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Hydrochlorothiazide; olmesartan medoxomil - Generic Drug Details

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Hydrochlorothiazide; 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 two Paragraph IV challenges. 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-one drug master file entries for hydrochlorothiazide; olmesartan medoxomil. Eight suppliers are listed for this compound.

Summary for Generic Name: hydrochlorothiazide; olmesartan medoxomil

Tradenames:2
Patents:2
Applicants:2
NDAs:2
Drug Master File Entries: see list31
Suppliers / Packaging: see list8
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: hydrochlorothiazide; olmesartan medoxomil

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Daiichi Sankyo
BENICAR HCT
hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL021532-003Jun 5, 2003RXNo5,616,599*PED► subscribeY► subscribe
Daiichi Sankyo
BENICAR HCT
hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL021532-002Jun 5, 2003RXNo5,616,599*PED► subscribeY► subscribe
Mylan Pharms Inc
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL078827-002Oct 26, 2016RXNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: hydrochlorothiazide; olmesartan medoxomil

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Daiichi Sankyo
BENICAR HCT
hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL021532-002Jun 5, 20035,616,599*PED► subscribe
Daiichi Sankyo
BENICAR HCT
hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL021532-005Jun 5, 20035,616,599*PED► subscribe
Daiichi Sankyo
BENICAR HCT
hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL021532-003Jun 5, 20035,616,599*PED► subscribe
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Non-Orange Book Patents for Generic Ingredient: hydrochlorothiazide; 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: hydrochlorothiazide; olmesartan medoxomil

Country Document Number Estimated Expiration
Finland112476► subscribe
Norway2011013► subscribe
Denmark0573218► 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: HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0503785/01Switzerland► subscribeFORMER OWNER: SANKYO COMPANY LIMITED, JP
C0025Belgium► subscribePRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
0503785/02Switzerland► subscribeFORMER OWNER: SANKYO COMPANY LIMITED, JP
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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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