Azacitidine - Generic Drug Details

What are the generic drug 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, Hetero Labs Ltd Vi, Jiangsu Hansoh Pharm, Lupin Ltd, Meitheal, Msn Labs Pvt Ltd, Natco Pharma Ltd, Norvium Bioscience, Shilpa Medicare, Bristol-myers, and Bristol, and is included in seventeen NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Azacitidine has one hundred 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:	100
US Patents:	3
Tradenames:	3
Applicants:	17
NDAs:	17
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	123
Clinical Trials:	603
Patent Applications:	6,428
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
Antonio M Jimenez Jimenez	Phase 1
Syndax Pharmaceuticals	Phase 1
Akeso	Phase 2

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
Natco Pharma Ltd	AZACITIDINE	azacitidine	POWDER;INTRAVENOUS, SUBCUTANEOUS	207234-001	Jun 23, 2017	AP	RX	No	No
Shilpa Medicare	AZACITIDINE	azacitidine	POWDER;INTRAVENOUS, SUBCUTANEOUS	207518-001	Sep 29, 2016	AP	RX	No	No
Bristol	ONUREG	azacitidine	TABLET;ORAL	214120-002	Sep 1, 2020		RX	Yes	Yes	11,571,436		Y
Meitheal	AZACITIDINE	azacitidine	POWDER;INTRAVENOUS, SUBCUTANEOUS	212128-001	Nov 2, 2020	AP	RX	No	No
Hetero Labs Ltd Vi	AZACITIDINE	azacitidine	POWDER;INTRAVENOUS, SUBCUTANEOUS	215765-001	Oct 15, 2024	AP	RX	No	No
Accord Hlthcare	AZACITIDINE	azacitidine	POWDER;INTRAVENOUS, SUBCUTANEOUS	207475-001	Jul 2, 2018	AP	RX	No	No
Bristol	ONUREG	azacitidine	TABLET;ORAL	214120-002	Sep 1, 2020		RX	Yes	Yes

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
Japan	6105547
Japan	2011520880
Canada	3094590	FORMULATIONS ORALES DE 5-AZACITIDINE ET METHODES D'UTILISATION (ORAL FORMULATIONS OF 5-AZACYTIDINE AND METHODS OF USE THEREOF)
Hungary	E059635
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).
Lithuania	3782612
Cyprus	1122681