CEDAZURIDINE; DECITABINE - Generic Drug Details

What are the generic drug sources for cedazuridine; decitabine and what is the scope of freedom to operate?

Cedazuridine; decitabine is the generic ingredient in one branded drug marketed by Otsuka and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cedazuridine; decitabine has sixty-two patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for CEDAZURIDINE; DECITABINE

International Patents:	62
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	40
DailyMed Link:	CEDAZURIDINE; DECITABINE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CEDAZURIDINE; DECITABINE

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for CEDAZURIDINE; DECITABINE

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

Sponsor	Phase
Pamela Munster	Phase 1
Otsuka Australia Pharmaceutical Pty Ltd	Phase 3
Taiho Oncology, Inc.	Phase 2

See all CEDAZURIDINE; DECITABINE clinical trials

Pharmacology for CEDAZURIDINE; DECITABINE

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

Anatomical Therapeutic Chemical (ATC) Classes for CEDAZURIDINE; DECITABINE

L01BC	Pyrimidine analogues
L01B	ANTIMETABOLITES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for CEDAZURIDINE; DECITABINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Otsuka	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576-001	Jul 7, 2020		RX	Yes	Yes				Y
Otsuka	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576-001	Jul 7, 2020		RX	Yes	Yes				Y
Otsuka	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576-001	Jul 7, 2020		RX	Yes	Yes
Otsuka	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576-001	Jul 7, 2020		RX	Yes	Yes
Otsuka	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576-001	Jul 7, 2020		RX	Yes	Yes			Y
Otsuka	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576-001	Jul 7, 2020		RX	Yes	Yes

International Patents for CEDAZURIDINE; DECITABINE

Country	Patent Number	Title	Estimated Expiration
Japan	2023518162	デシタビンとセダズリジンとの組み合わせの固形経口剤形
Montenegro	00997	2'-FLUOR-2 ' -DEOKSITETRAHIDROURIDINI KAO INHIBITORI CITIDIN DEAMINAZE (2 ' -FLU0R0-2 ' -DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS)
Malaysia	147970	2'-FLUORO-2'DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS
Finland	C20230040
Poland	2207786
Hungary	S2300045
Australia	2008312435	2 ' -flu0r0-2 ' -deoxytetrahydrouridines as cytidine deaminase inhibitors

Supplementary Protection Certificates for CEDAZURIDINE; DECITABINE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2207786	CR 2023 00038	Denmark		PRODUCT NAME: SAMMENSAETNING OMFATTENDE CEDAZURIDIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; OG DECITABIN; REG. NO/DATE: EU/1/23/1756 20230918
2207786	122023000069	Germany		PRODUCT NAME: ZUSAMMENSETZUNG UMFASSEND: CEDAZURIDIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; UND DECITABIN; REGISTRATION NO/DATE: EU/1/23/1756 20230915
2207786	CA 2023 00037	Denmark		PRODUCT NAME: CEDAZURIDIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/23/1756 20230918
2207786	2023C/550	Belgium		PRODUCT NAME: CEDAZURIDINE, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/23/1756 20230918
2207786	2023C/551	Belgium		PRODUCT NAME: UNE COMPOSITION COMPRENANT : DE LA CEDAZURIDINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ; ET LA DECITABINE; AUTHORISATION NUMBER AND DATE: EU/1/23/1756 20230918
2207786	CA 2023 00038	Denmark		PRODUCT NAME: SAMMENSAETNING OMFATTENDE CEDAZURIDIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; OG DECITABIN; REG. NO/DATE: EU/1/23/1756 20230918
2207786	LUC00327	Luxembourg		PRODUCT NAME: CEDAZURIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/23/1756 20230918

CEDAZURIDINE; DECITABINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cedazuridine and Decitabine

Introduction

The combination of cedazuridine and decitabine, marketed as Inqovi, has marked a significant milestone in the treatment of hematological malignancies, particularly acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). This article delves into the market dynamics and financial trajectory of this oral fixed-dose combination, highlighting its regulatory approvals, clinical efficacy, cost-effectiveness, and market impact.

Regulatory Approvals

European Commission Approval

In September 2023, the European Commission approved oral decitabine and cedazuridine (Inqovi) for the treatment of adult patients with newly diagnosed AML who are not candidates for standard induction chemotherapy. This approval was based on data from the Phase 3 ASCERTAIN trial, which demonstrated pharmacokinetic exposure equivalence to intravenous decitabine[3].

FDA Approval

The U.S. Food and Drug Administration (FDA) approved Inqovi in July 2020 for the treatment of adult patients with MDS. This approval was supported by data from the Phase 1/2 ASTX727-01-B trial and the ASCERTAIN trial[3].

Orphan Drug Designation

In December 2021, the oral decitabine and cedazuridine combination was granted orphan drug designation by the European Commission, which entitles the drug to ten years of market exclusivity once approved in the EU[1].

