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Last Updated: May 21, 2022

THALOMID Drug Patent Profile


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When do Thalomid patents expire, and when can generic versions of Thalomid launch?

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

This drug has twenty-nine 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.

DrugPatentWatch® 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 December 9, 2023. This may change due to patent challenges or generic licensing.

There have been eighteen 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

See drug prices for THALOMID

DrugPatentWatch® Estimated 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

Paragraph IV (Patent) Challenges for THALOMID
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
THALOMID Capsules thalidomide 150 mg 020785 1 2014-02-03
THALOMID Capsules thalidomide 50 mg and 100 mg 020785 1 2006-12-18
THALOMID Capsules thalidomide 200 mg 020785 1 2006-09-25

US Patents and Regulatory Information for THALOMID

THALOMID is protected by one US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of THALOMID is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting THALOMID

Pharmaceutical compositions and dosage forms of thalidomide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 020785-001 Jul 16, 1998 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-003 Jan 17, 2003 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-002 Jan 17, 2003 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-004 Jan 10, 2007 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 020785-001 Jul 16, 1998 See Plans and Pricing See Plans and Pricing
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-003 Jan 17, 2003 See Plans and Pricing See Plans and Pricing
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-001 Jul 16, 1998 See Plans and Pricing See Plans and Pricing
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-002 Jan 17, 2003 See Plans and Pricing See Plans and Pricing
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-001 Jul 16, 1998 See Plans and Pricing See Plans and Pricing
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-003 Jan 17, 2003 See Plans and Pricing See Plans and Pricing
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-002 Jan 17, 2003 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for THALOMID

When does loss-of-exclusivity occur for THALOMID?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 03290982
Estimated Expiration: See Plans and Pricing

Patent: 10201931
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 16240
Estimated Expiration: See Plans and Pricing

Canada

Patent: 05964
Estimated Expiration: See Plans and Pricing

China

Patent: 38607
Estimated Expiration: See Plans and Pricing

Patent: 1816626
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 13929
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 62556
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 62556
Estimated Expiration: See Plans and Pricing

Patent: 77512
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 88543
Estimated Expiration: See Plans and Pricing

Israel

Patent: 8585
Estimated Expiration: See Plans and Pricing

Japan

Patent: 27905
Estimated Expiration: See Plans and Pricing

Patent: 69280
Estimated Expiration: See Plans and Pricing

Patent: 06508983
Estimated Expiration: See Plans and Pricing

Patent: 09215310
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 05005162
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 0545
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 62556
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 62556
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0503927
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 0671366
Estimated Expiration: See Plans and Pricing

Patent: 050086624
Estimated Expiration: See Plans and Pricing

Spain

Patent: 03142
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 59659
Estimated Expiration: See Plans and Pricing

Patent: 77062
Estimated Expiration: See Plans and Pricing

Patent: 0505449
Estimated Expiration: See Plans and Pricing

Patent: 0731973
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering THALOMID around the world.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 0235440 See Plans and Pricing
Australia 780296 See Plans and Pricing
European Patent Office 1537870 See Plans and Pricing
Germany 69740095 See Plans and Pricing
European Patent Office 1264597 Compositions pour le traitement du cancer (Compositions for treating cancer) See Plans and Pricing
Japan 2009233326 METHOD FOR DELIVERING DRUG TO PATIENT WHILE AVOIDING OCCURRENCE OF ADVERSE SIDE EFFECT KNOWN OR SUSPECTED OF BEING CAUSED BY THE DRUG See Plans and Pricing
Australia 6248694 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for THALOMID

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0688211 CA 2008 00034 Denmark See Plans and Pricing
0620232 08C0036 France See Plans and Pricing PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
0688211 300358 Netherlands See Plans and Pricing 300358, 20140224, EXPIRES: 20190223
0688211 C300358 Netherlands See Plans and Pricing PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
0688211 SPC/GB08/039 United Kingdom See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
0688211 91471 Luxembourg See Plans and Pricing 91471, EXPIRES: 20190224
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. 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.