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Last Updated: March 28, 2024

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, 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-three 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
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Recent Clinical Trials for azacitidine

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SponsorPhase
Therapeutic Advances in Childhood Leukemia ConsortiumPhase 1/Phase 2
University Hospital HeidelbergPhase 2
Sheng-Li Xue, MDPhase 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
Bristol ONUREG azacitidine TABLET;ORAL 214120-002 Sep 1, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Eugia Pharma AZACITIDINE azacitidine POWDER;INTRAVENOUS, SUBCUTANEOUS 215066-001 Dec 30, 2022 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bristol ONUREG azacitidine TABLET;ORAL 214120-002 Sep 1, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal AZACITIDINE azacitidine POWDER;INTRAVENOUS, SUBCUTANEOUS 211549-001 Feb 3, 2022 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for azacitidine

Country Patent Number Title Estimated Expiration
Taiwan 201006478 Oral formulations of cytidine analogs and methods of use thereof ⤷  Try a Trial
European Patent Office 2299984 FORMULATIONS ORALES D'ANALOGUES DE CYTIDINE ET LEURS PROCÉDÉS D'UTILISATION (ORAL FORMULATIONS OF CYTIDINE ANALOGS AND METHODS OF USE THEREOF) ⤷  Try a Trial
Portugal 3782611 ⤷  Try a Trial
Denmark 2695609 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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