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Last Updated: October 4, 2024

AZACITIDINE Drug Patent Profile


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Which patents cover Azacitidine, and when can generic versions of Azacitidine launch?

Azacitidine is a drug marketed by Accord Hlthcare, Actavis Llc, Amneal, Cipla, Dr Reddys, Eugia Pharma, Eurohlth Intl Sarl, Jiangsu Hansoh Pharm, Lupin Ltd, Meitheal, Msn Labs Pvt Ltd, Mylan Institutional, Natco Pharma Ltd, and Shilpa Medicare. and is included in fourteen NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Azacitidine

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

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Summary for AZACITIDINE
Drug patent expirations by year for AZACITIDINE
Drug Prices for AZACITIDINE

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Recent Clinical Trials for AZACITIDINE

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

SponsorPhase
Antonio M Jimenez JimenezPhase 1
Syndax PharmaceuticalsPhase 1
AkesoPhase 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
Accord Hlthcare AZACITIDINE azacitidine POWDER;INTRAVENOUS, SUBCUTANEOUS 207475-001 Jul 2, 2018 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eurohlth Intl Sarl AZACITIDINE azacitidine POWDER;INTRAVENOUS, SUBCUTANEOUS 209337-001 Jun 8, 2020 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cipla AZACITIDINE azacitidine POWDER;INTRAVENOUS, SUBCUTANEOUS 209540-001 May 4, 2018 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan Institutional AZACITIDINE azacitidine POWDER;INTRAVENOUS, SUBCUTANEOUS 204949-001 Apr 28, 2016 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Jiangsu Hansoh Pharm AZACITIDINE azacitidine POWDER;INTRAVENOUS, SUBCUTANEOUS 215905-001 Jun 28, 2023 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Shilpa Medicare AZACITIDINE azacitidine POWDER;INTRAVENOUS, SUBCUTANEOUS 207518-001 Sep 29, 2016 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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