FLURBIPROFEN - Generic Drug Details

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

Flurbiprofen is the generic ingredient in four branded drugs marketed by Pharmacia And Upjohn, Ivax Sub Teva Pharms, Natco Pharma, Pliva, Rising, Sun Pharm Inds Inc, Teva, Theragen, Bausch And Lomb, and Allergan, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for flurbiprofen. Seven suppliers are listed for this compound.

Summary for FLURBIPROFEN

US Patents:	0
Tradenames:	4
Applicants:	10
NDAs:	11
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	167
Clinical Trials:	64
Patent Applications:	7,034
Drug Prices:	Drug price trends for FLURBIPROFEN
Drug Sales Revenues:	Drug sales revenues for FLURBIPROFEN
What excipients (inactive ingredients) are in FLURBIPROFEN?	FLURBIPROFEN excipients list
DailyMed Link:	FLURBIPROFEN at DailyMed

See drug prices for FLURBIPROFEN

See drug sales revenues for FLURBIPROFEN

Recent Clinical Trials for FLURBIPROFEN

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

Sponsor	Phase
Pfizer	Phase 1
Beijing Tiantan Hospital	N/A
NorthSea Therapeutics B.V.	Phase 1

See all FLURBIPROFEN clinical trials

Pharmacology for FLURBIPROFEN

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

Medical Subject Heading (MeSH) Categories for FLURBIPROFEN

Analgesics

Anti-Inflammatory Agents, Non-Steroidal

Cyclooxygenase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for FLURBIPROFEN

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva	FLURBIPROFEN	flurbiprofen	TABLET;ORAL	074431-001	May 31, 1995		RX	No	Yes
Teva	FLURBIPROFEN	flurbiprofen	TABLET;ORAL	074405-001	May 24, 1995		DISCN	No	No
Ivax Sub Teva Pharms	FLURBIPROFEN	flurbiprofen	TABLET;ORAL	074411-002	May 31, 1995		DISCN	No	No

Expired US Patents for FLURBIPROFEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pharmacia And Upjohn	ANSAID	flurbiprofen	TABLET;ORAL	018766-002	Oct 31, 1988	3,755,427
Pharmacia And Upjohn	ANSAID	flurbiprofen	TABLET;ORAL	018766-003	Oct 31, 1988	3,793,457
Pharmacia And Upjohn	ANSAID	flurbiprofen	TABLET;ORAL	018766-003	Oct 31, 1988	3,755,427

FLURBIPROFEN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Flurbiprofen

Introduction to Flurbiprofen

Flurbiprofen is a nonsteroidal anti-inflammatory drug (NSAID) belonging to the propionic acid derivative class, similar to ibuprofen and naproxen. It is used in the treatment of mild-to-moderate pain, symptoms of chronic arthritis, and other inflammatory conditions[5].

Current Market Status

The global flurbiprofen market has been experiencing significant growth in recent years. Here are some key points that highlight its current market status:

Market Size and Growth

The flurbiprofen market is projected to continue its substantial expansion from 2023 to 2031, indicating an optimistic outlook. The market has undergone rapid growth, driven by increasing demand for effective pain management and anti-inflammatory treatments[1].

Regional Dominance

North America holds a significant share of the global flurbiprofen market, accounting for 40% of the global revenue in 2024. This region is expected to continue its dominance due to advanced healthcare infrastructure and high demand for pharmaceuticals[4].

Market Drivers

Several factors are driving the growth of the flurbiprofen market:

Increasing Demand for Pain Management

The rising prevalence of chronic pain conditions such as osteoarthritis and rheumatoid arthritis is a major driver. Flurbiprofen's efficacy in managing these conditions makes it a preferred choice among healthcare providers[5].

Clinical Versatility

Flurbiprofen is used in various medical specialties, including oncology, ophthalmology, and pain management. Its use in ophthalmic drops for treating conditions like vernal keratoconjunctivitis and its potential as an intravenous injection for cancer pain further expand its market[2][3].

Regulatory Support

The nomination of flurbiprofen for inclusion on the FDA's 503B Bulks List highlights its potential for broader clinical use. This inclusion could facilitate its use in compounded medications, addressing unmet needs in patient care[2].

