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Last Updated: December 22, 2024

DICLOFENAC EPOLAMINE - Generic Drug Details

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What are the generic drug 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. Seven 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:	7
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	5
Patent Applications:	166
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

Generic Entry Date for DICLOFENAC EPOLAMINE^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: ⤷ Subscribe 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

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

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Glossary

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

Expired US Patents for DICLOFENAC EPOLAMINE

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

DICLOFENAC EPOLAMINE Market Analysis and Financial Projection Experimental

Diclofenac Epolamine Market Dynamics and Financial Trajectory

Market Overview

Diclofenac, a non-steroidal anti-inflammatory drug (NSAID), is widely used for managing pain and inflammatory disorders. The diclofenac market, including its various formulations such as diclofenac epolamine, is poised for significant growth driven by several key factors.

Market Size and Growth Projections

The global diclofenac market is projected to grow from USD 4.2 billion in 2023 to USD 6.4 billion by 2033, at a compound annual growth rate (CAGR) of 4.3% during the forecast period from 2024 to 2033[1][3].

Key Drivers of Market Growth

Rising Prevalence of Chronic Pain and Inflammatory Disorders

The increasing incidence of chronic pain and inflammatory conditions such as arthritis, migraines, and fibromyalgia is a significant driver of the diclofenac market. These conditions affect a large demographic globally, with the World Health Organization (WHO) estimating that over a billion people suffer from chronic diseases, thereby increasing the demand for effective pain relief solutions like diclofenac[3].

Increasing Geriatric Population

The growing geriatric population is highly susceptible to degenerative joint diseases such as osteoarthritis and rheumatoid arthritis. This demographic shift is expected to fuel the demand for diclofenac, as older adults are more prone to inflammation-related problems[3][4].

Advancements in Pharmaceutical Formulations

Recent developments in the formulation and delivery methods of diclofenac, such as topical patches and sprays, are aimed at minimizing side effects and enhancing patient outcomes. These innovations are critical in supporting the market’s growth by offering safer and more effective treatment options[1][3].

Regional Analysis

Asia Pacific

The Asia Pacific region dominates the diclofenac market with a 35.5% share, valued at USD 1.5 billion. This region's growth is driven by increasing healthcare expenditure, rising awareness of pain management solutions, and the expansion of healthcare systems in countries like China and India[1][3].

North America and Europe

North America and Europe are significant players in the diclofenac market, supported by robust medical infrastructure and high awareness of pain management therapies. However, these regions may experience slightly tempered growth due to stringent regulatory frameworks and the rising adoption of biologics[3][4].

Emerging Markets

Middle East & Africa and Latin America are emerging as promising markets for diclofenac, driven by gradual improvements in healthcare infrastructure and growing middle-class populations with access to medical care. These regions exhibit potential for high growth, although they currently contribute less to the global market compared to other regions[3].

Market Segmentation

By Type

Tablets lead the diclofenac types with a 55.5% market share, followed by other formulations such as topical patches and sprays. The preference for oral administration accounts for 37% of diclofenac usage[1][3].

By Disease Indication

Osteoarthritis indications account for 37.5% of diclofenac usage, followed by other conditions like ankylosing spondylitis, dysmenorrhea, and rheumatoid arthritis[1][3].

By Distribution Channel

Retail pharmacy dominates the distribution channels with a 68.4% market share, highlighting the importance of traditional retail outlets in the distribution of diclofenac[1].

Financial Trajectory

Revenue Projections

The diclofenac market is expected to reach USD 6.4 billion by 2033, up from USD 4.2 billion in 2023. This growth is driven by the increasing demand for effective pain management solutions and the expanding geriatric population[1][3].

Key Players and Market Competition

Companies like Teva Pharmaceuticals play a significant role in the diclofenac market, with the launch of authorized generics such as the diclofenac epolamine topical patch. Teva's extensive portfolio of generic medicines and its leading position in first-to-file opportunities contribute to the competitive landscape of the market[2].

Challenges and Restraints

Potential Side Effects

Despite the growth prospects, the diclofenac market faces challenges related to potential side effects such as cardiovascular and gastrointestinal issues. These side effects could restrain the market expansion and necessitate continuous innovation in safer formulations[1][3].

Regulatory and Competitive Pressures

The market is also influenced by regulatory landscapes, patent expiries, and generic penetration. Pharmaceutical companies must navigate these factors while competing with other pain management therapies, including biologics[3].

Innovations and Future Outlook

Enhanced Safety Profiles

Recent developments aimed at minimizing side effects and improving patient outcomes are crucial for the ongoing demand and market expansion of diclofenac. Innovations in drug formulation technologies, such as topical patches and sprays, are expected to drive the market forward[1][3].

Emerging Markets and Healthcare Infrastructure

The expansion into emerging markets, particularly in Asia-Pacific and Africa, presents lucrative opportunities for the introduction of affordable and effective pain management solutions like diclofenac. Improvements in healthcare infrastructure and growing awareness of treatment options in these regions will facilitate market growth[3].

Key Takeaways

Market Growth: The global diclofenac market is projected to grow from USD 4.2 billion in 2023 to USD 6.4 billion by 2033, with a CAGR of 4.3%.
Regional Dominance: Asia Pacific dominates the market with a 35.5% share.
Market Segmentation: Tablets lead with a 55.5% market share, and osteoarthritis indications account for 37.5% of diclofenac usage.
Distribution Channels: Retail pharmacy dominates with a 68.4% market share.
Challenges: Potential side effects and regulatory pressures are key restraints.

FAQs

Q: What is the projected market size of the global diclofenac market by 2033?

A: The global diclofenac market is projected to reach USD 6.4 billion by 2033[1][3].

Q: Which region dominates the diclofenac market?

A: The Asia Pacific region dominates the diclofenac market with a 35.5% share[1][3].

Q: What are the primary drivers of the diclofenac market growth?

A: The primary drivers include the rising prevalence of chronic pain and inflammatory disorders, and the increasing geriatric population[3].

Q: What are the common side effects associated with diclofenac?

A: Common side effects include cardiovascular and gastrointestinal issues[1].

Q: Which distribution channel dominates the diclofenac market?

A: Retail pharmacy dominates the distribution channels with a 68.4% market share[1].

Sources

Market.us News: "Diclofenac Market Growth Accelerates Amid Increased Demand" - July 22, 2024.
Teva Pharmaceuticals: "Teva Announces Launch of an Authorized Generic of Flector® Patch" - March 1, 2019.
Market.us: "Diclofenac Market Size, Share, Growth | CAGR of 4.3%".
IndustryARC: "Diclofenac Market Size Report, 2022-2027".

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