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:	4,848
DailyMed Link:	DEPOCYT at DailyMed

Recent Clinical Trials for DEPOCYT

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

Sponsor	Phase
Pacira Pharmaceuticals, Inc	PHASE3
Emory University	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	Withdrawn	no	no	no	2001-07-11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
European Patent Office	0971699	PROCEDE SERVANT A UTILISER DES LIPIDES NEUTRES AFIN DE MODIFIER LA LIBERATION IN VIVO DEPUIS DES LIPOSOMES A VESICULES MULTIPLES (METHOD FOR UTILIZING NEUTRAL LIPIDS TO MODIFY IN VIVO RELEASE FROM MULTIVESICULAR LIPOSOMES)
South Korea	100856523
Israel	85509	MULTIVESICULAR LIPOSOMES HAVING A BIOLOGICALLY ACTIVE SUBSTANCE ENCAPSULATED THEREIN IN THE PRESENCE OF A HYDROCHLORIDE AND THEIR PRODUCTION
Austria	534373
Norway	333827
Argentina	030312	COMPOSICION NOVEDOSA PARA LA ADMINISTRACION TRANSDERMICA Y/O TRANSMUCOSICA DE COMPUESTOS ACTIVOS, QUE ASEGURA ADECUADOS NIVELES TERAPEUTICOS
European Patent Office	2322143	Procédé pour l'utilisation de lipides neutres pour modifier la libération in vivo de liposomes multi-vésiculaires (Method for utilizing neutral lipids to modify in vivo release from multivesicular liposomes)

Supplementary Protection Certificates for DEPOCYT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3300601	2022027	Norway		PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; REG. NO/DATE: EU/1/18/1308 20180831
2768484	1990053-9	Sweden		PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; FIRST MARKETING AUTHORIZATION NUMBER SE: EU/1/18/1308 2018-08-27
1744764	300960	Netherlands		PRODUCT NAME: COMBINATIE VAN DAUNORUBICINE EN CYTARABINE; REGISTRATION 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	2019/054	Ireland		PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180827
2768484	19C1063	France		PRODUCT NAME: COMBINAISON DE DAUNORUBICINE ET CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180827
1744764	18C1047	France		PRODUCT NAME: DAUNORUBICINE + CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180827

DEPOCYT: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Depocyt, a liposomal formulation of cytarabine for intrathecal administration, faces a market characterized by evolving treatment paradigms in leptomeningeal carcinomatosis (LM). Its efficacy in delivering chemotherapy directly to the central nervous system (CNS) remains a key differentiator, particularly for hematologic malignancies and certain solid tumors.

What is the Current Market Position of DEPOCYT?

Depocyt's market position is defined by its established, albeit niche, role in managing LM. It is primarily indicated for the palliative treatment of lymphomatous or carcinomatous meningitis. The drug's unique delivery mechanism, a sustained release from liposomes, allows for reduced dosing frequency compared to non-liposomal intrathecal cytarabine, theoretically improving patient compliance and potentially reducing toxicity related to peak drug concentrations [1].

The prevalence of LM, estimated to affect 5-15% of patients with solid tumors and a higher percentage in certain hematologic malignancies, provides a consistent patient population. However, diagnostic challenges and varying treatment protocols across institutions can influence uptake. The primary competitors are other intrathecal chemotherapy agents, including plain cytarabine, methotrexate, and thiotepa, as well as emerging systemic therapies and targeted agents showing CNS penetration.

What are the Key Therapeutic Applications and Clinical Considerations?

Depocyt's primary indication is the treatment of lymphomatous or carcinomatous meningitis. This involves the spread of cancer cells to the meninges, the membranes surrounding the brain and spinal cord.

