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Last Updated: September 22, 2020

DrugPatentWatch Database Preview

Thalidomide - Generic Drug Details

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What are the generic sources for thalidomide and what is the scope of freedom to operate?

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

Thalidomide has forty-seven patent family members in nineteen countries.

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

Recent Clinical Trials for thalidomide

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Damietta UniversityPhase 2
Shanghai Chest HospitalPhase 2
Janssen Scientific Affairs, LLCPhase 2

See all thalidomide clinical trials

Pharmacology for thalidomide
Medical Subject Heading (MeSH) Categories for thalidomide
Paragraph IV (Patent) Challenges for THALIDOMIDE
Tradename Dosage Ingredient NDA Submissiondate
THALOMID CAPSULE;ORAL thalidomide 020785 2014-02-03
THALOMID CAPSULE;ORAL thalidomide 020785 2006-12-18
THALOMID CAPSULE;ORAL thalidomide 020785 2006-09-25

US Patents and Regulatory Information for thalidomide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-002 Jan 17, 2003 RX Yes No   Start Trial   Start Trial   Start Trial
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-001 Jul 16, 1998 RX Yes No   Start Trial   Start Trial   Start Trial
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-004 Jan 10, 2007 RX Yes No   Start Trial   Start Trial   Start Trial
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-003 Jan 17, 2003 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for thalidomide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-003 Jan 17, 2003   Start Trial   Start Trial
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-002 Jan 17, 2003   Start Trial   Start Trial
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-003 Jan 17, 2003   Start Trial   Start Trial
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-002 Jan 17, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for thalidomide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0688211 SPC/GB08/039 United Kingdom   Start Trial PRODUCT NAME: THALIDOMIDE (INTERNATIONAL NON-PROPRIETARY NAME) 2-(2,6-DIOXOPIPERIDIN-3-YL) ISOINDOLINE-1,3-DIONE (SYSTEMATIC (IUPAC) NAME); REGISTERED: UK EU/1/08/443/001 20080416
0620232 08C0036 France   Start Trial PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
0688211 08C0036 France   Start Trial PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
0688211 C300358 Netherlands   Start Trial PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
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Boehringer Ingelheim
Medtronic
Baxter

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