Orange Book product · Brand (NDA)

POMALYST

POMALIDOMIDE

Brand (NDA)NDA 204026TE ABRX BRISTOL

Feb 08, 2013

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Feb 08, 2013
13 yr 7 mo ago
Today
Exclusivity ends · ODE-296
Orphan-drug exclusivity (7 years)
May 14, 2027
in 11 mo
Exclusivity ends · ODE-297
Orphan-drug exclusivity (7 years)
May 14, 2027
in 11 mo
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Nov 14, 2027
in 1 yr 5 mo
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Nov 14, 2027
in 1 yr 5 mo
Patent 10555939 expires
Listed drug product patent expiration.
May 19, 2030
in 4 yr
Patent 9993467 expires
Listed drug product patent expiration.
May 19, 2030
in 4 yr
Patent 10555939*PED expires
Listed listed patent expiration.
Nov 19, 2030
in 4 yr 6 mo
Patent 9993467*PED expires
Listed listed patent expiration.
Nov 19, 2030
in 4 yr 6 mo
Patent 8828427 expires
Listed drug substance patent expiration.
Jun 21, 2031
in 5 yr 1 mo
Patent 8828427*PED expires
Listed listed patent expiration.
Dec 21, 2031
in 5 yr 7 mo

Active ingredient

POMALIDOMIDE

Strength

4MG

Dosage form

CAPSULE

Route

ORAL

TE code

Application

NDA 204026

Product number

004

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

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
10555939	May 19, 2030	in 4 yr	Product
9993467	May 19, 2030	in 4 yr	Product
10555939*PED	Nov 19, 2030	in 4 yr 6 mo
9993467*PED	Nov 19, 2030	in 4 yr 6 mo
8828427	Jun 21, 2031	in 5 yr 1 mo	SubstanceProduct
8828427*PED	Dec 21, 2031	in 5 yr 7 mo