Details for New Drug Application (NDA): 021880

✉ Email this page to a colleague

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

Subscribe to access the full database, or Sign Up
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	021880-001	Dec 27, 2005	⤷ Sign Up	⤷ Sign Up
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-001	Dec 27, 2005	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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.