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Hydrochlorothiazide; valsartan - Generic Drug Details

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Hydrochlorothiazide; valsartan is the generic ingredient in two branded drugs marketed by Novartis, Aurobindo Pharma Ltd, Watson Labs Inc, Mylan Pharms Inc, Apotex Inc, Macleods Pharms Ltd, Lupin Ltd, Alembic Ltd, and Prinston Inc, and is included in nine 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 eighty patent family members in thirty-three countries.

There are thirty-one drug master file entries for hydrochlorothiazide; valsartan. Twenty-five suppliers are listed for this compound.

Summary for Generic Name: hydrochlorothiazide; valsartan

Tradenames:2
Patents:1
Applicants:9
NDAs:9
Drug Master File Entries: see list31
Suppliers / Packaging: see list25
Formulation / Manufacturing:see details

Pharmacology for Ingredient: hydrochlorothiazide; valsartan

Clinical Trials for: hydrochlorothiazide; valsartan

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Pharms Inc
VALSARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; valsartan
TABLET;ORAL078020-004Sep 21, 2012RXNo<disabled><disabled>
Novartis
DIOVAN HCT
hydrochlorothiazide; valsartan
TABLET;ORAL020818-002Mar 6, 1998RXNo6,294,197*PED<disabled>Y<disabled>
Lupin Ltd
VALSARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; valsartan
TABLET;ORAL078946-005Mar 21, 2013RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: hydrochlorothiazide; valsartan

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
DIOVAN HCT
hydrochlorothiazide; valsartan
TABLET;ORAL020818-005Apr 28, 20065,399,578*PED<disabled>
Novartis
DIOVAN HCT
hydrochlorothiazide; valsartan
TABLET;ORAL020818-001Mar 6, 19985,399,578*PED<disabled>
Novartis
DIOVAN HCT
hydrochlorothiazide; valsartan
TABLET;ORAL020818-003Jan 17, 20025,399,578*PED<disabled>
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Non-Orange Book Patents for Generic Ingredient: hydrochlorothiazide; valsartan

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
6,858,228 Solid oral dosage forms of valsartan<disabled in preview>
6,485,745 Solid oral dosage forms of valsartan<disabled in preview>
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International Patent Family for Ingredient: hydrochlorothiazide; valsartan

Country Document Number Estimated Expiration
South Korea20110063587<disabled in preview>
Japan2003231634<disabled in preview>
Russian Federation2007100200<disabled in preview>
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Supplementary Protection Certificates for Tradename: HYDROCHLOROTHIAZIDE; VALSARTAN

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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