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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

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;ORAL020719-003Aug 4, 1997DISCNNo6,011,049<disabled> <disabled>
Pfizer Pharms
REZULIN
troglitazone
TABLET;ORAL020720-002Jan 29, 1997DISCNNo<disabled><disabled>
Sankyo
PRELAY
troglitazone
TABLET;ORAL020719-002Jan 29, 1997DISCNNo6,011,049<disabled> <disabled>
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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
Pfizer Pharms
REZULIN
troglitazone
TABLET;ORAL020720-003Aug 4, 19974,572,912<disabled>
Pfizer Pharms
REZULIN
troglitazone
TABLET;ORAL020720-002Jan 29, 19975,104,888<disabled>
Pfizer Pharms
REZULIN
troglitazone
TABLET;ORAL020720-001Jan 29, 19975,104,888<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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International Patent Family for Ingredient: troglitazone

Country Document Number Estimated Expiration
Bulgaria103671<disabled in preview>
Panama8447401<disabled in preview>
Estonia9900345<disabled in preview>
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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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