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Hydrochlorothiazide; telmisartan - Generic Drug Details

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Hydrochlorothiazide; telmisartan is the generic ingredient in two branded drugs marketed by Alembic Pharms Ltd, Mylan Pharms Inc, Lupin Ltd, Boehringer Ingelheim, Macleods Pharms Ltd, 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. Ten 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 list10
Formulation / Manufacturing:see details

Pharmacology for Ingredient: hydrochlorothiazide; telmisartan

Clinical Trials for: hydrochlorothiazide; telmisartan

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Torrent Pharms Ltd
TELMISARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; telmisartan
TABLET;ORAL201192-003Feb 25, 2014RXNo<disabled><disabled>
Alembic Pharms Ltd
TELMISARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; telmisartan
TABLET;ORAL203010-002Feb 25, 2014RXNo<disabled><disabled>
Macleods Pharms Ltd
TELMISARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; telmisartan
TABLET;ORAL204169-003Nov 2, 2015RXNo<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;ORAL021162-003Apr 19, 20045,591,762<disabled>
Boehringer Ingelheim
MICARDIS HCT
hydrochlorothiazide; telmisartan
TABLET;ORAL021162-002Nov 17, 20005,591,762<disabled>
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Non-Orange Book Patents for Generic Ingredient: hydrochlorothiazide; 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<disabled in preview>
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International Patent Family for Ingredient: hydrochlorothiazide; telmisartan

Country Document Number Estimated Expiration
Denmark1144386<disabled in preview>
Austria252564<disabled in preview>
Japan4700813<disabled in preview>
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Supplementary Protection Certificates for Tradename: HYDROCHLOROTHIAZIDE; TELMISARTAN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB02/037United Kingdom<disabled>PRODUCT 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
C0009Belgium<disabled>PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
0443983/03Switzerland<disabled>PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
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