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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 eight 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 list8
Suppliers: see list1
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details

Pharmacology for Ingredient: thalidomide

Clinical Trials for: thalidomide

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

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

High-dose Dexamethasone Combining Thalidomide Versus Dexamethasone Mono-therapy for Management of Newly-diagnosed ITP
Status: Recruiting Condition: Immune Thrombocytopenia

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

TT II: Multiple Myeloma Evaluating Anti-Angiogenesis With Thalidomide and Post-Transplant Consolidation Chemotherapy
Status: Completed Condition: Multiple Myeloma

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: Recruiting 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

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, 2003RXYes7,141,018<disabled><disabled>
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-003Jan 17, 2003RXYes7,435,745<disabled><disabled>
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-001Jul 16, 1998RXNo7,435,745<disabled><disabled>
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-003Jan 17, 2003RXYes7,874,984<disabled><disabled>
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-002Jan 17, 2003RXNo7,435,745<disabled><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
8,039,488Methods and compositions for inhibition of angiogenesis<disabled in preview>
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>
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International Patent Family for Ingredient: thalidomide

Country Document Number Publication Date
Germany69734290Jul 06, 2006
Canada2514681Apr 05, 2011
Spain2358687May 12, 2011
Japan4927905May 09, 2012
Australia746713May 02, 2002
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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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