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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Cipla
Fuji
Julphar
Harvard Business School
Covington
Johnson and Johnson
Deloitte
Colorcon

Generated: April 20, 2018

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 are fifteen patents 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 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 020785
Tradename:THALOMID
Applicant:Celgene
Ingredient:thalidomide
Patents:15
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
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 N 59572-205-97
THALOMID thalidomide CAPSULE;ORAL 020785 NDA Celgene Corporation 59572-205 N 59572-205-94

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Jul 16, 1998TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Aug 28, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA CALLED 'SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY' (S.T.E.P.S.)
Patent:➤ Sign UpPatent Expiration:Aug 28, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
Patent:➤ Sign UpPatent Expiration:Oct 23, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD FOR DELIVERING A DRUG TO A PATIENT IN NEED OF THE DRUG, WHILE AVOIDING THE OCCURENCE OF AN ADVERSE SIDE EFFECT KNOWN OR SUSPECTED OF BEING CAUSED BY SAID DRUG

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 ➤ Sign Up ➤ Sign Up
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-001 Jul 16, 1998 ➤ Sign Up ➤ Sign Up
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-001 Jul 16, 1998 ➤ Sign Up ➤ Sign Up
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-001 Jul 16, 1998 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Harvard Business School
Farmers Insurance
Federal Trade Commission
McKesson
Colorcon
Moodys
Deloitte
Baxter

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