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Olmesartan medoxomil - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for olmesartan medoxomil?

Olmesartan medoxomil is the generic ingredient in two branded drugs marketed by Mylan Pharms Inc and Daiichi Sankyo, and is included in two NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and twenty-nine patent family members in thirty-one countries.

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

Summary for Generic Name: olmesartan medoxomil

Tradenames:2
Patents:3
Applicants:2
NDAs:2
Drug Master File Entries: see list35
Suppliers / Packagers: see list12
Bulk Api Vendors: see list81
Clinical Trials: see list44
Patent Applications: see list2,406
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. Form Dosage
► Subscribe► SubscribeTABLET; ORAL5MG
► Subscribe► SubscribeTABLET; ORAL20MG
► Subscribe► SubscribeTABLET; ORAL40MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Daiichi Sankyo
BENICAR
olmesartan medoxomil
TABLET;ORAL021286-003Apr 25, 2002RXYesNo6,878,703*PED► SubscribeY► Subscribe
Mylan Pharms Inc
OLMESARTAN MEDOXOMIL
olmesartan medoxomil
TABLET;ORAL078276-002Oct 26, 2016RXNoNo► Subscribe► Subscribe
Daiichi Sankyo
BENICAR
olmesartan medoxomil
TABLET;ORAL021286-004Apr 25, 2002RXYesYes5,616,599*PED► Subscribe ► Subscribe
Mylan Pharms Inc
OLMESARTAN MEDOXOMIL
olmesartan medoxomil
TABLET;ORAL078276-001Oct 26, 2016RXNoNo► Subscribe► Subscribe
Mylan Pharms Inc
OLMESARTAN MEDOXOMIL
olmesartan medoxomil
TABLET;ORAL078276-003Oct 26, 2016RXNoNo► 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, 20025,616,599*PED► Subscribe
Daiichi Sankyo
BENICAR
olmesartan medoxomil
TABLET;ORAL021286-004Apr 25, 20025,616,599*PED► Subscribe
Daiichi Sankyo
BENICAR
olmesartan medoxomil
TABLET;ORAL021286-003Apr 25, 20025,616,599*PED► 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
Austria324890► Subscribe
Greece3035906► Subscribe
Japan2003048852► Subscribe
Norway304516► Subscribe
Japan3461863► 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
0503785/01Switzerland► SubscribeFORMER OWNER: SANKYO COMPANY LIMITED, JP
C0037France► SubscribePRODUCT NAME: OLMESARTAN MEDOXOMIL; NAT. REGISTRATION NO/DATE: NL28292 20030806; FIRST REGISTRATION: DE - 50202.00 20020813
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
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
/2009Austria► SubscribePRODUCT NAME: KOMBINATION VON OLMESARTAN MEDOXOMIL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH AKZEPTABLEN SALZES, MIT AMLODIPINBESILAT; NAT. REGISTRATION NO/DATE: 1-27894, 1-27895, 1-27896 20081217; FIRST REGISTRATION: NL 100989, 100990, 100991 20080819
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