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Serving leading biopharmaceutical companies globally:

Farmers Insurance
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Generated: November 19, 2017

DrugPatentWatch Database Preview

THALOMID Drug Profile

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What is the patent landscape for Thalomid, 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 and three supplementary protection certificates in three 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.
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;ORAL020785-004Jan 10, 2007RXYesNo► Subscribe► Subscribe ► Subscribe
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-002Jan 17, 2003RXYesNo► Subscribe► Subscribe ► Subscribe
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-001Jul 16, 1998RXYesNo► Subscribe► SubscribeY ► Subscribe
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-003Jan 17, 2003RXYesYes► Subscribe► Subscribe ► Subscribe
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-003Jan 17, 2003RXYesYes► Subscribe► Subscribe ► Subscribe
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-002Jan 17, 2003RXYesNo► Subscribe► Subscribe ► Subscribe
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-003Jan 17, 2003RXYesYes► Subscribe► Subscribe ► Subscribe
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-002Jan 17, 2003RXYesNo► Subscribe► Subscribe ► Subscribe
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-002Jan 17, 2003RXYesNo► Subscribe► Subscribe ► Subscribe
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-001Jul 16, 1998RXYesNo► Subscribe► Subscribe ► Subscribe
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Expired Patents for Tradename: THALOMID

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-004Jan 10, 2007► Subscribe► Subscribe
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-004Jan 10, 2007► Subscribe► Subscribe
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-001Jul 16, 1998► Subscribe► Subscribe
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-003Jan 17, 2003► Subscribe► Subscribe
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-001Jul 16, 1998► Subscribe► Subscribe
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-002Jan 17, 2003► Subscribe► Subscribe
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-004Jan 10, 2007► Subscribe► Subscribe
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-003Jan 17, 2003► Subscribe► Subscribe
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-002Jan 17, 2003► Subscribe► Subscribe
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-003Jan 17, 2003► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for THALOMID

Drugname Dosage Strength RLD Submissiondate
thalidomideCapsules150 mgThalomid2/3/2014
thalidomideCapsules50 mg and 100 mgThalomid12/18/2006
thalidomideCapsules200 mgThalomid9/25/2006

Non-Orange Book Patents for Tradename: 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
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
9,006,267Pharmaceutical compositions and dosage forms of thalidomide► Subscribe
8,039,488Methods and compositions for inhibition of angiogenesis► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: THALOMID

Country Document Number Estimated Expiration
Portugal1562556► Subscribe
Japan2009073844► Subscribe
Slovenia1562556► Subscribe
Hong Kong1028874► Subscribe
Israel150307► Subscribe
World Intellectual Property Organization (WIPO)9819649► Subscribe
Hong Kong1083064► Subscribe
European Patent Office2277512► Subscribe
Australia780486► Subscribe
Spain2358687► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: THALOMID

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0036France► SubscribePRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
C/GB08/039United Kingdom► SubscribePRODUCT 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
00358Netherlands► SubscribePRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
C0036France► SubscribePRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Healthtrust
Citi
Novartis
Colorcon
Johnson and Johnson
Federal Trade Commission
Express Scripts
Cerilliant
Chinese Patent Office
Harvard Business School

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 verifification 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.

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