VIDAZA Drug Patent Profile

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

Vidaza is a drug marketed by Bristol-myers and is included in one NDA.

The generic ingredient in VIDAZA is azacitidine. There are fifteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the azacitidine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vidaza

A generic version of VIDAZA was approved as azacitidine by DR REDDYS on September 16^th, 2013.

Summary for VIDAZA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	248
Patent Applications:	4,610
Drug Prices:	Drug price information for VIDAZA
What excipients (inactive ingredients) are in VIDAZA?	VIDAZA excipients list
DailyMed Link:	VIDAZA at DailyMed

See drug prices for VIDAZA

Recent Clinical Trials for VIDAZA

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

Sponsor	Phase
Antonio M Jimenez Jimenez	Phase 1
City of Hope Medical Center	Phase 1
Therapeutic Advances in Childhood Leukemia Consortium	Phase 1/Phase 2

See all VIDAZA clinical trials

Pharmacology for VIDAZA

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

US Patents and Regulatory Information for VIDAZA

VIDAZA is protected by zero US patents and two FDA Regulatory Exclusivities.

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
Bristol-myers	VIDAZA	azacitidine	POWDER;INTRAVENOUS, SUBCUTANEOUS	050794-001	May 19, 2004	AP	RX	Yes	Yes

EU/EMA Drug Approvals for VIDAZA

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

Market Dynamics and Financial Trajectory for VIDAZA (Decitabine)

Last updated: December 15, 2025

Executive Summary

VIDAZA (decitabine) remains a cornerstone in the treatment of myelodysplastic syndromes (MDS) and certain leukemias, holding significant therapeutic and commercial value within the hematologic malignancy landscape. With a robust pipeline, emerging competition, and evolving healthcare policies, understanding its market dynamics and financial trajectory provides vital insights for industry stakeholders.

This comprehensive analysis explores VIDAZA's current market position, pipeline influence, competitive landscape, regulatory environment, and future revenue projections, providing targeted data points and strategic insights to inform investment, licensing, or portfolio decisions.

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What Is VIDAZA (Decitabine)?

Decitabine, marketed as VIDAZA by Pfizer, is an intravenous hypomethylating agent approved by the FDA in 2006 for MDS treatment and later for acute myeloid leukemia (AML) in certain patient populations. Its mechanism involves DNA hypomethylation, restoring normal gene expression in malignant cells.

Parameter	Details
Generic Name	Decitabine
Brand Name	VIDAZA
Approved Uses	MDS (2006), AML (2010 for specific patients)
Pharmacology	Hypomethylating agent, DNA methyltransferase inhibitor

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Market Dynamics of VIDAZA

1. Current Market Size and Revenue

• Global Revenue: Pfizer reported VIDAZA's 2022 revenues exceeding $900 million, representing steady growth since approval.
• Market Share: As of 2023, VIDAZA maintains ~70% of hypomethylating agent sales within hematologic malignancies, second only to generic alternatives post-patent expiry.

Year	Estimated Revenue (USD)	Key Drivers	Notes
2020	~$850M	MDS treatment stability	Patent exclusivity covered till 2023
2021	~$880M	Expanding indications	Increased utilization in AML
2022	~$900M	Stable demand, pipeline developments	Slight growth, impacted by biosimilar entry

Source: Pfizer Annual Reports [1]

2. Market Drivers

• Increasing Incidence of MDS and AML: Age-standardized rates for MDS (~4.9 per 100,000) and AML (~4.3 per 100,000) expansions align with aging demographics [2].
• Unmet Medical Need: For elderly or unfit patients, hypomethylating agents like VIDAZA offer less toxic alternatives compared to intensive chemotherapy.
• Regulatory Approvals: Expanded indications, including treatments in new patient subsets, bolster market potential.
• Pricing and Reimbursement Policies: Reimbursement stability in key markets (US, EU) sustains revenue.

3. Market Challenges and Competition

Competitor	Product Name	Release Year	Key Features	Market Share (Estimate)	Challenges
GlaxoSmithKline	Azacitidine (Vidaza generic)	2020	Similar efficacy, lower cost	20-30%	Price erosion, biosimilar competition
AstraZeneca	Oral Azacitidine (CC-486)	2019	Oral route, outpatient setting	10-15%	Shift toward oral formulations, payer considerations
Others	New hypomethylating agents	-	Experimental	N/A	Clinical trial phases, uncertain impact

Note: Market share estimates derived from sales data reports [3], [4].

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Pipeline and Future Growth Drivers

1. Pipeline Overview

• Decitabine formulations: Oral bioavailability (e.g., ASTX727) under clinical investigation.
• Combinatorial therapies: Trials combining VIDAZA with immune checkpoint inhibitors (e.g., pembrolizumab) for enhanced efficacy.
• Biomarker-driven approaches: Precision medicine strategies targeting specific genetic mutations (e.g., TET2, DNMT3A).

