VIDAZA Drug Patent Profile

When do Vidaza patents expire, and what generic alternatives are available?

Vidaza is a drug marketed by Bristol-myers and is included in one NDA.

The generic ingredient in VIDAZA is azacitidine. There are fifteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the azacitidine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vidaza

A generic version of VIDAZA was approved as azacitidine by DR REDDYS on September 16^th, 2013.

Summary for VIDAZA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	124
Clinical Trials:	248
Patent Applications:	4,384
Drug Prices:	Drug price information for VIDAZA
What excipients (inactive ingredients) are in VIDAZA?	VIDAZA excipients list
DailyMed Link:	VIDAZA at DailyMed

See drug prices for VIDAZA

Recent Clinical Trials for VIDAZA

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

Sponsor	Phase
Antonio M Jimenez Jimenez	Phase 1
City of Hope Medical Center	Phase 1
Therapeutic Advances in Childhood Leukemia Consortium	Phase 1/Phase 2

See all VIDAZA clinical trials

Pharmacology for VIDAZA

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

US Patents and Regulatory Information for VIDAZA

VIDAZA is protected by zero US patents and two FDA Regulatory Exclusivities.

FDA Regulatory Exclusivity protecting VIDAZA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol-myers	VIDAZA	azacitidine	POWDER;INTRAVENOUS, SUBCUTANEOUS	050794-001	May 19, 2004	AP	RX	Yes	Yes
Bristol-myers	VIDAZA	azacitidine	POWDER;INTRAVENOUS, SUBCUTANEOUS	050794-001	May 19, 2004	AP	RX	Yes	Yes

EU/EMA Drug Approvals for VIDAZA

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