DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020785

Email this page to a colleague

See Plans and Pricing

« Back to Dashboard

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 nine 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 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:	9
Formulation / Manufacturing:	see details

Generic Entry Opportunity Date for 020785

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

Physiological Effect

Decreased Immunologically Active Molecule Activity

Medical Subject Heading (MeSH) Categories for 020785

Angiogenesis Inhibitors

Immunosuppressive Agents

Leprostatic Agents

Teratogens

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	50MG
Approval Date:	Jul 16, 1998	TE:		RLD:	Yes
Patent:		Patent Expiration:	Oct 23, 2020	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD FOR DELIVERING A DRUG TO A PATIENT IN NEED OF THE DRUG, WHILE AVOIDING THE OCCURRENCE OF AN ADVERSE SIDE EFFECT KNOWN OR SUSPECTED OF BEING CAUSED BY SAID DRUG
Patent:		Patent Expiration:	Oct 23, 2020	Product 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:		Patent Expiration:	Oct 23, 2020	Product 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.)

Expired US Patents for NDA 020785

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Celgene	THALOMID	thalidomide	CAPSULE;ORAL	020785-004	Jan 10, 2007
Celgene	THALOMID	thalidomide	CAPSULE;ORAL	020785-003	Jan 17, 2003
Celgene	THALOMID	thalidomide	CAPSULE;ORAL	020785-002	Jan 17, 2003
Celgene	THALOMID	thalidomide	CAPSULE;ORAL	020785-002	Jan 17, 2003
Celgene	THALOMID	thalidomide	CAPSULE;ORAL	020785-001	Jul 16, 1998
Celgene	THALOMID	thalidomide	CAPSULE;ORAL	020785-001	Jul 16, 1998
Celgene	THALOMID	thalidomide	CAPSULE;ORAL	020785-001	Jul 16, 1998

Complete Access Available with Subscription