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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 seventeen patents protecting this drug and three Paragraph IV challenges.

The generic ingredient in THALOMID is thalidomide. There are eight 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: see list1

Pharmacology for Tradename: THALOMID

Clinical Trials for: THALOMID

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

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

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

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

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

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

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

Phase III Randomized Trial of Thalidomide/Dexamethasone Versus Vincristine+Adriamycin+Dexamethasone (VAD)
Status: Terminated Condition: Multiple Myeloma

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

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;ORAL020785Jul 16, 1998RXNo7,874,984<disabled><disabled>
CAPSULE;ORAL020785Jan 17, 2003RXNo6,315,720<disabled><disabled>
CAPSULE;ORAL020785Jul 16, 1998RXNo7,141,018<disabled><disabled>
CAPSULE;ORAL020785Jan 10, 2007RXNo8,589,188<disabled><disabled>
CAPSULE;ORAL020785Jan 10, 2007RXNo7,435,745<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
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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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