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Last Updated: May 8, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020785

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NDA 020785 describes THALOMID, which is a drug marketed by Celgene and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and three Paragraph IV challenges. Additional details are available on the THALOMID profile page.

The generic ingredient in THALOMID is thalidomide. There are eleven 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 020785
Tradename:THALOMID
Applicant:Celgene
Ingredient:thalidomide
Patents:1
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 020785
Generic Entry Date for 020785*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 020785
Medical Subject Heading (MeSH) Categories for 020785
Suppliers and Packaging for NDA: 020785
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
THALOMID thalidomide CAPSULE;ORAL 020785 NDA Celgene Corporation 59572-205 59572-205-94 10 BLISTER PACK in 1 BOX (59572-205-94) > 28 CAPSULE in 1 BLISTER PACK (59572-205-14)
THALOMID thalidomide CAPSULE;ORAL 020785 NDA Celgene Corporation 59572-205 59572-205-97 10 BLISTER PACK in 1 BOX (59572-205-97) > 1 CAPSULE in 1 BLISTER PACK (59572-205-17)
Paragraph IV (Patent) Challenges for 020785
Tradename Dosage Ingredient NDA Submissiondate
THALOMID CAPSULE;ORAL thalidomide 020785 2014-02-03
THALOMID CAPSULE;ORAL thalidomide 020785 2006-12-18
THALOMID CAPSULE;ORAL thalidomide 020785 2006-09-25

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Jul 16, 1998TE:RLD:Yes
Patent:  Get Started for $10Patent Expiration:Dec 9, 2023Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Jan 17, 2003TE:RLD:Yes
Patent:  Get Started for $10Patent Expiration:Dec 9, 2023Product Flag?YSubstance Flag?Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Jan 17, 2003TE:RLD:Yes
Patent:  Get Started for $10Patent Expiration:Dec 9, 2023Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 020785

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-001 Jul 16, 1998   Get Started for $10   Get Started for $10
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-001 Jul 16, 1998   Get Started for $10   Get Started for $10
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-002 Jan 17, 2003   Get Started for $10   Get Started for $10
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-002 Jan 17, 2003   Get Started for $10   Get Started for $10
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-003 Jan 17, 2003   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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 verification 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.