ZIPSOR Drug Patent Profile

When do Zipsor patents expire, and when can generic versions of Zipsor launch?

Zipsor is a drug marketed by Assertio and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in ZIPSOR is diclofenac potassium. There are forty-seven drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the diclofenac potassium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zipsor

A generic version of ZIPSOR was approved as diclofenac potassium by TEVA on August 6^th, 1998.

Summary for ZIPSOR

US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	3
Patent Applications:	4,575
Drug Prices:	Drug price information for ZIPSOR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZIPSOR
What excipients (inactive ingredients) are in ZIPSOR?	ZIPSOR excipients list
DailyMed Link:	ZIPSOR at DailyMed

See drug prices for ZIPSOR

See drug sales revenues for ZIPSOR

Recent Clinical Trials for ZIPSOR

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

Sponsor	Phase
Depomed	Phase 4
Hospira, Inc.	Phase 1
Hospira, now a wholly owned subsidiary of Pfizer	Phase 1

See all ZIPSOR clinical trials

Pharmacology for ZIPSOR

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors
Physiological Effect	Decreased Prostaglandin Production

Paragraph IV (Patent) Challenges for ZIPSOR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZIPSOR	Capsules	diclofenac potassium	25 mg	022202	1	2012-11-14

US Patents and Regulatory Information for ZIPSOR

ZIPSOR is protected by six US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Assertio	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202-001	Jun 16, 2009	AB	RX	Yes	Yes
Assertio	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202-001	Jun 16, 2009	AB	RX	Yes	Yes
Assertio	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202-001	Jun 16, 2009	AB	RX	Yes	Yes
Assertio	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202-001	Jun 16, 2009	AB	RX	Yes	Yes

Expired US Patents for ZIPSOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Assertio	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202-001	Jun 16, 2009
Assertio	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202-001	Jun 16, 2009

International Patents for ZIPSOR

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1196147
Australia	770772
Mexico	PA02000583	COMPOSICIONES LIQUIDAS ORALES. (ORAL LIQUID COMPOSITIONS.)
Czech Republic	2002129

ZIPSOR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Zipsor

Introduction

Zipsor, a prescription strength nonsteroidal anti-inflammatory drug (NSAID), has been a significant player in the pain management market since its approval in 2009. Here, we delve into the market dynamics and financial trajectory of Zipsor, highlighting its unique features, market performance, and the impact of various factors on its sales.

Unique Features of Zipsor

Zipsor is distinguished by several key features:

• It is the first and only prescription strength NSAID available in a liquid-filled soft gelatin capsule, making it easier to swallow and providing a quick onset of action[1].
• It is the lowest available dose (25 mg) of any currently marketed diclofenac potassium product in the United States, aligning with FDA recommendations to prescribe the lowest possible dose NSAID as first-line therapy[1].

Market Position

Zipsor entered the market as a new therapeutic option for physicians, offering advantages over traditional tablets, gels, and patches. Its unique formulation and low dose made it an attractive choice for patients requiring NSAID therapy[1].

Financial Performance

Initial Launch and Growth

Upon its launch, Zipsor represented a significant milestone for Xanodyne, the company behind its development. The product was expected to capitalize on the growing demand for NSAIDs, particularly in the post-surgical pain management sector[1].

Recent Trends

However, the financial performance of Zipsor has faced challenges in recent years. The entry of generic versions in March 2022 significantly impacted its sales. Assertio Holdings, Inc., the current owner of Zipsor, reported a decline in Zipsor sales due to the introduction of generics and an unfavorable payor mix[3][5].

Impact of Generic Competition

The availability of generic versions has led to a reduction in Zipsor's market share. This is evident from Assertio Holdings' financial reports, which show lower sales volumes for Zipsor in 2022 compared to previous years. The company's net product sales for Zipsor decreased, partly due to the generic competition and changes in the payor mix[3][5].

Market Dynamics

Non-Opioid Pain Treatment Market

The non-opioid pain treatment market, in which Zipsor operates, is growing rapidly. This market is driven by strong demand for NSAIDs, government initiatives to reduce opioid usage, and advancements in healthcare infrastructure. The U.S. non-opioid pain treatment market, in particular, is expected to grow significantly, with NSAIDs like Zipsor continuing to dominate due to their effectiveness and safety profile[4].

