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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

Troglitazone in Treating Patients With Liposarcoma
Status: Active, not recruiting Condition: Sarcoma

TART - Troglitazone Atherosclerosis Regression Trial
Status: Completed Condition: Atherosclerosis; Diabetes Mellitus

To Compare the Effect of a Subcutaneous Canakinumab Administration to Placebo in Patients With Impaired Glucose Tolerance or Patients With Type 2 Diabetes With Differing Baseline Diabetes Therapies
Status: Completed Condition: Type 2 Diabetes Mellitus; Impaired Glucose Tolerance

Fracture Risk With Thiazolidinediones
Status: Completed Condition: Fractures, Bone; Type II Diabetes

Glibenclamide (Dose to be Titrated From Starting Dose of 5mg om) Plus Rosiglitazone 4mg om (Increased to 8mg om After 6 Months) and vs Glibenclamide (Dose to be Titrated With Starting Dose of 5mg om) Plus Placebo, Administered to Patients With Type 2 Diabetes Mellitus
Status: Completed Condition: Diabetes Mellitus, Type 2

Association Study of Genetic Polymorphisms of Candidate Genes With Thiazolidinedione-Related Peripheral Edema and Drug Responsiveness
Status: Recruiting Condition: Diabetes Mellitus

Lumbar Spinal Fusion System
Status: Completed Condition: Degenerative Disc Disease

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
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;ORAL020720-002Jan 29, 1997DISCNNo6,011,049<disabled><disabled>
Pfizer Pharms
REZULIN
troglitazone
TABLET;ORAL020720-003Aug 4, 1997DISCNNo5,859,037<disabled><disabled>
Sankyo
PRELAY
troglitazone
TABLET;ORAL020719-002Jan 29, 1997DISCNNo5,859,037<disabled><disabled>
Pfizer Pharms
REZULIN
troglitazone
TABLET;ORAL020720-003Aug 4, 1997DISCNNo6,011,049<disabled><disabled>
Pfizer Pharms
REZULIN
troglitazone
TABLET;ORAL020720-001Jan 29, 1997DISCNNo6,011,049<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
Japan2001512478Aug 21, 2001
South Africa9801343Nov 16, 1998
European Patent Office1514550Mar 16, 2005
El Salvador1998000010Feb 02, 1999
Bulgaria103671Apr 28, 2000
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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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