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. Nineteen 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:	19
Raw Ingredient (Bulk) Api Vendors:	88
Clinical Trials:	514
Patent Applications:	6,488
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
University of Washington	PHASE2
Swedish Orphan Biovitrum	PHASE2
Kyunghee Burkitt, DO, PhD	PHASE1

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
Eugia Pharma	DECITABINE	decitabine	INJECTABLE;INTRAVENOUS	214569-001	Sep 20, 2021		DISCN	No	No
Accord Hlthcare	DECITABINE	decitabine	INJECTABLE;INTRAVENOUS	203475-001	Feb 27, 2017	AP	RX	No	No
Jiangsu Hansoh Pharm	DECITABINE	decitabine	INJECTABLE;INTRAVENOUS	213472-001	Apr 15, 2022	AP	RX	No	No
Chemi Spa	DECITABINE	decitabine	INJECTABLE;INTRAVENOUS	206033-001	Sep 22, 2017	AP	RX	No	No
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/002221Treatment 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

Market Dynamics and Financial Trajectory for Decitabine

Last updated: July 27, 2025

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Introduction

Decitabine, a cytidine analog functioning as a hypomethylating agent, plays a prominent role in the treatment of myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). Approved by the FDA in 2006, decitabine’s unique mechanism involves inhibiting DNA methyltransferases, leading to reactivation of tumor suppressor genes and promoting differentiation of malignant cells. As an essential component in hematologic malignancies therapy, understanding its market dynamics and financial trajectory offers valuable insights for industry stakeholders, including pharmaceutical companies, investors, and healthcare providers.

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Market Overview and Key Drivers

Market Size and Growth Trends

The global market for decitabine remains robust, driven primarily by the rising incidence of hematologic cancers. According to industry reports, the AML segment is projected to witness compounded annual growth rates (CAGR) of approximately 7-9% over the next five years. The expansion is supported by increased diagnostic capabilities, aging populations, and advances in supportive care that improve patient outcomes during treatment.

Therapeutic Positioning and Regulatory Pathways

Decitabine's approval primarily addresses MDS and AML, where it is utilized both as monotherapy and in combination regimens. The drug’s orphan drug status in various jurisdictions facilitates regulatory support and market exclusivity, incentivizing commercialization. Additionally, ongoing clinical trials exploring its efficacy in solid tumors and other hematologic conditions have the potential to diversify its indications, further augmenting market prospects.

Competitive Landscape

While decitabine faces competition from other hypomethylating agents like azacitidine (Vidaza), the differentiation lies in its administration schedule and response rates in specific patient subsets. Enhanced formulations, such as extended-release modifications or combination therapies, aim to improve efficacy and reduce side effects, thereby maintaining its competitive edge.

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Market Challenges and Constraints

Pricing and Reimbursement Pressures

Pricing pressures from healthcare payers and governments across major markets such as the U.S., EU, and Asia pose significant challenges. The high cost of patented formulations can limit access, especially in lower-income regions. Reimbursement policies influence adoption rates, potentially constraining revenue growth.

Generic Entry and Patent Expiry

While decitabine benefits from patent protection, imminent patent expiry could usher in competition from generics and biosimilars, exerting downward pressure on prices. Companies are therefore investing in patented formulations and combination therapies to maintain market share.

Operational and Manufacturing Barriers

High-quality manufacturing standards and supply chain integrity are critical due to decitabine's complex synthesis and storage requirements. Disruptions can impact availability, influencing market stability.

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Financial Trajectory and Revenue Outlook

Historical Revenue Performance

Decitabine generated approximately USD 300-400 million globally in 2022. North America accounts for over 60% of sales, owing to the high prevalence of hematologic malignancies and established treatment pathways. Growth has been steady, driven by increased utilization in eligible patient populations and expanding indications.

Projected Revenue Growth

Analysts predict a CAGR of 6-8% over the next five years, contingent on several factors:

• New Indications: Positive outcomes from clinical trials could lead to approval in other hematologic or solid tumor indications.
• Combination Regimens: Synergistic combinations with targeted agents such as venetoclax have shown promising efficacy, potentially boosting sales.
• Market Penetration: Expansion into emerging markets, facilitated by strategic partnerships and affordability measures, will be critical to growth.

Impact of Patent Expiries and Generics

Patent expiration anticipated around 2025-2027 in key markets may result in significant revenue decline unless targeted by next-generation formulations or new patents. Companies are pursuing drug reformulations and biosimilars to sustain revenues.

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Future Market Trends

Personalized Medicine and Biomarker Integration

Emerging research emphasizes identifying biomarkers predictive of decitabine response. Personalized treatment protocols could optimize patient outcomes and justify premium pricing, positively influencing revenue streams.

Combination Therapy Approaches

The integration of decitabine with targeted therapies (e.g., FLT3 inhibitors) demonstrates synergistic potential, positioning it as part of multidrug regimens. This approach can enhance treatment efficacy, expand indications, and bolster sales.

Regulatory and Policy Influences

Global regulatory agencies are promoting accelerated approval pathways for innovative cancer treatments, enabling earlier market access. Reimbursement reforms and value-based pricing models will influence the product’s financial pathway.

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Strategic Considerations for Stakeholders

Pharmaceutical developers should focus on extending patent life through reformulations, securing approvals for new indications, and participating in combination trials.

Investors ought to monitor pipeline advancements and competitive threats driven by generics.

Healthcare providers require updated clinical guidelines reflecting the latest evidence to optimize decitabine utilization, thereby impacting sales volume.

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Key Takeaways

• The decitabine market is expected to grow modestly at a CAGR of 6-8% over the next five years, driven by increased incidence of hematologic malignancies and expanded clinical applications.
• Competitive differentiation, including clinical efficacy and formulation innovations, remains vital amid patent expiries and emerging generics.
• New combination therapies and personalized medicine approaches represent significant growth vectors.
• Pricing and reimbursement challenges, especially in emerging markets, could influence revenue trajectories.
• Strategic intellectual property management and diversification into new indications are essential for sustaining financial performance.

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FAQs

1. What factors influence decitabine’s market growth?
Market growth depends on rising hematologic cancer prevalence, clinical trial success for new indications, therapeutic combination strategies, regulatory approvals, and market access policies.

2. How does patent expiry impact decitabine’s financial outlook?
Patent expiries around 2025-2027 may lead to increased generic competition, reducing revenue unless offset by new formulations, indications, or exclusive rights.

3. What are the primary challenges faced by decitabine in the market?
Pricing pressures, reimbursement hurdles, competition from biosimilars, supply chain complexities, and regulatory shifts compound market challenges.

4. Which emerging trends could shape decitabine’s future?
Personalized medicine, biomarker-guided therapy, combination regimens, and accelerated regulatory pathways will influence its market trajectory.

5. How significant is the role of combination therapy involving decitabine?
Highly significant, as combinations with agents like venetoclax have shown improved response rates, expanding decitabine’s therapeutic utility and sales potential.

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References

[1] MarketWatch, 2023. "Global Decitabine Market Analysis."
[2] Allied Market Research, 2022. "Hypomethylating Agents Market Forecast."
[3] FDA Regulatory Updates, 2022. "Decitabine Approvals and Indications."
[4] PharmaIntelligence, 2023. "Therapeutic Landscape in Hematologic Malignancies."
[5] ClinicalTrials.gov, 2023. "Ongoing Trials of Decitabine in Solid Tumors."

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This comprehensive overview synthesizes current market insights and forecasts concerning decitabine, providing strategic clarity to industry stakeholders navigating its evolving landscape.