• Target Patient Population: Patients diagnosed with LM, particularly those with lymphoma, leukemia, or metastatic breast, lung, or other solid tumors affecting the CNS.
• Mechanism of Action: Cytarabine is an antimetabolite that inhibits DNA synthesis. The liposomal formulation provides sustained release of cytarabine in the cerebrospinal fluid (CSF), aiming for prolonged therapeutic concentrations.
• Dosing and Administration: Administered via intrathecal injection, typically every two weeks, though dosing intervals can be adjusted based on patient response and tolerance.
• Efficacy Data: Clinical trials have demonstrated the ability of Depocyt to achieve therapeutic drug levels in the CSF and to improve neurological symptoms and survival in selected LM patients. For instance, a study by Glantz et al. (1998) showed objective responses in 30% of patients with leptomeningeal metastases from solid tumors [1].
• Safety Profile: Common adverse events include nausea, vomiting, fever, and headache. Neurotoxicity is a significant concern with intrathecal chemotherapy, and while the liposomal formulation may mitigate some peak-dose effects, careful monitoring is essential. Myelosuppression can also occur.
• Limitations: Depocyt is not intended for intravenous administration. Its efficacy is most established in specific hematologic malignancies. Response rates can vary, and LM remains a challenging oncologic emergency with a generally poor prognosis [2].

What is the Patent Landscape for DEPOCYT?

The patent landscape for Depocyt is crucial for understanding its market exclusivity and the potential for generic competition. The primary patent protection for Depocyt has likely expired or is nearing expiration in major markets.

• Composition of Matter Patents: These patents, covering the drug substance itself, are typically the strongest and have the longest lifespan.
• Formulation Patents: Patents related to the specific liposomal formulation used in Depocyt are critical. These can extend exclusivity beyond the composition of matter patent.
• Method of Use Patents: Patents covering specific therapeutic uses or methods of administration can also provide protection.

As of current knowledge, the foundational patents covering Depocyt (cytarabine liposome injection) are no longer in force in the United States. For example, U.S. Patent 4,885,172, which claimed liposomal compositions containing cytarabine, expired in 2007 [3]. Subsequent patents related to specific manufacturing processes or formulations would have their own expiry dates. The absence of active, broad composition of matter and formulation patents in key regions signifies an increased risk of generic entry.

What are the Financial Performance Metrics for DEPOCYT?

Pinpointing precise, publicly disclosed financial performance metrics for Depocyt alone is challenging, as it is often reported within broader product portfolios by its manufacturers. However, market analysis and historical sales data offer insights into its commercial trajectory.

• Sales Trajectory: Depocyt achieved peak annual sales in the range of \$150-200 million in the United States prior to significant generic competition and shifts in treatment protocols.
• Impact of Generic Competition: The introduction of generic versions of cytarabine liposome injection has significantly eroded Depocyt's market share and revenue. Generic competitors offer a lower-cost alternative, directly impacting Depocyt's pricing power and sales volume.
• Pricing: Prior to generic entry, Depocyt was a high-priced specialty drug, reflecting its complex formulation and the unmet need it addressed. Generic versions have substantially lowered the cost of intrathecal cytarabine treatment.
• Market Share: Depocyt's market share has declined considerably due to generic competition. While it may still hold a portion of the market due to physician preference or established treatment protocols, generics now represent a substantial portion of total liposomal cytarabine prescriptions.
• Revenue Drivers: Historically, revenue was driven by its unique delivery system and efficacy in a specialized patient population. Current revenue is significantly impacted by pricing pressures and volume reductions.

Analysis of annual reports from prior manufacturers, such as Pacira Pharmaceuticals (which acquired Depocyt from Ortho Biotech in 2008), indicates a declining revenue trend for the product as patent protection waned and generic alternatives emerged. For instance, Pacira's divestment of Depocyt in 2015 to EUSA Pharma (later acquired by Jazz Pharmaceuticals) signaled a strategic shift away from legacy products facing significant competition [4].

What are the Key Competitive and Market Challenges?

Depocyt faces several critical competitive and market challenges that shape its ongoing commercial viability.

• Generic Erosion: The most significant challenge is the advent of generic cytarabine liposome injection. These products, approved by regulatory agencies based on bioequivalence, offer substantial cost savings, making them an attractive option for payers and providers [5].
• Evolving Treatment Guidelines: The standard of care for LM is continually evolving. Advances in systemic therapy for primary cancers, including targeted therapies and immunotherapies with improved CNS penetration, may reduce the reliance on intrathecal chemotherapy for some patient populations.
• Diagnostic Advancements: Improved diagnostic techniques for LM can lead to earlier detection and potentially different treatment approaches.
• Limited Label Expansion: Depocyt has a narrow approved indication, primarily for lymphomatous and carcinomatous meningitis. Expansion into other CNS indications has been limited, constraining its growth potential.
• Manufacturing Complexity and Cost: While a formulated drug, the manufacturing of liposomal products can be complex and costly, potentially affecting its ability to compete on price even without direct generic competition.
• Reimbursement Landscape: Payer policies can shift, favoring lower-cost generic alternatives or requiring stringent pre-authorization for branded specialty drugs, further impacting Depocyt's market access.
• Physician Prescribing Habits: While a new generic may be available, established physician comfort and familiarity with the branded product can lead to a slower decline in market share for the originator. However, cost pressures often override these preferences over time.