Market Challenges

Despite the growth, the flurbiprofen market faces several challenges:

Side Effects and Safety Concerns

Flurbiprofen, like other NSAIDs, can cause gastrointestinal side effects and has a rare but potential risk of liver injury. These safety concerns can impact its adoption and usage[5].

Competition from Other NSAIDs

The market is competitive, with other NSAIDs such as ibuprofen and naproxen being widely used. This competition can affect the market share of flurbiprofen[5].

Regulatory Hurdles

The process of getting approved for new indications or formulations can be lengthy and complex, which may slow down market growth[2].

Financial Trajectory

The financial trajectory of the flurbiprofen market is promising:

Compound Annual Growth Rate (CAGR)

The market is expected to grow at a CAGR of 5.20% from 2024 to the forecast period, indicating a steady and significant increase in revenue[4].

Revenue Projections

North America's market size, which held a substantial share in 2024, is expected to continue growing, contributing to the overall global revenue. The global market size is projected to expand significantly by 2031[1][4].

Key Players and Market Strategies

Several key players are involved in the flurbiprofen market, each with their own strategies to capture market share:

Pharmaceutical Companies

Companies are focusing on research and development to expand the indications for flurbiprofen and improve its formulations. Partnerships with outsourcing facilities to produce compounded medications are also a strategy to increase market presence[2].

Outsourcing Facilities

Outsourcing facilities are playing a crucial role in producing flurbiprofen in various forms, such as ophthalmic drops and potential intravenous injections, which are not commercially available in these forms[2].

Future Outlook

The future outlook for the flurbiprofen market is positive, driven by several factors:

Expanding Indications

The potential inclusion on the FDA's 503B Bulks List and ongoing clinical research could lead to new indications and broader use in different medical specialties[2].

Technological Advancements

Advancements in drug delivery systems and formulations could enhance the efficacy and safety profile of flurbiprofen, making it more appealing to healthcare providers and patients[5].

Conclusion

The flurbiprofen market is poised for significant growth, driven by increasing demand for effective pain management, clinical versatility, and regulatory support. Despite challenges such as side effects and competition, the financial trajectory indicates a promising future with steady revenue growth.

Key Takeaways

• Market Growth: The flurbiprofen market is expected to grow significantly from 2023 to 2031.
• Regional Dominance: North America holds a substantial share of the global market.
• Clinical Versatility: Flurbiprofen is used in various medical specialties, including oncology, ophthalmology, and pain management.
• Regulatory Support: Nomination for inclusion on the FDA's 503B Bulks List could expand its clinical use.
• Financial Trajectory: Expected to grow at a CAGR of 5.20% from 2024 onwards.

FAQs

Q1: What is flurbiprofen used for? Flurbiprofen is used for the management of mild-to-moderate pain and symptoms of chronic arthritis, as well as for conditions like vernal keratoconjunctivitis[3][5].

Q2: What are the potential side effects of flurbiprofen? Flurbiprofen can cause gastrointestinal side effects and has a rare but potential risk of liver injury[5].

Q3: Why is flurbiprofen nominated for the FDA's 503B Bulks List? Flurbiprofen is nominated to address the need for injectable and ophthalmic forms that are not commercially available, and to mitigate risks associated with FDA-approved tablets in chronic use[2].

Q4: What is the projected CAGR for the flurbiprofen market? The flurbiprofen market is expected to grow at a CAGR of 5.20% from 2024 to the forecast period[4].

Q5: Which region dominates the global flurbiprofen market? North America holds a significant share of the global flurbiprofen market, accounting for 40% of the global revenue in 2024[4].

Sources

1. Global Flurbiprofen Market Size, Scope And Forecast Report - Market Research Intellect
2. Flurbiprofen - University of Maryland, Baltimore - University of Maryland Center of Excellence in Regulatory Science and Innovation
3. 89- Flurbiprofen, Comprehensive Profile - ResearchGate
4. Flurbiprofen Market size will grow at a CAGR of 5.20% from 2024 to ... - Cognitive Market Research
5. Flurbiprofen - LiverTox - NCBI Bookshelf - NCBI Bookshelf