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Profile for Tradename: REZULIN

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Rezulin is a drug marketed by Pfizer Pharms and is included in one NDA. There are two patents protecting this drug.

This drug has forty-one patent family members in thirty-three countries.

The generic ingredient in REZULIN is troglitazone. Additional details are available on the troglitazone profile page.

Summary for Tradename: REZULIN

Patents:2
Applicants:1
NDAs:1

Clinical Trials for: REZULIN

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

Incretin-based Drugs and Acute Pancreatitis
Status: Completed Condition: Diabetes Mellitus, Type 2

Incretin-based Drugs and Pancreatic Cancer
Status: Completed Condition: Diabetes Mellitus, Type 2

Incretin-based Drugs and the Risk of Heart Failure
Status: Completed Condition: Type 2 Diabetes Mellitus

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;ORAL020720-001Jan 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>
Pfizer Pharms
REZULIN
troglitazone
TABLET;ORAL020720-003Aug 4, 1997DISCNNo5,859,037<disabled><disabled>
Pfizer Pharms
REZULIN
troglitazone
TABLET;ORAL020720-002Jan 29, 1997DISCNNo6,011,049<disabled><disabled>
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Premature patent expiration for: REZULIN

Expiration due to failure to pay maintenance fee

Patent Number Tradename Expiration Date
5,859,037
REZULIN
January 12, 2011
6,011,049
REZULIN
January 04, 2012

Non-Orange Book Patents for Tradename: REZULIN

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 Tradename: REZULIN

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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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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