Details for New Drug Application (NDA): 021880

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NDA 021880 describes REVLIMID, which is a drug marketed by Bristol Myers Squibb and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and three Paragraph IV challenges. Additional details are available on the REVLIMID profile page.

The generic ingredient in REVLIMID is lenalidomide. There are fourteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the lenalidomide profile page.

Summary for 021880

Tradename:	REVLIMID
Applicant:	Bristol Myers Squibb
Ingredient:	lenalidomide
Patents:	3

Pharmacology for NDA: 021880

Suppliers and Packaging for NDA: 021880

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
REVLIMID	lenalidomide	CAPSULE;ORAL	021880	NDA	Celgene Corporation	59572-402	59572-402-00	100 CAPSULE in 1 BOTTLE (59572-402-00)
REVLIMID	lenalidomide	CAPSULE;ORAL	021880	NDA	Celgene Corporation	59572-402	59572-402-28	28 CAPSULE in 1 BOTTLE (59572-402-28)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	5MG
Approval Date:	Dec 27, 2005	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	May 28, 2026
Regulatory Exclusivity Use:	INDICATED IN COMBINATION WITH A RITUXIMAB PRODUCT FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED FOLLICULAR LYMPHOMA (FL)
Regulatory Exclusivity Expiration:	May 28, 2026
Regulatory Exclusivity Use:	INDICATED IN COMBINATION WITH A RITUXIMAB PRODUCT FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED MARGINAL ZONE LYMPHOMA (MZL)
Regulatory Exclusivity Expiration:	Feb 22, 2024
Regulatory Exclusivity Use:	TREATMENT OF MULTIPLE MYELOMA (MM), AS MAINTENANCE FOLLOWING AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION (AUTO-HSCT)

Expired US Patents for NDA 021880

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-003	Jun 29, 2006	⤷ Sign Up	⤷ Sign Up
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-005	Dec 21, 2011	⤷ Sign Up	⤷ Sign Up
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-001	Dec 27, 2005	⤷ Sign Up	⤷ Sign Up
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-002	Dec 27, 2005	⤷ Sign Up	⤷ Sign Up
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-004	Jun 29, 2006	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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