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Last Updated: July 13, 2024

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 Bristol-myers and is included in one NDA.

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.

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Drug patent expirations by year for THALOMID
Drug Prices for THALOMID

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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

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

International Patents for THALOMID

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

Country Patent Number Title Estimated Expiration
European Patent Office 1245229 ⤷  Sign Up
Japan 2002513391 ⤷  Sign Up
Canada 2342974 METHODES ET COMPOSITIONS POUR L'INHIBITION DE L'ANGIOGENESE (METHODS AND COMPOSITIONS FOR INHIBITION OF ANGIOGENESIS) ⤷  Sign Up
South Korea 20050086624 PHARMACEUTICAL COMPOSITIONS AND DOSAGE FORMS OF THALIDOMIDE ⤷  Sign Up
Japan 2008088182 PHARMACEUTICAL PREPARATION INCLUDING THALIDOMIDE AS ACTIVE INGREDIENT ⤷  Sign Up
European Patent Office 1562556 COMPOSITIONS PHARMACEUTIQUES ET FORMES DE DOSAGE DE LA THALIDOMIDE (PHARMACEUTICAL COMPOSITIONS AND DOSAGE FORMS OF THALIDOMIDE) ⤷  Sign Up
>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 ⤷  Sign Up
0688211 91471 Luxembourg ⤷  Sign Up 91471, EXPIRES: 20190224
0688211 C300358 Netherlands ⤷  Sign Up PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
0688211 08C0036 France ⤷  Sign Up PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
0688211 SPC025/2008 Ireland ⤷  Sign Up SPC025/2008: 20090811, EXPIRES: 20190223
0688211 300358 Netherlands ⤷  Sign Up 300358, 20140224, EXPIRES: 20190223
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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