FDA Orange Book · active-ingredient family
Nitisinone
Nitisinone is approved as 3 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:HARLIKU · NDA 209449
3
Brand (NDA)
4
Generics (ANDA)
2
Listed patents
1
Exclusivity periods
Brand (NDA) products · capsule, suspension, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| HARLIKURLD×4 | CYCLE | NDA 209449 | — | Jun 10, 2025 | |
| ORFADINRLD | SWEDISH ORPHAN | NDA 206356 | — | Apr 22, 2016 | |
| ORFADINRLD×4 | SWEDISH ORPHAN | NDA 021232 | AB | Jan 18, 2002 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NITISINONE×4 | ETON | ANDA 216201 | AB | May 25, 2023 | |
| NITISINONE×4 | TORRENT | ANDA 215908 | — | Jan 09, 2023 | |
| NITISINONE×4 | MEDUNIK | ANDA 212390 | AB | May 26, 2022 | |
| NITISINONE×3 | NOVITIUM PHARMA | ANDA 211041 | AB | Aug 26, 2019 |
Marketing exclusivity (1)
- ODE-529Orphan-drug exclusivity (7 years)
Jun 10, 2032
in 6 yr 1 mo
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9301932 | Feb 28, 2033 | in 6 yr 10 mo | ProductU-1836 |
| 10328029 | Jan 05, 2035 | in 8 yr 8 mo | ProductU-1836 |
Nitisinone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