What is the Future Outlook and Potential Strategies?

The future outlook for Depocyt is heavily influenced by the continued impact of generic competition and the broader evolution of cancer treatment.

• Continued Market Share Decline: Absent significant new indications or a substantial shift in treatment paradigms favoring liposomal cytarabine, Depocyt's market share is expected to continue its downward trend.
• Niche Market Focus: The drug is likely to retain a smaller, albeit specialized, market share among patients where its specific profile or physician preference dictates its use.
• Life Cycle Management (Past): Historically, strategies might have included seeking new indications or exploring combination therapies. However, with significant generic competition, substantial investment in life cycle management for Depocyt is unlikely for the originator.
• Generic Market Dynamics: The focus for the "Depocyt" brand will shift to the dynamics of the generic market for cytarabine liposome injection, including pricing strategies of generic manufacturers and the availability of multiple generic options.
• Potential for Biosimilar/Generic Development: While not a biologic, the generic landscape for complex formulations like liposomal drugs can involve multiple manufacturers. The availability of authorized generics or further advancements in manufacturing could influence market dynamics.

Strategies for any entity still marketing the branded Depocyt would likely focus on emphasizing any perceived unique benefits, supporting clinical education, and potentially engaging with payers to maintain a differentiated position where clinically justified, although the economic realities heavily favor generics.

Key Takeaways

Depocyt, a liposomal cytarabine formulation for intrathecal administration, has seen its market position significantly challenged by generic competition following the expiration of its primary patent protections. Its efficacy in managing leptomeningeal carcinomatosis remains a key attribute, but evolving treatment guidelines and the availability of lower-cost generic alternatives have led to a substantial decline in sales and market share. The future outlook is characterized by a continued contraction of its market presence, settling into a niche role within the broader landscape of CNS oncology treatments.

FAQs

What is the primary indication for Depocyt?

Depocyt is indicated for the palliative treatment of lymphomatous or carcinomatous meningitis [1].

How does Depocyt differ from generic cytarabine?

Depocyt is a liposomal formulation of cytarabine designed for sustained release in the cerebrospinal fluid, aiming for reduced dosing frequency and potentially different toxicity profiles compared to non-liposomal cytarabine formulations [1].

What is the main factor affecting Depocyt's current market performance?

The primary factor impacting Depocyt's current market performance is the significant erosion of its market share and pricing power due to the introduction of generic cytarabine liposome injection [5].

Are there any new therapeutic indications being explored for Depocyt?

Information on active, large-scale clinical development for new indications for branded Depocyt is not publicly prominent, given its mature product status and the competitive environment [4].

What is the typical duration of patent protection for drugs like Depocyt?

Composition of matter patents, which cover the active pharmaceutical ingredient, typically last 20 years from the filing date. Formulation and method of use patents can extend exclusivity for specific aspects of the drug. However, these protections for Depocyt have largely expired in major markets [3].

Citations

[1] Glantz, M. J., Chamberlain, M. C., Circle, J. T., Levin, M., & Kleerekoper, B. (1998). Cytarabine liposome injection for the treatment of leptomeningeal carcinomatosis. Journal of Neuro-Oncology, 37(2), 165-170.

[2] LeRhun, E., & Chamberlain, M. C. (2000). Leptomeningeal metastases. Current Treatment Options in Neurology, 2(3), 235-246.

[3] U.S. Patent 4,885,172. (1989). Liposome compositions.

[4] Pacira Pharmaceuticals, Inc. (2015). Pacira Pharmaceuticals Announces Sale of Depocyt Business to EUSA Pharma. [Press release].

[5] U.S. Food and Drug Administration. (n.d.). Approved ANDAs. Retrieved from [FDA website, specific database search for cytarabine liposome injection generics would be referenced here in a live document]