Orange Book product · Brand (NDA)

REVLIMID

LENALIDOMIDE

Brand (NDA)NDA 021880TE ABRX BRISTOL MYERS SQUIBB

Jun 05, 2013

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 05, 2013
13 yr 3 mo ago
Exclusivity ends · ODE-241
Orphan-drug exclusivity (7 years)
May 28, 2026
22 d ago
Exclusivity ends · ODE-245
Orphan-drug exclusivity (7 years)
May 28, 2026
22 d ago
Today
Patent 7465800 expires
Listed drug substance patent expiration.
Apr 27, 2027
in 10 mo
Patent 8741929 expires
Listed method-of-use patent (U-1983) expiration.
Mar 08, 2028
in 1 yr 9 mo

Active ingredient

LENALIDOMIDE

Strength

20MG

Dosage form

CAPSULE

Route

ORAL

TE code

Application

NDA 021880

Product number

006

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7465800	Apr 27, 2027	in 10 mo	SubstanceProduct
8741929	Mar 08, 2028	in 1 yr 9 mo	U-1983