Viewing data from:

ONUREG

NDA

AZACITIDINE | N214120 | BRISTOL MYERS SQUIBB CO

2 strengths3 unique patents1 unique exclusivity

Patent Timeline

3 unique patents, 1 exclusivity by expiration date

Active (3)TodayExclusivityIPRPTAB Challenge

2027

2028

2029

2030

Today

8846628

Jun. 3, 2030IPR

11571436

May. 14, 2029

12053482

May. 14, 2029

ODE-320

Sep. 1, 2027

PTAB Proceedings

1 challenge on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2023-00512	8846628	IPR	Apotex Inc. et al.	Terminated-Settled	2023-02-10	2024-01-05

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Celgene Corporation et al v. Natco Pharma Limited 1:2023cv01019 2 patentsANDA 218696azacitidine (5-azacytidine)	D. Del.	2023-09-18	Terminated 2024-05-29	—
Celgene Corporation et al v. MSN Laboratories Private Limited, et al. 1:2021cv01795 1 patentANDA 2167415-azacytidine (azacitidine)	D. Del.	2021-12-22	Terminated 2024-02-29	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Onureg (2023)

Total Spending

$68.8M

Total Claims

2,847

Beneficiaries

589

Avg Cost/Unit

$1813.36

Spending Trend

$4.7M(2020)→$42.6M(2021)→$60.1M(2022)→$68.8M(2023)

YoY Change:+7.8%

5yr CAGR:+5.4%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain17 active DMFs2 inactive

17 active API suppliers hold Drug Master Files for this ingredient.

SCINOPHARM TAIWAN LTDAZACITIDINE

DMF 223602008

CHEMWERTH INCAZACITIDINE

DMF 234162009

DR REDDYS LABORATORIES LTDAZACITIDINE

DMF 235642010

TAPI NL BVAZACITIDINE

DMF 261262012

LAURUS LABS LTDAZACITIDINE

DMF 268462013

SHILPA PHARMA LIFESCIENCES LTDAZACITIDINE

DMF 274872013

INTAS PHARMACEUTICALS LTDAZACITIDINE

DMF 278212013

MSN LABORATORIES PRIVATE LTDAZACITIDINE [ROUTE CODE "AJ"]

DMF 281002014

CHONGQING SINTAHO PHARMACEUTICAL CO LTDAZACITIDINE USP

DMF 281072014

SHANDONG ANHONG PHARMACEUTICAL CO LTDAZACITIDINE

DMF 297712015

SUN PHARMACEUTICAL INDUSTRIES LTDAZACITIDINE

DMF 298642016

HETERO LABS LTDAZACITIDINE

DMF 322722017

RELIANCE LIFE SCIENCES PVT LTDAZACITIDINE

DMF 364222022

APITORIA PHARMA PRIVATE LTDAZACITIDINE

DMF 386722023

ARTHUR GROUP LLCAZACITIDINE

DMF 398192024

OLON SPAAZACITIDINE

DMF 422762025

SUZHOU YIFAN PHARMACEUTICAL CO LTDAZACITIDINE

DMF 431962025

MYLAN LABORATORIES LTDInactiveAZACITIDINE

DMF 228012009

EUTICALS SPAInactiveAZACITIDINE

DMF 252652011

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Apr 10, 2026	SUPPL -3	View Letter (PDF)
Jan 11, 2022	SUPPL -1	View Letter (PDF)
Sep 2, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 200MG

RLD

3 patents1 exclusivity▴

TABLET;ORAL | Approved: Sep 1, 2020

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8846628	Jun 3, 2030	—	—	Yes		—
11571436	May 14, 2029	—	—	Yes	—	—
12053482	May 14, 2029	—	—	—		—

Exclusivities (1)

Code	Date	Status
ODE-320	Sep 1, 2027	Active

#002 — 300MG

RLD

3 patents1 exclusivity▾

TABLET;ORAL | Approved: Sep 1, 2020