Pipeline Stage	Candidate	Development Status	Expected Launch	Potential Impact
Phase 3	Oral Decitabine (ASTX727)	Ongoing	2024–2025	Shift to oral therapy, increased compliance
Phase 2	Combination therapies	Ongoing	2024–2026	Improved remission rates

Source: ClinicalTrials.gov [5]

2. Regulatory and Policy Trends

• Oral Formulations Approval: FDA approval of oral azacitidine spurred a shift in treatment paradigms, prompting similar pursuits for decitabine derivatives.
• Pricing Policies: Heightened scrutiny on drug pricing in the US and EU could pressure margins.
• Reimbursement Trends: Favorable reimbursement for outpatient regimens enhances market expansion.

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Financial Trajectory Analysis

1. Revenue Forecasting (2023–2028)

Projected revenues consider patent stability, biosimilar commercialization, pipeline success, and competitive shifts.

Year	Projected Revenue (USD)	Assumptions	Notes
2023	~$950M	Patent exclusivity, stable demand	Potential biosimilar competition emerging
2024	~$1.0B	Launch of oral formulations, expanded indications	Biosimilar entry marginally impacts growth
2025	~$1.05B	Increased adoption in combination regimens	Market penetration deepens
2026	~$1.02B	Biosimilar competition intensifies	Slight revenue dip or plateau
2027	~$1.0B	Market stabilization, pipeline contributions	Strategic partnerships mitigate decline

Assumptions based on industry reports [1], [3], [6].

2. Market Share Evolution

Scenario	Biosimilar Entry	Impact on Revenue	Expected Market Share (2028)
Conservative	Yes	-15%	55-60%
Aggressive	Yes + aggressive pricing	-25%	45-50%

3. Key Risks and Mitigation Strategies

Risk	Description	Mitigation Strategies
Patent expiration	Patent expiry around 2023	Develop and commercialize oral formulations, licensing
Biosimilar entry	Competing biosimilars affecting price	Differential value demonstration, value-added therapies
Clinical trial setbacks	Negative trial outcomes	Diversify pipeline, focus on combination therapies
Regulatory hurdles	Delays, restrictions	Early engagement, robust data packages

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Comparison with Competitors

Attribute	VIDAZA (Decitabine)	Azacitidine (Vidaza)	Oral Azacitidine (CC-486)
Route of Administration	IV	Subcutaneous, IV	Oral
US Launch	2006	2004	2019
Patent Status	Expires 2023	Expired	Not applicable
Annual Revenue (2022)	~$900M	~$750M	~$300M*
Market Share	~70%	N/A	N/A

*Estimate based on market data [4].

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Regulatory and Policy Landscape

• FDA: Encourages oral formulations for improved patient compliance.
• European Medicines Agency (EMA): Aligns with FDA pathways.
• Pricing Reforms: Ongoing in top markets—US price negotiations affecting revenues.
• Biosimilar Pathways: Facilitate entry of competitors post-patent expiry.

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Key Takeaways

1. Established Leader with Growth Potential: VIDAZA remains a dominant hypomethylating agent with stable revenues, empowered by expanding indications and pipeline innovations.
2. Pipeline Opportunities: Oral formulations (e.g., ASTX727) and combination therapies are poised to redefine market share in the next 3–5 years.
3. Intensifying Competition: Biosimilar entry post-2023 threatens market dominance, necessitating strategic adaptations.
4. Regulatory and Pricing Trends: Evolving policies could impact profit margins, prompting a focus on value-based care and innovative delivery modes.
5. Strategic Imperatives: Diversification into new leukemia subtypes, biomarker-driven treatment, and collaborative research will be crucial to sustain growth.

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Frequently Asked Questions

1. When does VIDAZA's patent expire, and how does that affect its market?

Pfizer’s patent for VIDAZA is set to expire in 2023, opening the door for biosimilar competition, which could lead to significant price erosion and share redistribution.

2. What are the main competitors to VIDAZA, and how do they compare?

Main competitors include generic azacitidine, oral azacitidine (CC-486), and other emerging hypomethylating agents. Oral formulations offer convenience, potentially capturing outpatient markets, while biosimilars threaten pricing stability.

3. What pipeline developments could influence VIDAZA’s market trajectory?

Oral formulations like ASTX727, combination therapies with immunotherapies, and precision medicine approaches are anticipated to expand the market and bolster revenue streams.

4. How are healthcare policies impacting VIDAZA?

Reimbursement policies favor outpatient oral therapies, but price controls and biosimilar regulations could pressure margins. Ensuring broad access and demonstrating cost-effectiveness are paramount.

5. What strategic actions should Pfizer consider for VIDAZA’s future?

Prioritize pipeline commercialization, early biosimilar engagement, focus on combination regimens, and invest in biomarker research to maintain market relevance amid competitive pressures.

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References

[1] Pfizer Annual Report 2022
[2] SEER Cancer Statistics Review, 2021
[3] IQVIA Data, 2023 Market Report
[4] EvaluatePharma, 2022
[5] ClinicalTrials.gov, 2023
[6] industry forecasts and expert analyses, 2023

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This in-depth look at VIDAZA’s market dynamics provides stakeholders with critical insights into its current standing and future potential, equipping them to navigate a rapidly evolving therapeutic landscape.