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Last Updated: June 8, 2023

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.

There is one tentative approval for the generic drug (thalidomide), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for THALOMID
Drug Prices for THALOMID

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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 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 ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-003 Jan 17, 2003 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-002 Jan 17, 2003 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a 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 020785-004 Jan 10, 2007 ⤷  Try a Trial ⤷  Try a Trial
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-004 Jan 10, 2007 ⤷  Try a Trial ⤷  Try a Trial
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-002 Jan 17, 2003 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for THALOMID

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Bristol-Myers Squibb Pharma EEIG Thalidomide BMS (previously Thalidomide Celgene) thalidomide EMEA/H/C/000823
Thalidomide BMS in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged >/= 65 years or ineligible for high dose chemotherapy., , Thalidomide BMS is prescribed and dispensed according to the Thalidomide Celgene Pregnancy Prevention Programme (see section 4.4).,
Authorised no no no 2008-04-16
Lipomed GmbH Thalidomide Lipomed thalidomide EMEA/H/C/005715
Thalidomide Lipomed in combination with melphalan and prednisone is indicated as first line treatment of patients with untreated multiple myeloma, aged ≥ 65 years or ineligible for high dose chemotherapy.Thalidomide Lipomed is prescribed and dispensed in accordance with the Thalidomide Lipomed Pregnancy Prevention Programme (see section 4.4).
Authorised no no no 2022-09-19
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for THALOMID

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0688211 CA 2008 00034 Denmark ⤷  Try a Trial
0688211 91471 Luxembourg ⤷  Try a Trial 91471, EXPIRES: 20190224
0688211 SPC025/2008 Ireland ⤷  Try a Trial SPC025/2008: 20090811, EXPIRES: 20190223
>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.