Azacitidine - Generic Drug Details

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.

Summary for azacitidine

International Patents:	100
US Patents:	3
Tradenames:	3
Applicants:	17
NDAs:	17
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	123
Clinical Trials:	603
Patent Applications:	7,120
Drug Prices:	Drug price trends for azacitidine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for azacitidine
What excipients (inactive ingredients) are in azacitidine?	azacitidine excipients list
DailyMed Link:	azacitidine at DailyMed

See drug prices for azacitidine

Recent Clinical Trials for azacitidine

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

Sponsor	Phase
Antonio M Jimenez Jimenez	Phase 1
Syndax Pharmaceuticals	Phase 1
Akeso	Phase 2

See all azacitidine clinical trials

Pharmacology for azacitidine

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

Medical Subject Heading (MeSH) Categories for azacitidine

Antimetabolites, Antineoplastic

Enzyme Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for azacitidine

L01BC	Pyrimidine analogues
L01B	ANTIMETABOLITES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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-myers	VIDAZA	azacitidine	POWDER;INTRAVENOUS, SUBCUTANEOUS	050794-001	May 19, 2004	AP	RX	Yes	Yes
Actavis Llc	AZACITIDINE	azacitidine	POWDER;INTRAVENOUS, SUBCUTANEOUS	208216-001	Apr 29, 2016	AP	RX	No	No
Msn Labs Pvt Ltd	AZACITIDINE	azacitidine	POWDER;INTRAVENOUS, SUBCUTANEOUS	212580-001	May 16, 2024	AP	RX	No	No
Bristol	ONUREG	azacitidine	TABLET;ORAL	214120-001	Sep 1, 2020		RX	Yes	No	11,571,436		Y
Bristol	ONUREG	azacitidine	TABLET;ORAL	214120-001	Sep 1, 2020		RX	Yes	No	12,053,482
Bristol	ONUREG	azacitidine	TABLET;ORAL	214120-001	Sep 1, 2020		RX	Yes	No
Eugia Pharma	AZACITIDINE	azacitidine	POWDER;INTRAVENOUS, SUBCUTANEOUS	215066-001	Dec 30, 2022	AP	RX	No	No

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
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
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
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

International Patents for azacitidine

Country	Patent Number	Title	Estimated Expiration
Australia	2015202884
Denmark	3782612
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)
European Patent Office	2299984
Israel	209307
New Zealand	589437	IMMEDIATE RELEASE TABLET COMPRISING 5-AZACYTIDINE AND A NON-ENTERIC COATING APPLIED WITH AN ETHANOL SOLVENT
Slovenia	2299984

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.