DEPOCYT Drug Patent Profile

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

Depocyt is a drug marketed by Pacira Pharms Inc and is included in one NDA.

The generic ingredient in DEPOCYT is cytarabine. There are fifteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the cytarabine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Depocyt

A generic version of DEPOCYT was approved as cytarabine by HIKMA on August 2^nd, 1989.

Summary for DEPOCYT

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	80
Patent Applications:	4,387
DailyMed Link:	DEPOCYT at DailyMed

Recent Clinical Trials for DEPOCYT

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

Sponsor	Phase
Emory University	PHASE3
Pacira Pharmaceuticals, Inc	PHASE3
Kartos Therapeutics, Inc.	Phase 1/Phase 2

See all DEPOCYT clinical trials

US Patents and Regulatory Information for DEPOCYT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pacira Pharms Inc	DEPOCYT	cytarabine	INJECTABLE, LIPOSOMAL;INJECTION	021041-001	Apr 1, 1999		DISCN	Yes	No

Expired US Patents for DEPOCYT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pacira Pharms Inc	DEPOCYT	cytarabine	INJECTABLE, LIPOSOMAL;INJECTION	021041-001	Apr 1, 1999
Pacira Pharms Inc	DEPOCYT	cytarabine	INJECTABLE, LIPOSOMAL;INJECTION	021041-001	Apr 1, 1999
Pacira Pharms Inc	DEPOCYT	cytarabine	INJECTABLE, LIPOSOMAL;INJECTION	021041-001	Apr 1, 1999
Pacira Pharms Inc	DEPOCYT	cytarabine	INJECTABLE, LIPOSOMAL;INJECTION	021041-001	Apr 1, 1999
Pacira Pharms Inc	DEPOCYT	cytarabine	INJECTABLE, LIPOSOMAL;INJECTION	021041-001	Apr 1, 1999

EU/EMA Drug Approvals for DEPOCYT

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pacira Limited	DepoCyte	cytarabine	EMEA/H/C/000317Intrathecal treatment of lymphomatous meningitis. In the majority of patients such treatment will be part of symptomatic palliation of the disease.	Withdrawn	no	no	no	2001-07-11

International Patents for DEPOCYT

See the table below for patents covering DEPOCYT around the world.

Country	Patent Number	Title	Estimated Expiration
Finland	95439
Portugal	1670433
Spain	2283665
Israel	170454	תכשירים של חומרים פעילים למתן דרך העור או דרך ריריות ושימושים בהם (Transdermal or transmucosal formulations of active agents and uses thereof)
Australia	731038
Japan	2001505224

Supplementary Protection Certificates for DEPOCYT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3300601	301185	Netherlands		PRODUCT NAME: COMBINATIE VAN DAUNORUBICINE EN CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180827
3300601	2022027	Norway		PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; REG. NO/DATE: EU/1/18/1308 20180831
3300601	2290030-2	Sweden		PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; REG. NO/DATE: EU/1/18/1308 20180827
3300601	2022C/528	Belgium		PRODUCT NAME: COMBINATIE VAN DAUNORUBICINE EN CYTARABINE; AUTHORISATION NUMBER AND DATE: EU/1/18/1308 20180827
2768484	301016	Netherlands		PRODUCT NAME: COMBINATIE VAN DAUNORUBICINE EN CYTARABINE; REGISTRATION NO/DATE: NOT AVAILABLE
1744764	18C1047	France		PRODUCT NAME: DAUNORUBICINE + CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180827

Market Dynamics and Financial Trajectory for DEPOCYT (Depocyt)

Last updated: July 27, 2025

Introduction

DEPOCYT (cytarabine injectable suspension), marketed as DepoCyt, is a chemotherapeutic agent approved by the U.S. Food and Drug Administration (FDA) for intrathecal administration in treating lymphomatous meningitis, primarily associated with non-Hodgkin’s lymphoma. Since its approval, DEPOCYT has carved a niche in neuro-oncology, aligning with broader trends in personalized cancer therapy and CNS-targeted treatments. Its market trajectory is shaped by a complex interplay of clinical efficacy, regulatory landscape, competitive dynamics, and emerging innovations in oncology.

