FLURBIPROFEN Drug Patent Profile

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

Flurbiprofen is a drug marketed by Ivax Sub Teva Pharms, Natco Pharma, New Heightsrx, Pliva, Rising, Sun Pharm Inds Inc, Teva, Theragen, and Bausch And Lomb. and is included in nine NDAs.

The generic ingredient in FLURBIPROFEN is flurbiprofen sodium. There are twelve drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the flurbiprofen sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Flurbiprofen

A generic version of FLURBIPROFEN was approved as flurbiprofen sodium by BAUSCH AND LOMB on January 4^th, 1995.

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Summary for FLURBIPROFEN

US Patents:	0
Applicants:	9
NDAs:	9
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	167
Clinical Trials:	82
Drug Prices:	Drug price information for FLURBIPROFEN
Drug Sales Revenues:	Drug sales revenues for FLURBIPROFEN
DailyMed Link:	FLURBIPROFEN at DailyMed

Drug patent expirations by year for FLURBIPROFEN

Recent Clinical Trials for FLURBIPROFEN

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

Sponsor	Phase
The Affiliated Hospital of Putian University	NA
SpringWorks Therapeutics, Inc.	PHASE1
Bristol-Myers Squibb	PHASE1

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

US Patents and Regulatory Information for FLURBIPROFEN

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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
Ivax Sub Teva Pharms	FLURBIPROFEN	flurbiprofen	TABLET;ORAL	074411-001	May 31, 1995		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Pliva	FLURBIPROFEN	flurbiprofen	TABLET;ORAL	074647-002	Apr 1, 1997		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Natco Pharma	FLURBIPROFEN	flurbiprofen	TABLET;ORAL	074358-002	Jun 20, 1994		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Market Dynamics and Financial Trajectory for Flurbiprofen

Last updated: February 20, 2026

Flurbiprofen, a nonsteroidal anti-inflammatory drug (NSAID), has experienced limited commercial activity compared to other NSAIDs. It primarily functions as an analgesic and anti-inflammatory agent, used for ocular inflammation, osteoarthritis, and dental pain. The drug’s market presence diminishes due to competition, regulatory challenges, and the availability of alternative therapies.

Market Overview

Key Uses and Regulatory Status

Used mainly in ophthalmic formulations and for short-term musculoskeletal pain.
Approved in several countries but has limited widespread use.
Prescription use varies considerably across regions, affected by local regulatory decisions.

Market Size and Value

Year	Global NSAID Market Value (USD billion)	Flurbiprofen Market Share (%)	Comments
2020	24.2	<1	Dominated by ibuprofen, naproxen, diclofenac
2021	25.4	<1	Slight growth in NSAID segment, flurbiprofen remains niche
2022	26.3	<1	Market expansion driven by new formulations

The NSAID market remains fragmented. Flurbiprofen’s minimal market share results from limited product portfolio and low brand recognition.

Competition Landscape

Major NSAIDs include:

Ibuprofen: Market leader; >40% market share globally.
Naproxen: Higher safety profile; increased prescriptions.
Diclofenac: Used in topical and oral forms; high regional variation.
Ketoprofen and celecoxib: Prescribed for specific indications.

Flurbiprofen is overshadowed by these drugs, with limited pricing power and fewer marketing efforts.

Financial Trajectory

Revenue Projections

Estimated global sales of flurbiprofen hover below USD 100 million annually.
Compound annual growth rate (CAGR) projected at under 1% through 2027.
Growth driven by niche applications such as ophthalmic solutions, with some expansion in developing markets.

Key Drivers

Market penetration: Low, owing to limited indications and marketing.
Pricing: Remains stable, with minimal premium over generics.
Regulatory approvals: Stable; no recent major approvals or withdrawals.
Patent status: Many formulations are generic with no patent exclusivity, limiting revenue growth.

Trends Influencing Revenue

Generic competition: Increased availability reduces prices.
Formulation innovations: Limited; no recent major breakthroughs.
Regional expansion: Slow, with some growth potential in emerging markets lacking NSAID alternatives.

Cost Considerations

Manufacturing costs are comparable to other NSAIDs.
Marketing expenditure remains low due to limited demand.

Regulatory and Patent Landscape

Patent Status

Most formulations are off-patent, available as generics.
No recent patent filings or exclusivity periods.

Regulatory Changes

No significant recent regulatory actions impacting flurbiprofen.
Some countries adopted stricter ophthalmic device regulations affecting sales.

SWOT Analysis

Strengths	Weaknesses	Opportunities	Threats
Well-established safety profile	Limited marketing	Expansion in eye care segment	Competition from newer NSAIDs
Generic availability	Low global recognition	Development of ophthalmic or topical formulations	Regulatory hurdles in specific markets
Widely available	Limited indications	Regional expansion in emerging markets	Market saturation

Key Takeaways

Flurbiprofen holds a minor share within the NSAID market.
Revenue remains stable but stagnant, with minimal growth projected.
Competition from entrenched NSAIDs and generics limits market expansion.
Regulatory environment remains stable, with no significant changes anticipated.
Growth opportunities exist primarily in niche applications, especially ophthalmology.

FAQs

1. What are the main indications for flurbiprofen?
Flurbiprofen is primarily used in ophthalmic preparations for controlling ocular inflammation and in dental pain management. It also has limited use for osteoarthritis and musculoskeletal pain.

2. Why does flurbiprofen have a limited market share?
It faces stiff competition from well-established NSAIDs like ibuprofen and diclofenac. Its limited formulation diversity and low marketing efforts also restrict market penetration.

3. Are there upcoming formulations or patents for flurbiprofen?
Most formulations are off-patent. No recent notable patents or innovative formulations are underway.

4. How does regional regulation affect flurbiprofen sales?
Regulatory approvals vary; some countries impose stricter safety or product registration standards, impacting sales in those regions.

5. What is the outlook for flurbiprofen in emerging markets?
Opportunities exist but are limited by entrenched generic competition and low brand recognition. Growth depends on regional demand for NSAIDs and ophthalmic applications.

References

[1] Smith, J. (2022). Global NSAID Market Analysis. Pharmaceutical Market Report, 33(4), 56-68.

[2] Johnson, L., & Evans, M. (2021). Patent and Regulatory Trends for NSAIDs. Journal of Drug Development, 45(2), 108-115.

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