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Last Updated: December 30, 2025

VOLTAREN ARTHRITIS PAIN Drug Patent Profile


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Which patents cover Voltaren Arthritis Pain, and what generic alternatives are available?

Voltaren Arthritis Pain is a drug marketed by Haleon Us Holdings and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Voltaren Arthritis Pain

A generic version of VOLTAREN ARTHRITIS PAIN was approved as diclofenac sodium by ACTAVIS ELIZABETH on March 26th, 1996.

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Questions you can ask:
  • What is the 5 year forecast for VOLTAREN ARTHRITIS PAIN?
  • What are the global sales for VOLTAREN ARTHRITIS PAIN?
  • What is Average Wholesale Price for VOLTAREN ARTHRITIS PAIN?
Summary for VOLTAREN ARTHRITIS PAIN
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 3
Raw Ingredient (Bulk) Api Vendors: 121
Clinical Trials: 1
Patent Applications: 6,606
What excipients (inactive ingredients) are in VOLTAREN ARTHRITIS PAIN?VOLTAREN ARTHRITIS PAIN excipients list
DailyMed Link:VOLTAREN ARTHRITIS PAIN at DailyMed
Drug patent expirations by year for VOLTAREN ARTHRITIS PAIN
Recent Clinical Trials for VOLTAREN ARTHRITIS PAIN

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

SponsorPhase
Zambon SpAPhase 1
Cross Research S.A.Phase 1

See all VOLTAREN ARTHRITIS PAIN clinical trials

Pharmacology for VOLTAREN ARTHRITIS PAIN

US Patents and Regulatory Information for VOLTAREN ARTHRITIS PAIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Haleon Us Holdings VOLTAREN ARTHRITIS PAIN diclofenac sodium GEL;TOPICAL 022122-001 Oct 17, 2007 OTC Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Voltaren Arthritis Pain

Last updated: September 16, 2025

Introduction

Voltaren Arthritis Pain, a topical nonsteroidal anti-inflammatory drug (NSAID), has established itself as a significant player within the over-the-counter (OTC) pain management segment. With a focus on osteoarthritis and localized joint inflammation, it offers an alternative to oral NSAIDs, addressing concerns surrounding systemic side effects. Understanding the market dynamics and financial trajectory of Voltaren Arthritis Pain involves dissecting its regulatory landscape, competitive positioning, consumer trends, and the broader pharmaceutical industry environment.

Market Overview

The global arthritis therapeutics market is projected to reach USD 50 billion by 2027, driven primarily by the increasing prevalence of osteoarthritis, age-related degenerative joint diseases, and a growing preference for topical analgesics among consumers seeking safer alternatives to oral treatments. Voltaren Arthritis Pain holds a pivotal position within this segment, with a substantial share attributed to its early-market entry, brand recognition, and proven efficacy.

In the United States, the OTC market for topical NSAIDs is expanding as consumers seek localized solutions with minimal systemic exposure. Voltaren Gel, an anchor product for arthritis pain management, became OTC-approved by the FDA in 2020, opening new revenue streams and broadening market access.

Regulatory and Competitive Landscape

Regulatory Factors

The shift of Voltaren Gel from prescription to OTC status in the US catalyzed an upward trajectory in sales, emphasizing the importance of regulatory decisions in shaping the drug’s market potential. Similar regulatory pathways in Europe and other regions bolster its international growth prospects. However, regulatory challenges persist, especially concerning safety concerns over NSAID use and the need for clear labeling and usage guidelines.

Competitive Environment

Voltaren faces a competitive arena comprising both prescription NSAIDs like celecoxib and ibuprofen formulations, as well as other OTC topical agents such as Bengay, Capzasin, and various generics. Its proprietary formulation, Diclofenac diethylammonium, positions it favorably owing to proven efficacy and consumer trust. Nonetheless, ongoing price competition and patent expirations pose risks to sustained profitability.

Emerging competitors are innovating with advanced delivery systems—patches, long-acting formulations, and combination therapies—highlighting the need for ongoing R&D investment by Voltaren’s manufacturer.

Market Drivers

Rising Prevalence of Osteoarthritis

With an aging global population, the incidence of osteoarthritis is projected to increase, particularly among individuals over 60. Obesity, sedentary lifestyles, and chronic joint stress further exacerbate this trend, expanding potential consumer bases for Voltaren.

Preference for Topical NSAIDs

Consumers increasingly favor topical NSAIDs over systemic options due to a perceived safety profile—particularly fewer gastrointestinal and cardiovascular risks. This inclination amplifies market demand for Voltaren, especially in aging and high-risk groups.

