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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-seven 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 list27
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
Aurobindo Pharma Ltd
VALSARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; valsartan
TABLET;ORAL202519-005Mar 21, 2013RXNo<disabled><disabled>
Lupin Ltd
VALSARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; valsartan
TABLET;ORAL078946-004Mar 21, 2013RXNo<disabled><disabled>
Mylan Pharms Inc
VALSARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; valsartan
TABLET;ORAL078020-002Sep 21, 2012RXNo<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;ORAL020818-004Apr 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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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: hydrochlorothiazide; valsartan

Country Document Number Estimated Expiration
China1951372<disabled in preview>
Germany69730834<disabled in preview>
Slovakia285902<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: HYDROCHLOROTHIAZIDE; VALSARTAN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2011 00026Denmark<disabled>PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216
C/GB99/008United Kingdom<disabled>PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE)(GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/98/086/001 19981015; UK EU/1/98/086/002 19981015; UK EU/1/98/086/003 19981015; UK EU/1/98/086/004 19981015; UK EU/1/98/086/005 19981015; UK EU/1/98/086/006 19981015
C0030France<disabled>PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
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