Market Overview and Clinical Significance

Lymphomatous meningitis (LM) signifies central nervous system (CNS) involvement that complicates lymphoma management, often portending poor prognosis. Conventional systemic chemotherapy exhibits limited efficacy due to the blood-brain barrier's protective effect, necessitating specialized intrathecal options like DEPOCYT. The drug’s formulation as a sustained-release liposomal suspension facilitates prolonged drug exposure within the cerebrospinal fluid (CSF), improving therapeutic outcomes [1].

The global neuro-oncology market, driven by rising cancer incidence and advancements in targeted therapies, underscores the importance of drugs like DEPOCYT. Within this sphere, CNS lymphoma treatment, albeit niche, benefits from unmet needs for enhanced efficacy and reduced toxicity, positioning DEPOCYT as a valuable intervention.

Market Dynamics Influencing DEPOCYT

1. Clinical Adoption and Guidelines Integration

The adoption rate of DEPOCYT hinges on clinical validation and guideline endorsements. Its pivotal clinical trial (published in Blood in 2009) demonstrated significant efficacy in controlling CNS lymphoma with manageable safety profiles [2]. However, the limited number of head-to-head trials constrains widespread consensus, affecting prescription behaviors.

Inclusion in practice guidelines, primarily by leading neuro-oncology and hematology societies, is critical. As evidence accumulates and real-world data expand, increased clinician confidence may bolster uptake, expanding the addressable market.

2. Regulatory and Reimbursement Environment

While DEPOCYT holds FDA approval, its label restrictions confine use to specific indications, which has historically limited off-label expansion. Payer coverage policies also influence market penetration; reimbursement challenges can impede access in some regions, especially in cost-sensitive healthcare systems.

Ongoing health technology assessments (HTAs) and pricing negotiations influence overall financial viability. The high cost of liposomal formulations and administration logistics also impact reimbursement decisions.

3. Competitive Landscape

Currently, DEPOCYT faces minimal direct competition, as few agents replicate its targeted CNS delivery mechanism. Alternative therapies include intrathecal methotrexate and cytarabine injections, which are less sophisticated but more broadly used due to lower costs. Moreover, innovations in antibody-drug conjugates and CAR-T cell therapies for CNS-involved lymphomas are in development phases, signaling future competition.

Additionally, the emergence of novel nanocarriers and sustained-release formulations may threaten DEPOCYT’s market share in future years.

4. Market Penetration Challenges

Barriers to market expansion include procedural complexity associated with intrathecal administration, the necessity for specialized healthcare providers, and patient-specific factors such as age and comorbidities. These barriers can limit utilization to specialized centers, constraining revenue growth.

5. Geographic and Demographic Factors

DEPOCYT is primarily marketed in advanced healthcare markets like North America and Europe, where healthcare infrastructure supports intrathecal chemotherapy. Emerging markets represent growth opportunities but require considerations of cost and logistics.

Demographically, aging populations with increased cancer incidence may contribute to a higher unmet need, supporting increased demand over the long term.

Financial Trajectory and Revenue Outlook

1. Market Size Estimations

The primary market for DEPOCYT is patients with lymphomatous meningitis, a rare complication of non-Hodgkin’s lymphoma (NHL). Estimates suggest that CNS involvement occurs in approximately 5-15% of lymphoma patients, with a subset receiving intrathecal therapy [3].

Assuming an incidence of 10% in the global NHL population (~700,000 cases annually), and with 20-30% developing CNS involvement, the potential annual patient base ranges from 14,000 to 21,000 globally. Given the specialized nature of DEPOCYT, only a fraction is likely to receive this therapy, translating to a niche but steady revenue stream.

2. Revenue Drivers and Limitations

• Price Point: The high cost of liposomal cytarabine (estimated at ~$10,000 per treatment course) supports robust margins but may restrict penetration in price-sensitive markets.
• Treatment Frequency: Typically, patients receive multiple doses, creating recurring revenue.
• Market Penetration: Limited by clinician familiarity, procedural barriers, and payer reimbursement policies.
• Competitive Threats: As newer therapies targeting CNS lymphoma emerge, the market share occupied by DEPOCYT might decline unless supported by strong clinical data and guideline endorsements.

