Azacitidine - Generic Drug Details

What are the generic sources for azacitidine and what is the scope of patent protection?

Azacitidine is the generic ingredient in three branded drugs marketed by Accord Hlthcare, Actavis Llc, Amneal, Cipla, Dr Reddys, Eugia Pharma, Eurohlth Intl Sarl, Jiangsu Hansoh Pharm, Lupin Ltd, Meitheal, Mylan Institutional, Natco Pharma Ltd, Shilpa Medicare, Bristol-myers, and Bristol, and is included in fifteen NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Azacitidine has ninety-eight patent family members in thirty-five countries.

There are fifteen drug master file entries for azacitidine. Eighteen suppliers are listed for this compound.

Summary for azacitidine

International Patents:	98
US Patents:	2
Tradenames:	3
Applicants:	15
NDAs:	15
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	123
Clinical Trials:	586
Patent Applications:	6,780
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for azacitidine
What excipients (inactive ingredients) are in azacitidine?	azacitidine excipients list
DailyMed Link:	azacitidine at DailyMed

See drug prices for azacitidine

Recent Clinical Trials for azacitidine

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Therapeutic Advances in Childhood Leukemia Consortium	Phase 1/Phase 2
University Hospital Heidelberg	Phase 2
Otsuka Australia Pharmaceutical Pty Ltd	Phase 3

See all azacitidine clinical trials

Pharmacology for azacitidine

Drug Class	Nucleoside Metabolic Inhibitor
Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Medical Subject Heading (MeSH) Categories for azacitidine

Antimetabolites, Antineoplastic

Enzyme Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for azacitidine

L01BC	Pyrimidine analogues
L01B	ANTIMETABOLITES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for AZACITIDINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ONUREG	Tablets	azacitidine	200 mg and 300 mg	214120	1	2021-09-30

US Patents and Regulatory Information for azacitidine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal	AZACITIDINE	azacitidine	POWDER;INTRAVENOUS, SUBCUTANEOUS	211549-001	Feb 3, 2022	AP	RX	No	No
Dr Reddys	AZACITIDINE	azacitidine	POWDER;INTRAVENOUS, SUBCUTANEOUS	201537-001	Sep 16, 2013	AP	RX	No	No
Bristol-myers	VIDAZA	azacitidine	POWDER;INTRAVENOUS, SUBCUTANEOUS	050794-001	May 19, 2004	AP	RX	Yes	Yes
Bristol	ONUREG	azacitidine	TABLET;ORAL	214120-002	Sep 1, 2020		RX	Yes	Yes
Actavis Llc	AZACITIDINE	azacitidine	POWDER;INTRAVENOUS, SUBCUTANEOUS	208216-001	Apr 29, 2016	AP	RX	No	No
Bristol-myers	VIDAZA	azacitidine	POWDER;INTRAVENOUS, SUBCUTANEOUS	050794-001	May 19, 2004	AP	RX	Yes	Yes
Jiangsu Hansoh Pharm	AZACITIDINE	azacitidine	POWDER;INTRAVENOUS, SUBCUTANEOUS	215905-001	Jun 28, 2023	AP	RX	No	No

EU/EMA Drug Approvals for azacitidine

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bristol-Myers Squibb Pharma EEIG	Vidaza	azacitidine	EMEA/H/C/000978 Vidaza is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with: intermediate 2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS),chronic myelomonocytic leukaemia (CMML) with 10 29 % marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (AML) with 20 30 % blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) classification.Vidaza is indicated for the treatment of adult patients aged 65 years or older who are not eligible for HSCT with AML with >30% marrow blasts according to the WHO classification.	Authorised	no	no	no	2008-12-17
Accord Healthcare S.L.U.	Azacitidine Accord	azacitidine	EMEA/H/C/005147 Azacitidine Accord is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with:- intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS),- chronic myelomonocytic leukaemia (CMML) with 10-29 % marrow blasts without myeloproliferative disorder,- acute myeloid leukaemia (AML) with 20-30 % blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) classification,- AML with >30% marrow blasts according to the WHO classification.	Authorised	yes	no	no	2020-02-13
Mylan Ireland Limited	Azacitidine Mylan	azacitidine	EMEA/H/C/004984 Azacitidine Mylan is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with:intermediate 2 and high risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS),chronic myelomonocytic leukaemia (CMML) with 10 29% marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (AML) with 20 30% blasts and multi lineage dysplasia, according to World Health Organisation (WHO) classification,AML with > 30% marrow blasts according to the WHO classification.	Authorised	yes	no	no	2020-03-27
betapharm Arzneimittel GmbH	Azacitidine betapharm	azacitidine	EMEA/H/C/005075 Azacitidine betapharm is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with:intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS),chronic myelomonocytic leukaemia (CMML) with 10 % to 29 % marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (AML) with 20 % to 30 % blasts and multi-lineage dysplasia, according to World Health Organization (WHO) classification,AML with > 30 % marrow blasts according to the WHO classification.	Authorised	yes	no	no	2020-03-24
Bristol-Myers Squibb Pharma EEIG	Onureg	azacitidine	EMEA/H/C/004761 Onureg is indicated as maintenance therapy in adult patients with acute myeloid leukaemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (HSCT).	Authorised	no	no	no	2021-06-17
Celgene Europe BV	Azacitidine Celgene	azacitidine	EMEA/H/C/005300 Azacitidine Celgene is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with:intermediate 2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS),chronic myelomonocytic leukaemia (CMML) with 10 29 % marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (AML) with 20 30 % blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) classification,AML with >30% marrow blasts according to the WHO classification.	Withdrawn	no	no	no	2019-08-02

International Patents for azacitidine

Country	Patent Number	Title	Estimated Expiration
Croatia	P20211398
Chile	2013001097	Composicion farmaceutica oral que comprende 5-azacitidina, en donde la composicion libera la 5-azacitidina substancialmente en el estomago despues de su administracion, util para tratar una enfermedad asociada a la proliferacion anormal de celulas, tal como sindrome mielodisplasico y cancer ovarico (divisional de la solicitud 1170-09).
Russian Federation	2018109222	ПЕРОРАЛЬНЫЕ СОСТАВЫ, СОДЕРЖАЩИЕ АНАЛОГИ ЦИТИДИНА, И СПОСОБЫ ИХ ИСПОЛЬЗОВАНИЯ
Poland	2695609
Croatia	P20190100
Denmark	3782611
European Patent Office	3692983	FORMULATIONS ORALES D'ANALOGUES DE CYTIDINE ET LEURS PROCÉDÉS D'UTILISATION (ORAL FORMULATIONS OF CYTIDINE ANALOGS AND METHODS OF USE THEREOF)