AZACITIDINE - Generic Drug Details

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, Hetero Labs Ltd Vi, Jiangsu Hansoh Pharm, Lupin Ltd, Meitheal, Msn Labs Pvt Ltd, Natco Pharma Ltd, Norvium Bioscience, Reliance Life, Shilpa Medicare, Bristol-myers, and Bristol, and is included in eighteen 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. Twenty-two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for AZACITIDINE

International Patents:	100
US Patents:	3
Tradenames:	3
Applicants:	18
NDAs:	18
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	22
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	715
Patent Applications:	7,628
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
Swedish Orphan Biovitrum	PHASE2
Break Through Cancer Foundation	PHASE1
Jacqueline Garcia, MD	PHASE1

See all AZACITIDINE clinical trials

Generic filers with tentative approvals for AZACITIDINE

Applicant	Application No.	Strength	Dosage Form
		300MG	TABLET

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Cipla	AZACITIDINE	azacitidine	POWDER;INTRAVENOUS, SUBCUTANEOUS	209540-001	May 4, 2018	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

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/000978Vidaza 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/005147Azacitidine 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/004984Azacitidine 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

International Patents for AZACITIDINE

Country	Patent Number	Title	Estimated Expiration
Portugal	3692983
Slovenia	3782611
Spain	2893785

Market Dynamics and Financial Trajectory for AZACITIDINE

Last updated: October 25, 2025

Introduction

Azacitidine, a chemical compound marketed under various brand names including Vidaza, is an important therapeutic agent primarily used in the treatment of myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), and other hematologic disorders. Its unique mechanism as a hypomethylating agent has cemented its role in oncology, influencing market trends, competitive landscape, and financial prospects within the pharmaceutical industry. This analysis explores the evolving market dynamics, key drivers, challenges, and revenue trajectories shaping azacitidine’s commercial outlook.

Pharmacological Profile and Therapeutic Indications

Azacitidine functions as a nucleoside metabolic inhibitor, promoting hypomethylation of DNA and RNA, which restores tumor suppressor gene activity and induces cell differentiation in malignant cells[^1]. Approved by regulatory agencies such as the U.S. Food and Drug Administration (FDA) in 2004, azacitidine primarily targets MDS—considered a precursor to AML—and is also approved for AML in specific adult populations.

Its therapeutic niche remains relatively stable owing to limited alternatives for certain hematologic disorders. Generic formulations entered markets globally post-patent expiration, leading to pricing pressures but potential expansion in access and usage—factors influencing its market dynamics.

Market Landscape and Competitive Environment

Key Players

The core incumbent for azacitidine was Celgene Corporation, acquired by Bristol-Myers Squibb (BMS) in 2019, which continued marketing Vidaza. Now, global manufacturers of generic azacitidine—including Teva, Hikma, and others—compete predominantly on price and supply.

Emerging pipeline agents, such as oral formulations like CC-486 (oral azacitidine by Bristol-Myers Squibb), are designed to improve patient adherence and convenience, potentially disrupting traditional injection-based regimens.

Market Penetration & Adoption Trends

While azacitidine remains a cornerstone in MDS and AML management, its adoption rate varies globally. Developed markets exhibit high residual demand, bolstered by established treatment guidelines and recognition of clinical efficacy. Conversely, in emerging markets, growth hinges on generic availability, pricing, and healthcare infrastructure.

The increasing awareness of MDS and AML, improved diagnostic capabilities, and expanding treatment guidelines are key drivers fostering incremental market penetration. The shift toward outpatient administration of oral formulations could further accelerate adoption rates.

Market Drivers Influencing Azacitidine

Unmet Medical Needs

Despite its proven efficacy, azacitidine’s limitations—such as injection administration, side effects including cytopenias, and the need for regular hospital visits—fuel demand for oral alternatives and combination therapies.

Regulatory Progress and Label Expansions

Regulatory approvals for sequenced and combinatorial regimens, such as azacitidine plus venetoclax, have enhanced its utility, contributing to increased market size—especially for elderly AML populations unfit for aggressive chemotherapy[^2].

Pricing and Reimbursement Policies

Price sensitivity influences market dynamics. Patented formulations enjoyed premium pricing, but generic entry led to significant price reductions worldwide, increasing patient access but compressing margins for original developers.

Product Innovation

Oral azacitidine (CC-486) received FDA approval in 2014 for maintenance therapy in AML, with subsequent indications expanding to MDS, promising to improve patient compliance and capture new segments.

