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Last Updated: February 22, 2024

Thalidomide - Generic Drug Details


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What are the generic sources for thalidomide and what is the scope of patent protection?

Thalidomide is the generic ingredient in two branded drugs marketed by Natco and Bristol-myers, and is included in two NDAs. There is one patent protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Thalidomide has twenty-nine patent family members in nineteen countries.

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

Recent Clinical Trials for thalidomide

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

SponsorPhase
Shenyang Tenth People's HospitalPhase 2
Beijing Tsinghua Changgeng HospitalPhase 2
University Hopsital Schleswig Holstein Campus LübeckPhase 2/Phase 3

See all thalidomide clinical trials

Generic filers with tentative approvals for THALIDOMIDE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial200MGCAPSULE; ORAL
⤷  Try a Trial⤷  Try a Trial150MGCAPSULE; ORAL
⤷  Try a Trial⤷  Try a Trial100MGCAPSULE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for thalidomide
Medical Subject Heading (MeSH) Categories for thalidomide
Paragraph IV (Patent) Challenges for THALIDOMIDE
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 thalidomide

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 020785-004 Jan 10, 2007 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Natco THALIDOMIDE thalidomide CAPSULE;ORAL 213267-001 Apr 27, 2023 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bristol-myers THALOMID thalidomide CAPSULE;ORAL 020785-001 Jul 16, 1998 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bristol-myers THALOMID thalidomide CAPSULE;ORAL 020785-003 Jan 17, 2003 RX Yes Yes ⤷  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 thalidomide

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

EU/EMA Drug Approvals for thalidomide

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 thalidomide

Country Patent Number Title Estimated Expiration
Taiwan I359659 ⤷  Try a Trial
Australia 2010201931 Pharmaceutical compositions and dosage forms of thalidomide ⤷  Try a Trial
Mexico PA05005162 COMPOSICIONES Y FORMAS DE DOSIFICACION FARMACEUTICAS DE TALIDOMIDA. (PHARMACEUTICAL COMPOSITIONS AND DOSAGE FORMS OF THALIDOMIDE.) ⤷  Try a Trial
Australia 2003290982 PHARMACEUTICAL COMPOSITIONS AND DOSAGE FORMS OF THALIDOMIDE ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for thalidomide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0688211 08C0036 France ⤷  Try a Trial PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
0620232 08C0036 France ⤷  Try a Trial PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
0688211 SPC/GB08/039 United Kingdom ⤷  Try a 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 C300358 Netherlands ⤷  Try a 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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