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Thalidomide - Generic Drug Details

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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.

This ingredient has seventy patent family members in twenty 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 / Packaging: see list1
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details

Pharmacology for Ingredient: thalidomide

Clinical Trials for: thalidomide

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-002Jan 17, 2003RXNo6,908,432<disabled> <disabled>
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-001Jul 16, 1998RXNo6,908,432<disabled> <disabled>
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-004Jan 10, 2007RXNo6,561,977<disabled> <disabled>
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Expired Orange Book Patents for Generic Ingredient: thalidomide

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-002Jan 17, 20038,143,283<disabled>
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-003Jan 17, 20038,143,283<disabled>
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-004Jan 10, 20076,235,756<disabled>
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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
8,039,488Methods and compositions for inhibition of angiogenesis<disabled in preview>
9,006,267Pharmaceutical compositions and dosage forms of thalidomide<disabled in preview>
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<disabled in preview>
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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
Japan2009233326<disabled in preview>
Hong Kong1088543<disabled in preview>
Denmark1562556<disabled in preview>
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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
C/GB08/039United Kingdom<disabled>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
C0036France<disabled>PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
C0036France<disabled>PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
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