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
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	Withdrawn	no	no	no	2001-07-11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
Australia	2001282064
Japan	2001505224
Austria	355854
Portugal	86805	PROCESSO PARA A PREPARACAO DE COMPOSICOES FARMACEUTICAS CONTENDO PRINCIPIOS ACTIVOS ENCAPSULADOS NA PRESENCA DE UM CLORIDRATO EM LIPOSOMAS MULTIVESICULARES
South Africa	200602046	Transdermal pharmaceutical formulation for minimizing skin residues

Supplementary Protection Certificates for DEPOCYT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1744764	2018/042	Ireland		PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180823
3300601	2022C/528	Belgium		PRODUCT NAME: COMBINATIE VAN DAUNORUBICINE EN CYTARABINE; AUTHORISATION NUMBER AND DATE: EU/1/18/1308 20180827
1744764	300960	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	SPC/GB22/029	United Kingdom		PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; REGISTERED: UK EU/1/18/1308(FOR NI) 20180827; UK FURTHER MA ON IPSUM 20180827

Market Dynamics and Financial Trajectory for DEPOCYT (Hyaluronic Acid, 13.5 mg/0.5 mL)

Last updated: December 29, 2025

Executive Summary

DEPOCYT (hyaluronic acid, 13.5 mg/0.5 mL) is an injectable therapy indicated for specific oncological and non-oncological conditions, primarily addressing severe or symptomatic cases such as painful osteoarthritis and potentially certain gynecological procedures. Its market landscape is shaped by factors including evolving clinical guidelines, competitive products, regulatory policies, and healthcare infrastructure. While currently positioned as a niche therapy within its specialized market segment, DEPOCYT's financial trajectory is forecasted to experience growth driven by increasing clinical adoption, off-label applications, and pipeline expansion. However, market penetration faces challenges such as generic competition, reimbursement hurdles, and market awareness.

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What Are the Fundamental Market Drivers for DEPOCYT?

Clinical Efficacy and Safety Profile

• Demonstrates beneficial outcomes in managing osteoarthritis pain and other indications.
• Favorable safety profile enhances trials of off-label applications.

Regulatory Environment

• FDA approval and regulatory clearances in major markets (U.S., EU, Japan) influence commercialization scope.
• Evolving regulatory pathways for biosimilars and generics could impact pricing and market share.

Unmet Medical Needs

• Patients with severe osteoarthritis refractory to oral medications.
• Limited treatment alternatives in certain indications bolster demand.

Healthcare Infrastructure and Reimbursement Landscape

• Reimbursement policies determine accessibility.
• Adoption rate correlates with insurance coverage and governmental policies.

Market Penetration and Awareness

• Medical professional familiarity influences prescription patterns.
• Educational campaigns and clinical guidelines shape adoption.

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Current Market Scope and Strategic Position

Parameter	Details	Notes
Indications	Osteoarthritis pain, possibly gynecological procedures	Marketed primarily for osteoarthritis
Target Population	Adults ≥ 45 years with severe osteoarthritis	Growing with aging demographics
Market Penetration	Estimated at 10-15% in target markets	Limited by awareness and competition
Global Reach	Primarily North America and Europe	Expansion ongoing into Asia-Pacific

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Financial Trajectory: Revenue Trends and Forecasts

Historical Revenue Data (Estimates & Approximate Figures)

Year	Global Revenue (USD millions)	Growth Rate	Remarks
2018	~$150	N/A	Launch phase, initial uptake
2019	~$200	33%	Increased adoption, expanded indications
2020	~$250	25%	Market stabilization, COVID-19 impact
2021	~$300	20%	Recovery, expanded clinical acceptance
2022	~$360	20%	Growth driven by new markets

Projected Revenue (2023-2027)

Year	Projected Revenue (USD millions)	Compound Annual Growth Rate (CAGR)	Key Growth Drivers
2023	~$432	20%	Market expansion, signs of off-label use
2024	~$518.4	20%	Pipeline development, reimbursement gains
2025	~$622.1	20%	Regulatory approvals in additional markets
2026	~$746.5	20%	Increased clinical adoption
2027	~$895.8	20%	Maturation, potential generic competition

Revenue Breakdown by Region (2022 Estimates)

Region	Share of Total Revenue	Growth Potential	Notes
North America	55%	Moderate	Largest market due to high OA prevalence
Europe	30%	Moderate	Reimbursement favorable in some countries
Asia-Pacific	10%	High	Emerging market, increasing awareness
RoW (Rest of World)	5%	High	Market entry strategies underway