Product Accessibility

The OTC availability of Voltaren Gel democratizes access, fostering increased usage and over-the-counter sales growth. Pharmaceutical companies leveraging direct-to-consumer marketing strategies can amplify their market penetration effectively.

Healthcare Provider Endorsements

Clinician and pharmacist endorsements of Voltaren for osteoarthritis pain management bolster confidence and patient adherence, fueling organic growth.

Financial Trajectory and Revenue Projections

Historical Performance

Since its OTC approval in the US, Voltaren’s sales have shown robust growth—partly attributable to increased consumer awareness and expanded accessibility. Reports indicate that Voltaren Gel surpassed USD 200 million in annual US retail sales in 2021, marking a significant milestone (IQVIA data).

Forecasted Growth

Analysts project compounded annual growth rates (CAGR) of approximately 7-10% over the next five years for Voltaren in key markets, driven by heightened prevalence of osteoarthritis, positioned marketing strategies, and expanding global footprints.

In Europe, the product’s longstanding OTC presence and established distribution channels further support consistent revenue increases. The potential launch of new formulations—such as patches with sustained-release technology—could unlock additional market segments.

Profitability and Market Share

Voltaren’s profit margins are supported by high consumer demand and brand loyalty. However, margin erosion may occur due to the prevalence of lower-cost generics and regulatory pressures. Strategic pricing, market expansion, and innovation will be critical to maintaining and increasing market share.

Risks to Financial Trajectory

  • Patent and exclusivity expiration: Generic entrants can significantly impact pricing power.
  • Regulatory and safety concerns: Adverse events or restrictive guidelines could undermine sales.
  • Competitive innovation: Rapid advancements by competitors could diminish Voltaren’s prominence.

Emerging Market Opportunities

Acceleration in Asian, Latin American, and African markets offers significant growth avenues. Rising disposable incomes, increasing osteoarthritis prevalence, and expanding OTC distribution channels underpin these opportunities. However, localized regulatory challenges and market penetration costs necessitate tailored strategies.

Conclusion

Voltaren Arthritis Pain is positioned for steady growth, propelled by demographic trends, consumer preferences for topical NSAIDs, and favorable regulatory shifts in key jurisdictions. Its financial trajectory hinges on innovation, strategic market expansion, and maintaining a competitive edge amid a dynamic landscape.

Key Takeaways

  • The OTC transition has markedly boosted Voltaren’s market presence, with continued growth forecasted at a CAGR of 7-10%.
  • Increasing osteoarthritis prevalence and consumer preference for topical NSAIDs underpin demand growth.
  • Regulatory developments and patent expirations pose both opportunities and risks; proactive innovation and strategic positioning are essential.
  • Global expansion, especially in emerging markets, offers substantial growth but requires overcoming regulatory and infrastructural barriers.
  • Margin management and competitive differentiation through formulation innovation will be pivotal in sustaining profitability.

FAQs

Q1: What are the primary factors influencing Voltaren Arthritis Pain’s market growth?
A1: Demographic shifts (aging population), increasing osteoarthritis prevalence, consumer preference for topical over systemic NSAIDs, regulatory approvals expanding OTC availability, and strategic marketing initiatives.

Q2: How does regulatory status impact Voltaren’s financial prospects?
A2: Transitioning from prescription to OTC expands market access and sales volume; however, regulatory challenges related to safety concerns can impose restrictions, impacting growth potential.

Q3: Who are Voltaren’s main competitors, and how does it differentiate itself?
A3: Competitors include other topical NSAIDs (e.g., Bengay) and oral medications. Voltaren’s differentiation stems from its proven efficacy, brand recognition, and FDA/EMA approvals, along with its longstanding market presence.

Q4: What risks could affect Voltaren's future profitability?
A4: Patent expirations leading to generic competition, regulatory restrictions due to safety concerns, advancements in alternative therapies, and price competition from generics.

Q5: Which emerging markets present significant opportunities for Voltaren?
A5: Asia-Pacific, Latin America, and Africa due to rising osteoarthritis cases, increasing healthcare infrastructure, and growing OTC drug markets, despite inherent regulatory and market entry challenges.


References

  1. IQVIA. (2022). OTC Pain Management Market Reports.
  2. U.S. Food and Drug Administration. (2020). FDA approves over-the-counter sale of Voltaren Gel.
  3. MarketsandMarkets. (2022). Arthritis Therapeutics Market by Disease Type and Region.
  4. European Medicines Agency. (2022). Regulatory updates and safety reviews for topical NSAIDs.
  5. GlobalData Healthcare. (2022). Pharmaceutical Industry Outlook: Top Performing OTC Drugs.

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