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Generated: December 17, 2017

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Olmesartan medoxomil - Generic Drug Details

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What are the generic sources for olmesartan medoxomil and what is the scope of olmesartan medoxomil freedom to operate?

Olmesartan medoxomil
is the generic ingredient in two branded drugs marketed by Daiichi Sankyo, Accord Hlthcare, Alembic Pharms Ltd, Alkem Labs Ltd, Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Teva Pharms Usa, Torrent Pharms Ltd, and Zydus Pharms Usa Inc, and is included in thirteen NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Olmesartan medoxomil has one hundred and one patent family members in twenty-seven countries and nineteen supplementary protection certificates in seven countries.

There are thirty-five drug master file entries for olmesartan medoxomil. Twenty-five suppliers are listed for this compound. There are four tentative approvals for this compound.

Pharmacology for olmesartan medoxomil

Medical Subject Heading (MeSH) Categories for olmesartan medoxomil

Tentative approvals for OLMESARTAN MEDOXOMIL

Applicant Application No. Strength Dosage Form
u► Subscribe5MGTABLET; ORAL
u► Subscribe40MGTABLET; ORAL
u► Subscribe20MGTABLET; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zydus Pharms Usa IncOLMESARTAN MEDOXOMILolmesartan medoxomilTABLET;ORAL205192-003Apr 24, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms UsaOLMESARTAN MEDOXOMILolmesartan medoxomilTABLET;ORAL091079-003Apr 24, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms UsaOLMESARTAN MEDOXOMILolmesartan medoxomilTABLET;ORAL091079-001Apr 24, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Jubilant GenericsOLMESARTAN MEDOXOMILolmesartan medoxomilTABLET;ORAL205482-001Apr 24, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Torrent Pharms LtdOLMESARTAN MEDOXOMILolmesartan medoxomilTABLET;ORAL202375-002Apr 24, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Lupin LtdOLMESARTAN MEDOXOMILolmesartan medoxomilTABLET;ORAL206631-003Apr 27, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Jubilant GenericsOLMESARTAN MEDOXOMILolmesartan medoxomilTABLET;ORAL205482-003Apr 24, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Lupin LtdOLMESARTAN MEDOXOMILolmesartan medoxomilTABLET;ORAL206631-002Apr 27, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Macleods Pharms LtdOLMESARTAN MEDOXOMILolmesartan medoxomilTABLET;ORAL204814-001Apr 24, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Alembic Pharms LtdOLMESARTAN MEDOXOMILolmesartan medoxomilTABLET;ORAL203012-003Apr 24, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: olmesartan medoxomil

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Daiichi SankyoBENICARolmesartan medoxomilTABLET;ORAL021286-001Apr 25, 2002► Subscribe► Subscribe
Daiichi SankyoBENICARolmesartan medoxomilTABLET;ORAL021286-004Apr 25, 2002► Subscribe► Subscribe
Daiichi SankyoBENICARolmesartan medoxomilTABLET;ORAL021286-003Apr 25, 2002► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: olmesartan medoxomil

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 Ingredient: olmesartan medoxomil

Country Document Number Estimated Expiration
China1189490► Subscribe
China1045770► Subscribe
JapanH0578328► Subscribe
Norway931980► Subscribe
South Korea0128289► Subscribe
JapanH0649036► Subscribe
European Patent Office0573218► Subscribe
Finland112941► Subscribe
Luxembourg91847► Subscribe
New Zealand247750► 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: OLMESARTAN MEDOXOMIL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2011Austria► SubscribePRODUCT NAME: KOMBINATION AUS OLMESARTAN MEDOXOMIL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH AKZEPTABLEN SALZES, AMLODIPIN BESILAT UND HYDROCHLOROTHIAZID; NAT. REGISTRATION NO/DATE: 1-30068 - 1-30072 20110216; FIRST REGISTRATION: DE 79810.00.00 - 79814.00.00, UND 79815.00.00 - 79819.00.00 20101216
571Luxembourg► Subscribe91571, EXPIRES: 20170221
0503785/03Switzerland► SubscribeFORMER REPRESENTATIVE: BOHEST AG, CH
330Luxembourg► SubscribeCERTIFICATE TITLE: UNE COMBINAISON D'OLMESARTAN MEDOXOMIL, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET D'HYDROCHLOROTHIAZIDE (OLMETEC PLUS)
00133Netherlands► SubscribePRODUCT NAME: OLMESARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN DE CARBOXYGROEP GEKOZEN UIT DE VOLGENDE : EEN ALKYLGROEP 1-4 KOOLSTOFATOMEN, EEN BENZYLGROEP, EEN ALKANOYLOXYALKYLGROEP WAARIN HET ALKANOYLDEEL 1-5; NATL. REGISTRATION NO/DATE: RVG 28785-RVG 28787 20030527; FIRST REGISTRATION: DE 502.02.00.00,502.02.01.00, 502.02.02.00 20020813
0503785/01Switzerland► SubscribeFORMER OWNER: SANKYO COMPANY LIMITED, JP
2006 00012Denmark► Subscribe
C0037France► SubscribePRODUCT NAME: OLMESARTAN MEDOXOMIL; NAT. REGISTRATION NO/DATE: NL28292 20030806; FIRST REGISTRATION: DE - 50202.00 20020813
056Luxembourg► Subscribe91056, EXPIRES: 20170221
00486Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN OLMESARTANMEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, AMLODIPINEBESYLAAT AND HYDROCHLOORTHIAZIDE; NATL REGISTRATION NO/DATE: RVG 106667, RVG 106671-74, RVG 106682-86 20101221; FIRST REGISTRATION: DE 79810.00.00-79814.00.00 20101216
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Serving leading biopharmaceutical companies globally:

Cipla
QuintilesIMS
Express Scripts
Fuji
Julphar
Harvard Business School
Merck
Healthtrust
AstraZeneca
McKesson

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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