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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. Thirty 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 list30
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: hydrochlorothiazide; valsartan

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Prinston Inc
VALSARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; valsartan
TABLET;ORAL206083-001Feb 8, 2016RXNo► subscribe► subscribe
Macleods Pharms Ltd
VALSARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; valsartan
TABLET;ORAL203145-002Apr 19, 2013RXNo► subscribe► subscribe
Prinston Inc
VALSARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; valsartan
TABLET;ORAL206083-005Feb 8, 2016RXNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: hydrochlorothiazide; valsartan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
DIOVAN HCT
hydrochlorothiazide; valsartan
TABLET;ORAL020818-001Mar 6, 19985,399,578*PED► subscribe
Novartis
DIOVAN HCT
hydrochlorothiazide; valsartan
TABLET;ORAL020818-005Apr 28, 20065,399,578*PED► subscribe
Novartis
DIOVAN HCT
hydrochlorothiazide; valsartan
TABLET;ORAL020818-004Apr 28, 20065,399,578*PED► subscribe
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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► subscribe
6,485,745 Solid oral dosage forms of valsartan► subscribe
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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
Slovenia1410797► subscribe
Hungary229134► subscribe
Indonesia17553► subscribe
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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
C0025Belgium► subscribePRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
0443983/03Switzerland► subscribePRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
C/GB99/008United Kingdom► subscribePRODUCT 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
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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 data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. 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.

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