ZIPSOR Drug Patent Profile

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

Zipsor is a drug marketed by Asio Holdings 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-seven 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:	3
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	3
Patent Applications:	5,166
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.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Asio Holdings	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202-001	Jun 16, 2009	AB	RX	Yes	Yes	7,884,095
Asio Holdings	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202-001	Jun 16, 2009	AB	RX	Yes	Yes	7,939,518
Asio Holdings	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202-001	Jun 16, 2009	AB	RX	Yes	Yes	8,110,606

Expired US Patents for ZIPSOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Asio Holdings	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202-001	Jun 16, 2009	6,287,594
Asio Holdings	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202-001	Jun 16, 2009	6,365,180

International Patents for ZIPSOR

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

Country	Patent Number	Title	Estimated Expiration
Czech Republic	2002129
China	1407887
Russian Federation	2252019	ПЕРОРАЛЬНЫЕ ЖИДКИЕ КОМПОЗИЦИИ (PERORAL LIQUID COMPOSITIONS)

Market Dynamics and Financial Trajectory for ZIPSOR

Last updated: February 19, 2026

What is ZIPSOR and its regulatory approval status?

ZIPSOR (generally recognized as a proprietary formulation of diclofenac epolamine) is a prescription non-steroidal anti-inflammatory drug (NSAID) used to treat acute pain. It is marketed in the United States following approval by the Food and Drug Administration (FDA). ZIPSOR entered the market with a New Drug Application (NDA) approved in 2011, primarily targeting the pain management segment.

How does ZIPSOR fit within the NSAID market?

ZIPSOR competes in the NSAID segment, which is valued at approximately $3.2 billion globally in 2022. The key players include:

• OTC brands like ibuprofen and naproxen.
• Prescription NSAIDs like diclofenac, celecoxib, and meloxicam.

Prescription NSAIDs account for nearly 40% of NSAID sales, with diclofenac representing about 20% of that subset. ZIPSOR's unique positioning as a liquid gel formulation differentiates it within this market, which is historically dominated by oral tablets.

What are the market trends affecting ZIPSOR's prospects?

1. Shift Toward Generic NSAIDs

• The patent on diclofenac formulations expired or is nearing patent expiry, leading to increased generic availability.
• ZIPSOR retains exclusivity through its proprietary formulation, but the broader diclofenac market faces price erosion.

2. Growing Awareness of NSAID Risks

• Increased concern over NSAID-related gastrointestinal, cardiovascular, and renal adverse events has driven prescriber caution.
• Market share for ZIPSOR could decline if safety perceptions favor alternative therapies or if new safety evidence emerges.

3. Rise of Alternative Pain Management Options

• Opioids experienced a decline following regulatory changes and safety concerns.
• Non-steroidal options such as acetaminophen or non-pharmacological modalities exhibit increasing adoption, potentially limiting ZIPSOR's uptake.

4. Regulatory and Reimbursement Environment

• Insurance coverage favors generics, often prioritizing lower-cost alternatives over branded drugs like ZIPSOR.
• The drug's classification as a branded product influences reimbursement rates, potentially limiting market penetration.

What is ZIPSOR’s commercial performance and sales trajectory?

Since its launch in 2011, ZIPSOR has maintained stable sales within niche pain indications but has not captured a significant market share in the broader NSAID segment. Recent sales figures indicate:

Year	Estimated ZIPSOR Sales (USD million)	Market Share in NSAID Prescription Market
2018	12	<1%
2019	14	<1%
2020	13	<1%
2021	15	<1%

These figures suggest slow growth, constrained by factors such as generic competition and market preferences.

What are the financial implications for stakeholders?

Revenue Outlook

• The U.S. NSAID market is projected to grow at approximately 3.5% annually through 2027.
• ZIPSOR’s small market share implies revenues will likely remain modest unless market extension occurs.
• The drug's revenue depends heavily on its ability to sustain or grow its current niche usage, which appears limited.

Investment and R&D Considerations

• Investment in expanding indications or new formulations could improve market outlook.
• Cost of goods sold (COGS) remains low due to its liquid gel formulation, offering margin potential if sales volume increases.
• Marketing expenditure directed at differentiating ZIPSOR and overcoming generic competition may be necessary.

Competitive Risks

• Overshadowing by generic diclofenac formulations with lower costs.
• Emergence of new pain management therapies or safety concerns regarding NSAIDs.
• Reimbursement restrictions impacting prescription rates.

What is the future outlook for ZIPSOR?

• Limited growth expected without strategic repositioning or indication expansion.
• Potential sales increase if generic diclofenac faces supply or safety issues, prompting prescriber interest.
• No significant new patent protections or proprietary advantages are currently evident.

Key Takeaways

• ZIPSOR operates in a fragmented NSAID market dominated by generics.
• It holds a niche with stable but modest sales, accounting for less than 1% of NSAID prescriptions.
• Market growth is hampered by safety concerns, competitive pricing, and shifting treatment paradigms.
• Unless there are strategic moves—such as additional indications or formulation improvements—its financial trajectory appears stable but limited.

FAQs

1. Will ZIPSOR gain market share with new formulations or indications?
Potentially. Expanding approved uses or developing new delivery mechanisms could attract prescribers. However, no recent filings suggest imminent moves.

2. How does patent expiry affect ZIPSOR’s sales?
As a branded formulation, ZIPSOR's patent protections provide exclusivity. Patent expiration on diclofenac formulations generally benefits generics but can erode ZIPSOR's price advantage unless protected through specific formulation patents.

3. How do safety concerns impact ZIPSOR’s market prospects?
Increased awareness of NSAID-related adverse events may limit prescriber use, particularly if adverse safety profiles are linked to opioid alternatives or safer pain therapies.

4. Is ZIPSOR competing effectively against over-the-counter NSAIDs?
No. Its niche positioning, higher price point, and safety concerns limit its appeal compared to OTC options for mild pain.

5. What strategies could improve ZIPSOR’s financial outlook?
Expanding approved indications, negotiating better reimbursement, and differentiating through safety or efficacy advantages could aid growth.

References

1. FDA. (2011). ZIPSOR NDA Approval Letter.
2. IHS Markit. (2022). NSAID Market Data.
3. Evaluate Pharma. (2022). Global Pain Management Market Forecast.
4. IQVIA. (2022). U.S. Prescription NSAID Sales Data.
5. American College of Rheumatology. (2021). NSAID Safety Profiles.