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Profile for Tradename: THALOMID

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Thalomid is a drug marketed by Celgene and is included in one NDA. It is available from one supplier. There are sixteen patents protecting this drug and three Paragraph IV challenges.

This drug has seventy patent family members in twenty countries.

The generic ingredient in THALOMID is thalidomide. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the thalidomide profile page.

Summary for Tradename: THALOMID

Suppliers / Packagers: see list5

Pharmacology for Tradename: THALOMID

Clinical Trials for: THALOMID

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

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

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

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

Preoperative Thalidomide With Radiation Therapy For Patients With Low-Grade Primary Soft Tissue Sarcoma or Thalidomide With Radiation Therapy and Chemotherapy For Patients With High-Grade or Intermediate-Grade Primary Soft Tissue Sarcoma of the Arm, Leg, or Body Wall
Status: Terminated Condition: Recurrent Adult Soft Tissue Sarcoma; Stage I Adult Soft Tissue Sarcoma; Stage II Adult Soft Tissue Sarcoma; Stage III Adult Soft Tissue Sarcoma

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

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

Irinotecan Plus Thalidomide in Second Line Advanced Gastric Cancer
Status: Recruiting Condition: Gastric Cancer

Thalidomide and Temozolomide or Camptothecin-11 (CPT-11) in Patients With Gliomas
Status: Completed Condition: Glioblastoma Multiforme; Glioma

Courtesy of
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
CAPSULE;ORAL020785-004Jan 10, 2007RXNo7,141,018<disabled> <disabled>
CAPSULE;ORAL020785-002Jan 17, 2003RXNo6,755,784<disabled> <disabled>
CAPSULE;ORAL020785-001Jul 16, 1998RXNo7,230,012<disabled>Y <disabled>
CAPSULE;ORAL020785-003Jan 17, 2003RXYes6,315,720<disabled> <disabled>
CAPSULE;ORAL020785-003Jan 17, 2003RXYes8,589,188<disabled> <disabled>
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Paragraph IV activity for: THALOMID

Drugname Dosage Strength RLD Submissiondate
thalidomideCapsules150 mgThalomid2/3/2014
thalidomideCapsules50 mg and 100 mgThalomid12/18/2006
thalidomideCapsules200 mgThalomid9/25/2006

Non-Orange Book Patents for Tradename: THALOMID

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
9,006,267Pharmaceutical compositions and dosage forms of thalidomide<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>
8,039,488Methods and compositions for inhibition of angiogenesis<disabled in preview>
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International Patent Family for Tradename: THALOMID

Country Document Number Publication Date
Canada2270887May 14, 1998
Portugal1586322Oct 27, 2008
European Patent Office2277512Jul 04, 2012
Japan2004512617Apr 22, 2004
Australia2010200186Nov 17, 2011
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Preferred citation:

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

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