Orange Book product · Brand (NDA)

ONUREG

AZACITIDINE

Brand (NDA)NDA 214120RX BRISTOL

Sep 01, 2020

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Sep 01, 2020
5 yr 11 mo ago
Today
Exclusivity ends · ODE-320
Orphan-drug exclusivity (7 years)
Sep 01, 2027
in 1 yr 3 mo
Patent 11571436 expires
Listed drug product patent expiration.
May 14, 2029
in 2 yr 11 mo
Patent 12053482 expires
Listed method-of-use patent (U-2950) expiration.
May 14, 2029
in 2 yr 11 mo
Patent 8846628 expires
Listed drug product patent expiration.
Jun 03, 2030
in 4 yr

Active ingredient

AZACITIDINE

Strength

200MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 214120

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

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

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11571436	May 14, 2029	in 2 yr 11 mo	Product
12053482	May 14, 2029	in 2 yr 11 mo	U-2950
8846628	Jun 03, 2030	in 4 yr	ProductU-2950