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Last Updated: March 16, 2025

Azacitidine - Generic Drug Details


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What are the generic 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. Seventeen suppliers are listed for this compound.

Drug Prices for azacitidine

See drug prices for azacitidine

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

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Bristol-myers VIDAZA azacitidine POWDER;INTRAVENOUS, SUBCUTANEOUS 050794-001 May 19, 2004 AP RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Bristol ONUREG azacitidine TABLET;ORAL 214120-001 Sep 1, 2020 RX Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Bristol ONUREG azacitidine TABLET;ORAL 214120-001 Sep 1, 2020 RX Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Eugia Pharma AZACITIDINE azacitidine POWDER;INTRAVENOUS, SUBCUTANEOUS 215066-001 Dec 30, 2022 AP RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 4 of 4 entries

EU/EMA Drug Approvals for azacitidine

CompanyDrugnameInnProduct Number / IndicationStatusGenericBiosimilarOrphanMarketing AuthorisationMarketing 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
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
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
>Company>Drugname>Inn>Product Number / Indication>Status>Generic>Biosimilar>Orphan>Marketing Authorisation>Marketing Refusal
Showing 1 to 4 of 4 entries

International Patents for azacitidine

CountryPatent NumberTitleEstimated Expiration
Denmark 3782612 ⤷  Try for Free
European Patent Office 4327888 FORMULATIONS ORALES D'ANALOGUES DE CYTIDINE ET LEURS PROCÉDÉS D'UTILISATION (ORAL FORMULATIONS OF CYTIDINE ANALOGS AND METHODS OF USE THEREOF) ⤷  Try for Free
Israel 209307 ⤷  Try for Free
New Zealand 589437 IMMEDIATE RELEASE TABLET COMPRISING 5-AZACYTIDINE AND A NON-ENTERIC COATING APPLIED WITH AN ETHANOL SOLVENT ⤷  Try for Free
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 4 of 4 entries

Market Dynamics and Financial Trajectory for Azacitidine

Introduction to Azacitidine

Azacitidine is a demethylation agent used primarily in the treatment of myelodysplastic syndromes (MDS) and certain types of leukemia, such as chronic myelomonocytic leukemia (CMML). It works by reactivating silenced genes, thereby promoting normal cell function.

Global Market Size and Growth

The global azacitidine market is projected to experience significant growth over the coming years. As of 2024, the market size is estimated to be USD 81.5 million, with a forecasted expansion to USD 139.68 million by 2031, driven by a Compound Annual Growth Rate (CAGR) of 8.00% from 2024 to 2031[1].

Regional Market Dynamics

North America

North America currently dominates the azacitidine market, driven by the high prevalence of MDS and other blood diseases, advanced healthcare infrastructure, and significant investments in cancer research. The region's market size in 2024 is estimated at USD 32.6 million, with a CAGR of 6.2% from 2024 to 2031[1].

Asia-Pacific

The Asia-Pacific region is expected to exhibit the highest CAGR of 10% during the forecast period. This growth is attributed to the increasing prevalence of blood-related diseases, improvements in healthcare infrastructure, and greater awareness of early cancer diagnosis and treatment in countries like China, India, and Japan. The market size in this region was USD 18.75 million in 2024[1].

Europe

Europe also holds a significant share of the azacitidine market. Countries like Spain, Italy, and Russia contribute to the regional growth, with market sizes and CAGRs varying by country. For instance, Spain's market size in 2024 was USD 2 million, with a CAGR of 5.6% from 2024 to 2031[1].

Latin America and Middle East & Africa

These regions have smaller but growing markets. Latin America's market size was USD 4.08 million in 2024, with a CAGR of 7.4%, while the Middle East and Africa had a market size of USD 1.63 million in 2024, with a CAGR of 7.7% from 2024 to 2031[1].

Key Drivers of Market Growth

Increasing Prevalence of Chronic Diseases

The rise in the number of people suffering from chronic diseases such as MDS, CMML, breast cancer, and melanoma is a primary driver of the azacitidine market. These conditions require effective treatments, and azacitidine's efficacy in these areas contributes to its growing demand[1][3].

