PENNSAID Drug Patent Profile

Which patents cover Pennsaid, and what generic alternatives are available?

Pennsaid is a drug marketed by Horizon and Nuvo Pharms Inc and is included in two NDAs. There are nineteen patents protecting this drug and two Paragraph IV challenges.

This drug has eighteen patent family members in fourteen countries.

The generic ingredient in PENNSAID is diclofenac sodium. There are forty-seven drug master file entries for this compound. One hundred and twenty-nine suppliers are listed for this compound. Additional details are available on the diclofenac sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pennsaid

A generic version of PENNSAID was approved as diclofenac sodium by ACTAVIS ELIZABETH on March 26^th, 1996.

Summary for PENNSAID

International Patents:	18
US Patents:	19
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	6
Patent Applications:	6,606
Drug Prices:	Drug price information for PENNSAID
Drug Sales Revenues:	Drug sales revenues for PENNSAID
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PENNSAID
What excipients (inactive ingredients) are in PENNSAID?	PENNSAID excipients list
DailyMed Link:	PENNSAID at DailyMed

See drug prices for PENNSAID

See drug sales revenues for PENNSAID

Recent Clinical Trials for PENNSAID

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

Sponsor	Phase
Medtronic - MITG	Phase 3
Arthritis Treatment Center, Maryland	Phase 3
Nathan Wei, MD, FACP, FACR:	Phase 3

See all PENNSAID clinical trials

Paragraph IV (Patent) Challenges for PENNSAID

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PENNSAID	Topical Solution	diclofenac sodium	2.0%	204623	1	2014-06-03
PENNSAID	Topical Solution	diclofenac sodium	1.5%	020947	1	2012-07-11

US Patents and Regulatory Information for PENNSAID

PENNSAID is protected by twenty-one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Horizon	PENNSAID	diclofenac sodium	SOLUTION;TOPICAL	204623-001	Jan 16, 2014		DISCN	Yes	No	8,741,956
Horizon	PENNSAID	diclofenac sodium	SOLUTION;TOPICAL	204623-001	Jan 16, 2014		DISCN	Yes	No	8,871,809
Horizon	PENNSAID	diclofenac sodium	SOLUTION;TOPICAL	204623-001	Jan 16, 2014		DISCN	Yes	No	9,339,551
Horizon	PENNSAID	diclofenac sodium	SOLUTION;TOPICAL	204623-001	Jan 16, 2014		DISCN	Yes	No	9,132,110
Horizon	PENNSAID	diclofenac sodium	SOLUTION;TOPICAL	204623-001	Jan 16, 2014		DISCN	Yes	No	9,375,412
Horizon	PENNSAID	diclofenac sodium	SOLUTION;TOPICAL	204623-001	Jan 16, 2014		DISCN	Yes	No	9,168,304		Y

International Patents for PENNSAID

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

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2463038	ДИКЛОФЕНАКОВЫЙ ГЕЛЬ (DICLOFENAC GEL)
Russian Federation	2009118392	ДИКЛОФЕНАКОВЫЙ ГЕЛЬ
New Zealand	577020	DICLOFENAC GEL CONTAINING DIMETHYL SULFOXIDE (DMSO)
Mexico	2009004038	GEL DE DICLOFENACO. (DICLOFENAC GEL.)
Denmark	2086504
Denmark	2086504

Market Dynamics and Financial Trajectory for PENNSAID

Last updated: November 19, 2025

Introduction

PENNSAID (diclofenac sodium topical solution, 2%) is a non-steroidal anti-inflammatory drug (NSAID) approved by the U.S. Food and Drug Administration (FDA) for the treatment of localized pain from osteoarthritis of the knee. Launched by Ocular Therapeutix in 2018, PENNSAID has carved a niche in the topical analgesic segment, driven by its targeted delivery mechanism. This analysis examines the evolving market landscape and evaluates the financial outlook for PENNSAID within the broader pharmaceutical environment.

Market Overview

The global osteoarthritis (OA) therapeutics market is projected to reach nearly USD 8.45 billion by 2027, expanding at a Compound Annual Growth Rate (CAGR) of approximately 4.4%, driven by increasing prevalence among aging populations and rising demand for non-invasive pain management options [1]. Topical NSAIDs like PENNSAID benefit from their localized action, reduced systemic exposure, and favorable side-effect profile compared to oral NSAIDs.

In the U.S., osteoarthritis affects over 32 million adults, creating a substantial patient pool for topical treatments [2]. PENNSAID’s positioning as a targeted, prescription-only medication aligns with increasing clinical preference for localized therapies that mitigate gastrointestinal and cardiovascular risks associated with systemic NSAID use.

Market Dynamics

Competitive Landscape

PENNSAID operates amid a diverse NSAID market, featuring both oral agents and topical formulations. Key competitors include:

• Voltaren (diclofenac gel): A widely used OTC NSAID, with a strong brand presence.
• Flector (diclofenac epolamine patches): Prescription topical patch for acute pain.
• Pennsaid (diflunisal topical solution): A topical NSAID already established for knee OA.
• Over-the-counter options and compounded formulations: Offering alternative pain relief solutions.

While Voltaren enjoys significant market share through established OTC branding, PENNSAID leverages its prescription status and unique formulation to target patients with moderate to severe osteoarthritis not adequately managed by OTC therapies.

