FDA Orange Book · active-ingredient family
Deferiprone
Deferiprone is approved as 3 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
3
Brand (NDA)
3
Generics (ANDA)
7
Listed patents
15
Exclusivity periods
Brand (NDA) products · solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FERRIPROXRLD | CHIESI | NDA 212269 | — | May 19, 2020 | |
| FERRIPROXRLD×2 | CHIESI | NDA 021825 | AB | Jul 25, 2019 | |
| FERRIPROXRLD×2 | CHIESI | NDA 208030 | — | Apr 20, 2018 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DEFERIPRONE×2 | SENORES PHARMS | ANDA 220132 | AB | Dec 11, 2025 | |
| DEFERIPRONE×2 | TARO | ANDA 208800 | AB | Nov 22, 2023 | |
| DEFERIPRONE×2 | HIKMA | ANDA 213239 | AB | Feb 08, 2022 |
Marketing exclusivity (15)
- ODE-417Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 11 mo
- ODE-418Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 11 mo
- ODE-419Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 11 mo
- ODE-417Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 11 mo
- ODE-418Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 11 mo
- ODE-419Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 11 mo
- ODE-417Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 11 mo
- ODE-420Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 11 mo
- ODE-421Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 11 mo
- ODE-417Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 11 mo
- ODE-420Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 11 mo
- ODE-421Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 11 mo
- ODE-417Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 11 mo
- ODE-420Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 11 mo
- ODE-421Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 11 mo
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8703156 | Oct 26, 2029 | in 3 yr 5 mo | ProductU-3083 |
| 11723874 | Oct 25, 2038 | in 12 yr 6 mo | U-3083 |
| 11357731 | Oct 25, 2038 | in 12 yr 6 mo | U-3083 |
| 10940115 | Oct 25, 2038 | in 12 yr 6 mo | ProductU-3083 |
| 10780055 | Oct 25, 2038 | in 12 yr 6 mo | ProductU-3083 |
| 11458103 | Oct 25, 2038 | in 12 yr 6 mo | Product |
| 10940116 | Oct 25, 2038 | in 12 yr 6 mo | Product |
Deferiprone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
