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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Cantor Fitzgerald
Deloitte
Teva
Colorcon
Chinese Patent Office
Baxter
AstraZeneca
UBS
Argus Health

Generated: December 12, 2017

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AZOR Drug Profile

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When do Azor patents expire, and what generic 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.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Daiichi SankyoAZORamlodipine besylate; olmesartan medoxomilTABLET;ORAL022100-001Sep 26, 2007ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Daiichi SankyoAZORamlodipine besylate; olmesartan medoxomilTABLET;ORAL022100-004Sep 26, 2007ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Daiichi SankyoAZORamlodipine besylate; olmesartan medoxomilTABLET;ORAL022100-002Sep 26, 2007ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Daiichi SankyoAZORamlodipine besylate; olmesartan medoxomilTABLET;ORAL022100-003Sep 26, 2007ABRXYesNo► Subscribe► 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 SankyoAZORamlodipine besylate; olmesartan medoxomilTABLET;ORAL022100-001Sep 26, 2007► Subscribe► Subscribe
Daiichi SankyoAZORamlodipine besylate; olmesartan medoxomilTABLET;ORAL022100-004Sep 26, 2007► Subscribe► Subscribe
Daiichi SankyoAZORamlodipine besylate; olmesartan medoxomilTABLET;ORAL022100-003Sep 26, 2007► Subscribe► Subscribe
Daiichi SankyoAZORamlodipine besylate; olmesartan medoxomilTABLET;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
China1189490► Subscribe
Czech Republic289244► Subscribe
Taiwan228521► Subscribe
Ireland970752► Subscribe
China1045770► Subscribe
Finland920749► Subscribe
Czech Republic9301050► Subscribe
Netherlands300133► Subscribe
Israel105825► Subscribe
Norway2009019► 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
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
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
12/018Ireland► SubscribePRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705
056Luxembourg► Subscribe91056, EXPIRES: 20170221
00528Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
07C/043Belgium► SubscribePRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
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
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
0503785/02Switzerland► SubscribeFORMER OWNER: SANKYO COMPANY LIMITED, JP
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Serving leading biopharmaceutical companies globally:

Citi
Healthtrust
Argus Health
Chubb
Dow
Deloitte
Novartis
Johnson and Johnson
Cipla
Farmers Insurance

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