AZACITIDINE Drug Patent Profile

Which patents cover Azacitidine, and what generic alternatives are available?

Azacitidine is a drug 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, and Shilpa Medicare. and is included in sixteen NDAs.

The generic ingredient in AZACITIDINE is azacitidine. There are fifteen drug master file entries for this compound. Twenty-one 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 16^th, 2013.

Summary for AZACITIDINE

US Patents:	0
Applicants:	16
NDAs:	16
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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
Eurohlth Intl Sarl	AZACITIDINE	azacitidine	POWDER;INTRAVENOUS, SUBCUTANEOUS	209337-001	Jun 8, 2020	AP	RX	No	No
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
Hetero Labs Ltd Vi	AZACITIDINE	azacitidine	POWDER;INTRAVENOUS, SUBCUTANEOUS	215765-001	Oct 15, 2024	AP	RX	No	No
Shilpa Medicare	AZACITIDINE	azacitidine	POWDER;INTRAVENOUS, SUBCUTANEOUS	207518-001	Sep 29, 2016	AP	RX	No	No

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.