Epidemiology and Demographic Trends

Global aging populations predispose to higher MDS and AML incidence rates. The epidemiological shift supports steady demand growth, especially in regions experiencing demographic aging.

Challenges and Market Barriers

Patent Expiry and Generic Competition

Patent expiration has substantially reduced azacitidine’s pricing power in mature markets, leading to increased consumption but lower revenues for original developers.

Pricing Pressures and Healthcare Cost Containment

Healthcare systems worldwide are cost-conscious, pressing for price reductions and value-based pricing models. This influences revenue streams, particularly in value-sensitive markets.

Development of Alternative Therapies

Emerging agents, such as decitabine variants, hypomethylating drugs with oral formulations, and novel targeted therapies (e.g., IDH inhibitors), threaten azacitidine's market share.

Regulatory Hurdles for New Indications

While expanding labels can boost sales, regulatory delays and stringent approval processes pose barriers to rapid market expansion.

Financial Trajectory and Revenue Outlook

Historical Revenue Performance

Azacitidine’s revenues peaked in early 2010s, with global sales reaching approximately $800 million annually pre-generic entry[^3]. Post-patent expiry, revenues declined in mature markets but have stabilised with generics and expanded indications.

Current andProjected Revenues

Estimated global sales for azacitidine are projected to stabilize between $500 million to $700 million annually over the next five years. Growth is anticipated primarily in emerging markets, where pricing controls and supply chains improve access.

Impact of Line Extensions and Formulation Innovation

Oral formulations like CC-486 are poised to create new revenue streams, especially with expanding indications in maintenance therapy and combination regimens. These next-generation products could mitigate revenue declines precipitated by generics.

Potential Growth Catalysts

• Expansion of indications: Broader label approvals in MDS, AML, and other hematologic malignancies.
• Combination therapies: Integration with targeted agents and immunotherapies.
• Oral formulations: Improved patient compliance, reduced hospitalization costs.
• Geographical expansion: Penetration into underserved emerging markets.

Market Trends and Future Outlook

The azacitidine market is poised for gradual growth driven by demographic trends, evolving treatment paradigms, and increasing adoption of oral formulations. Despite pricing pressures, the launch of innovative dosage forms and expanded indications are expected to bolster revenues. However, competition from novel agents and biosimilars, alongside regulatory challenges, will influence long-term viability.

Conclusion

Azacitidine’s market dynamics are characterized by a transition from growth driven by patent protection and limited competition toward a more mature phase where price competition and generic penetration dominate. Financially, the trajectory hinges on innovating formulations, expanding indications, and penetrating emerging markets. The clinical importance of azacitidine and evolving treatment landscapes imply sustained relevance, but success depends on strategic investments in product innovation and market access.

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Key Takeaways

• Market stabilization post-generic entry: Patents expired, leading to lower prices but broader accessibility.
• Growth through innovation: Oral formulations and combination therapies are central to future revenue prospects.
• Demographic influence: Aging populations globally will continue to sustain demand.
• Competitive pressures: Emergence of new agents and biosimilars pose long-term threats.
• Strategic expansion: Focus on new indications and geographies remains critical for maintaining financial trajectory.

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FAQs

Q1: How does the patent expiration impact azacitidine’s market revenue?
Patent expiry introduces generic competition, leading to significant price reductions and a decline in revenue for original developers. However, it also broadens patient access and volume sales, partially offsetting revenue losses.

Q2: What role do oral formulations play in azacitidine’s future market?
Oral formulations like CC-486 are expected to enhance patient adherence, reduce hospitalization costs, and expand indications, potentially driving growth in clinical and commercial adoption.

Q3: Are there any new indications that could significantly alter azacitidine's market outlook?
Yes. FDA approvals for maintenance therapy in AML and expanded use in other hematologic disorders can increase sales and extend product lifecycle.

Q4: How does competition from emerging therapies affect azacitidine?
Emerging therapies, particularly targeted agents and other hypomethylating drugs, may capture market share, especially if they demonstrate superior efficacy, convenience, or tolerability.

Q5: What are the key factors insurers and healthcare systems consider for azacitidine reimbursement?
Cost-effectiveness, clinical efficacy, safety profile, and the availability of alternatives influence reimbursement decisions, impacting market access and revenue.

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References:
[^1]: Issued clinical pharmacology literature, 2022.
[^2]: FDA approval notices, 2020.
[^3]: Industry sales reports, 2018–2022.