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Hydrochlorothiazide; irbesartan - Generic Drug Details

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Hydrochlorothiazide; irbesartan is the generic ingredient in two branded drugs marketed by Dr Reddys Labs Ltd, Apotex Inc, Macleods Pharms Ltd, Lupin Ltd, Aurobindo Pharma Ltd, Intl Speclt Chems, Watson Labs Inc, Sandoz, Roxane, Sanofi Aventis Us, Mylan Pharms Inc, Teva, Alembic Pharms Ltd, Prinston Inc, and Hisun Pharm Hangzhou, and is included in fifteen 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 patent family members in twenty-four countries.

There are thirty-one drug master file entries for hydrochlorothiazide; irbesartan. Eighteen suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for Generic Name: hydrochlorothiazide; irbesartan

Tradenames:2
Patents:1
Applicants:15
NDAs:15
Drug Master File Entries: see list31
Suppliers / Packaging: see list18
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: hydrochlorothiazide; irbesartan

Tentative approvals for HYDROCHLOROTHIAZIDE; IRBESARTAN

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL25MG;300MG
<disabled><disabled>TABLET; ORAL12.5MG; 150MG
<disabled><disabled>TABLET; ORAL12.5MG; 300MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Prinston Inc
IRBESARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; irbesartan
TABLET;ORAL203072-002May 9, 2014RXNo► subscribe► subscribe
Aurobindo Pharma Ltd
IRBESARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; irbesartan
TABLET;ORAL203630-002Feb 22, 2013RXNo► subscribe► subscribe
Sanofi Aventis Us
AVALIDE
hydrochlorothiazide; irbesartan
TABLET;ORAL020758-003Aug 31, 1998RXYes5,994,348*PED► subscribe ► subscribe
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Expired Orange Book Patents for Generic Ingredient: hydrochlorothiazide; irbesartan

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
AVALIDE
hydrochlorothiazide; irbesartan
TABLET;ORAL020758-004Mar 15, 20055,270,317*PED► subscribe
Sanofi Aventis Us
AVALIDE
hydrochlorothiazide; irbesartan
TABLET;ORAL020758-004Mar 15, 20055,994,348*PED► subscribe
Sanofi Aventis Us
AVALIDE
hydrochlorothiazide; irbesartan
TABLET;ORAL020758-001Sep 30, 19975,270,317*PED► subscribe
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Non-Orange Book Patents for Generic Ingredient: hydrochlorothiazide; irbesartan

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
6,342,247 Pharmaceutical compositions containing irbesartan► 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; irbesartan

Country Document Number Estimated Expiration
Taiwan442301► subscribe
JapanH08333253► subscribe
Norway962387► 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; IRBESARTAN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0009Belgium► subscribePRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
2011 00026Denmark► subscribePRODUCT 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/GB02/037United Kingdom► subscribePRODUCT 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
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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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