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Serving leading biopharmaceutical companies globally:

Argus Health
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Federal Trade Commission
Deloitte
Harvard Business School
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Generated: October 22, 2017

DrugPatentWatch Database Preview

AZOR Drug Profile

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What is the patent landscape for Azor, and what generic Azor alternatives are available?

Azor is a drug marketed by Daiichi Sankyo and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has one hundred and one patent family members in twenty-seven countries and thirty-two supplementary protection certificates in nine countries.

The generic ingredient in AZOR is amlodipine besylate; olmesartan medoxomil. There are fifty drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the amlodipine besylate; olmesartan medoxomil profile page.

Summary for Tradename: AZOR

US Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Bulk Api Vendors: see list34
Clinical Trials: see list4
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:AZOR at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Daiichi Sankyo
AZOR
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL022100-001Sep 26, 2007ABRXYesNo► Subscribe► Subscribe ► Subscribe
Daiichi Sankyo
AZOR
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL022100-004Sep 26, 2007ABRXYesYes► Subscribe► Subscribe ► Subscribe
Daiichi Sankyo
AZOR
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL022100-002Sep 26, 2007ABRXYesNo► Subscribe► Subscribe ► Subscribe
Daiichi Sankyo
AZOR
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL022100-003Sep 26, 2007ABRXYesNo► Subscribe► Subscribe ► 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, 2007► Subscribe► Subscribe
Daiichi Sankyo
AZOR
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL022100-003Sep 26, 2007► Subscribe► Subscribe
Daiichi Sankyo
AZOR
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL022100-004Sep 26, 2007► Subscribe► Subscribe
Daiichi Sankyo
AZOR
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL022100-002Sep 26, 2007► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges 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
Russian Federation2092481► Subscribe
Greece3035906► Subscribe
JapanH07121918► Subscribe
China1188645► Subscribe
Israel105825► Subscribe
HungaryT64329► Subscribe
Hong Kong1011983► Subscribe
Finland955248► Subscribe
Netherlands300227► Subscribe
Czech Republic289194► 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
0625Netherlands► SubscribePRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414
C0033France► SubscribePRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: 6167801 20110705
330Luxembourg► SubscribeCERTIFICATE TITLE: UNE COMBINAISON D'OLMESARTAN MEDOXOMIL, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET D'HYDROCHLOROTHIAZIDE (OLMETEC PLUS)
C/GB11/010United Kingdom► SubscribePRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK
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
2006 00012Denmark► Subscribe
00499Netherlands► SubscribePRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114
00625Netherlands► SubscribePRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414
0443983/03Switzerland► SubscribePRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0133Netherlands► Subscribe300133, 20120221, EXPIRES: 20170220
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Moodys
Johnson and Johnson
Chinese Patent Office
Daiichi Sankyo
QuintilesIMS
Accenture
US Department of Justice
McKinsey
Healthtrust

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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