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:	123
Clinical Trials:	79
Patent Applications:	4,448
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DEPOCYT
DailyMed Link:	DEPOCYT at DailyMed

Recent Clinical Trials for DEPOCYT

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

Sponsor	Phase
Kartos Therapeutics, Inc.	Phase 1/Phase 2
University of Florida	Phase 2
Medical College of Wisconsin	Phase 1

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	7,198,801
Pacira Pharms Inc	DEPOCYT	cytarabine	INJECTABLE, LIPOSOMAL;INJECTION	021041-001	Apr 1, 1999	5,455,044
Pacira Pharms Inc	DEPOCYT	cytarabine	INJECTABLE, LIPOSOMAL;INJECTION	021041-001	Apr 1, 1999	6,071,534
Pacira Pharms Inc	DEPOCYT	cytarabine	INJECTABLE, LIPOSOMAL;INJECTION	021041-001	Apr 1, 1999	5,962,016
Pacira Pharms Inc	DEPOCYT	cytarabine	INJECTABLE, LIPOSOMAL;INJECTION	021041-001	Apr 1, 1999	5,723,147

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/000317 Intrathecal 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	Withdrawn	no	no	no	2001-07-11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
Denmark	1670433
Austria	485837
Israel	170454	תכשירים של חומרים פעילים למתן דרך העור או דרך ריריות ושימושים בהם (Transdermal or transmucosal formulations of active agents and uses thereof)
Austria	355854
Brazil	PI0414551
European Patent Office	1307232	COMPOSITION POUR L'ADMINISTRATION TRANSDERMIQUE ET/OU TRANSMUQUEUSE DE COMPOSES ACTIFS ASSURANT DES NIVEAUX D'EFFICACITE THERAPEUTIQUE ADEQUATS (NOVEL COMPOSITION FOR TRANSDERMAL AND/OR TRANSMUCOSAL ADMINISTRATION OF ACTIVE COMPOUNDS THAT ENSURES ADEQUATE THERAPEUTIC LEVELS)
Poland	1670433

Supplementary Protection Certificates for DEPOCYT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2768484	SPC/GB19/067	United Kingdom		PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; REGISTERED: UK EU/1/18/1308(FOR NI) 20180827; UK PLGB 31626/0004 20180827
3300601	LUC00271	Luxembourg		PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; AUTHORISATION NUMBER AND DATE: EU/1/18/1308 20180827
1744764	18C1047	France		PRODUCT NAME: DAUNORUBICINE + 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
3300601	2290030-2	Sweden		PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; REG. NO/DATE: EU/1/18/1308 20180827
2768484	LUC00135	Luxembourg		PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND 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

DEPOCYT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DEPOCYT

Introduction

DEPOCYT, a liposomal formulation of cytarabine, has been a significant player in the treatment of lymphomatous meningitis, a life-threatening complication of lymphoma. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting its development, regulatory issues, and the impact of its discontinuation.

Development and Approval

DEPOCYT was originally developed by DepoTech and received accelerated approval from the U.S. Food and Drug Administration (FDA) in 1999 for the intrathecal treatment of lymphomatous meningitis. Full approval followed in 2007[1][3][4].

Technology and Mechanism

The drug utilizes SkyePharma's proprietary lipid-based drug delivery technology, DepoFoam, which allows for the sustained release of cytarabine into the cerebral spinal fluid, extending the dosing interval to once every two weeks compared to standard intrathecal chemotherapy dosing of twice a week[3].

Market Presence

DEPOCYT was the only FDA-approved treatment for lymphomatous meningitis, making it a critical option for patients with this condition. However, its market presence was marred by several challenges.

Regulatory and Manufacturing Issues

The drug faced significant regulatory and manufacturing hurdles. In 1999, it was voluntarily withdrawn from the market due to stability issues, and it was reintroduced in 2001 after resolving these problems[3].

