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Serving 500+ biopharmaceutical companies globally:

US Army
Baxter
UBS
Federal Trade Commission
McKesson
Boehringer Ingelheim
Cantor Fitzgerald
Julphar
Fish and Richardson
Argus Health

Generated: September 26, 2017

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 sixteen 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 NDA: 020785

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:16
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details

Pharmacology for NDA: 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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Jul 16, 1998TE:RLD:Yes
Patent:► SubscribePatent 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:► SubscribePatent 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:► SubscribePatent 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 Orange Book Patents for NDA: 020785

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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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Baxter
UBS
Boehringer Ingelheim
Express Scripts
Merck
Cerilliant
Moodys
Chubb
Argus Health

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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