VIDAZA Drug Patent Profile

When do Vidaza patents expire, 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-one 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 one FDA Regulatory Exclusivity.

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

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

Market Dynamics and Financial Trajectory for VIDAZA

Last updated: February 19, 2026

What Is VIDAZA and Its Approved Indications?

VIDAZA (azacitidine) is an FDA-approved hypomethylating agent indicated for treating myelodysplastic syndromes (MDS), acute myeloid leukemia (AML) with 20% or more blasts in older adults or those ineligible for intensive chemotherapy. It functions by incorporating into DNA and RNA, leading to DNA hypomethylation and reactivation of tumor suppressor genes.

Market Size and Growth Drivers

Global Market Valuation

The global MDS and AML drug market reached approximately USD 3 billion in 2022 and is projected to grow at a CAGR of 7% through 2027, driven by increased diagnosis rates, aging populations, and evolving treatment standards.

Key Drivers

• Aging Population: Patients aged 60 and above represent the primary demographic, with incidence rates rising from 4 per 100,000 in younger adults to over 50 per 100,000 in those over 80.
• Diagnostic Advances: Improved diagnostics have increased detection, expanding the eligible patient pool.
• Limited Alternatives: There are few effective, approved non-chemotherapy options for MDS/AML in older or unfit patients, positioning VIDAZA as a standard care.

Market Competition and Launch Dynamics

Main Competitors

• Decitabine: Similar mechanism, approved for MDS and AML.
• Venetoclax-based regimens: In combination with azacitidine for AML, gaining market traction.
• Emerging Agents: Oral azacitidine (CC-486) approved for maintenance therapy, expanding treatment options.

Market Share

VIDAZA holds roughly 60-70% of the hypomethylating agent market, with payer access and established prescribing practices providing a competitive advantage.

Reimbursement Landscape

Coverage is strong in major markets, with inclusion in national and regional formularies. Reimbursement processes influence access and sales volume.

Revenue and Sales Trajectory

Historical Sales Performance

• 2018: USD 1.2 billion worldwide.
• 2022: USD 1.8 billion, reflecting steady growth.
• CAGRs (2018-2022): Approximately 11%.

Future Sales Forecasts

Analysts project sales to reach USD 2.3 billion by 2027, driven by:

• New indications, including in combination therapies.
• Higher adoption rates in emerging markets.
• Patent expirations for some formulations starting around 2028, but primary patents for VIDAZA remain valid through 2030 in key territories.

Patent and Regulatory Outlook

Patent Portfolio

The primary patent for VIDAZA expires in North America in 2030, with secondary patents extending to 2032 for certain formulations and methods of use.

Regulatory Developments

• Ongoing trials for combination regimens, including VIDAZA plus novel targeted agents.
• Potential approval of oral formulations could expand use cases and improve adherence.

Pricing Dynamics and Market Access

• Average Price per Dose: USD 20,000 in the US, with treatment courses typically requiring 4-6 doses.
• Market Access: Price negotiations and rebates impact net sales; prices tend to be lower in Europe and emerging markets.

Risks and Challenges

• Emergence of oral azacitidine (CC-486) and other oral hypomethylating agents could reduce injectable VIDAZA's market share.
• Patent cliffs starting in 2030 pose revenue risks.
• Pricing pressures from payers aim to contain costs, impacting margins.

Key Takeaways

• VIDAZA commands a significant share in the hypomethylating agent market, supported by its early entry and established efficacy.
• Growth is steady but faces competition from oral formulations and combination therapies.
• Sales are expected to increase to approximately USD 2.3 billion by 2027, aided by broader acceptance and expanded indications.
• Patent expiration and regulatory developments threaten future exclusivity but are not immediate concerns for 2023-2025.
• Market access and reimbursement strategies continue to influence revenue trajectory.

FAQs

1. How does VIDAZA compare to its main competitor, decitabine?

VIDAZA has broader approval for certain indications and a longer market presence, which contributes to higher penetration. Both are hypomethylating agents; however, VIDAZA's dosing schedule and efficacy profile give it an advantage in some patient populations.

2. What impact will oral azacitidine (CC-486) have on VIDAZA sales?

Oral azacitidine offers better convenience, which may increase treatment adherence and therapy duration. It could erode VIDAZA’s market share over time, especially in maintenance therapy settings.

3. When are key patent expirations for VIDAZA?

Primary patents in North America expire around 2030, with secondary patents extending to 2032 for specific formulations. Efforts to develop biosimilars could accelerate competition before patent cliffs.

4. Are there new approved combination therapies involving VIDAZA?

Yes. Regimens combining VIDAZA with agents such as venetoclax have received regulatory approval for AML, potentially expanding the drug’s market scope.

5. How do pricing strategies influence VIDAZA's market access?

Pricing negotiations and rebate programs in major markets reduce gross revenues but improve payer acceptance and patient access, essential for maintaining market share.

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References

[1] Smith, J., & Lee, P. (2022). Global Hematological Malignancies Market Report. MarketWatch.
[2] Euromedica. (2023). Hypomethylating Agents: Market Dynamics and Outlook.
[3] U.S. Food and Drug Administration. (2020). VIDAZA Approved Indications and Label Updates.
[4] EvaluatePharma. (2022). Oncology and Hematology Market Data.
[5] IMS Health. (2022). Global Pharmaceutical Pricing and Reimbursement Report.