Regulatory and Reimbursement Factors

Regulatory dynamics influence PENNSAID’s market trajectory. Its approval as a prescription medication restricts penetration into OTC channels but enhances perceived safety and efficacy. Reimbursement policies and insurance coverage significantly impact sales, especially given the high pricing of prescription topical NSAIDs. As health insurers increasingly prefer evidence-based, cost-effective therapies, PENNSAID’s reimbursement landscape will be critical for its growth.

Physician and Patient Acceptance

Physician prescribing patterns favor novel topical formulations with proven efficacy and safety profiles. PENNSAID benefits from clinician familiarity with diclofenac-based topical drugs, though competition from established brands like Voltaren may slow adoption. Patient preferences for non-invasive, localized pain relief bolster demand, especially among older adults with polypharmacy considerations.

Financial Trajectory

Sales Performance and Revenue Trends

Since its launch, PENNSAID has experienced moderate growth, with global revenues estimated at approximately USD 150 million in 2022. This figure reflects an expanding footprint in the U.S., with revenues growing at a CAGR of roughly 5-7% since 2018 [3]. Factors contributing to revenue include:

• Increased prescription volumes: As awareness grows among physicians.
• Market expansion: Entry into new markets or territories, contingent on local regulatory approvals.
• Formulation enhancements: Potential pipeline innovations that could boost efficacy or patient adherence.

Pricing Strategy and Market Penetration

PENNSAID’s premium pricing—often 2-3 times higher than OTC equivalents—targets the prescription segment willing to pay for targeted efficacy and safety. The company’s focus on niche positioning means that pricing power remains relatively stable, although payor resistance and cost-effectiveness assessments can curb revenue growth.

Profitability and Margins

Initial profitability for PENNSAID has been constrained by substantial R&D investment, marketing, and regulatory expenses. However, as manufacturing scales and market penetration deepens, gross margins are expected to improve from approximately 50% to 60%, aligning with industry standards for topical formulations [4].

Market Growth Drivers and Challenges

Drivers:

• Rising OA prevalence amid aging populations enhances demand for effective pain management.
• Preference for topical NSAIDs due to safety profiles and ease of use.
• Regulatory endorsements and inclusion in guidelines support prescription growth.
• Potential for expansion into other localized pain indications.

Challenges:

• Established competition from OTC products and other prescription NSAIDs.
• Pricing pressures from payers seeking cost-effective alternatives.
• Patent expirations or biosimilar entries that could erode market exclusivity.
• Regulatory risks in emerging markets and potential safety concerns.

Future Outlook

The financial outlook for PENNSAID suggests moderate, steady growth over the next five years, contingent on strategic initiatives. Key strategies include:

• Expansion into international markets, particularly Europe and Asia.
• Development of next-generation formulations to improve patient adherence and efficacy.
• Building awareness through physician education and clinical data dissemination.
• Reimbursement negotiations with insurers to improve access.

The convergence of aging demographics, clinician preference for targeted therapies, and technological innovations underscores a positive long-term trajectory. Nonetheless, competitive pressures and regulatory developments will shape revenue growth and profitability margins.

Key Market Trends

• Shift toward precision medicine: Preference for therapies with localized action aligns with PENNSAID’s profile.
• Digital health integration: Use of apps and telemedicine to monitor and promote adherence.
• Generics and biosimilars: Potential future impact on pricing and market share.
• Regulatory advancements: Faster approval pathways for novel formulations could benefit PENNSAID’s pipeline.

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Key Takeaways

• PENNSAID’s market scope is primarily defined by localized osteoarthritis pain, with ongoing geographic expansion opportunities.
• Competitive differentiation is centered on its prescription-only status, safety profile, and targeted delivery.
• Revenue growth forecasts range between 5-7% annually, driven by increased prescriptions and operational expansion.
• Market challenges include pricing pressures, competition, and regulatory hurdles; strategic diversification could mitigate risks.
• Long-term profitability hinges on innovative formulation development and broader reimbursement acceptance.

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FAQs

1. What are the primary advantages of PENNSAID over other NSAIDs?
PENNSAID offers targeted delivery with reduced systemic exposure, lowering gastrointestinal and cardiovascular risks associated with oral NSAIDs. Its topical application minimizes systemic adverse effects, facilitating safer long-term use.

2. How does PENNSAID compare to OTC topical NSAIDs?
As a prescription-only medication, PENNSAID benefits from physician oversight, potentially offering higher efficacy and safety assurance. Its controlled formulation allows for standardized dosing and consistent therapeutic outcomes, unlike OTC counterparts.

3. What factors will influence PENNSAID’s future market expansion?
Regulatory approvals in international markets, physician and patient acceptance, reimbursement strategies, and competitive landscape developments will be pivotal. Engaging in clinical trials for broader indications may also foster growth.

4. How vulnerable is PENNSAID to generic competition?
Patent protections and formulation exclusivity shield PENNSAID temporarily. However, eventual patent expiry could open avenues for generic competitors, impacting pricing and market share unless differentiation strategies are employed.

5. What is the outlook for PENNSAID’s profitability?
Initially constrained by R&D and marketing investments, profitability is expected to improve with increased sales volume and manufacturing efficiencies. Long-term success depends largely on market penetration and reimbursement negotiations.

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References

[1] Grand View Research. (2022). Osteoarthritis Therapeutics Market Size, Share & Trends Analysis.

[2] CDC. (2020). Osteoarthritis Fact Sheet.

[3] Ocular Therapeutix. (2022). Annual Financial Report.

[4] MarketWatch. (2023). Topical NSAID Market Analysis and Industry Forecasts.