DECITABINE - Generic Drug Details

What are the generic drug sources for decitabine and what is the scope of patent protection?

Decitabine is the generic ingredient in two branded drugs marketed by Otsuka, Accord Hlthcare, Chemi Spa, Cipla, Dr Reddys, Eugia Pharma, Gland, Hetero Labs Ltd Vi, Jiangsu Hansoh Pharm, Lupin Ltd, Meitheal, MSN, Nivagen Pharms Inc, Novast Labs, Pharmascience Inc, Qilu Pharm Hainan, Sagent Pharms Inc, Sandoz, Wockhardt Bio Ag, Zydus Pharms, and Sun Pharm, and is included in twenty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for decitabine. Twenty-four suppliers are listed for this compound.

Summary for DECITABINE

US Patents:	0
Tradenames:	2
Applicants:	21
NDAs:	21
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	450
Patent Applications:	6,878
Drug Prices:	Drug price trends for DECITABINE
What excipients (inactive ingredients) are in DECITABINE?	DECITABINE excipients list
DailyMed Link:	DECITABINE at DailyMed

See drug prices for DECITABINE

Recent Clinical Trials for DECITABINE

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

Sponsor	Phase
Benjamin Tomlinson	Phase 1/Phase 2
Pamela Munster	Phase 1
University Hospital Tuebingen	Phase 2

See all DECITABINE clinical trials

Pharmacology for DECITABINE

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

Anatomical Therapeutic Chemical (ATC) Classes for DECITABINE

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

US Patents and Regulatory Information for DECITABINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmascience Inc	DECITABINE	decitabine	INJECTABLE;INTRAVENOUS	204607-001	May 31, 2017	AP	RX	No	No
Novast Labs	DECITABINE	decitabine	INJECTABLE;INTRAVENOUS	210984-001	Sep 16, 2019	AP	RX	No	No
Cipla	DECITABINE	decitabine	INJECTABLE;INTRAVENOUS	208601-001	Nov 16, 2017		DISCN	No	No
Sun Pharm	DECITABINE	decitabine	POWDER;INTRAVENOUS	205582-001	Jan 28, 2014		RX	Yes	Yes
Nivagen Pharms Inc	DECITABINE	decitabine	INJECTABLE;INTRAVENOUS	212117-001	Dec 7, 2020	AP	RX	No	No

EU/EMA Drug Approvals for DECITABINE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Janssen-Cilag International N.V.	Dacogen	decitabine	EMEA/H/C/002221 Treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organization (WHO) classification, who are not candidates for standard induction chemotherapy.	Authorised	no	no	yes	2012-09-20

DECITABINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Decitabine

Introduction

Decitabine, a nucleoside analog and DNA methyltransferase inhibitor, has emerged as a crucial therapeutic agent in the treatment of hematological malignancies, particularly myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). Here, we delve into the market dynamics and financial trajectory of Decitabine, highlighting its growth, challenges, and future prospects.

Mechanism of Action and Clinical Use

Decitabine works by incorporating itself into DNA during replication, disrupting DNA methylation and leading to the reactivation of tumor suppressor genes. This mechanism makes it effective in inducing cell differentiation and apoptosis in malignant cells, often with fewer side effects compared to traditional chemotherapy[1].

Market Growth and Projections

The Decitabine market has experienced significant growth in recent years, driven by several key factors:

• Increasing Prevalence of Blood Cancers: The rising incidence of MDS and AML has created a higher demand for effective treatments.
• Advancements in Drug Formulation: Innovations such as oral delivery systems and liposomal formulations have enhanced patient compliance and reduced side effects.
• Heightened Awareness of Personalized Medicine: The shift towards personalized treatment approaches has increased the adoption of Decitabine, which can be tailored to individual patient needs[1].

The market is projected to reach a valuation of over $1 billion by the end of this decade, with a Compound Annual Growth Rate (CAGR) of around 8%[1].

Recent Trends and Innovations

Oral and Liposomal Formulations

Recent advancements include the development of oral Decitabine formulations and liposomal delivery systems. These innovations aim to maintain therapeutic levels while minimizing side effects, making the treatment more accessible and manageable for patients[1].

Regulatory Landscape

Regulatory bodies have streamlined the approval process for oncology drugs, expediting the time it takes for innovative therapies to reach the market. This has fostered competition and encouraged pharmaceutical companies to invest in Decitabine-related research, potentially leading to new indications and applications[1].

Strategic Partnerships

Collaborations between pharmaceutical companies and academic institutions are becoming more common. These partnerships focus on exploring the potential of Decitabine in combination therapies, which could enhance its effectiveness against resistant cancer strains[1].