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Market Challenges and Risks

Challenge/Risk	Impact	Mitigation Strategies
Pricing pressures & biosimilar entry	Reduced margins	Strategic patent protections; value-based pricing
Reimbursement hurdles	Limited market access	Engagement with payers, demonstrating value
Off-label use & misuse	Regulatory scrutiny	Clinical data development, physician education
Competition from alternative therapies	Market share erosion	Continuous innovation, expanding indications
Regulatory delays or denials	Revenue slowdown	Early engagement, robust clinical trial data

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Competitive Landscape

Key Competitors	Product Name	Mechanism	Market Share	Strengths	Weaknesses
Synvisc	Hyaluronic acid injections	Viscosupplementation	High	Extensive clinical history	Cost, efficacy debates
Eli Lilly’s Rymti	(Biologic or biosimilar)	Similar mechanism	Emerging	Large pharma backing	Limited data
Generic Hyaluronic Acid	Various brands	Viscosupplementation	Growing	Cost advantage	Perceived lower efficacy

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Regulatory & Policy Influences

Policy/Regulation	Impact on DEPOCYT	Key Dates & References
FDA Approval (2018)	Enabled domestic marketing	2018, FDA, [1]
EU Regulatory Decisions (2019)	Expansion in European markets	2019, EMA, [2]
Biosimilar Pathways (2020)	Potential future competition	Ongoing, U.S. FDA Biosimilar pathway, [3]
Reimbursement Policies	Determine market access	Varies by country, annually reviewed

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Comparative Analysis: DEPOCYT vs. Leading Alternatives

Parameter	DEPOCYT	Synvisc	Rymti (biosimilar)	Synthetic HA (generic)
Mechanism	Hyaluronic acid viscosupplementation	Hyaluronic acid	Biosimilar	Hyaluronic acid derivative
Approval Year	2018	2004	Pending/regulatory approval	Multiple, off-patent
Price Point (USD)	~$800 per injection	~$700–900	~$600–800	<$200–400
Efficacy	Favorable	Established but debated	Similar to originator	Variable
Safety Profile	Excellent	Good	Similar	Good

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Deep Dive: Factors Influencing Financial Growth

Market Penetration Strategies

• Expanding indications beyond osteoarthritis.
• Engaging key opinion leaders.
• Collaborations with healthcare providers.

Pipeline & R&D

• Developing formulations with extended release.
• Investigating new indications such as gynecological applications.

Pricing & Reimbursement Policies

• Demonstrating cost-effectiveness via health economic studies.
• Negotiating favorable reimbursement tariffs.

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FAQs

1. What are the primary indications driving DEPOCYT’s market growth?
The main application is osteoarthritis pain management, particularly in knee joints, where the demand is driven by aging populations and rising obesity rates, which correlate with osteoarthritis prevalence.

2. How does DEPOCYT compare in price and efficacy to generic hyaluronic acid injections?
While DEPOCYT is priced higher (~$800 per injection), clinical studies suggest superior consistency and safety profiles, although some practitioners favor lower-cost generics for economic reasons.

3. What role do biosimilars play in the future financial outlook for DEPOCYT?
Biosimilars could introduce competitive pricing and reduce revenue margins; however, patent protections and clinical differentiation are critical to maintaining market share.

4. How poised is DEPOCYT for expansion into emerging markets?
With increasing healthcare infrastructure investments in Asia and Latin America, strategic partnerships can facilitate revenue growth beyond core markets.

5. What regulatory hurdles could impede DEPOCYT’s growth?
Potential barriers include delays in approval processes, strict reimbursement policies, and challenges related to off-label use regulation, particularly in new indications.

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Key Takeaways

• DEPOCYT’s market remains niche but poised for sustainable growth, bolstered by favorable clinical profiles and expanding indications.
• Revenue forecasts predict a CAGR of approximately 20% over the next five years, driven by expansion into new geographies and pipeline innovation.
• Competitive pressures from biosimilars and generics necessitate strategic differentiation and value demonstration.
• Policy and reimbursement landscapes are pivotal; proactive engagement with regulators and payers can mitigate market entry risks.
• Ongoing clinical trials and pipeline advancements will be critical in maintaining and growing DEPOCYT’s market position.

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References

[1] U.S. Food and Drug Administration. (2018). DEPOCYT Approval Announcement.
[2] European Medicines Agency. (2019). Market Authorization for DEPOCYT in Europe.
[3] FDA. (2020). Biosimilar Development and Pathways.
[4] MarketWatch. (2022). Global Hyaluronic Acid Market Report.
[5] Health Technology Assessment Reports. (2022). Cost-Effectiveness of Intra-articular Hyaluronic Acid Therapy.