DEPODUR Drug Patent Profile

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

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

The generic ingredient in DEPODUR is morphine sulfate. There are twenty-three drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Depodur

A generic version of DEPODUR was approved as morphine sulfate by HOSPIRA on September 30^th, 1992.

Summary for DEPODUR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	11
Patent Applications:	2,962
DailyMed Link:	DEPODUR at DailyMed

Recent Clinical Trials for DEPODUR

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

Sponsor	Phase
Columbia University	Phase 4
Washington University School of Medicine	N/A
Wake Forest University	Phase 4

See all DEPODUR clinical trials

US Patents and Regulatory Information for DEPODUR

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	DEPODUR	morphine sulfate	INJECTABLE, LIPOSOMAL;EPIDURAL	021671-001	May 18, 2004		DISCN	No	No
Pacira Pharms Inc	DEPODUR	morphine sulfate	INJECTABLE, LIPOSOMAL;EPIDURAL	021671-002	May 18, 2004		DISCN	No	No
Pacira Pharms Inc	DEPODUR	morphine sulfate	INJECTABLE, LIPOSOMAL;EPIDURAL	021671-003	May 18, 2004		DISCN	No	No

Expired US Patents for DEPODUR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pacira Pharms Inc	DEPODUR	morphine sulfate	INJECTABLE, LIPOSOMAL;EPIDURAL	021671-003	May 18, 2004	5,807,572
Pacira Pharms Inc	DEPODUR	morphine sulfate	INJECTABLE, LIPOSOMAL;EPIDURAL	021671-001	May 18, 2004	6,193,998
Pacira Pharms Inc	DEPODUR	morphine sulfate	INJECTABLE, LIPOSOMAL;EPIDURAL	021671-002	May 18, 2004	5,962,016

International Patents for DEPODUR

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

Country	Patent Number	Title	Estimated Expiration
Brazil	9609717
Norway	20100437
Canada	2277956	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)

DEPODUR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DepoDur

Introduction

DepoDur, a morphine sulfate extended-release liposome injection, is a groundbreaking medication developed by Pacira Pharmaceuticals, utilizing their innovative DepoFoam technology. This article delves into the market dynamics and financial trajectory of DepoDur, highlighting its unique value proposition, market penetration, and the financial performance of the companies involved in its distribution.

Unique Value Proposition of DepoDur

DepoDur stands out as the only FDA-approved opioid for epidural use, providing pain relief for up to 48 hours following major surgery without the need for an indwelling epidural catheter. This single-dose extended-release formulation reduces the complications associated with traditional epidural catheters, making it a valuable asset in post-surgical pain management[1][4].

Market Need and Target Audience

The demand for effective post-surgical pain management is significant, with millions of surgical procedures conducted annually. In Europe alone, there are an estimated 5 million surgical procedures where DepoDur can be utilized to manage post-operative pain in hospitalized patients[4].

Acquisition and Distribution Rights

The rights to DepoDur have been acquired by several companies to expand its market reach. EKR Therapeutics acquired the exclusive marketing and distribution rights for the Americas, while Flynn Pharma secured these rights for Europe and other markets. These acquisitions reflect the strategic importance of DepoDur in the acute care and hospital settings[1][4].

Market Penetration and Launch Strategies

EKR Therapeutics and Flynn Pharma have implemented robust launch strategies to maximize DepoDur’s market penetration. EKR commenced pre-launch activities, including interactions with opinion leaders, and planned to deploy its sales force early in the launch year. Similarly, Flynn Pharma initiated meetings with key opinion leaders and expected to have its UK sales force fully supporting DepoDur early in 2008[1][4].

Financial Performance of EKR Therapeutics

The acquisition of DepoDur by EKR Therapeutics was seen as a key growth milestone. EKR anticipated significant growth prospects, expecting a ramp-up in sales for DepoDur and another product, Gelclair. The company’s strategy focused on building a portfolio of premier products in the acute care space, with DepoDur fitting well into this model due to its innovative technology and market need[1].

