FLECTOR Drug Patent Profile

When do Flector patents expire, and what generic alternatives are available?

Flector is a drug marketed by Ibsa and is included in one NDA.

The generic ingredient in FLECTOR is diclofenac epolamine. There are forty-seven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the diclofenac epolamine profile page.

Summary for FLECTOR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	5
Patent Applications:	103
Drug Prices:	Drug price information for FLECTOR
What excipients (inactive ingredients) are in FLECTOR?	FLECTOR excipients list
DailyMed Link:	FLECTOR at DailyMed

See drug prices for FLECTOR

See drug sales revenues for FLECTOR

Recent Clinical Trials for FLECTOR

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

Sponsor	Phase
Fidia Farmaceutici s.p.a.	Phase 3
Fidia Farmaceutici s.p.a.	Phase 1
Actavis Inc.	Phase 3

See all FLECTOR clinical trials

Pharmacology for FLECTOR

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

Paragraph IV (Patent) Challenges for FLECTOR

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 FLECTOR

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

Expired US Patents for FLECTOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ibsa	FLECTOR	diclofenac epolamine	SYSTEM;TOPICAL	021234-001	Jan 31, 2007	4,948,805
Ibsa	FLECTOR	diclofenac epolamine	SYSTEM;TOPICAL	021234-001	Jan 31, 2007	5,607,690

International Patents for FLECTOR

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

Country	Patent Number	Title	Estimated Expiration
Japan	H0344062
Italy	8622320
Germany	3769943

FLECTOR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for FLECTOR

Introduction to FLECTOR

FLECTOR, a brand name for the topical formulation of diclofenac, is a non-steroidal anti-inflammatory drug (NSAID) used for the treatment of acute pain due to minor strains, sprains, and contusions. It is available in various forms, including patches, gels, and sprays.

Market Overview of Diclofenac

The diclofenac market, which includes FLECTOR, is poised for significant growth driven by several key factors.

• Increasing Geriatric Population: The growing number of geriatric individuals globally is a major driver, as this population is highly susceptible to inflammation-related problems such as osteoarthritis and rheumatoid arthritis[3][4].
• Regulatory Approvals: The market benefits from increasing regulatory approvals and the launch of new diclofenac formulations, including generics and innovative delivery systems like patches and gels[1][3].

Segmentation Analysis

Route of Administration

The diclofenac market, including FLECTOR, is segmented based on the route of administration:

• Oral: Although oral formulations dominate the market, they are not directly relevant to FLECTOR.
• Parenteral: This segment is significant but not the primary focus for FLECTOR.
• Topical: This segment, where FLECTOR is categorized, is expected to grow significantly. Topical diclofenac medications, such as gels, creams, sprays, and patches, are highly adopted for treating muscle sprains and other acute pain conditions due to their ease of application and lower systemic side effects[1][3].

Geographical Market

North America

North America holds a dominant market share in the diclofenac market, including FLECTOR. This is attributed to:

• Robust Medical Infrastructure: Advanced healthcare systems and widespread understanding of diclofenac usage.
• High Prevalence of Arthritis: Growing cases of arthritis and trauma injuries sustain the demand for diclofenac products[1][3][4].

Asia-Pacific

The Asia-Pacific region is expected to offer lucrative growth opportunities due to:

• Increasing Geriatric Population: Rising senior population and associated physical ailments.
• Government Support and FDI: Local governments allowing foreign direct investment (FDI) for medicinal developments and robust medical advertisements[3].

Market Drivers for FLECTOR

Growing Demand for Topical NSAIDs

The demand for topical NSAIDs, such as FLECTOR, is increasing due to their ease of application and lower systemic side effects compared to oral or parenteral routes. This is particularly true for treating acute pain from minor strains, sprains, and contusions[2][3].

Sports Injuries

The rise in sporting events and associated injuries also drives the demand for topical diclofenac formulations like FLECTOR. For example, the increase in sports-related injuries due to events like the ICC T20 World Cup contributes to market growth[3].

Financial Trajectory

Market Size and Growth

The diclofenac market, which includes FLECTOR, is projected to grow at a CAGR of 3.9% from 2022 to 2027, reaching a market size of $6.1 billion by 2027[3].

Revenue Impact

The COVID-19 pandemic had a temporary negative impact on the diclofenac market in 2020, but the market recovered in 2021 with the relaxation of government restrictions and normalization of supply chains. This recovery is expected to continue, contributing to the steady growth of the market[1].

Regional Revenue

North America, where FLECTOR is widely used, procured significant revenue in 2019, with the region expected to continue its dominance. The Asia-Pacific region, however, is set to offer substantial growth opportunities due to its growing geriatric population and supportive government policies[3][4].

Competitive Landscape

Key Players and Product Innovations

Companies like Pfizer and GlaxoSmithKline are key players in the diclofenac market. These companies are launching novel products and formulations, such as patches and gels, to gain fast-track approvals and expand their market share. The FLECTOR Direct program, for instance, offers a convenient and cost-effective way for patients to access the medication[2][5].

Challenges and Opportunities

Side Effects and Regulatory Scrutiny

Despite the growth potential, the diclofenac market faces challenges related to unwanted side effects and regulatory scrutiny. However, the development of new formulations and delivery systems, such as topical patches, helps mitigate these risks and enhances patient acceptance[3][4].

Increasing Research and Development

Ongoing research on selective cyclooxygenase-2 inhibitors and other NSAIDs continues to drive innovation in the market. This research aims to reduce the undesirable effects of NSAIDs while maintaining their efficacy, which could further boost the market for products like FLECTOR[4].

Key Takeaways

• The diclofenac market, including FLECTOR, is driven by an increasing geriatric population and the growing prevalence of chronic medical conditions.
• Topical formulations like FLECTOR are gaining traction due to their ease of application and lower systemic side effects.
• North America dominates the market, but the Asia-Pacific region offers significant growth opportunities.
• The market is expected to grow at a CAGR of 3.9% from 2022 to 2027, reaching $6.1 billion by 2027.
• Innovations in product formulations and delivery systems are key to market growth.

FAQs

1. What is FLECTOR used for? FLECTOR is used for the topical treatment of acute pain due to minor strains, sprains, and contusions.

2. What are the key drivers of the diclofenac market? The key drivers include the growing geriatric population, increasing regulatory approvals, and the launch of new formulations.

3. How did the COVID-19 pandemic impact the diclofenac market? The pandemic had a negative impact in 2020 due to decreased demand and supply, but the market recovered in 2021 with the relaxation of government restrictions.

4. Which region dominates the diclofenac market? North America currently dominates the market due to robust medical infrastructure and high disease literacy.

5. What is the projected market size of the diclofenac market by 2027? The diclofenac market is projected to reach $6.1 billion by 2027, growing at a CAGR of 3.9% from 2022 to 2027.

Citations

1. Fortune Business Insights - Diclofenac Market Size, Trends, Growth, 2032
2. Cigna - Topical Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
3. IndustryARC - Diclofenac Market Size Report, 2022-2027
4. GlobeNewswire - NSAIDs Market to Reach USD 24.35 Billion by 2027
5. Flector - Flector Direct Program