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AZOR Drug Profile

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Azor is a drug marketed by Daiichi Sankyo 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 ninety-eight patent family members in twenty-seven countries.

The generic ingredient in AZOR is amlodipine besylate; olmesartan medoxomil. There are forty-nine drug master file entries for this compound. Six suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the amlodipine besylate; olmesartan medoxomil profile page.

Summary for Tradename: AZOR

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Formulation / Manufacturing:see details
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Daiichi Sankyo
AZOR
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL022100-001Sep 26, 2007RXNo5,616,599*PED► subscribeY► subscribe
Daiichi Sankyo
AZOR
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL022100-004Sep 26, 2007RXYes5,616,599*PED► subscribeY► subscribe
Daiichi Sankyo
AZOR
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL022100-002Sep 26, 2007RXNo5,616,599*PED► subscribeY► subscribe
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Expired Patents for Tradename: AZOR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Daiichi Sankyo
AZOR
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL022100-001Sep 26, 20075,616,599*PED► subscribe
Daiichi Sankyo
AZOR
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL022100-004Sep 26, 20075,616,599*PED► subscribe
Daiichi Sankyo
AZOR
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL022100-003Sep 26, 20075,616,599*PED► subscribe
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Paragraph IV activity for: AZOR

Drugname Dosage Strength RLD Submissiondate
amlodipine besylate and olmesartan medoxomilTablets10 mg/20 mg and 5 mg/40 mgAzor3/31/2008
amlodipine besylate and olmesartan medoxomilTablets5 mg/20 mg and 10 mg/40 mgAzor2/11/2008

Non-Orange Book Patents for Tradename: AZOR

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
5,646,171 Angiotensin II antagonist 1-biphenylmethylimidazole compounds and their therapeutic use► 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: AZOR

Country Document Number Estimated Expiration
Czech Republic9200516► subscribe
Australia647887► subscribe
Israel114996► 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: AZOR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0048France► subscribePRODUCT NAME: AMLODIPINE OU UN DE SES SELS D?ADDITION D?ACIDES PHARMACAUTIQUEMENT ACCEPTABLES/ ATORVASTATINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: NL 29929 DU 20050707; REGISTRATION NO/DATE AT EEC: NL 29929 DU 20050707
C/GB03/024United Kingdom► subscribePRODUCT NAME: OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHAMACEUTICALLY ACCEPTABLE SALT; REGISTERED: DE 50202.00.00 20020813; DE 50202.01.00 20020813; DE 50202.02.00 20020813; DE 50205.00.00 20020813; DE 50205.01.00 20020813; DE 50205.02.00 20020813; UK PL 08265/0015 20030522; UK PL 08265/0016 20030522; UK PL08265/0017 20030522
0443983/03Switzerland► subscribePRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
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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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