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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

Patents:16
Applicants:1
NDAs:1
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: Completed 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

Lenalidomide, Thalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma
Status: Active, not recruiting Condition: Myeloma

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

UARK 98-026 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 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;ORAL020785-004Jan 10, 2007RXNo7,141,018<disabled> <disabled>
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-002Jan 17, 2003RXNo6,755,784<disabled> <disabled>
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-001Jul 16, 1998RXNo7,230,012<disabled>Y <disabled>
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Expired Patents for Tradename: THALOMID

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-004Jan 10, 20077,723,361<disabled>
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-002Jan 17, 20037,723,361<disabled>
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-002Jan 17, 20038,143,283<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
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 Tradename: THALOMID

Country Document Number Publication Date
Hong Kong1028874May 12, 2006
Austria493983Jan 15, 2011
European Patent Office2143444Jan 13, 2010
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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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