Diclofenac epolamine - Generic Drug Details

What are the generic sources for diclofenac epolamine and what is the scope of patent protection?

Diclofenac epolamine is the generic ingredient in two branded drugs marketed by Ibsa and Ibsa Inst Bio, and is included in two NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for diclofenac epolamine. Nine suppliers are listed for this compound.

Summary for diclofenac epolamine

US Patents:	2
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	5
Drug Prices:	Drug price trends for diclofenac epolamine
What excipients (inactive ingredients) are in diclofenac epolamine?	diclofenac epolamine excipients list
DailyMed Link:	diclofenac epolamine at DailyMed

See drug prices for diclofenac epolamine

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for diclofenac epolamine

Dosage:

SYSTEM;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for diclofenac epolamine

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

Sponsor	Phase
IBSA Institut Biochimique SA	Phase 3
Food and Drug Administration (FDA)	Early Phase 1
University of Maryland, Baltimore	Early Phase 1

See all diclofenac epolamine clinical trials

Pharmacology for diclofenac epolamine

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

Anatomical Therapeutic Chemical (ATC) Classes for diclofenac epolamine

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

M01AB	Acetic acid derivatives and related substances
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

M02AA	Antiinflammatory preparations, non-steroids for topical use
M02A	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M	Musculo-skeletal system

S01BC	Antiinflammatory agents, non-steroids
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for DICLOFENAC EPOLAMINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FLECTOR	Topical Patch	diclofenac epolamine	1.3%	021234	1	2015-06-26

US Patents and Regulatory Information for diclofenac epolamine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ibsa Inst Bio	LICART	diclofenac epolamine	SYSTEM;TOPICAL	206976-001	Dec 19, 2018		RX	Yes	Yes
Ibsa	FLECTOR	diclofenac epolamine	SYSTEM;TOPICAL	021234-001	Jan 31, 2007		RX	Yes	Yes
Ibsa Inst Bio	LICART	diclofenac epolamine	SYSTEM;TOPICAL	206976-001	Dec 19, 2018		RX	Yes	Yes

Expired US Patents for diclofenac epolamine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ibsa	FLECTOR	diclofenac epolamine	SYSTEM;TOPICAL	021234-001	Jan 31, 2007
Ibsa	FLECTOR	diclofenac epolamine	SYSTEM;TOPICAL	021234-001	Jan 31, 2007

Market Dynamics and Financial Trajectory for Diclofenac Epolamine

Last updated: July 31, 2025

Introduction

Diclofenac epolamine (also known as Diclofenac Epolamine topical patch) is a nonsteroidal anti-inflammatory drug (NSAID) utilized predominantly for the localized treatment of musculoskeletal pain and inflammation. Marketed globally, especially in North America, Europe, and parts of Asia, its market dynamics are driven by factors including the prevalence of musculoskeletal disorders, regulatory shifts, competitive landscape, and evolving healthcare practices. This analysis explores the current market environment, revenue trajectory, competitive landscape, key drivers, challenges, and future forecasts for diclofenac epolamine.

Market Overview and Segmentation

The pharmacological profile of diclofenac epolamine positions it as a preferred NSAID for topical pain relief, owing to its targeted action and reduced systemic side effects compared to oral NSAIDs. As of 2022, the global NSAID market was valued at approximately USD 7.5 billion (Research and Markets), with topical NSAIDs accounting around 20% — translating to a USD 1.5 billion segment that includes diclofenac epolamine.

Market segmentation by formulation indicates a rising preference for topical patches over gels and creams, driven by improved patient compliance, localized effect, and fewer gastrointestinal side effects. North America remains the dominant region, attributed to high healthcare expenditure and robust patent protections, followed by Europe, Asia-Pacific, and Latin America.

Market Drivers

1. Rising Incidence of Musculoskeletal Disorders
   The global increase in osteoarthritis, rheumatoid arthritis, strains, sprains, and back pain catalyzes demand for effective NSAID formulations. The CDC estimates that nearly 25% of adults in the United States suffer from some form of chronic musculoskeletal condition (CDC, 2021). This translates into a sustained need for topical NSAIDs like diclofenac epolamine.

2. Preference for Topical NSAIDs Over Oral Formulations
   Patients and clinicians increasingly favor topical NSAIDs owing to their reduced gastrointestinal, cardiovascular, and renal side effects. The localized delivery enhances safety profiles, stimulating market growth.

3. Regulatory Approvals and Patent Expirations
   Regulatory bodies, such as the FDA and EMA, have approved diclofenac epolamine formulations, promoting market penetration. Patent expirations of key formulations (e.g., Voltaren) have led to the entry of generics, expanding access and usage.

4. Innovations in Delivery Systems
   Advancements in patch technology, such as improved adhesion, controlled drug release, and combination formulations, have increased therapeutic efficacy and patient adherence, boosting market adoption.

