azacitidine - Profile

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, Pharmobedient, 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 is one tentative approval for this compound.

Summary for azacitidine

International Patents:	100
US Patents:	3
Tradenames:	3
Applicants:	18
NDAs:	18
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for azacitidine

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.

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
Actavis Llc	AZACITIDINE	azacitidine	POWDER;INTRAVENOUS, SUBCUTANEOUS	208216-001	Apr 29, 2016	AP	RX	No	No
Amneal	AZACITIDINE	azacitidine	POWDER;INTRAVENOUS, SUBCUTANEOUS	211549-001	Feb 3, 2022	AP	RX	No	No
Cipla	AZACITIDINE	azacitidine	POWDER;INTRAVENOUS, SUBCUTANEOUS	209540-001	May 4, 2018	AP	RX	No	No
Dr Reddys	AZACITIDINE	azacitidine	POWDER;INTRAVENOUS, SUBCUTANEOUS	201537-001	Sep 16, 2013	AP	RX	No	No
Eugia Pharma	AZACITIDINE	azacitidine	POWDER;INTRAVENOUS, SUBCUTANEOUS	215066-001	Dec 30, 2022	AP	RX	No	No
Eurohlth Intl Sarl	AZACITIDINE	azacitidine	POWDER;INTRAVENOUS, SUBCUTANEOUS	209337-001	Jun 8, 2020	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/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
betapharm Arzneimittel GmbH	Azacitidine betapharm	azacitidine	EMEA/H/C/005075Azacitidine 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/004761Onureg 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/005300Azacitidine 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
Hungary	E047707
Taiwan	201513869	Oral formulations of cytidine analogs and methods of use thereof
Croatia	P20231439
Costa Rica	11789
Canada	3094580
New Zealand	589437
Canada	3094590

Investment Scenario and Fundamentals Analysis for AZACITIDINE

Last updated: February 19, 2026

What is AZACITIDINE?

AZACITIDINE (marketed as Vidaza) is an approved hypomethylating agent used primarily in treating myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), and other hematologic malignancies. It functions by inhibiting DNA methyltransferase, leading to DNA demethylation and reactivation of tumor suppressor genes.

Market Overview

Therapeutic Indications

• Myelodysplastic syndromes (MDS)
• Acute myeloid leukemia (AML)
• Chronic myelomonocytic leukemia (CMML)

Size and Growth

• The global MDS treatment market was valued at approximately $1.2 billion in 2022.
• The AML drug market exceeds $4.4 billion annually.
• CAGR projections for hematologic malignancies treatments: 8% over the next five years (Research and Markets, 2021).

Key Competitors

Drug	Class	Approximate Market Share (2022)	Status
Azacitidine	Hypomethylating agent	65%	Blockbuster; patent expiry in 2028
Decitabine	Hypomethylating agent	20%	Off-label use in AML
Others	Various	15%	Including experimental drugs

Market Drivers

• Increasing incidence of MDS and AML, particularly in aging populations.
• Favorable reimbursement policies.
• Expanding indications through clinical trials.

Market Challenges

• Patent expiration approaching in 2028, increasing generic competition.
• Treatment complexity and toxicity concerns.
• Competitive pipeline with novel agents (e.g., oral formulations, targeted therapies).

Patent and Regulatory Landscape

• Patent for AZACITIDINE expires in 2028.
• FDA approval granted in 2004; indication expansions in subsequent years.
• Patent litigation and biosimilar development threaten price and market share.

Financial Fundamentals

Sales and Revenue Trends

Year	Estimated Global Sales (USD millions)	Notes
2020	950	Stable, with moderate growth
2021	1,000	Slight increase due to expanded indications
2022	1,150	Growth driven by rising AML and MDS treatment demand

Profitability

• Cost of goods sold (COGS): Low, given manufacturing simplicity.
• Operating expenses: Significant R&D investments for pipeline expansion and comparator trials.
• Margin analysis: Gross margins estimated at 70%-80%.

R&D Pipeline and Line Extensions

• Clinical trials underway for oral azacitidine formulations.
• Combination therapies with targeted agents.
• Trials exploring earlier-line use for AML and MDS.

Investment Risks

• Patent expiry in 2028 may lead to generic erosion.
• Increasing competition and pipeline shifts could reduce market share.
• Regulatory risks associated with expanding indications.
• Potential safety concerns or adverse events impacting usage.

Strategic Considerations

• Licensing agreements and partnerships pivotal for maintaining market share.
• Investing in formulation innovations (e.g., oral delivery) can extend lifecycle.
• Diversification into related hematologic agents offers growth avenues.

Valuation Outlook

• Current valuation largely driven by existing sales and pipeline prospects.
• Anticipated revenue plateau post-2028 absent patent extensions or new indications.
• Equity risk increases approaching patent expiry, favoring licensing or divestment strategies.

Key Takeaways

• AZACITIDINE remains a leading treatment for MDS/AML, with stable sales and a solid market position.
• Patent expiry in 2028 creates near-term risk of revenue erosion.
• The outlook depends on pipeline success, pipeline diversification, and patent strategy.
• Industry trends favor oral and combo formulations to extend market relevance.
• Competitive landscape intensifies, emphasizing the need for innovation.

FAQs

1. What is the primary clinical application of AZACITIDINE?
It treats myelodysplastic syndromes and acute myeloid leukemia by reactivating silenced tumor suppressor genes through DNA hypomethylation.

2. When does the AZACITIDINE patent expire?
Patents are expected to expire in 2028, exposing the drug to generic competition.

3. How significant is the market for AZACITIDINE?
The drug accounts for around 65% of hypomethylating agent sales in hematologic malignancies, with global sales over $1 billion in 2022.

4. What are the main risks to investment?
Patent expiration, competition from new therapies, pipeline failure, and regulatory hurdles.

5. What strategies could extend AZACITIDINE’s commercial life?
Developing oral formulations, combining with targeted therapies, and securing new indications.

References

1. Research and Markets. (2021). Hematologic Malignancies Market. Retrieved from https://www.researchandmarkets.com
2. Company reports and filings (e.g., Celgene/Bristol-Myers Squibb). Various annual and quarterly reports.
3. GlobalData. (2022). Hematology Market Analysis.
4. FDA Database. (2023). AZACITIDINE approval and patent data.

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