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Last Updated: November 26, 2022

Azacitidine - Generic Drug Details


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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, Eurohlth Intl Sarl, Lupin Ltd, Meitheal, Mylan Institutional, Natco Pharma Ltd, Shilpa Medicare, Celgene, and Celgene Corp, and is included in thirteen NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Azacitidine has eighty patent family members in thirty-four countries.

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

Summary for azacitidine
Drug Prices for azacitidine

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Recent Clinical Trials for azacitidine

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

SponsorPhase
CSPC Pharmaceutical Group LimitedPhase 2
Blueprint Medicines CorporationPhase 1/Phase 2
Chipscreen Biosciences, Ltd.Phase 2

See all azacitidine clinical trials

Pharmacology for azacitidine
Medical Subject Heading (MeSH) Categories for azacitidine
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
Celgene Corp ONUREG azacitidine TABLET;ORAL 214120-002 Sep 1, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Eurohlth Intl Sarl AZACITIDINE azacitidine POWDER;INTRAVENOUS, SUBCUTANEOUS 209337-001 Jun 8, 2020 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Actavis Llc AZACITIDINE azacitidine POWDER;INTRAVENOUS, SUBCUTANEOUS 208216-001 Apr 29, 2016 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Celgene Corp ONUREG azacitidine TABLET;ORAL 214120-002 Sep 1, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Amneal AZACITIDINE azacitidine POWDER;INTRAVENOUS, SUBCUTANEOUS 211549-001 Feb 3, 2022 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for azacitidine

Country Patent Number Title Estimated Expiration
South Korea 20110015629 ORAL FORMULATIONS OF CYTIDINE ANALOGS AND METHODS OF USE THEREOF See Plans and Pricing
Slovenia 2695609 See Plans and Pricing
Lithuania 2299984 See Plans and Pricing
Mexico 2010012470 FORMULACIONES ORALES DE ANALOGOS DE CITIDINA Y METODOS PARA USAR LOS MISMOS. (ORAL FORMULATIONS OF CYTIDINE ANALOGS AND METHODS OF USE THEREOF.) See Plans and Pricing
Australia 2015202884 ORAL FORMULATIONS OF CYTIDINE ANALOGS AND METHODS OF USE THEREOF See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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