Question 1

Is there a generic for Azacitidine?

Accepted Answer

Yes. The FDA Orange Book lists 15 approved generic (ANDA) applications for Azacitidine, referencing the brand ONUREG. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

Question 2

What is the reference-listed drug for Azacitidine?

Accepted Answer

ONUREG (NDA 214120, BRISTOL) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Azacitidine?

Accepted Answer

The Orange Book lists 3 patents against Azacitidine products, with the earliest listed expiry in 2029. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Azacitidine have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 3 marketing-exclusivity periods for Azacitidine. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Azacitidine are approved?

Accepted Answer

Azacitidine is approved in the following dosage forms: powder, tablet.

Product	Applicant	Application	TE	Approved
ONUREGRLD×2	BRISTOL	NDA 214120	—	Sep 01, 2020
VIDAZARLD	BRISTOL-MYERS	NDA 050794	AP	May 19, 2004
AZACITIDINE	ACTAVIS LLC	NDA 208216	AP	Apr 29, 2016

Product	Applicant	Application	TE	Approved
AZACITIDINE	RELIANCE LIFE	ANDA 217453	AP	May 20, 2025
AZACITIDINE	HETERO LABS LTD VI	ANDA 215765	AP	Oct 15, 2024
AZACITIDINE	MSN LABS PVT LTD	ANDA 212580	AP	May 16, 2024
AZACITIDINE	JIANGSU HANSOH PHARM	ANDA 215905	AP	Jun 28, 2023
AZACITIDINE	EUGIA PHARMA	ANDA 215066	AP	Dec 30, 2022
AZACITIDINE	AMNEAL	ANDA 211549	—	Feb 03, 2022
AZACITIDINE	MEITHEAL	ANDA 212128	AP	Nov 02, 2020
AZACITIDINE	EUROHLTH INTL SARL	ANDA 209337	AP	Jun 08, 2020
AZACITIDINE	LUPIN	ANDA 210748	—	Feb 27, 2019
AZACITIDINE	ACCORD HLTHCARE	ANDA 207475	AP	Jul 02, 2018
AZACITIDINE	CIPLA	ANDA 209540	AP	May 04, 2018
AZACITIDINE	NATCO PHARMA LTD	ANDA 207234	AP	Jun 23, 2017
AZACITIDINE	SHILPA MEDICARE	ANDA 207518	AP	Sep 29, 2016
AZACITIDINE	PHARMOBEDIENT	ANDA 204949	—	Apr 28, 2016
AZACITIDINE	DR REDDYS	ANDA 201537	AP	Sep 16, 2013

Patent	Expires	In	Type
12053482	May 14, 2029	in 2 yr 11 mo	U-2950
11571436	May 14, 2029	in 2 yr 11 mo	Product
8846628	Jun 03, 2030	in 4 yr	ProductU-2950

Azacitidine

Brand (NDA) products · powder, tablet

Generic (ANDA) products (15)

Marketing exclusivity (3)

Listed patents (3)

Azacitidine — frequently asked questions

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