Competitive Landscape

The competitive landscape for NSAIDs is robust, with several other products like Cambia, Cataflam, Dyloject, and Zorvolex competing in the market. Despite this competition, Zipsor's unique formulation and low dose have maintained its relevance. However, the entry of generics has altered the competitive dynamics, making it challenging for branded products like Zipsor to maintain market share[4].

Financial Impact on Assertio Holdings

Revenue and Net Income

Assertio Holdings' financial performance has been influenced by the decline in Zipsor sales. While the company has seen overall growth in net product sales driven by other products like Indocin and Sympazan, the decline in Zipsor sales has been a notable factor. In 2022, Assertio reported a significant increase in net income, largely due to a tax benefit, but the underlying sales performance of Zipsor was less favorable[2][3].

Operational Expenses

The company's operational expenses, including selling, general, and administrative expenses, have increased due to higher stock-based compensation and sales and marketing expenses related to new product additions like Sympazan. These expenses have been partially offset by the growth in other product lines, but the decline in Zipsor sales has still had a noticeable impact[2].

Future Outlook

Generic Competition and Market Share

The future outlook for Zipsor is challenging due to the ongoing presence of generic competition. Assertio Holdings will need to focus on other products in its portfolio to offset the decline in Zipsor sales. The company's strategy to acquire new products and leverage its commercial platform through digital and non-personal promotional means is crucial for maintaining its market position[3].

Market Growth and Opportunities

Despite the challenges, the non-opioid pain treatment market continues to grow, presenting opportunities for innovative products. Assertio Holdings' ability to adapt to market changes and invest in new therapeutic areas will be key to its long-term success. The company's focus on acquiring products with significant patent life or exclusivity and leveraging its commercial platform will help in navigating the competitive landscape[3][4].

Key Takeaways

• Unique Formulation: Zipsor's liquid-filled soft gelatin capsule and low dose (25 mg) of diclofenac potassium differentiate it in the NSAID market.
• Generic Competition: The entry of generic versions in 2022 has significantly impacted Zipsor's sales and market share.
• Financial Performance: Assertio Holdings' financial reports show a decline in Zipsor sales, offset by growth in other product lines.
• Market Dynamics: The non-opioid pain treatment market is growing, driven by demand for NSAIDs and government initiatives to reduce opioid usage.
• Future Outlook: Assertio Holdings must focus on new product acquisitions and leveraging its commercial platform to maintain market position.

FAQs

What is Zipsor and how is it unique?

Zipsor is a prescription strength NSAID available in a liquid-filled soft gelatin capsule, offering the lowest available dose (25 mg) of diclofenac potassium in the U.S. market. Its unique formulation provides an easy-to-swallow option with a quick onset of action[1].

How has the introduction of generic versions affected Zipsor's sales?

The introduction of generic versions in March 2022 has significantly reduced Zipsor's sales, as generic competition has led to lower sales volumes and an unfavorable payor mix[3][5].

What is the current market size and growth rate of the non-opioid pain treatment market?

The non-opioid pain treatment market was valued at USD 48.38 billion in 2024 and is projected to reach USD 96.25 billion by 2034, with a CAGR of 7.12% from 2024 to 2034[4].

How has Assertio Holdings' financial performance been impacted by Zipsor's decline?

Assertio Holdings' net product sales have been impacted by the decline in Zipsor sales, although overall growth in other product lines has helped offset this decline. The company's net income has seen significant increases due to tax benefits and other factors[2][3].

What strategies is Assertio Holdings adopting to mitigate the impact of generic competition?

Assertio Holdings is focusing on acquiring new products with significant patent life or exclusivity, leveraging its commercial platform through digital and non-personal promotional means, and integrating its virtual sales team to maximize effectiveness[3].

Sources

1. Zipsor - MM+M - Medical Marketing and Media
2. Assertio Reports Fourth Quarter and Full Year 2022 Financial Results
3. Assertio Holdings, Inc. - 10K - Annual Report - March 08, 2023 - Fintel
4. Non-opioid Pain Treatment Market Size to Hit USD 96.25 by 2034
5. ASSERTIO HOLDINGS, INC. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS