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Serving leading biopharmaceutical companies globally:

Cerilliant
Argus Health
Daiichi Sankyo
Queensland Health
Deloitte
Baxter
Cipla
Cantor Fitzgerald
US Army
US Department of Justice

Generated: October 18, 2017

DrugPatentWatch Database Preview

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 Alembic Pharms Ltd, Macleods Pharms Ltd, Lupin Ltd, Accord Hlthcare, Alkem Labs Ltd, Torrent Pharms Ltd, Mylan Pharms Inc, Teva Pharms Usa, Glenmark Pharms Ltd, Jubilant Generics, Daiichi Sankyo, Zydus Pharms Usa Inc, and Aurobindo Pharma Ltd, 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.

Summary for Generic Name: olmesartan medoxomil

US Patents:1
Tradenames:2
Applicants:13
NDAs:13
Drug Master File Entries: see list35
Suppliers / Packagers: see list25
Bulk Api Vendors: see list81
Clinical Trials: see list125
Patent Applications: see list4,265
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:olmesartan medoxomil at DailyMed

Pharmacology for Ingredient: 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
Aurobindo Pharma Ltd
OLMESARTAN MEDOXOMIL
olmesartan medoxomil
TABLET;ORAL204798-002Apr 24, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Accord Hlthcare
OLMESARTAN MEDOXOMIL
olmesartan medoxomil
TABLET;ORAL207662-001Apr 24, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Lupin Ltd
OLMESARTAN MEDOXOMIL
olmesartan medoxomil
TABLET;ORAL206631-002Apr 27, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Daiichi Sankyo
BENICAR
olmesartan medoxomil
TABLET;ORAL021286-003Apr 25, 2002ABRXYesNo► Subscribe► Subscribe ► Subscribe
Alkem Labs Ltd
OLMESARTAN MEDOXOMIL
olmesartan medoxomil
TABLET;ORAL206763-003Apr 24, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma Ltd
OLMESARTAN MEDOXOMIL
olmesartan medoxomil
TABLET;ORAL204798-001Apr 24, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Torrent Pharms Ltd
OLMESARTAN MEDOXOMIL
olmesartan medoxomil
TABLET;ORAL202375-002Apr 24, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
OLMESARTAN MEDOXOMIL
olmesartan medoxomil
TABLET;ORAL078276-002Oct 26, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Glenmark Pharms Ltd
OLMESARTAN MEDOXOMIL
olmesartan medoxomil
TABLET;ORAL203281-002May 25, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Alembic Pharms Ltd
OLMESARTAN MEDOXOMIL
olmesartan medoxomil
TABLET;ORAL203012-002Apr 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 Sankyo
BENICAR
olmesartan medoxomil
TABLET;ORAL021286-001Apr 25, 2002► Subscribe► Subscribe
Daiichi Sankyo
BENICAR
olmesartan medoxomil
TABLET;ORAL021286-004Apr 25, 2002► Subscribe► Subscribe
Daiichi Sankyo
BENICAR
olmesartan medoxomil
TABLET;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
Brazil1100452► Subscribe
Spain2157895► Subscribe
China1051766► Subscribe
JapanH07121918► Subscribe
HungaryT64329► Subscribe
Austria199548► Subscribe
China1101384► Subscribe
New Zealand241681► Subscribe
Norway2011013► Subscribe
Luxembourg91847► 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
2009 00015Denmark► SubscribePRODUCT NAME: EN KOMBINATION AF OLMESARTANMEDOXOMIL, EVT. I FORM AF ET FARMACEUTISK ACCEPTABELT SALT OG AMLODIPIN-BESILAT; NAT. REG. NO/DATE: MT 42061, 42062, 42063 20081120; FIRST REG. NO/DATE: NL RVG 100984 20080819
0503785/02Switzerland► SubscribeFORMER OWNER: SANKYO COMPANY LIMITED, JP
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
00375Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN OLMESARTAN MEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN AMLODIPINEBESILAAT; REGISTRATION NO/DATE: RVG100984, RVG100986-87, RVG100989-91, RVG100993-95 20080819
C0037France► SubscribePRODUCT NAME: OLMESARTAN MEDOXOMIL; NAT. REGISTRATION NO/DATE: NL28292 20030806; FIRST REGISTRATION: DE - 50202.00 20020813
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
0503785/04Switzerland► SubscribeFORMER REPRESENTATIVE: BOHEST AG, CH
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
330Luxembourg► SubscribeCERTIFICATE TITLE: UNE COMBINAISON D'OLMESARTAN MEDOXOMIL, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET D'HYDROCHLOROTHIAZIDE (OLMETEC PLUS)
0503785/01Switzerland► SubscribeFORMER OWNER: SANKYO COMPANY LIMITED, JP
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

QuintilesIMS
Boehringer Ingelheim
Harvard Business School
Cipla
Mallinckrodt
Express Scripts
Novartis
Fuji
Colorcon
Cerilliant

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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