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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
Chubb
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Fuji
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Generated: September 25, 2017

DrugPatentWatch Database Preview

Thalidomide - Generic Drug Details

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What are the generic sources for thalidomide and what is the scope of thalidomide freedom to operate?

Thalidomide
is the generic ingredient in one branded drug marketed by Celgene and is included in one NDA. There are sixteen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Thalidomide has seventy-three patent family members in twenty-one countries.

There are nine drug master file entries for thalidomide. One supplier is listed for this compound.

Summary for Generic Name: thalidomide

Tradenames:1
Patents:16
Applicants:1
NDAs:1
Drug Master File Entries: see list9
Suppliers / Packagers: see list1
Bulk Api Vendors: see list91
Clinical Trials: see list438
Patent Applications: see list7,190
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:thalidomide at DailyMed

Pharmacology for Ingredient: 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;ORAL020785-004Jan 10, 2007RXYesNo► Subscribe► Subscribe ► Subscribe
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-001Jul 16, 1998RXYesNo► 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;ORAL020785-004Jan 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► Subscribe ► Subscribe
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-003Jan 17, 2003RXYesYes► Subscribe► Subscribe ► Subscribe
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-004Jan 10, 2007RXYesNo► Subscribe► Subscribe ► Subscribe
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-002Jan 17, 2003RXYesNo► Subscribe► Subscribe ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: thalidomide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-003Jan 17, 2003► 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;ORAL020785-004Jan 10, 2007► 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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Non-Orange Book Patents for Generic Ingredient: thalidomide

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
9,006,267Pharmaceutical compositions and dosage forms of thalidomide► Subscribe
8,039,488Methods 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
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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 Ingredient: thalidomide

Country Document Number Estimated Expiration
Japan2009215310► Subscribe
World Intellectual Property Organization (WIPO)9819649► Subscribe
Australia2010201931► Subscribe
Germany69738935► Subscribe
Japan2009073844► Subscribe
Taiwan200731973► Subscribe
Austria493983► Subscribe
European Patent Office1330765► Subscribe
Austria305301► Subscribe
Australia780486► 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: THALIDOMIDE

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
C0036France► SubscribePRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
00358Netherlands► 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 500+ biopharmaceutical companies globally:

Merck
Harvard Business School
US Department of Justice
Cipla
Federal Trade Commission
Express Scripts
Citi
Johnson and Johnson
Covington
Fish and Richardson

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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