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Troglitazone - Generic Drug Details

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Troglitazone is the generic ingredient in two branded drugs marketed by Sankyo and Pfizer Pharms, and is included in two NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has forty-four patent family members in thirty-five countries.

Summary for Generic Name: troglitazone

Tradenames:2
Patents:2
Applicants:2
NDAs:2
Drug Master File Entries: 0
Formulation / Manufacturing:see details
Drug Prices:see low prices

Clinical Trials for: troglitazone

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sankyo
PRELAY
troglitazone
TABLET;ORAL020719-002Jan 29, 1997DISCNNo6,011,049Nov 13, 2017
Sankyo
PRELAY
troglitazone
TABLET;ORAL020719-002Jan 29, 1997DISCNNo5,859,037Nov 13, 2017
Sankyo
PRELAY
troglitazone
TABLET;ORAL020719-001Jan 29, 1997DISCNNo5,859,037Nov 13, 2017
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Expired Orange Book Patents for Generic Ingredient: troglitazone

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sankyo
PRELAY
troglitazone
TABLET;ORAL020719-001Jan 29, 19976,046,202<disabled>
Pfizer Pharms
REZULIN
troglitazone
TABLET;ORAL020720-003Aug 4, 19975,457,109<disabled>
Pfizer Pharms
REZULIN
troglitazone
TABLET;ORAL020720-003Aug 4, 19975,602,133<disabled>
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Non-Orange Book Patents for Generic Ingredient: troglitazone

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
5,972,973 Sulfonylurea-glitazone combinations for diabetes<disabled in preview>
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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: troglitazone

Country Document Number Estimated Expiration
Australia741215<disabled in preview>
Panama8447401<disabled in preview>
Poland335166<disabled in preview>
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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: TROGLITAZONE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB97/084United Kingdom<disabled>PRODUCT NAME: TROGLITAZONE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK 10949/0277 19970729; UK 10949/0278 19970729; UK 10949/0279 19970729; UK 06384/0005 19970729; UK 06384/0006 19970729; UK 06384/0007 19970729
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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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