ONUREG Drug Patent Profile

When do Onureg patents expire, and when can generic versions of Onureg launch?

Onureg is a drug marketed by Bristol and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred patent family members in thirty-five countries.

The generic ingredient in ONUREG 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 Onureg

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

Summary for ONUREG

International Patents:	100
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	124
Clinical Trials:	39
Patent Applications:	578
Drug Prices:	Drug price information for ONUREG
What excipients (inactive ingredients) are in ONUREG?	ONUREG excipients list
DailyMed Link:	ONUREG at DailyMed

See drug prices for ONUREG

Recent Clinical Trials for ONUREG

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

Sponsor	Phase
Acute Leukemia French Association	Phase 2
French Innovative Leukemia Organisation	Phase 2
Bristol-Myers Squibb	Phase 2

See all ONUREG clinical trials

Pharmacology for ONUREG

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

Paragraph IV (Patent) Challenges for ONUREG

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 ONUREG

ONUREG is protected by three 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	ONUREG	azacitidine	TABLET;ORAL	214120-001	Sep 1, 2020		RX	Yes	No	8,846,628		Y
Bristol	ONUREG	azacitidine	TABLET;ORAL	214120-002	Sep 1, 2020		RX	Yes	Yes	11,571,436		Y
Bristol	ONUREG	azacitidine	TABLET;ORAL	214120-001	Sep 1, 2020		RX	Yes	No
Bristol	ONUREG	azacitidine	TABLET;ORAL	214120-002	Sep 1, 2020		RX	Yes	Yes
Bristol	ONUREG	azacitidine	TABLET;ORAL	214120-001	Sep 1, 2020		RX	Yes	No	12,053,482
Bristol	ONUREG	azacitidine	TABLET;ORAL	214120-001	Sep 1, 2020		RX	Yes	No	11,571,436		Y

EU/EMA Drug Approvals for ONUREG

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
Celgene Europe BV	Azacitidine Celgene	azacitidine	EMEA/H/C/005300 Azacitidine 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 ONUREG

See the table below for patents covering ONUREG around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	PI0912717	COMPOSIÇÃO FARMACÊUTICA, E, USO DE 5-AZACITIDINA
Russian Federation	2765076	ПЕРОРАЛЬНЫЕ СОСТАВЫ, СОДЕРЖАЩИЕ АНАЛОГИ ЦИТИДИНА, И СПОСОБЫ ИХ ИСПОЛЬЗОВАНИЯ (ORAL COMPOUNDS CONTAINING CYTIDINE ANALOGUES AND METHODS FOR USE THEREOF)
Cyprus	1121350
Hungary	E047707
Hungary	E059635
European Patent Office	3782611	FORMULATIONS ORALES D'ANALOGUES DE CYTIDINE ET LEURS PROCÉDÉS D'UTILISATION (ORAL FORMULATIONS OF CYTIDINE ANALOGS AND METHODS OF USE THEREOF)

ONUREG Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Onureg

Introduction to Onureg

Onureg, also known as azacitidine, is a medication used in the treatment of certain types of blood and bone marrow cancers, notably Acute Myeloid Leukemia (AML) and other myelodysplastic syndromes. Here, we will delve into the market dynamics and financial trajectory of Onureg.

Market Need and Unmet Needs

Onureg addresses a significant unmet need in the treatment of AML, particularly for patients whose disease is under control but for whom a stem cell transplant is not feasible. AML is a aggressive form of blood cancer that leads to fewer mature blood cells, resulting in symptoms such as weakness, infection, and bleeding[3].

Regulatory Approvals

Onureg has received regulatory approvals in several regions. In the European Union, it was granted a marketing authorization on June 17, 2021, for the maintenance therapy of adult patients with AML who have achieved complete remission or complete remission with incomplete hematologic recovery following induction therapy[4].

Clinical Benefits and Side Effects

The clinical benefits of Onureg include a significant improvement in survival for patients with AML. However, the treatment is associated with side effects, primarily gastrointestinal toxicities and myelosuppression, which can be managed through dose adjustments and best supportive care[3][4].

