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Details for Generic Name: hydrochlorothiazide; telmisartan

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Hydrochlorothiazide; telmisartan is the generic ingredient in two branded drugs marketed by Boehringer Ingelheim, Alembic Pharms Ltd, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, and Torrent Pharms Ltd, and is included in six NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has forty-two patent family members in thirty-four countries.

There are thirty-one drug master file entries for hydrochlorothiazide; telmisartan. Four suppliers are listed for this compound.

Summary for Generic Name: hydrochlorothiazide; telmisartan

Tradenames:2
Patents:1
Applicants:6
NDAs:6
Drug Master File Entries: see list31
Suppliers / Packaging: see list13

Pharmacology for Ingredient: hydrochlorothiazide; telmisartan

Clinical Trials for: hydrochlorothiazide; telmisartan

Telmisartan and Hydrochlorothiazide Antihypertensive Treatment Study in High Sodium Intake Population
Status: Completed Condition: Hypertension

Telmisartan 80mg Plus Hydrochlorothiazide 25mg First Line in Moderate or Severe Hypertension
Status: Completed Condition: Hypertension

Efficacy and Safety of Chronic Administration of Telmisartan as Monotherapy or in Combination With Hydrochlorothiazide or Other Antihypertensive Medications in Patients With Mild to Moderate Hypertension
Status: Completed Condition: Hypertension

Effects of Telmisartan/Hydrochlorothiazide Treatment in Hypertensive Patients Under Real-life Setting
Status: Completed Condition: Primary Hypertension

Telmisartan Plus Hydrochlorothiazide in Subjects With Mild-to-moderate Hypertension Who Failed to Respond to Telmisartan Monotherapy
Status: Completed Condition: Hypertension

Courtesy of ClinicalTrials.org
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
TELMISARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; telmisartan
TABLET;ORAL091648-001Feb 25, 2014RXNo<disabled><disabled>
Macleods Pharms Ltd
TELMISARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; telmisartan
TABLET;ORAL204169-003Nov 2, 2015RXNo<disabled><disabled>
Torrent Pharms Ltd
TELMISARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; telmisartan
TABLET;ORAL201192-003Feb 25, 2014RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: hydrochlorothiazide; telmisartan

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
MICARDIS HCT
hydrochlorothiazide; telmisartan
TABLET;ORAL021162-001Nov 17, 20005,591,762<disabled>
Boehringer Ingelheim
MICARDIS HCT
hydrochlorothiazide; telmisartan
TABLET;ORAL021162-002Nov 17, 20005,591,762<disabled>
Boehringer Ingelheim
MICARDIS HCT
hydrochlorothiazide; telmisartan
TABLET;ORAL021162-003Apr 19, 20045,591,762<disabled>
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International Patent Family for Ingredient: hydrochlorothiazide; telmisartan

Country Document Number Publication Date
Slovakia285429Jan 04, 2007
Hungary0105148Jul 29, 2002
Germany50004150Nov 27, 2003
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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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