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
University of Maryland	Early Phase 1
Food and Drug Administration (FDA)	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	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
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: February 20, 2026

Overview

Diclofenac epolamine is a topical nonsteroidal anti-inflammatory drug (NSAID) used primarily for pain relief associated with minor injuries, musculoskeletal conditions, and inflammation. It is marketed under various brand names, with Voltaren Emulgel being a leading product. The global market for topical NSAIDs including diclofenac epolamine is expanding, driven by increasing prevalence of musculoskeletal disorders and a trend toward localized, non-invasive treatments.

Market Size and Growth

The global topical NSAID market, of which diclofenac epolamine constitutes a significant segment, was valued at approximately USD 2.4 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of roughly 4.5% from 2023 to 2030. This growth is primarily attributable to rising incidences of joint and muscle pain, aging populations, and the trend toward outpatient, self-administered therapies.

Regional Market Distribution

Region	Market Share (2022)	CAGR (2023-2030)	Key Drivers
North America	45%	4.2%	High prevalence of osteoarthritis, favorable reimbursement schemes
Europe	28%	4.7%	Aging population, extensive OTC distribution
Asia-Pacific	15%	5.3%	Growing healthcare infrastructure, increasing awareness
Rest of World	12%	4.9%	Emerging markets, urbanization trends

Competitive Landscape

Major players include:

• Novartis AG (Voltaren)
• Teva Pharmaceutical Industries Ltd.
• Mylan NV
• Pfizer Inc.
• Perrigo Company plc

Market entry is characterized by a mix of patent-protected formulations, generic competition, and OTC availability. Patent expiries for certain formulations, notably Voltaren Emulgel in various regions, have led to the proliferation of generics, intensifying price competition.

Patent and Regulatory Environment

Most innovations in topical NSAIDs rely on formulation patents, including transdermal delivery enhancements. The expiration of key patents between 2015 and 2020 prompted the entry of generics and biosimilar-like competitors, reducing average selling prices (ASPs).

Regulatory bodies like the FDA and EMA permit OTC and prescription status depending on concentration and formulation. Efforts to extend patent life include reformulations and combination products.

Financial Trajectory

Year	Estimated Global Revenue (USD billions)	Remarks
2022	2.4	Market size for topical NSAIDs including diclofenac epolamine
2025	3.0 (projected)	Growth driven by increasing OTC sales in emerging markets
2030	3.7 (projected)	Continued adoption, new formulations, chronic pain management trends

R&D and Innovation Trends

Developing enhanced skin penetration and sustained-release formulations influences market expansion. Partnerships with dermatology-device companies for delivery systems are increasing.

Key Regulatory and Market Challenges

• Stringent safety assessments for long-term use.
• Restrictions on OTC sales in certain regions.
• Pricing pressures due to generic competition.

Conclusion

The diclofenac epolamine market exhibits steady growth driven by demographic shifts, increasing use of localized NSAIDs, and ongoing formulation innovations. Patent expiries have created opportunities for generics, but ongoing R&D and regulatory modifications could shape future competitive dynamics.

Key Takeaways

• The global topical NSAID market is projected to reach USD 3.7 billion by 2030, with diclofenac epolamine as a dominant component.
• North America and Europe currently lead in revenue, with Asia-Pacific showing rapid growth.
• Patent expiries have increased generic competition, impacting pricing and margins.
• R&D centers on improving skin absorption and delivery duration to maintain market relevance.
• Regulatory hurdles and safety concerns influence product development and commercialization strategies.

FAQs

1. What factors influence the pricing of diclofenac epolamine products?
   Manufacturing costs, patent status, competition from generics, and regional regulatory policies.

2. How does patent expiry affect the market?
   Patent expiry leads to increased generic competition, reducing prices and reshaping market share.

3. Are there ongoing innovations in diclofenac epolamine formulations?
   Yes, innovations focus on enhancing transdermal absorption and sustained delivery.

4. What are the main barriers to OTC sales of diclofenac epolamine?
   Regulatory restrictions based on concentration, safety concerns regarding prolonged use, and regional pharmacy policies.

5. What trends are shaping future growth?
   Growing use in chronic pain management, increased adoption in emerging markets, and development of combination formulations.

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References

[1] MarketWatch. (2023). Global topical NSAID market size, share, and trends.
[2] Novartis AG Annual Reports. (2022). Voltaren product portfolio and patent status.
[3] Grand View Research. (2023). Topical NSAID market analysis and forecast.
[4] European Medicines Agency. (2022). Regulations on OTC NSAID products.
[5] U.S. Food and Drug Administration. (2022). Guidance on topical NSAID approvals.