Orange Book product · Brand (NDA)

HARLIKU

NITISINONE

Brand (NDA)NDA 209449RX CYCLE

View NITISINONE family Open on FDA Orange Book

At a glance

Jun 10, 2025

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Jun 10, 2025
1 yr ago
Today
Exclusivity ends · ODE-529
Orphan-drug exclusivity (7 years)
Jun 10, 2032
in 6 yr 1 mo

Pharmaceutical detail

Active ingredient

NITISINONE

Strength

2MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 209449

Product number

004

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Marketing exclusivity (1)

ODE-529Orphan-drug exclusivity (7 years)
Jun 10, 2032
in 6 yr 1 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.

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