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Last Updated: December 22, 2024

DECITABINE Drug Patent Profile


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Which patents cover Decitabine, and when can generic versions of Decitabine launch?

Decitabine is a drug marketed by 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 NDAs.

The generic ingredient in DECITABINE is decitabine. There are eighteen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the decitabine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Decitabine

A generic version of DECITABINE was approved as decitabine by DR REDDYS on July 11th, 2013.

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Summary for DECITABINE
Drug patent expirations by year for DECITABINE
Drug Prices for DECITABINE

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Recent Clinical Trials for DECITABINE

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SponsorPhase
Benjamin TomlinsonPhase 1/Phase 2
Pamela MunsterPhase 1
University Hospital TuebingenPhase 2

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Pharmacology for DECITABINE

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
Accord Hlthcare DECITABINE decitabine INJECTABLE;INTRAVENOUS 203475-001 Feb 27, 2017 AP RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Wockhardt Bio Ag DECITABINE decitabine INJECTABLE;INTRAVENOUS 209056-001 Apr 9, 2019 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hetero Labs Ltd Vi DECITABINE decitabine INJECTABLE;INTRAVENOUS 215355-001 May 10, 2024 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dr Reddys DECITABINE decitabine INJECTABLE;INTRAVENOUS 203131-001 Jul 11, 2013 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Nivagen Pharms Inc DECITABINE decitabine INJECTABLE;INTRAVENOUS 212117-001 Dec 7, 2020 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm DECITABINE decitabine POWDER;INTRAVENOUS 205582-001 Jan 28, 2014 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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].

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