Cost-Effectiveness and Pricing

The cost-effectiveness of Onureg is a critical factor in its market dynamics. In Canada, for instance, Onureg was not considered cost-effective at a willingness-to-pay threshold of $50,000 per quality-adjusted life-year (QALY) relative to best supportive care. A significant price reduction of at least 85% would be necessary to make it cost-effective at this threshold[3].

Market Size and Growth

The leukemia therapeutics market, which includes Onureg, is expected to grow significantly. The global leukemia therapeutics market is projected to reach $14.16 billion by 2031, growing at a CAGR of 6.1% from 2021 to 2031. This growth is driven by factors such as the rise in prevalence of chronic lymphocytic leukemia, increased adoption of targeted therapies, and improvements in healthcare infrastructure in emerging markets[1].

Regional Market Performance

North America, where Onureg is approved and marketed by Bristol Myers Squibb, is expected to maintain its dominance in the leukemia therapeutics market. The region's well-established healthcare infrastructure, high purchasing power, and the presence of key players like Bristol Myers Squibb contribute to this dominance[1].

However, the Asia-Pacific region is anticipated to witness the highest growth rate during the forecast period. This is due to the growing infrastructure of industries, rise in disposable incomes, and the well-established presence of domestic pharmaceutical companies in countries like China and India[1].

Competitive Landscape

Onureg operates within a competitive landscape that includes several major pharmaceutical companies. Bristol Myers Squibb, the manufacturer of Onureg, has a strong portfolio of innovative medicines, including other oncology treatments like Reblozyl and Breyanzi. The company's strategic approach to capital allocation and its focus on research and development help maintain its competitive edge[2].

Financial Performance

Bristol Myers Squibb has invested significantly in research and development, with $9.5 billion allocated to this area in recent years. The company has also seen substantial cash flow from operating activities and has returned $12.6 billion to shareholders through dividends and stock repurchases. These financial metrics indicate a strong foundation for the company to support the marketing and development of Onureg and other therapeutic products[2].

Recent Developments and Strategies

Bristol Myers Squibb has adopted several strategies to enhance the market position of Onureg. These include product approvals, expansions into new indications, and investments in digital and onsite training to build healthcare capacity, particularly in regions with limited access to oncology care[2].

Key Takeaways

• Regulatory Approvals: Onureg has received marketing authorization in the EU and is used for maintenance therapy in AML patients.
• Clinical Benefits: Onureg offers significant survival benefits but comes with manageable side effects.
• Cost-Effectiveness: The drug requires significant price reductions to be considered cost-effective in some regions.
• Market Growth: The leukemia therapeutics market, including Onureg, is expected to grow substantially by 2031.
• Regional Performance: North America dominates the market, but Asia-Pacific is expected to grow at the highest rate.
• Competitive Landscape: Onureg competes in a market with several major pharmaceutical players, with Bristol Myers Squibb maintaining a strong position through innovation and strategic investments.

FAQs

1. What is Onureg used for? Onureg (azacitidine) is used for the maintenance therapy of adult patients with Acute Myeloid Leukemia (AML) who have achieved complete remission or complete remission with incomplete hematologic recovery following induction therapy[4].

2. What are the common side effects of Onureg? Common side effects include gastrointestinal toxicities such as nausea, vomiting, and diarrhea, as well as myelosuppression. These side effects can be managed through dose adjustments and best supportive care[3][4].

3. Is Onureg cost-effective? In some regions, Onureg is not considered cost-effective at current prices. For example, in Canada, a price reduction of at least 85% would be necessary to make it cost-effective at a willingness-to-pay threshold of $50,000 per QALY[3].

4. Who manufactures Onureg? Onureg is manufactured by Bristol Myers Squibb, a leading biopharmaceutical company[2].

5. What is the expected growth of the leukemia therapeutics market? The global leukemia therapeutics market, which includes Onureg, is expected to reach $14.16 billion by 2031, growing at a CAGR of 6.1% from 2021 to 2031[1].

Sources

1. Allied Market Research - Leukemia Therapeutics Market Statistics and Forecast- 2031
2. Bristol Myers Squibb - 2022 ESG Report
3. CADTH - Azacitidine (Onureg) - Canada's Drug Agency
4. European Medicines Agency - Onureg
5. Bristol Myers Squibb - J.P. Morgan 2021 Presentation