020850-002Nov 10, 1998RXYes8,003,679<disabled><disabled>
Mylan Pharms Inc
TABLET;ORAL202397-001Jul 7, 2014RXNo<disabled><disabled>
Mylan Pharms Inc
TABLET;ORAL202397-003Jul 7, 2014RXNo<disabled><disabled>
Watson Labs
TABLET;ORAL078710-001Jan 8, 2014RXNo<disabled><disabled>
Sandoz Inc
TABLET;ORAL203867-001Nov 3, 2014RXNo<disabled><disabled>
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International Patent Family for Ingredient: telmisartan

Country Document Number Publication Date
Portugal1023067Sep 30, 2005
Japan4700813Jun 15, 2011
Czech Republic20012634Oct 17, 2001
Australia765081Sep 11, 2003
Japan2003521437Jul 15, 2003
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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