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Details for Generic Name: telmisartan

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Telmisartan is the generic ingredient in two branded drugs marketed by 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 eleven 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

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
Mylan Pharms Inc
TABLET;ORAL202397-002Jul 7, 2014RXNo<disabled><disabled>
Amneal Pharms
TABLET;ORAL204415-002Sep 8, 2015RXNo<disabled><disabled>
Zydus Pharms Usa Inc
TABLET;ORAL203325-001Aug 26, 2014RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: telmisartan

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
TABLET;ORAL020850-003Apr 4, 20005,591,762<disabled>
Boehringer Ingelheim
TABLET;ORAL020850-001Nov 10, 19985,591,762<disabled>
Boehringer Ingelheim
TABLET;ORAL020850-002Nov 10, 19985,591,762<disabled>
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International Patent Family for Ingredient: telmisartan

Country Document Number Publication Date
South Korea20050085966Aug 29, 2005
Poland340838Feb 26, 2001
Poland197164Mar 31, 2008
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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 information. There is no warranty that the information contained herein is error free. 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.

Copyright 2002-2016 thinkBiotech LLC
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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