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Details for Generic Name: troglitazone

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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-one patent family members in thirty-three 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
Pfizer Pharms
REZULIN
troglitazone
TABLET;ORAL020720-003Aug 4, 1997DISCNNo5,859,037<disabled><disabled>
Sankyo
PRELAY
troglitazone
TABLET;ORAL020719-001Jan 29, 1997DISCNNo6,011,049<disabled><disabled>
Sankyo
PRELAY
troglitazone
TABLET;ORAL020719-003Aug 4, 1997DISCNNo5,859,037<disabled><disabled>
Sankyo
PRELAY
troglitazone
TABLET;ORAL020719-002Jan 29, 1997DISCNNo5,859,037<disabled><disabled>
Pfizer Pharms
REZULIN
troglitazone
TABLET;ORAL020720-001Jan 29, 1997DISCNNo5,859,037<disabled><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 Publication Date
Costa Rica6128Nov 30, 2000
China1244801Feb 16, 2000
Japan2002529417Sep 10, 2002
Australia741215Nov 29, 2001
World Intellectual Property Organization (WIPO)0027401May 18, 2000
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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 information. There is no warranty that the information contained herein is error free. 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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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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