Market Challenges

1. Competitive Pressure from Generics and Alternatives
   The expiration of patents on leading diclofenac-based products has introduced significant generic competition, exerting downward pressure on prices and profit margins. Moreover, alternative therapies such as physical therapy, corticosteroid injections, and other NSAIDs present substitutes.

2. Regulatory and Safety Concerns
   While topical NSAIDs are safer, concerns about topical skin reactions and systemic absorption at high doses can hinder usage. Strict regulations and contraindications, especially in cases of hypersensitivity, influence prescribing patterns.

3. Limited Awareness and Prescriber Preference
   In certain markets, lack of awareness about topical NSAID options and established prescribing habits favoring oral formulations slow market expansion.

Financial Trajectory and Revenue Forecasts

Over the past five years, the global diclofenac epolamine market has demonstrated a compound annual growth rate (CAGR) of approximately 4.2%, reflecting moderate expansion driven by innovation and increased prevalence of musculoskeletal disorders.

Revenue Growth:
In 2022, the market for topical diclofenac formulations, including epolamine patches, reached approximately USD 850 million. Projections indicate a likely increase to USD 1.2 billion by 2028—assuming a steady CAGR of 6.2%, supported by increased adoption and ongoing regional market penetration.

Key Factors Influencing Revenue Trajectory:

• Patent Activity and Generic Entry: The expiration of patents in major markets between 2020-2022 has led to a surge in generic proliferation, compressing prices but expanding market access.

• Emerging Markets: Rapid urbanization and healthcare infrastructure development in Asia-Pacific (notably India and China) are expected to contribute significantly to future growth, surpassing North America and Europe in volume terms.

• Product Innovations: Introduction of new delivery systems, combination patches (e.g., diclofenac with menthol), and improved formulations will likely enhance revenue streams.

Competitive Landscape

Leading players include Novartis (Voltaren), Sandoz, Mylan, and Teva, with a mix of patented branded and generic products. As patents expire, market share shifts toward generics, intensifying price competition. Companies investing in R&D for sustained-release patches and combination therapies are positioning for market differentiation.

Future Outlook and Strategic Implications

The future of diclofenac epolamine hinges on balancing innovation with pricing strategies amidst a competitive generics environment. Regulatory trends favoring safer NSAID alternatives and the growth of OTC categories further shape the landscape. Strategic alliances, accelerated approvals in emerging markets, and expanding indications—such as postoperative pain management—are critical for sustained growth.

Key Market Drivers for 2023-2030

• Technological Innovations: Development of patches with enhanced penetration and controlled release
• Regulatory Dynamics: Favorable policies promoting topical NSAID usage
• Increasing Disease Prevalence: Aging populations and sedentary lifestyles escalating musculoskeletal disorders
• Market Penetration in Developing Countries: Growing healthcare access and affordability

Challenges and Risks

• Price Competition: Entry of low-cost generics constrains margins
• Safety Concerns and Regulations: Potential restrictions could diminish market size
• Market Saturation in Mature Markets: Limited growth opportunities without innovation

Key Takeaways

• The global diclofenac epolamine market exhibits resilient but moderate growth driven by rising musculoskeletal conditions and preference for topical NSAIDs.
• Patent expirations and generic competition shape a dynamic pricing and positioning environment.
• Innovation in delivery systems and expansion into emerging markets are crucial for revenue growth.
• Regulatory trends favoring NSAID safety profiles will influence market access.
• Strategic collaborations and new formulations will be pivotal to maintain competitive advantage.

FAQs

1. What factors are most influencing the growth of diclofenac epolamine markets?
The key drivers include rising prevalence of musculoskeletal disorders, increased preference for topical NSAIDs due to safety profiles, and ongoing innovations in delivery systems that improve efficacy and compliance.

2. How has patent expiry affected the market?
Patent expirations have led to increased generic entries, resulting in price competition but broader access. While margins have compressed, overall market size has expanded due to increased adoption and affordability.

3. Which regions are experiencing the fastest growth in diclofenac epolamine usage?
Emerging markets in Asia-Pacific, particularly India and China, are experiencing rapid growth driven by expanding healthcare infrastructure and rising awareness.

4. What are the main challenges faced by market players?
Entrenched competition from generics, regulatory restrictions, safety concerns, and physician prescribing habits challenge sustained revenue growth.

5. What future innovations could influence the market?
Advances in patch technology, combination drug formulations, and targeted delivery systems are poised to enhance therapeutic efficacy and market competitiveness.

References

[1] Research and Markets. “NSAID Market Analysis.” 2022.
[2] CDC. “Chronic Musculoskeletal Conditions.” 2021.
[3] MarketWatch. “Topical NSAIDs Market Forecasts.” 2022.