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THALOMID Drug Profile

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Thalomid is a drug marketed by Celgene and is included in one NDA. It is available from one supplier. There are sixteen patents protecting this drug and three Paragraph IV challenges.

This drug has seventy patent family members in twenty 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 Tradename: THALOMID

Patents:16
Applicants:1
NDAs:1
Suppliers / Packagers: see list1

Pharmacology for Tradename: THALOMID

Clinical Trials for: THALOMID

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-004Jan 10, 2007RXNo7,141,018<disabled> <disabled>
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-002Jan 17, 2003RXNo6,755,784<disabled> <disabled>
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-001Jul 16, 1998RXNo7,230,012<disabled>Y <disabled>
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Expired Patents for Tradename: THALOMID

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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;ORAL020785-002Jan 17, 20037,723,361<disabled>
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-004Jan 10, 20078,143,283<disabled>
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Paragraph IV activity 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<disabled in preview>
8,039,488Methods and compositions for inhibition of angiogenesis<disabled in preview>
9,006,267Pharmaceutical compositions and dosage forms of thalidomide<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 Tradename: THALOMID

Country Document Number Estimated Expiration
Spain2313154<disabled in preview>
Australia2005202596<disabled in preview>
TaiwanI377062<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: THALOMID

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0036France<disabled>PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
00358Netherlands<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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