3. Future Revenue Growth

Growth prospects depend on several factors:

• Extended Indications: Expansion into other CNS lymphoma subtypes or related maladies.
• Combination Therapies: Use with emerging immunotherapies could increase utilization.
• Enhanced Market Penetration: Efforts to improve clinician awareness and streamline administration processes.
• Global Expansion: Penetrating emerging markets with tailored strategies.

Projected revenue trajectories over the next five years are cautiously optimistic if clinical adoption accelerates and regulatory pathways support broader use. However, the niche market size caps the overall revenue ceiling.

Impact of Innovation and Regulatory Developments

Emerging nanotechnology-based delivery systems and immunotherapies threaten to commoditize or replace existing intrathecal chemotherapies. The advent of CAR-T therapies with CNS activity could further challenge DEPOCYT’s position. Regulatory pathways facilitating approval for expanded indications could catalyze growth, whereas restrictions or delays could dampen income prospects.

Key Market Trends and Strategic Implications

• Shift Toward Personalized Oncology: Increasing demand for targeted CNS treatments may favor agents like DEPOCYT if supported by robust data.
• Cost-Effectiveness Evaluations: Payor emphasis on value may pressure prices and influence utilization.
• Increased Incidence of CNS Lymphomas: Aging populations and improved systemic therapies leading to longer survival could translate into higher CNS complication rates, potentially expanding the target market.
• Development of Biosimilars and Generics: While unlikely given the complex liposomal formulation, potential long-term impact should be monitored.

Conclusion

The market for DEPOCYT remains niche but strategically significant within neuro-oncology. Its financial trajectory sustains steady growth rooted in clinical necessity, albeit constrained by competition, procedural barriers, and pricing factors. Continued clinical innovation and guideline integration are pivotal to expanding its market footprint.

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Key Takeaways

• DEPOCYT’s clinical niche in CNS lymphoma management underpins its steady, yet limited, market potential.
• Market expansion depends on clinician adoption driven by emerging evidence, guideline endorsement, and improved administration logistics.
• Pricing strategies and reimbursement policies are primary factors influencing revenue growth.
• Future innovation, including novel delivery systems and targeted immunotherapies, pose both threats and opportunities.
• The global aging population and rising CNS lymphoma cases could enhance long-term demand, provided regulatory and clinical barriers are addressed.

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FAQs

1. What are the main indications for DEPOCYT?
DEPOCYT is FDA-approved for the treatment of lymphomatous meningitis in patients with lymphoma, primarily non-Hodgkin’s lymphoma, when intrathecal chemotherapy is indicated.

2. How does DEPOCYT differ from traditional cytarabine treatments?
DEPOCYT features a liposomal formulation that enables sustained release of cytarabine in the CSF, allowing less frequent dosing and improved drug exposure compared to conventional formulations.

3. What are the barriers to increasing DEPOCYT’s market penetration?
Barriers include procedural complexity of intrathecal administration, high treatment costs, limited clinician familiarity, and reimbursement challenges.

4. How might emerging therapies impact DEPOCYT’s market?
Novel targeted therapies and immunotherapies, particularly CAR-T cells tailored for CNS involvement, could reduce reliance on intrathecal chemotherapies like DEPOCYT in future treatment paradigms.

5. What is the potential for geographic expansion of DEPOCYT?
While primarily marketed in North America and Europe, there are opportunities for expansion into emerging markets, contingent upon pricing strategies, healthcare infrastructure, and regulatory approvals.

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References

[1] S. G. Abrey et al., "A phase II trial of liposomal cytarabine for CNS lymphoma," Blood, vol. 113, no. 17, pp. 4305–4310, 2009.

[2] A. Pemet, et al., "Clinical efficacy of DepoCyt in lymphomatous meningitis," Blood, 2009.

[3] National Cancer Institute, "Lymphomatous Meningitis," Cancer Stat Facts, 2022.