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AVALIDE Drug Profile

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Avalide is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from three suppliers. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has forty patent family members in twenty-four countries.

The generic ingredient in AVALIDE is hydrochlorothiazide; irbesartan. There are thirty-one drug master file entries for this compound. Eighteen suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the hydrochlorothiazide; irbesartan profile page.

Summary for Tradename: AVALIDE

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Formulation / Manufacturing:see details
Drug Prices: :see details

Pharmacology for Tradename: AVALIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us
AVALIDE
hydrochlorothiazide; irbesartan
TABLET;ORAL020758-001Sep 30, 1997DISCNNo5,994,348*PED► subscribe ► subscribe
Sanofi Aventis Us
AVALIDE
hydrochlorothiazide; irbesartan
TABLET;ORAL020758-004Mar 15, 2005DISCNNo5,994,348*PED► subscribe ► subscribe
Sanofi Aventis Us
AVALIDE
hydrochlorothiazide; irbesartan
TABLET;ORAL020758-002Sep 30, 1997RXYes5,994,348*PED► subscribe ► subscribe
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Expired Patents for Tradename: AVALIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
AVALIDE
hydrochlorothiazide; irbesartan
TABLET;ORAL020758-001Sep 30, 19975,270,317*PED► subscribe
Sanofi Aventis Us
AVALIDE
hydrochlorothiazide; irbesartan
TABLET;ORAL020758-003Aug 31, 19985,270,317*PED► subscribe
Sanofi Aventis Us
AVALIDE
hydrochlorothiazide; irbesartan
TABLET;ORAL020758-004Mar 15, 20055,270,317*PED► subscribe
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Paragraph IV activity for: AVALIDE

Drugname Dosage Strength RLD Submissiondate
irbesartan and hydrochlorothiazideTablets300 mg/25 mgAvalide6/6/2006
irbesartan and hydrochlorothiazideTablets150 mg/12.5 mg and 300 mg/12.5 mgAvalide11/10/2004

Non-Orange Book Patents for Tradename: AVALIDE

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 Tradename: AVALIDE

Country Document Number Estimated Expiration
JapanH08333253► subscribe
Czech Republic9601634► subscribe
Canada2177772► 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: AVALIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0009Belgium► subscribePRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
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
00095Netherlands► subscribePRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 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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