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Last Updated: March 19, 2026

flurbiprofen - Profile


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What are the generic drug 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.

Summary for flurbiprofen
US Patents:0
Tradenames:4
Applicants:11
NDAs:11

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
Pharmacia And Upjohn ANSAID flurbiprofen TABLET;ORAL 018766-002 Oct 31, 1988 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pharmacia And Upjohn ANSAID flurbiprofen TABLET;ORAL 018766-003 Oct 31, 1988 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Ivax Sub Teva Pharms FLURBIPROFEN flurbiprofen TABLET;ORAL 074411-001 May 31, 1995 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Ivax Sub Teva Pharms FLURBIPROFEN flurbiprofen TABLET;ORAL 074411-002 May 31, 1995 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Investment Scenario and Fundamentals Analysis for Flurbiprofen

Last updated: February 20, 2026

What is Flurbiprofen?

Flurbiprofen is a non-steroidal anti-inflammatory drug (NSAID) used primarily for pain relief, inflammation reduction, and treatment of conditions such as arthritis and ocular inflammation. It is available in oral and topical formulations. Its chemical name is (RS)-2-(3-Fluorophenyl)propanoic acid. The drug was first introduced in the 1980s and has a market presence primarily in ophthalmology and rheumatology.

Market Overview and Sales Drivers

Current Market Size and Growth

  • Global NSAID market size was valued at approximately $16.5 billion in 2021.
  • Flurbiprofen accounted for an estimated niche within this, especially in ophthalmic indications.
  • Projected CAGR (Compound Annual Growth Rate) for NSAIDs is around 3.2% from 2022–2027 [1].

Key Market Segments

Segment Market Share Main Use Cases
Rheumatology 45% Osteoarthritis, rheumatoid arthritis
Ophthalmology 30% Postoperative inflammation, uveitis
Miscellaneous 25% Dental pain, other inflammatory conditions

Drivers of Growth

  • Rising prevalence of osteoarthritis and rheumatoid arthritis.
  • Advancements in ophthalmic drug delivery systems.
  • Growing geriatric population globally.

Patent and Regulatory Landscape

Patent Status

  • Original patents for flurbiprofen expired in the early 2000s.
  • Several secondary patents exist around formulations, delivery methods, and specific indications.
  • Companies are exploring new formulations—e.g., sustained-release, nanoparticle-based topical applications—to extend exclusivity.

Regulatory Approvals

  • Approved by FDA for ophthalmic use (e.g., Voltarol FS in the US—although marketed under different brand names for NSAID eye drops).
  • In the EU, marketed as ocufen for ocular inflammation.
  • Limited approvals for oral pain management due to gastrointestinal side effects.

Competitive Landscape

Major Players Notable Developments
Allergan (AbbVie) Ophthalmic formulations, recent licensing of NSAID new compounds
Novartis Focused on combination therapies
Generic manufacturers Large share post-patent expiry, offering cost-effective options

R&D and Pipeline Trends

  • Focused on improving bioavailability, reducing systemic side effects.
  • Research into nanoformulations and targeted delivery methods.
  • Development of combination drugs incorporating flurbiprofen with other anti-inflammatory agents.

Investment Considerations

Opportunities

  • Niche ophthalmic applications with increasing demand.
  • Potential for formulations with extended patent protection.
  • Growth in OTC availability in emerging markets for pain relief.

Risks

  • Patent expirations leading to generic competition.
  • Safety concerns related to NSAID gastrointestinal and cardiovascular side effects.
  • Regulatory hurdles for new formulations or indications.

Financial and Business Impacts

Aspect Details
Revenue Potential Limited in broad NSAID markets; higher in niche indications
Cost of R&D Moderate, focused on formulation enhancement
Margins Generally lower in generic markets, higher with innovative formulations

Limitations and Future Outlook

  • Flurbiprofen’s market share is constricted by competition from other NSAIDs with established safety profiles, such as ibuprofen and naproxen.
  • Label expansion into new indications could boost revenues but faces regulatory and clinical trial requirements.
  • Strategic partnerships for formulation innovation present opportunities.

Key Takeaways

  • Flurbiprofen operates mainly in niche ophthalmic and rheumatology segments.
  • Market growth is driven by increasing chronic inflammatory conditions and ophthalmic needs.
  • Patent expiry has led to widespread generic competition, impacting margins.
  • Innovation in delivery methods and new formulations could extend its commercial viability.
  • Regulatory pathways remain challenging but offer opportunities for formulation-based differentiation.

FAQs

What are the main indications for flurbiprofen?
Ophthalmic inflammation, post-surgical pain, osteoarthritis, and rheumatoid arthritis.

Is flurbiprofen available as an OTC drug?
In some markets, certain NSAIDs with flurbiprofen are OTC, especially for topical or ophthalmic applications, but oral formulations usually require prescriptions.

What are the key safety concerns?
Gastrointestinal bleeding, cardiovascular risk, and renal impairment associated with NSAIDs.

Are there pipeline drugs related to flurbiprofen?
Yes, research focuses on novel formulations, nano-drug delivery systems, and combination therapies.

What competitive advantages could new formulations offer?
Extended duration of action, reduced systemic side effects, and patent protection.


References

[1] MarketsandMarkets. (2022). NSAID market forecast and analysis.

[2] FDA. (2022). Regulatory status of NSAID ophthalmic drugs.

[3] European Medicines Agency. (2021). Product approvals and guidelines.

[4] Global Data. (2022). Market share and competitive landscape report.

[5] Novartis. (2021). Pipeline and research initiatives in NSAID formulations.

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