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Last Updated: December 3, 2022

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 one branded drug marketed by Celgene and is included in one NDA. 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.

Recent Clinical Trials for thalidomide

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

SponsorPhase
Erasmus Medical CenterPhase 4
RenJi HospitalPhase 4
Jiangxi Provincial People's HopitalN/A

See all thalidomide clinical trials

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
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 020785-004 Jan 10, 2007 RX Yes No See Plans and Pricing See Plans and Pricing 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
>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
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-002 Jan 17, 2003 See Plans and Pricing See Plans and Pricing
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-004 Jan 10, 2007 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
>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

Supplementary Protection Certificates for thalidomide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0620232 08C0036 France See Plans and Pricing PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
0688211 C300358 Netherlands See Plans and Pricing PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: 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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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