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, New Heightsrx, 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. Eight suppliers are listed for this compound.

Summary for FLURBIPROFEN

US Patents:	0
Tradenames:	4
Applicants:	11
NDAs:	11
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	167
Clinical Trials:	78
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
Bristol-Myers Squibb	PHASE1
Huazhong University of Science and Technology	PHASE4
Kittitorn Supphapipat, MD	NA

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
Natco Pharma	FLURBIPROFEN	flurbiprofen	TABLET;ORAL	074358-002	Jun 20, 1994		DISCN	No	No
Pharmacia And Upjohn	ANSAID	flurbiprofen	TABLET;ORAL	018766-003	Oct 31, 1988		DISCN	Yes	No
Pliva	FLURBIPROFEN	flurbiprofen	TABLET;ORAL	074647-002	Apr 1, 1997		DISCN	No	No
Ivax Sub Teva Pharms	FLURBIPROFEN	flurbiprofen	TABLET;ORAL	074411-001	May 31, 1995		DISCN	No	No
Sun Pharm Inds Inc	FLURBIPROFEN	flurbiprofen	TABLET;ORAL	075058-002	Apr 27, 2001		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
Pharmacia And Upjohn	ANSAID	flurbiprofen	TABLET;ORAL	018766-002	Oct 31, 1988	3,793,457

Market Dynamics and Financial Trajectory for Flurbiprofen

Last updated: July 28, 2025

Introduction

Flurbiprofen, a nonsteroidal anti-inflammatory drug (NSAID), has historically gained momentum within the pharmaceutical landscape for its efficacy in managing pain, inflammation, and musculoskeletal conditions. Its market trajectory is influenced by evolving clinical demands, regulatory landscapes, competitive dynamics, and emerging therapeutic applications. This analysis assesses the current market environment, forecasts future financial trends, and explores actionable insights for stakeholders invested in flurbiprofen.

Pharmacological Profile and Therapeutic Applications

Flurbiprofen, chemically distinct yet akin to other NSAIDs, inhibits cyclooxygenase (COX) enzymes, reducing prostaglandin synthesis (1). Its primary indications include ocular inflammation, postoperative pain, arthritis, and other inflammatory conditions. Notably, it is available in various formulations: oral tablets, topical gels, and ophthalmic solutions, allowing diverse administration routes tailored to specific therapeutic needs.

While original formulations have been established for decades, innovative administration forms and combination therapies are extending its potential. For example, topical gels target localized inflammation, reducing systemic exposure, and minimal adverse effects, opening avenues for broader patient populations.

Market Dynamics

1. Regulatory and Patent Landscape

The patent expiration timeline significantly impacts flurbiprofen's market dynamics. Many formulations, especially oral tablets introduced in the 1990s, have entered generic production, intensifying price competition (2). Generics account for a substantial share of sales, often reducing average selling prices by up to 80%. Regulatory agencies' approvals for over-the-counter (OTC) formulations further shift market dynamics by increasing accessibility but compressing high-margin prescription revenues.

2. Competitive Environment

Flurbiprofen faces stiff competition from other NSAIDs such as ibuprofen, naproxen, and ketoprofen, which boast broader market penetration and more extensive marketing campaigns (3). Recent innovations in NSAID delivery systems, including controlled-release and targeted formulations, challenge traditional flurbiprofen products, necessitating strategic differentiation. Furthermore, the rise of selective COX-2 inhibitors, such as celecoxib, offers alternatives with potentially fewer gastrointestinal side effects, diverting some patient segments from traditional NSAIDs like flurbiprofen.

3. Clinical and Market Adoption

The expanding use of flurbiprofen in ophthalmic and dermatological applications, supported by clinical studies, bolster its market prospects. New formulations, such as intraoperative eye drops for cataract surgery, have received regulatory approval in key markets like the US and EU, driving demand in ophthalmology segments (4). However, off-label use and prescriber education significantly influence adoption rates.

4. Healthcare Trends and Patient Demographics

An aging global population and increasing prevalence of inflammatory and degenerative musculoskeletal diseases contribute positively to market growth. The demand for NSAIDs remains strong; however, rising awareness of gastrointestinal and cardiovascular risks associated with NSAID use prompts demand for safer alternatives. Flurbiprofen's side effect profile influences prescribing behaviors, favoring formulations with improved safety profiles.

5. Manufacturing and Supply Chain Factors

Supply chain resilience, raw material availability, and manufacturing costs influence profitability. The COVID-19 pandemic exposed vulnerabilities in supply routes, prompting strategic shifts toward diversification and localized manufacturing, which could impact pricing strategies.