Investment Opportunities

The Decitabine market presents several investment opportunities:

• Innovation in Drug Formulations: Companies can invest in developing new formulations that enhance efficacy and reduce side effects.
• Strategic Partnerships: Collaborations with research institutions can facilitate the development of combination therapies and expand market reach.
• Addressing Patient Access and Affordability: Companies that address the high treatment costs and improve patient access, especially in low- and middle-income countries, can significantly enhance their market presence[1].

Challenges

Despite the growth and opportunities, the Decitabine market faces several challenges:

• Competition from Other Epigenetic Drugs: The market is becoming increasingly competitive with the development of other epigenetic drugs, which could pose a threat to Decitabine’s market share.
• Affordability Issues: High treatment costs limit patient access, particularly in regions with limited healthcare resources[1].

Clinical Decision-Making and Treatment Outcomes

Decitabine is a first-line treatment for higher-risk MDS and is also used in the treatment of AML. Clinical decision-making involves identifying patient risk, symptoms, and conducting a risk-benefit analysis. For MDS, the treatment goal is to improve cytopenia, quality of life, and overall survival. Decitabine, along with other hypomethylating agents, plays a critical role in achieving these goals[2].

Financial Trajectory

The financial trajectory of Decitabine is promising, driven by its increasing adoption and the expanding market for blood cancer therapies:

• Market Valuation: The Decitabine market is projected to exceed $1 billion by the end of this decade.
• CAGR: The market is expected to grow at a CAGR of around 8%, reflecting strong demand for effective treatments[1].
• Revenue Streams: Revenue is generated through the sale of Decitabine formulations, with potential additional streams from combination therapies and new indications[4].

Regional Analysis

The global Decitabine market is segmented by region, with different regions showing varying levels of growth:

• North America and Europe: These regions are expected to dominate the market due to advanced healthcare infrastructure and higher adoption rates of innovative therapies.
• Asia-Pacific: This region is anticipated to show significant growth due to increasing healthcare expenditure and a rising prevalence of blood cancers[4].

Competitive Analysis

The competitive landscape of the Decitabine market is characterized by several key players:

• Pharmaceutical Companies: Companies like Otsuka Pharmaceutical and others are actively involved in developing new formulations and combination therapies.
• Research Institutions: Collaborations with academic institutions are crucial for advancing the therapeutic potential of Decitabine[1].

Future Prospects

The future of Decitabine looks promising, with several factors contributing to its continued growth:

• Ongoing Clinical Trials: Continued validation through clinical trials will further establish Decitabine’s efficacy and open up new treatment avenues.
• Technological Advancements: The use of artificial intelligence (AI) in drug discovery and development could further optimize Decitabine’s formulation and delivery methods[3].

"AI can recognize hit and lead compounds, and provide a quicker validation of the drug target and optimization of the drug structure design," highlighting the potential for AI to enhance the development process of Decitabine and other drugs[3].

Key Takeaways

• Decitabine is a vital drug in the treatment of MDS and AML, with a unique mechanism of action that targets epigenetic changes in cancer cells.
• The market is projected to reach over $1 billion by the end of this decade, with a CAGR of around 8%.
• Innovations in drug formulations, strategic partnerships, and addressing patient access and affordability are key drivers of market growth.
• The market faces challenges from competition and affordability issues but has significant investment opportunities.

FAQs

What is Decitabine used for?

Decitabine is primarily used in the treatment of myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML).

How does Decitabine work?

Decitabine works by disrupting DNA methylation, leading to the reactivation of tumor suppressor genes and inducing cell differentiation and apoptosis in malignant cells.

What are the recent innovations in Decitabine formulations?

Recent innovations include oral delivery systems and liposomal formulations designed to enhance efficacy and reduce side effects.

What are the key drivers of the Decitabine market growth?

Key drivers include the increasing prevalence of blood cancers, advancements in drug formulation, and heightened awareness of personalized medicine.

What challenges does the Decitabine market face?

The market faces challenges from competition with other epigenetic drugs and affordability issues that limit patient access.

How is the regulatory landscape impacting the Decitabine market?

Regulatory bodies have streamlined the approval process for oncology drugs, expediting the time for innovative therapies to reach the market and fostering competition.

Sources

1. Market Research Intellect: "Navigating the Decitabine Landscape: Opportunities and Challenges in the Market"[1].
2. Blood: "Clinical decision-making and treatment of myelodysplastic syndromes"[2].
3. Drug Discovery Today: "Role of artificial intelligence (AI) in drug discovery"[3].
4. Cognitive Market Research: "Decitabine Drug Market Report 2024 (Global Edition)"[4].