FLURBIPROFEN SODIUM - Generic Drug Details

What are the generic sources for flurbiprofen sodium and what is the scope of freedom to operate?

Flurbiprofen sodium is the generic ingredient in two branded drugs marketed by Bausch And Lomb and Allergan, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for flurbiprofen sodium. Four suppliers are listed for this compound.

Summary for FLURBIPROFEN SODIUM

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	30
Clinical Trials:	2
Patent Applications:	211
What excipients (inactive ingredients) are in FLURBIPROFEN SODIUM?	FLURBIPROFEN SODIUM excipients list
DailyMed Link:	FLURBIPROFEN SODIUM at DailyMed

Recent Clinical Trials for FLURBIPROFEN SODIUM

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

Sponsor	Phase
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4
Federal University of São Paulo	Phase 4
Guangxi Medical University	Phase 4

See all FLURBIPROFEN SODIUM clinical trials

Pharmacology for FLURBIPROFEN SODIUM

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for FLURBIPROFEN SODIUM

M01AE	Propionic acid derivatives
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

R02AX	Other throat preparations
R02A	THROAT PREPARATIONS
R02	THROAT PREPARATIONS
R	Respiratory system

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

US Patents and Regulatory Information for FLURBIPROFEN SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch And Lomb	FLURBIPROFEN SODIUM	flurbiprofen sodium	SOLUTION/DROPS;OPHTHALMIC	074447-001	Jan 4, 1995		RX	No	Yes
Allergan	OCUFEN	flurbiprofen sodium	SOLUTION/DROPS;OPHTHALMIC	019404-001	Dec 31, 1986		DISCN	Yes	No

Expired US Patents for FLURBIPROFEN SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	OCUFEN	flurbiprofen sodium	SOLUTION/DROPS;OPHTHALMIC	019404-001	Dec 31, 1986	3,755,427
Allergan	OCUFEN	flurbiprofen sodium	SOLUTION/DROPS;OPHTHALMIC	019404-001	Dec 31, 1986	3,793,457

FLURBIPROFEN SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Flurbiprofen Sodium

Introduction to Flurbiprofen Sodium

Flurbiprofen sodium is a nonsteroidal anti-inflammatory drug (NSAID) known for its analgesic, antipyretic, and anti-inflammatory properties. It is used in various formulations, including ophthalmic solutions, injections, patches, and tablets, to manage pain and inflammation in different medical conditions.

Global Market Size and Growth

The global flurbiprofen market, which includes flurbiprofen sodium, has been experiencing significant growth. As of 2023, the market size was valued at USD XX billion and is anticipated to reach USD XX billion by 2031, exhibiting a compound annual growth rate (CAGR) of 5.2% from 2024 to 2031[3].

Regional Market Dynamics

North America

North America holds a substantial share of the global flurbiprofen market, accounting for over 40% of the global revenue. The region's market size was estimated at USD XX million in 2024 and is expected to grow at a CAGR of 3.4% from 2024 to 2031. The high prevalence of musculoskeletal disorders, arthritis, and inflammatory conditions, along with an aging population, drives the demand for pain management solutions in this region. Flurbiprofen injections are the dominant segment here, providing rapid and potent relief from pain and inflammation[1].

Europe

Europe accounts for over 30% of the global market size, with a market value of USD XX million in 2024. The region is expected to grow at a CAGR of 3.7% from 2024 to 2031. The aging population and the prevalence of musculoskeletal disorders and arthritis are key drivers. The patch segment is dominant in Europe, offering continuous and site-specific pain relief, particularly for conditions like osteoarthritis[1].

Asia Pacific

The Asia Pacific region holds around 23% of the global revenue, with a market size of USD XX million in 2024. It is projected to grow at a CAGR of 7.2% from 2024 to 2031. Rapid urbanization, improving healthcare infrastructure, and increasing awareness of pain management contribute to the market's growth. Injections are the dominant segment in this region, driven by innovative formulations and advancements in injection technologies[1].

South America

South America accounts for more than 5% of the global revenue, with a market size of USD XX million in 2024. The region is expected to grow at a CAGR of 4.6% from 2024 to 2031. The rising prevalence of musculoskeletal disorders and inflammatory conditions, along with increasing awareness of pain management, drives the demand. Patches are a significant segment here, offering a non-invasive alternative to traditional oral medications[1].

Middle East and Africa

The Middle East and Africa region accounts for around 2% of the global revenue, with a market size of USD XX million in 2024. It is projected to grow at a CAGR of 4.9% from 2024 to 2031. The prevalence of musculoskeletal disorders and inflammatory conditions, coupled with an increasing focus on healthcare infrastructure development, contributes to the demand for flurbiprofen in this region[1].

