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. Eighteen 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:	2
Raw Ingredient (Bulk) Api Vendors:	124
Clinical Trials:	248
Patent Applications:	4,330
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/000978 Vidaza 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/005147 Azacitidine 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/004984 Azacitidine 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/005075 Azacitidine 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/004761 Onureg 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

VIDAZA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for VIDAZA (Azacitidine)

Introduction to VIDAZA (Azacitidine)

VIDAZA, also known as azacitidine, is a demethylation agent used in the treatment of various hematological malignancies, including myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), and chronic myelomonocytic leukemia (CMML). Here, we will delve into the market dynamics and financial trajectory of VIDAZA.

Market Size and Growth Projections

The global azacitidine market, which includes VIDAZA, is experiencing significant growth. As of 2022, the market size was valued at USD 77.51 million and is projected to reach USD 142.41 million by 2030, growing at a compound annual growth rate (CAGR) of 7.9% during the forecast period from 2023 to 2030[1].

Another report indicates that the global azacitidine market size will be USD 81.5 million in 2024 and is expected to expand at a CAGR of 8% from 2024 to 2031[3].

Key Drivers of Market Growth

Increasing Prevalence of Chronic Diseases

The rise in the number of people suffering from chronic diseases such as MDS, AML, and CMML is a primary factor boosting the growth of the azacitidine market. These conditions are more prevalent among the elderly, and the global aging population is driving the demand for azacitidine-based treatments[1][3].

Regulatory Approvals and Expanding Indications

The European Commission's approval of VIDAZA for the treatment of elderly patients with AML who are not eligible for hematopoietic stem cell transplantation has significantly expanded its market potential. This approval was based on the AML-001 study, which showed a median overall survival of 10.4 months for patients receiving VIDAZA compared to 6.5 months for those receiving conventional treatment regimens[2].

Advanced Healthcare Infrastructure

Regions like North America, with advanced healthcare infrastructure and significant investments in cancer research, are driving the market growth. The presence of leading pharmaceutical companies in these regions also enhances the availability and use of azacitidine-based medicines[3].

Market Segmentation

The azacitidine market is segmented based on several criteria:

Type

• 99.5%
• <99.5%

Product

• Vidaza
• Generic Vidaza

Application

• Refractory anemia (RA)
• Refractory anemia with excess blasts (RAEB)
• Chronic Myelomonocytic leukemia (CMML)
• Others

Route of Administration

• Injectable
• Oral
• Others

Distribution Channel

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies

End User

• Hospitals
• Homecare
• Specialty Clinics
• Others[1].

Regional Market Analysis

North America

North America currently dominates the azacitidine market, driven by the growing prevalence of MDS and other blood diseases, advanced healthcare infrastructure, and significant investments in cancer research. The U.S. market, in particular, accounts for a substantial share, with a CAGR of 6% from 2024 to 2031[3].

Asia-Pacific

The Asia-Pacific region is expected to experience the highest CAGR during the projected period, driven by rising cancer prevalence, particularly blood-related diseases like MDS. Countries such as China, India, and Japan are seeing increased demand for azacitidine due to improvements in healthcare infrastructure and increased awareness of early cancer diagnosis and treatment[3].

Europe

Europe also holds a significant market share, with countries like the UK, France, and Germany contributing to the growth. The region's CAGR is expected to be around 6.5% from 2024 to 2031[3].

Latin America and Middle East & Africa

These regions, though smaller in market share, are also expected to grow, with Latin America projected to have a CAGR of 7.4% and the Middle East & Africa at 7.7% from 2024 to 2031[3].

Financial Performance and Projections

The financial trajectory of the azacitidine market is robust, with significant revenue growth anticipated. Here are some key financial metrics:

• Global Revenue: Expected to reach USD 142.41 million by 2030 from USD 77.51 million in 2022, growing at a CAGR of 7.9%[1].
• Regional Revenue: North America is expected to generate USD 32.6 million in 2024, with a CAGR of 6.2% from 2024 to 2031. Europe's revenue is projected at USD 24.45 million in 2024, growing at a CAGR of 6.5% during the same period[3].

Competitive Landscape

The market for azacitidine is competitive, with major pharmaceutical companies like Celgene (now part of Bristol Myers Squibb) playing a significant role. The approval of generic versions of Vidaza is also expected to influence market dynamics, offering patients more affordable treatment options[1][3].

Regulatory Framework and Market Protection

The European Commission's approval of Vidaza for new indications has provided extended market protection for an additional year throughout the European Economic Area. This regulatory support is crucial for maintaining market exclusivity and driving revenue growth[2].

Patient Epidemiology and Clinical Benefits

Azacitidine has demonstrated significant clinical benefits, particularly in elderly patients with AML who cannot undergo intensive therapies. The AML-001 study showed a median overall survival of 10.4 months for patients receiving Vidaza, which is a clinically relevant benefit compared to conventional treatment regimens[2].

"Today’s announcement brings hope to patients with AML, particularly the elderly and more frail patients who cannot undergo intensive therapies such as stem cell transplantation," said Hervé Dombret, M.D., Chief, Blood Disease Department (Leukaemia Unit), University Hospital Saint-Louis, AP-HP, Paris, France[2].

Challenges and Opportunities

Challenges

• The market faces challenges such as the potential for generic competition, which could impact the revenue of branded products like Vidaza.
• Patients with renal or hepatic impairment require careful monitoring and dose adjustments, which can be a clinical challenge[5].

Opportunities

• The growing prevalence of hematological malignancies and the aging population present significant opportunities for market growth.
• Expanding indications and regulatory approvals can further enhance the market potential of azacitidine[1][3].

Key Takeaways

• The global azacitidine market is projected to grow significantly, driven by increasing prevalence of chronic diseases and regulatory approvals.
• North America and Asia-Pacific are key regions driving market growth.
• The financial trajectory indicates robust revenue growth, with the market expected to reach USD 142.41 million by 2030.
• Clinical benefits, particularly in elderly patients with AML, are a significant factor in market growth.

FAQs

What is the current market size of the global azacitidine market?

The global azacitidine market size was valued at USD 77.51 million in 2022 and is expected to reach USD 142.41 million by 2030[1].

What are the primary drivers of the azacitidine market growth?

The primary drivers include the increasing prevalence of chronic diseases like MDS and AML, regulatory approvals, and advanced healthcare infrastructure in key regions[1][3].

Which regions are expected to drive the growth of the azacitidine market?

North America and Asia-Pacific are expected to be the key drivers of market growth, with significant contributions from Europe as well[3].

What are the clinical benefits of azacitidine in treating AML?

Azacitidine has demonstrated a median overall survival of 10.4 months in elderly patients with AML who are not eligible for intensive therapies, providing a clinically relevant benefit compared to conventional treatments[2].

How does the regulatory framework impact the azacitidine market?

Regulatory approvals and extended market protection provide significant support to the market, ensuring exclusivity and driving revenue growth[2].

What are the potential challenges facing the azacitidine market?

The market faces challenges such as generic competition and the need for careful monitoring and dose adjustments in patients with renal or hepatic impairment[1][5].

Sources

1. Data Bridge Market Research: Global Azacitidine Market – Industry Trends and Forecast to 2030.
2. European Pharmaceutical Review: EC approves Vidaza as a new treatment for elderly patients with AML.
3. Cognitive Market Research: Azacitidine Market Report.
4. Grand View Research: Myelodysplastic Syndrome Drugs Market Size Report, 2030.
5. Bristol Myers Squibb: VIDAZA Product Monograph.