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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Federal Trade Commission
Merck
Moodys
McKesson
Boehringer Ingelheim
Dow
UBS
Chubb
Chinese Patent Office

Generated: January 18, 2018

DrugPatentWatch Database Preview

THALOMID Drug 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 are sixteen patents protecting this drug and three Paragraph IV challenges.

This drug has eighty-one patent family members in twenty-one countries.

The generic ingredient in THALOMID is thalidomide. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the thalidomide profile page.
Summary for THALOMID
Drug patent expirations by year for THALOMID
Pharmacology for THALOMID
Medical Subject Heading (MeSH) Categories for THALOMID

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
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-003 Jan 17, 2003 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-003 Jan 17, 2003 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-002 Jan 17, 2003 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-002 Jan 17, 2003 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-003 Jan 17, 2003 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-002 Jan 17, 2003 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-003 Jan 17, 2003 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-002 Jan 17, 2003 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-002 Jan 17, 2003 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-003 Jan 17, 2003 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 ➤ Subscribe ➤ Subscribe
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-003 Jan 17, 2003 ➤ Subscribe ➤ Subscribe
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-001 Jul 16, 1998 ➤ Subscribe ➤ Subscribe
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-004 Jan 10, 2007 ➤ Subscribe ➤ Subscribe
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-004 Jan 10, 2007 ➤ Subscribe ➤ Subscribe
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-002 Jan 17, 2003 ➤ Subscribe ➤ Subscribe
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-004 Jan 10, 2007 ➤ Subscribe ➤ Subscribe
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-001 Jul 16, 1998 ➤ Subscribe ➤ Subscribe
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-001 Jul 16, 1998 ➤ Subscribe ➤ Subscribe
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-001 Jul 16, 1998 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for THALOMID
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Capsules 150 mg ➤ Subscribe 2/3/2014
➤ Subscribe Capsules 50 mg and 100 mg ➤ Subscribe 12/18/2006
➤ Subscribe Capsules 200 mg ➤ Subscribe 9/25/2006

Non-Orange Book US Patents for THALOMID

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,039,488 Methods and compositions for inhibition of angiogenesis ➤ Subscribe
6,767,326 Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug ➤ Subscribe
9,006,267 Pharmaceutical compositions and dosage forms of thalidomide ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for THALOMID

Supplementary Protection Certificates for THALOMID

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00358 Netherlands ➤ Subscribe PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
C0036 France ➤ Subscribe PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
C0036 France ➤ Subscribe PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
C/GB08/039 United Kingdom ➤ Subscribe 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Novartis
Chubb
Merck
Johnson and Johnson
Julphar
Dow
Boehringer Ingelheim
Queensland Health
Fuji

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