Market Segmentation

By Formulation

The flurbiprofen market is segmented into injections, patches, and tablets. Injections are particularly valuable in acute and severe conditions, while patches offer continuous and site-specific pain relief. Tablets are used for various pain-related conditions, including dysmenorrhea, post-operative pain, and toothache[3].

By Application

The market is also segmented by application, including nonsteroidal anti-inflammatory drugs, topical administration for joint and muscle pain, soft tissue disease, dysmenorrhea, post-operative pain, toothache, and other applications. Each segment caters to different patient needs and medical conditions[3].

Drivers and Opportunities

• Aging Population: The increasing aging population globally contributes significantly to the demand for pain management solutions like flurbiprofen, as elderly individuals are more prone to musculoskeletal disorders and arthritis[1].
• Improving Healthcare Infrastructure: Rapid urbanization and improving healthcare infrastructure in regions like Asia Pacific drive the growth of the flurbiprofen market[1].
• Innovative Formulations: The ongoing development of innovative formulations and advancements in injection technologies further shape the market landscape[1].
• Increasing Awareness: Growing awareness of pain management and the benefits of non-invasive treatments like patches contribute to market growth[1].

Challenges and Restraints

• Regulatory Complexities: Companies must navigate complex regulatory landscapes and adapt to diverse healthcare systems, particularly in regions like Europe and the Middle East and Africa[1].
• Economic Disparities: Economic disparities in regions like South America require stakeholders to tailor their strategies to address these challenges[1].
• Side Effects and Safety Concerns: NSAIDs, including flurbiprofen, can have side effects such as gastrointestinal issues, which necessitate careful patient monitoring and management[5].

Key Players and Competitive Landscape

The flurbiprofen market is competitive, with several key players including Teva, Mylan Pharmaceuticals, Tokuhon, Recordati, Mikasa Seiyaku, Bausch Health, Pfizer, AbbVie, Abbott, Allergan, and others. These companies are focused on developing innovative formulations and expanding their market presence through strategic partnerships and product launches[3].

Mechanism of Action and Clinical Significance

Flurbiprofen sodium works by inhibiting the cyclo-oxygenase enzyme, which is essential in the production of prostaglandins. Prostaglandins are mediators of inflammation and pain. In ophthalmic use, flurbiprofen sodium is indicated for the inhibition of intraoperative miosis and has been shown to have no significant effect on intraocular pressure[5].

Innovative Developments

Recent studies have focused on developing dual-action compounds that combine the inhibitory action of flurbiprofen against cyclo-oxygenase (COX) with fatty acid amide hydrolase (FAAH) inhibition. These compounds, such as Flu-AM4, have shown promising results in animal pain models, offering potential for improved analgesic and anti-inflammatory efficacy without the gastrointestinal side effects associated with traditional NSAIDs[2].

Key Takeaways

• The global flurbiprofen market is projected to grow at a CAGR of 5.2% from 2024 to 2031.
• North America, Europe, and Asia Pacific are the major regions driving market growth.
• The aging population and improving healthcare infrastructure are key drivers.
• Innovative formulations and dual-action compounds are emerging trends.
• Regulatory complexities and economic disparities are significant challenges.

Frequently Asked Questions (FAQs)

Q: What is the projected CAGR for the global flurbiprofen market from 2024 to 2031? A: The global flurbiprofen market is projected to grow at a CAGR of 5.2% from 2024 to 2031[1].

Q: Which region holds the largest share of the global flurbiprofen market? A: North America holds over 40% of the global revenue, making it the largest market for flurbiprofen[1].

Q: What are the dominant formulations in different regions? A: Injections are dominant in North America and Asia Pacific, while patches are dominant in Europe and Latin America[1].

Q: What are the key drivers of the flurbiprofen market? A: The aging population, improving healthcare infrastructure, and increasing awareness of pain management are key drivers[1].

Q: What are the potential side effects of flurbiprofen sodium? A: Flurbiprofen sodium, like other NSAIDs, can have side effects such as gastrointestinal issues, and it is contraindicated in individuals hypersensitive to its components[5].

Cited Sources:

1. Cognitive Market Research - Flurbiprofen Market Report[1]
2. Journal of Enzyme Inhibition and Medicinal Chemistry - DiVA Portal[2]
3. Market Research Intellect - Global Flurbiprofen Market Report[3]
4. Market Reports World - Flurbiprofen Sodium Market[4]
5. FDA - OCUFEN (flurbiprofen sodium ophthalmic solution, USP) 0.03%[5]