Orange Book product · Brand (NDA)
FERRIPROX
DEFERIPRONE
At a glance
May 19, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 19, 2020
6 yr 2 mo ago
Today
Exclusivity ends · ODE-417
Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 11 mo
Exclusivity ends · ODE-420
Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 11 mo
Exclusivity ends · ODE-421
Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 11 mo
Patent 10780055 expires
Listed drug product patent expiration.
Oct 25, 2038
in 12 yr 6 mo
Patent 10940115 expires
Listed drug product patent expiration.
Oct 25, 2038
in 12 yr 6 mo
Patent 10940116 expires
Listed drug product patent expiration.
Oct 25, 2038
in 12 yr 6 mo
Patent 11357731 expires
Listed method-of-use patent (U-3083) expiration.
Oct 25, 2038
in 12 yr 6 mo
Patent 11458103 expires
Listed drug product patent expiration.
Oct 25, 2038
in 12 yr 6 mo
Patent 11723874 expires
Listed method-of-use patent (U-3083) expiration.
Oct 25, 2038
in 12 yr 6 mo
Pharmaceutical detail
Active ingredient
DEFERIPRONE
Strength
1GM
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 212269
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (3)
- 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 (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10780055 | Oct 25, 2038 | in 12 yr 6 mo | ProductU-3083 |
| 10940115 | Oct 25, 2038 | in 12 yr 6 mo | ProductU-3083 |
| 10940116 | Oct 25, 2038 | in 12 yr 6 mo | Product |
| 11357731 | Oct 25, 2038 | in 12 yr 6 mo | U-3083 |
| 11458103 | Oct 25, 2038 | in 12 yr 6 mo | Product |
| 11723874 | Oct 25, 2038 | in 12 yr 6 mo | U-3083 |
