Orange Book product · Generic (ANDA)
POMALIDOMIDE
POMALIDOMIDE
At a glance
Oct 30, 2020
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 30, 2020
5 yr 9 mo ago
Today
Exclusivity ends · PC
Patent-challenge (180-day generic) exclusivity
Aug 29, 2026
in 2 mo
Pharmaceutical detail
Active ingredient
POMALIDOMIDE
Strength
3MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
ANDA 210111
Product number
003
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of POMALIDOMIDE
- 2013POMALYSTBrand (NDA)
NDA 204026 · BRISTOL
- 2024POMALIDOMIDEGeneric (ANDA)
ANDA 210236 · HETERO LABS LTD V
- 2024POMALIDOMIDEGeneric (ANDA)
ANDA 210164 · APOTEX
- 2022POMALIDOMIDEGeneric (ANDA)
ANDA 209956 · TEVA PHARMS USA
- 2022POMALIDOMIDEGeneric (ANDA)
ANDA 210275 · MYLAN
- 2020POMALIDOMIDEGeneric (ANDA)
ANDA 210249 · EUGIA PHARMA
Marketing exclusivity (1)
- PCPatent-challenge (180-day generic) exclusivity
Aug 29, 2026
in 2 mo
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