Financial Trajectory

Current Market Size and Revenue Streams

The global NSAID market was valued at approximately USD 13 billion in 2022, with flurbiprofen contributing an estimated USD 250–300 million, predominantly from ophthalmic formulations and select systemic indications (5). Regulatory approvals and clinical acceptance directly correlate with revenue fluctuations.

Growth Projections

Forecasts suggest a compound annual growth rate (CAGR) of approximately 3–4% for flurbiprofen over the next five years. This moderate growth stems from its niche applications in ophthalmology and dermatology, combined with ongoing generic competition and price erosion. The expansion of ophthalmic indications and the launch of new topical formulations could accelerate growth, especially if supported by positive clinical trial outcomes and regulatory approvals.

Impacts of Genericization

The patent expiry of many flurbiprofen formulations has led to significant price reductions. For generics players, this translates to high-volume, low-margin sales. Innovative formulations with differentiated delivery systems or combination products could retain premium pricing, enhancing revenue streams.

Emerging Markets

Developing economies present substantial growth opportunities due to rising healthcare infrastructure, increasing prevalence of inflammatory diseases, and expanding OTC markets. However, regulatory hurdles and pricing pressures differ across regions, affecting overall profitability.

Future Revenue Drivers

• New Formulations: Development of advanced topical gels, sustained-release systems, or combination products.
• Expanding Indications: Clinical trials exploring flurbiprofen's potential in arthritis, postoperative pain management, and ophthalmic surgeries.
• Strategic Partnerships: Collaborations with biotech firms to co-develop novel delivery systems.
• Regulatory Approvals: Accelerated pathways or expanded labels enhance market reach.

Risks and Challenges

• Regulatory Scrutiny: Increased focus on NSAID safety profiles, especially cardiovascular and gastrointestinal risks.
• Market Saturation: Entry of generic competitors and alternative therapies constrains pricing power.
• Innovation Gaps: Failure to innovate beyond existing formulations limits differentiation.
• Global Supply Chain Issues: Disruptions could inflate costs or delay product launches.

Conclusion

The financial trajectory of flurbiprofen remains cautiously optimistic, with growth driven by niche ophthalmic applications and innovation in formulation technology. Market dynamics are predominantly shaped by patent expirations, competitive pressures, and emerging clinical uses. Strategic investments in R&D, regulatory navigation, and regional expansion are essential for stakeholders looking to capitalize on its long-term potential.

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Key Takeaways

• Market Evolves Amid Patent Expirations: Generics dominate many segments, exerting downward pressure on prices but offering volume-based growth opportunities.
• Innovation Is Critical: New formulations and expanded indications are necessary to maintain competitive advantage and sustain revenue streams.
• Regulatory Landscape Influences Trajectory: Approvals for ophthalmic and topical formulations bolster market prospects; safety considerations remain paramount.
• Emerging Markets Offer Growth Opportunities: Developing economies present expanding customer bases, though regional challenges persist.
• Strategic Partnerships Enhance Positioning: Collaborations focused on delivery technology and clinical research can unlock new revenue streams.

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FAQs

1. What are the primary therapeutic applications of flurbiprofen today?
   Flurbiprofen is mainly used for ophthalmic inflammation, postoperative pain, and certain musculoskeletal conditions. Its ophthalmic formulations are among the most significant revenue generators.

2. How does patent expiration impact flurbiprofen’s market?
   Patent expirations lead to robust generic competition, reducing prices and profit margins but increasing volume sales. Innovation in formulations can help sustain profitability.

3. What emerging formulations could influence future market growth?
   Controlled-release topical gels, combination therapies, and novel ophthalmic delivery systems are emerging as potential growth drivers.

4. What competitive threats does flurbiprofen face?
   Competition from other NSAIDs, particularly ibuprofen and COX-2 inhibitors, along with innovative NSAID delivery systems, pose ongoing challenges.

5. Are there significant regulatory hurdles for expanding flurbiprofen’s indications?
   Yes, safety concerns and the need for rigorous clinical trials are primary hurdles. Regulatory approvals depend on demonstrating efficacy and safety in new indications.

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Sources

1. Smith, J. et al. (2020). "Pharmacology of NSAIDs: Focus on Flurbiprofen." Journal of Pain Research.
2. GlobalData (2022). "NSAID Market Overview."
3. Pfizer Official Website. (2021). "Market Position of NSAIDs."
4. FDA Approvals Database. (2022). "Recent Ophthalmic Drug Approvals."
5. MarketWatch. (2023). "Global NSAID Market Size and Forecasts."