In 2012, an inspection by the U.K. Medicines & Healthcare Products Regulatory Agency led to the European Medicines Agency recommending a precautionary product withdrawal in European countries where alternative treatments were available. This was due to manufacturing deficiencies, including a lack of adequate sterility assurance[1][4].

Discontinuation of Production

In 2017, Pacira Pharmaceuticals announced the discontinuation of DEPOCYT production due to persistent technical issues specific to the manufacturing process. This decision included a $5 million charge in the second quarter of 2017, comprising asset write-offs and other costs such as lease and employee severance[1][4].

Financial Impact

The discontinuation had a minimal immediate impact on Pacira's share price, which remained steady at around $48 per share. However, the decision reflected broader financial implications:

• Revenue Contribution: DEPOCYT accounted for a small fraction of Pacira's total revenues, approximately 2.5% in the previous year. Sales of DEPOCYT and other immaterial product lines totaled $724,000 in the first three months of 2017, down 3% from the same period the previous year[1].
• Royalty Revenues: Pacira also collected royalty revenues on DEPOCYT sales by its commercial partners, Sigma-Tau and MundiPharma[1].

Alternative Treatments

The discontinuation of DEPOCYT raised concerns about the availability of alternative treatments. While other cytarabine products are available, they are not in the same liposomal formulation and may not be approved for intrathecal use. This has potential implications for patient care and treatment options[4].

Market Dynamics Post-Discontinuation

The discontinuation of DEPOCYT has shifted the market dynamics for lymphomatous meningitis treatments. Physicians may now rely on non-liposomal cytarabine or other chemotherapy agents, which could affect treatment outcomes and patient compliance.

Competitive Landscape

The competitive landscape for chemotherapy agents, particularly those targeting lymphomatous meningitis, remains intense. Other manufacturers, such as Hospira, Mylan, West-Ward, and Fresenius-Kabi, produce cytarabine in different formulations, but none are liposomal[4].

Future Implications

The discontinuation of DEPOCYT highlights the challenges faced by pharmaceutical companies in maintaining complex manufacturing processes and ensuring regulatory compliance. It also underscores the importance of having robust life-cycle management plans to address potential issues and ensure continuous product availability.

Key Takeaways

• Regulatory Challenges: DEPOCYT faced multiple regulatory issues, including stability and sterility concerns.
• Manufacturing Issues: Persistent technical problems led to the discontinuation of production.
• Financial Impact: The drug contributed a small fraction to Pacira's revenues, but its discontinuation had broader financial and operational implications.
• Alternative Treatments: The market now relies on non-liposomal cytarabine and other chemotherapy agents.
• Competitive Landscape: The competitive environment for chemotherapy agents remains competitive, with multiple manufacturers producing different formulations.

FAQs

Q: What is DEPOCYT used for? A: DEPOCYT is used for the intrathecal treatment of lymphomatous meningitis, a life-threatening complication of lymphoma.

Q: Why was DEPOCYT discontinued? A: DEPOCYT was discontinued due to persistent technical issues specific to its manufacturing process.

Q: What technology does DEPOCYT use? A: DEPOCYT uses SkyePharma's proprietary lipid-based drug delivery technology, DepoFoam.

Q: How did the discontinuation affect Pacira's share price? A: The discontinuation had a minimal immediate impact on Pacira's share price.

Q: Are there alternative treatments available for lymphomatous meningitis? A: Yes, other cytarabine products are available, although they are not in the same liposomal formulation as DEPOCYT.

Sources

1. BioPharma Dive - Pacira halts production of Depocyt - BioPharma Dive
2. Annual Reports - Enzon Pharmaceuticals - Annual Reports
3. Cancer Network - DepoCyt, Liposomal Cytarabine, Reintroduced Into US Market
4. The FDA Law Blog - cGMP Problems Shrink the DepoCyt Chemotherapy Market
5. Pacira Pharmaceuticals - United States Securities and Exchange Commission - Investors