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Last Updated: September 22, 2020

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THALOMID Drug Profile

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Which patents cover Thalomid, and what generic alternatives are available?

Thalomid is a drug marketed by Celgene and is included in one NDA. There are nine patents protecting this drug and three Paragraph IV challenges.

This drug has forty-seven patent family members in nineteen countries.

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

US ANDA Litigation and Generic Entry Outlook for Thalomid

Thalomid was eligible for patent challenges on July 16, 2002.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 23, 2020. This may change due to patent challenges or generic licensing.

There have been twenty patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for THALOMID
Drug Prices for THALOMID

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Generic Entry Opportunity Date for THALOMID
Generic Entry Date for THALOMID*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for THALOMID

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

SponsorPhase
Emory UniversityPhase 2
Janssen Scientific Affairs, LLCPhase 2
Nanfang Hospital of Southern Medical UniversityPhase 3

See all THALOMID clinical trials

Pharmacology for THALOMID
Paragraph IV (Patent) Challenges for THALOMID
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 THALOMID

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 020785-004 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
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-003 Jan 17, 2003 RX Yes Yes   Start Trial   Start Trial   Start Trial
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-002 Jan 17, 2003 RX Yes No   Start Trial   Start Trial   Start Trial
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-002 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 020785-001 Jul 16, 1998 RX Yes No   Start Trial   Start Trial Y   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 THALOMID

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
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-004 Jan 10, 2007   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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for THALOMID

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0688211 91471 Luxembourg   Start Trial 91471, EXPIRES: 20190224
0688211 SPC025/2008 Ireland   Start Trial SPC025/2008: 20090811, EXPIRES: 20190223
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
0688211 08C0036 France   Start Trial PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
0620232 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
0688211 300358 Netherlands   Start Trial 300358, 20140224, EXPIRES: 20190223
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
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Harvard Business School
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Dow

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