FDA Orange Book · active-ingredient family
Pomalidomide
Pomalidomide is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
1
Brand (NDA)
6
Generics (ANDA)
6
Listed patents
20
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| POMALYSTRLD×4 | BRISTOL | NDA 204026 | AB | Feb 08, 2013 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| POMALIDOMIDE×4 | HETERO LABS LTD V | ANDA 210236 | AB | Sep 26, 2024 | |
| POMALIDOMIDE×4 | APOTEX | ANDA 210164 | AB | Jun 11, 2024 | |
| POMALIDOMIDE×4 | TEVA PHARMS USA | ANDA 209956 | AB | May 04, 2022 | |
| POMALIDOMIDE×4 | MYLAN | ANDA 210275 | — | Jan 26, 2022 | |
| POMALIDOMIDE×4 | BRECKENRIDGE | ANDA 210111 | AB | Oct 30, 2020 | |
| POMALIDOMIDE×4 | EUGIA PHARMA | ANDA 210249 | AB | Oct 30, 2020 |
Marketing exclusivity (20)
- PCPatent-challenge (180-day generic) exclusivity
Aug 29, 2026
in 2 mo
- PCPatent-challenge (180-day generic) exclusivity
Aug 29, 2026
in 2 mo
- PCPatent-challenge (180-day generic) exclusivity
Aug 29, 2026
in 2 mo
- PCPatent-challenge (180-day generic) exclusivity
Aug 29, 2026
in 2 mo
- ODE-296Orphan-drug exclusivity (7 years)
May 14, 2027
in 11 mo
- ODE-297Orphan-drug exclusivity (7 years)
May 14, 2027
in 11 mo
- PEDPediatric exclusivity (adds 6 months)
Nov 14, 2027
in 1 yr 5 mo
- PEDPediatric exclusivity (adds 6 months)
Nov 14, 2027
in 1 yr 5 mo
- ODE-296Orphan-drug exclusivity (7 years)
May 14, 2027
in 11 mo
- ODE-297Orphan-drug exclusivity (7 years)
May 14, 2027
in 11 mo
- PEDPediatric exclusivity (adds 6 months)
Nov 14, 2027
in 1 yr 5 mo
- PEDPediatric exclusivity (adds 6 months)
Nov 14, 2027
in 1 yr 5 mo
- ODE-296Orphan-drug exclusivity (7 years)
May 14, 2027
in 11 mo
- ODE-297Orphan-drug exclusivity (7 years)
May 14, 2027
in 11 mo
- PEDPediatric exclusivity (adds 6 months)
Nov 14, 2027
in 1 yr 5 mo
- PEDPediatric exclusivity (adds 6 months)
Nov 14, 2027
in 1 yr 5 mo
- ODE-296Orphan-drug exclusivity (7 years)
May 14, 2027
in 11 mo
- ODE-297Orphan-drug exclusivity (7 years)
May 14, 2027
in 11 mo
- PEDPediatric exclusivity (adds 6 months)
Nov 14, 2027
in 1 yr 5 mo
- PEDPediatric exclusivity (adds 6 months)
Nov 14, 2027
in 1 yr 5 mo
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10555939 | May 19, 2030 | in 4 yr | Product |
| 9993467 | May 19, 2030 | in 4 yr | Product |
| 9993467*PED | Nov 19, 2030 | in 4 yr 6 mo | |
| 10555939*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 |
Pomalidomide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
