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Details for Generic Name: thalidomide

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Thalidomide is the generic ingredient in one branded drug marketed by Celgene and is included in one NDA. There are sixteen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has seventy patent family members in twenty countries.

There are nine drug master file entries for thalidomide. One supplier is listed for this compound.

Summary for Generic Name: thalidomide

Tradenames:1
Patents:16
Applicants:1
NDAs:1
Drug Master File Entries: see list9
Suppliers / Packaging: see list5
Therapeutic Class:Antineoplastics

Pharmacology for Ingredient: thalidomide

Clinical Trials for: thalidomide

Phase II Trial of Thalidomide Combined With Concurrent Chemoradiotherapy in Esophageal Cancer
Status: Recruiting Condition: Esophageal Cancer

Thalidomide Plus Dexamethasone as Maintenance Therapy for Multiple Myeloma
Status: Completed Condition: Multiple Myeloma

Efficacy of Thalidomide in Preventing Chemotherapy-induced Delayed Nausea and Vomiting
Status: Recruiting Condition: Neoplasms

Long-term Effects of Thalidomide for Recurrent Gastrointestinal Bleeding Due to Vascular Malformation
Status: Completed Condition: Obscure Gastrointestinal Bleeding; Angiodysplasia; Gastric Antral Vascular Ectasia; Thalidomide

Retreatment and Its Efficiency of Thalidomide for Vascular Malformation Patients With Failure of First Course Treatment
Status: Not yet recruiting Condition: Gastrointestinal Bleeding of Unknown Origin; Gastrointestinal Vascular Malformation; Thalidomide Efficiency

Phase II Clinical Study of Thalidomide in the Treatment of Ankylosing Spondylitis
Status: Completed Condition: Ankylosing Spondylitis

Irinotecan and Thalidomide in Treating Patients With Advanced Solid Tumors
Status: Completed Condition: Unspecified Adult Solid Tumor, Protocol Specific

Thalidomide for the Treatment of Hormone-Dependent Prostate Cancer
Status: Completed Condition: Prostate Cancer

Thalidomide Plus Peginterferon and Ribavirin in Patients With Interferon Resistance
Status: Recruiting Condition: Hepatitis C

Thalidomide and Rituximab in Waldenstrom's Macroglobulinemia
Status: Completed Condition: Waldenstrom's Macroglobulinemia; Lymphoplasmacytic Lymphoma

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
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-003Jan 17, 2003RXYes8,315,886<disabled> <disabled>
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-003Jan 17, 2003RXYes6,561,976<disabled> <disabled>
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-004Jan 10, 2007RXNo7,874,984<disabled> <disabled>
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Expired Orange Book Patents for Generic Ingredient: thalidomide

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-001Jul 16, 19985,629,327<disabled>
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-003Jan 17, 20038,143,283<disabled>
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-003Jan 17, 20036,235,756<disabled>
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Non-Orange Book Patents for Generic Ingredient: thalidomide

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
6,767,326 Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug<disabled in preview>
9,006,267Pharmaceutical compositions and dosage forms of thalidomide<disabled in preview>
8,039,488Methods and compositions for inhibition of angiogenesis<disabled in preview>
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International Patent Family for Ingredient: thalidomide

Country Document Number Publication Date
South Korea20050086624Aug 30, 2005
New Zealand336035Mar 28, 2002
Japan2009215310Sep 24, 2009
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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.

Copyright 2002-2016 thinkBiotech LLC
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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