Clinical Efficacy

ASCERTAIN Trial

The ASCERTAIN trial, a Phase 3 study, was pivotal in securing regulatory approvals. It showed that the oral combination of decitabine and cedazuridine achieved exposure equivalence to a standard 5-day regimen of intravenous decitabine. The trial also demonstrated a comparable safety profile to intravenous decitabine[1][3].

Patient Benefits

The oral formulation offers a more convenient administration regimen compared to traditional intravenous chemotherapy, which can significantly improve patient quality of life. It reduces the need for hospital visits and minimizes the disutility associated with intravenous administration[1][3].

Market Dynamics

Competitive Landscape

The market for hypomethylating agents is competitive, with azacitidine being a key competitor. However, the oral formulation of decitabine and cedazuridine offers a unique advantage in terms of convenience and patient compliance, potentially capturing a significant market share[4].

Patient Population

The drug is targeted at patients with AML and MDS who are not candidates for intensive chemotherapy. This niche but significant patient population presents a substantial market opportunity, especially given the lack of oral alternatives in this therapeutic area[1][3].

Cost-Effectiveness

Pharmacoeconomic Analysis

A pharmacoeconomic report by the Canadian Agency for Drugs and Technologies in Health (CADTH) highlighted the complexity of assessing the cost-effectiveness of decitabine and cedazuridine. While the drug may offer a small quality-adjusted life year (QALY) benefit due to reduced administration costs and disutility, its cost-effectiveness is highly sensitive to assumptions about treatment effects and costs compared to azacitidine[4].

Budget Impact Analysis

The introduction of decitabine and cedazuridine is estimated to have a mixed impact on drug plan budgets. CADTH reanalyses suggested an increase in drug plan budgets over the first three years, although the sponsor's analysis indicated potential cost savings[4].

Financial Trajectory

Revenue Potential

Given the regulatory approvals and the unique selling proposition of an oral formulation, the revenue potential for Inqovi is significant. The drug's market exclusivity in the EU and its approval in key markets like the U.S. and Europe position it for substantial revenue growth.

Pricing Strategy

The pricing strategy will be crucial in determining the drug's financial trajectory. A price reduction of over 15% may be necessary to make the drug cost-effective compared to azacitidine, according to some analyses[4].

Market Impact

Patient Access

The approval and availability of Inqovi are expected to improve patient access to hypomethylating agents, particularly for those who cannot tolerate or access intravenous treatments. This could lead to better health outcomes and improved quality of life for these patients.

Healthcare System Benefits

The convenience of oral administration can reduce healthcare system costs associated with hospital visits and intravenous chemotherapy administration. This shift could also alleviate some of the burden on healthcare resources.

Key Takeaways

• Regulatory Approvals: Inqovi has received approvals from the European Commission and FDA, marking a significant milestone in the treatment of AML and MDS.
• Clinical Efficacy: The ASCERTAIN trial demonstrated exposure equivalence and a comparable safety profile to intravenous decitabine.
• Market Dynamics: The oral formulation offers a unique advantage in terms of convenience, potentially capturing a significant market share.
• Cost-Effectiveness: The drug's cost-effectiveness is sensitive to assumptions about treatment effects and costs compared to azacitidine.
• Financial Trajectory: The revenue potential is significant, but pricing strategy will be crucial in determining cost-effectiveness and market adoption.

FAQs

Q: What is the primary advantage of the oral decitabine and cedazuridine combination?

A: The primary advantage is the convenience of oral administration, which can improve patient compliance and quality of life compared to intravenous chemotherapy.

Q: Which regulatory bodies have approved Inqovi?

A: Inqovi has been approved by the European Commission and the U.S. Food and Drug Administration (FDA).

Q: What is the significance of the ASCERTAIN trial?

A: The ASCERTAIN trial demonstrated pharmacokinetic exposure equivalence of the oral decitabine and cedazuridine combination to intravenous decitabine, supporting its regulatory approvals.

Q: How does Inqovi compare to azacitidine in terms of cost-effectiveness?

A: The cost-effectiveness of Inqovi compared to azacitidine is highly sensitive to assumptions about treatment effects and costs, with some analyses indicating a need for a price reduction to be considered cost-effective.

Q: What is the impact of Inqovi on healthcare system costs?

A: Inqovi can reduce healthcare system costs associated with hospital visits and intravenous chemotherapy administration, alleviating some of the burden on healthcare resources.

Sources

1. Astex Pharmaceuticals, Inc. - European Medicines Agency commences review of oral fixed-dose combination of decitabine and cedazuridine for the treatment of adults with acute myeloid leukemia.
2. ChemoExperts - Decitabine and Cedazuridine (Inqovi®) - ChemoExperts.
3. Cancer Network - Decitabine/Cedazuridine Earns European Approval in Acute Myeloid Leukemia.
4. CADTH - Pharmacoeconomic Report for decitabine and cedazuridine (Inqovi).
5. Blood Advances - Cedazuridine/decitabine: from preclinical to clinical development in patients with myeloid malignancies.