DACOGEN Drug Patent Profile

Which patents cover Dacogen, and what generic alternatives are available?

Dacogen is a drug marketed by Otsuka and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dacogen

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

Summary for DACOGEN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	88
Clinical Trials:	136
Drug Prices:	Drug price information for DACOGEN
What excipients (inactive ingredients) are in DACOGEN?	DACOGEN excipients list
DailyMed Link:	DACOGEN at DailyMed

See drug prices for DACOGEN

Recent Clinical Trials for DACOGEN

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

Sponsor	Phase
University Hospital Tuebingen	Phase 2
Franziska Wachter	Phase 2
Harvard Clinical and Translational Science Center (Harvard Catalyst)	Phase 2

See all DACOGEN clinical trials

US Patents and Regulatory Information for DACOGEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Otsuka	DACOGEN	decitabine	INJECTABLE;INTRAVENOUS	021790-001	May 2, 2006		DISCN	Yes	No

EU/EMA Drug Approvals for DACOGEN

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 DACOGEN (Decitabine)

Last updated: February 8, 2026

DACOGEN (decitabine) is an FDA-approved hypomethylating agent primarily used to treat myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), and certain other hematological malignancies. Its market position, growth prospects, and revenue trajectory depend on epidemiology, competitive landscape, regulatory developments, and pricing strategies.

Market Size and Epidemiology

• Target Diseases: MDS, AML, chronic myelomonocytic leukemia (CMML).
• Market Estimates (2023): The global MDS market was valued at approximately $750 million, with AML at about $4 billion, driven by rising prevalence, particularly among aging populations.
• Prevalence and Incidence: MDS affects an estimated 4 per 100,000 individuals annually in the U.S., rising sharply in age groups over 60. AML incidence exceeds 20,000 cases annually in the U.S., with increasing numbers due to aging demographics.

Market Drivers

• Growing Aging Population: The global population over 60 is expected to reach 2 billion by 2050, increasing the patient pool for MDS and AML.
• Unmet Medical Need: Limited effective therapies for higher-risk MDS and elderly AML patients who are ineligible for intensive chemotherapy.
• DACOGEN’s Approved Indications: The drug's efficacy in improving survival and quality of life maintains steady demand.

Competitive Landscape

• Key Competitors: Azacitidine (Vidaza), vemurafenib, and emerging targeted therapies.
• Differentiators: DACOGEN's administration schedule (primarily as a 5-day intravenous or subcutaneous treatment) position it as a standard treatment option.
• Pipeline: Other hypomethylating agents and novel agents targeting epigenetic modifications or immune pathways could impact market share in coming years.

Regulatory and Pricing Dynamics

• Patent Status: DACOGEN's patent protections expired in 2018 in the U.S., opening the market to biosimilars and generics, which may pressure prices.
• Pricing: Current wholesale acquisition cost (WAC) in the U.S. is approximately $15,000 to $20,000 per treatment cycle [1].
• Reimbursement: Managed through Medicare and private insurers; formulary coverage impacts sales consistency.

Financial Trajectory Analysis

Year	Estimated Global Sales (USD)	Growth Rate	Key Factors
2023	$350 million	N/A	Market maturity; biosimilar entry begins impacting prices.
2024	$310 million	-11.4%	Biosimilar competition influences revenue.
2025	$270 million	-12.9%	Market saturation; incremental pipeline approvals.
2026	$230 million	-14.8%	Continued biosimilar erosion, potential new indications.

• Decline Factors: Biosimilar entry in 2019-2020 led to initial price erosion. Further generic competition anticipated to sustain downward pressure.
• Growth Opportunities: Expansion into indications such as solid tumors or combination therapies. Development of oral formulations could improve patient adherence and expand market access.
• Emerging Trends: Adoption of personalized medicine and molecular profiling may shift demand toward targeted therapies, potentially reducing reliance on DACOGEN.

Recent Developments

• Pipeline and Expansion: GSK (the current manufacturer) is exploring combination regimens with other agents and revised dosing schedules to extend DACOGEN’s market relevance.
• Regulatory Approvals: No recent approvals or major label expansions reported post-2018. However, ongoing Phase II trials examine DACOGEN's efficacy in other hematological malignancies.
• Market Access Challenges: Biosimilars in the U.S. began entering the market in 2021, exerting pricing pressure.

Future Outlook

• The U.S. and European markets will experience steady declines due to biosimilar competition until a new indication or formulation revitalizes sales.
• Procuring patent extensions or regulatory exclusivities (e.g., orphan drug status for certain indications) could temporarily stabilize revenue.
• Market growth in emerging regions (Asia-Pacific, Latin America) remains uncertain, influenced by healthcare infrastructure and pricing policies.

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Key Takeaways

• DACOGEN faces declining revenues primarily driven by biosimilar competition since patent expiration.
• The market for MDS and AML remains sizable largely due to demographic trends but is subject to pricing pressures.
• Growth hinges on pipeline developments, new indications, combination therapies, and potential formulation innovations.
• Regulatory and reimbursement landscape stability significantly affects revenue trajectories.
• The drug's long-term viability depends on strategic diversification and pipeline success.

FAQs

1. What are the main competitors to DACOGEN?
   Azacitidine (Vidaza) is the principal competitor; other emerging therapies targeting epigenetic pathways or novel mechanisms also pose threats.

2. How does biosimilar entry affect DACOGEN’s revenue?
   Biosimilars launched post-patent expiry lead to price competition and volume shifts, causing revenue declines.

3. Are there plans to extend DACOGEN’s indications?
   Currently, no significant regulatory filings have been announced, but ongoing clinical trials explore additional hematological and solid tumor indications.

4. What is the potential for oral formulations?
   An oral decitabine formulation is under development, which could improve patient adherence and reduce healthcare delivery costs, expanding the market.

5. How might pricing regulations influence future sales?
   Price controls and reimbursement policies, especially in Europe and Asia, can significantly impact revenue growth or contraction.

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Sources

[1] Medications.com. DACOGEN Price & Cost. 2022. [2] IQVIA, 2023. Market Reports on Hematological Malignancies. [3] U.S. FDA. Drug Approval and Patent Information. [4] GSK Annual Reports, 2022. [5] Market Research Future. Hematological Malignancies Market, 2023.