Financial Performance of Flynn Pharma

Flynn Pharma’s acquisition of DepoDur for European markets was part of its strategy to add innovative products to its hospital product portfolio. The company was optimistic about its growth prospects, planning to expand DepoDur’s use beyond the UK through the mutual recognition procedure and by selecting marketing partners in Europe. This strategic move was expected to enhance Flynn’s presence in the secondary healthcare market[4].

Financial Impact on Pacira Pharmaceuticals

Pacira Pharmaceuticals, the developer of DepoDur, saw significant financial benefits from the licensing and distribution agreements. For instance, in the first quarter of 2012, Pacira recognized $5.8 million in collaborative licensing and development revenue following the termination of the licensing agreement with EKR Therapeutics. This revenue boost contributed to a total revenue increase from $3.9 million to $7.8 million compared to the same quarter in the previous year[5].

Market Synergies and Competitive Advantage

Both EKR Therapeutics and Flynn Pharma aimed to leverage their existing sales forces and market presence to promote DepoDur. The concentrated nature of the hospital marketplace allows for significant marketing synergies, enabling these companies to effectively target key institutions and maximize the product’s commercial potential[1][4].

Regulatory and Clinical Context

DepoDur’s approval by regulatory bodies such as the FDA and the UK's MHRA underscores its clinical efficacy and safety. The product received FDA approval in 2004 for long-acting post-surgical pain management, and it is the only opioid approved in Europe for epidural use[1][4].

Challenges and Opportunities

While DepoDur offers a unique solution for post-surgical pain, it operates within a competitive landscape. The opioid market is subject to various regulatory and societal pressures, particularly concerning opioid use and abuse. However, the product’s extended-release formulation and the absence of an indwelling catheter reduce some of the risks associated with traditional opioids, presenting a compelling opportunity for growth[1][4].

Key Takeaways

• Innovative Technology: DepoDur utilizes Pacira’s DepoFoam technology, providing extended-release pain relief without the need for an indwelling epidural catheter.
• Market Need: Significant demand for effective post-surgical pain management across millions of surgical procedures annually.
• Strategic Acquisitions: EKR Therapeutics and Flynn Pharma acquired rights to expand DepoDur’s market reach in the Americas and Europe.
• Financial Performance: The product contributed to revenue growth for companies involved, such as Pacira Pharmaceuticals and EKR Therapeutics.
• Market Synergies: Leveraging existing sales forces and market presence to maximize commercial potential.

FAQs

What is DepoDur and how does it work?

DepoDur is a morphine sulfate extended-release liposome injection that provides pain relief for up to 48 hours following major surgery through a single injection into the lumbar epidural space, utilizing Pacira’s DepoFoam technology[1][4].

Which companies have acquired the rights to DepoDur?

EKR Therapeutics acquired the rights for the Americas, while Flynn Pharma acquired the rights for Europe and other markets[1][4].

What are the key benefits of DepoDur in post-surgical pain management?

DepoDur offers extended-release pain relief without the need for an indwelling epidural catheter, reducing associated complications and providing effective pain management for up to 48 hours[1][4].

How has DepoDur impacted the financial performance of the companies involved?

The product has contributed to revenue growth for companies like Pacira Pharmaceuticals through licensing and development revenue, and for EKR Therapeutics and Flynn Pharma through increased sales and market penetration[1][5].

What are the regulatory approvals for DepoDur?

DepoDur is approved by the FDA for long-acting post-surgical pain management and by the UK's MHRA for epidural use in Europe[1][4].

What are the market synergies associated with DepoDur?

Both EKR Therapeutics and Flynn Pharma leverage their existing sales forces and market presence to target key hospitals and institutions, maximizing the product’s commercial potential[1][4].

Sources

1. EKR Therapeutics Achieves Key Growth Milestone with the Acquisition of Rights from Pacira Pharmaceuticals to DepoDur® - Investor Relations
2. Indivior Q3 and YTD 2024 Financial Results FINAL - Indivior
3. Untitled - Investor Relations - Mallinckrodt
4. Flynn Pharma Acquires Rights from Pacira Pharmaceuticals to DepoDur® - Business Wire
5. Pacira Pharmaceuticals, Inc. Reports First Quarter 2012 Financial Results - Business Wire