Advancements in Healthcare Infrastructure

Improvements in healthcare infrastructure, particularly in the Asia-Pacific region, enhance the accessibility and availability of azacitidine-based treatments. This infrastructure development includes better diagnostic facilities and increased awareness of early cancer diagnosis and treatment[1].

Recommendations by Medical Professionals

Increased recommendations by medical professionals for azacitidine as a treatment option for various blood-related diseases also boost market growth. The drug's inclusion in treatment protocols by healthcare providers is a significant factor in its expanding market share[3].

Market Players and Competitive Landscape

The azacitidine market is characterized by the presence of several key players, including Celgene, Mylan, Shilpa Medicare, Accord Healthcare, Natco Pharma, and Dr. Reddy's Laboratories. These companies are involved in the development and distribution of both branded (Vidaza®) and generic versions of azacitidine[4].

Financial Performance and Projections

Revenue Projections

The global azacitidine market is expected to reach USD 142.41 million by 2030, growing at a CAGR of 7.9% from 2023 to 2030, according to Data Bridge Market Research. Another forecast suggests the market will reach USD 112.4 million by 2030, with a CAGR of 3.4% from 2024 to 2030[3][4].

Regional Revenue Breakdown

  • North America: USD 32.6 million in 2024, growing at a CAGR of 6.2%[1].
  • Asia-Pacific: USD 18.75 million in 2024, growing at a CAGR of 10%[1].
  • Latin America: USD 4.08 million in 2024, growing at a CAGR of 7.4%[1].
  • Middle East & Africa: USD 1.63 million in 2024, growing at a CAGR of 7.7%[1].

Challenges and Opportunities

Regulatory Framework

The regulatory environment plays a crucial role in the azacitidine market. Strict regulations and the need for continuous compliance can pose challenges, but they also ensure the quality and safety of the drug, which is essential for maintaining market trust[3].

Pipeline Analysis and New Developments

The development of new drugs and therapies by major market players is an opportunity for growth. Continuous research and innovation in the field of demethylation agents can lead to more effective treatments and expand the market further[3].

Patient Epidemiology and Pricing Analysis

Understanding patient epidemiology is critical for market growth. The increasing prevalence of target diseases and the pricing strategies of pharmaceutical companies influence the demand and affordability of azacitidine. Pricing analysis helps in understanding the competitive landscape and in setting market-friendly prices[3].

Key Takeaways

  • The global azacitidine market is projected to grow significantly, driven by increasing prevalence of chronic diseases and advancements in healthcare infrastructure.
  • North America and Asia-Pacific are key regions driving market growth.
  • Major pharmaceutical companies play a crucial role in the market through the development and distribution of azacitidine.
  • Regulatory compliance and continuous innovation are essential for market expansion.

FAQs

What is the current global market size of azacitidine?

The global azacitidine market size was estimated at USD 81.5 million in 2024[1].

What is the projected growth rate of the azacitidine market from 2024 to 2031?

The azacitidine market is expected to grow at a Compound Annual Growth Rate (CAGR) of 8.00% from 2024 to 2031[1].

Which region dominates the azacitidine market?

North America currently dominates the azacitidine market, driven by the high prevalence of MDS and other blood diseases, advanced healthcare infrastructure, and significant investments in cancer research[1].

What are the key drivers of the azacitidine market growth?

Key drivers include the increasing prevalence of chronic diseases, advancements in healthcare infrastructure, and recommendations by medical professionals[1][3].

Who are the major players in the azacitidine market?

Major players include Celgene, Mylan, Shilpa Medicare, Accord Healthcare, Natco Pharma, and Dr. Reddy's Laboratories[4].

Cited Sources:

  1. Cognitive Market Research: Global Azacitidine Market Report 2024.
  2. Biospace: ImmunoGen Reports Recent Progress and First Quarter 2023 Financial Results.
  3. Data Bridge Market Research: Global Azacitidine Market – Industry Trends and Forecast to 2030.
  4. Valuates Reports: Global Azacitidine Drug Market Research Report 2024.
  5. Faron Pharmaceuticals Ltd.: 2023 Half-Year Financial Results.

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