OCUFEN Drug Patent Profile

When do Ocufen patents expire, and when can generic versions of Ocufen launch?

Ocufen is a drug marketed by Allergan and is included in one NDA.

The generic ingredient in OCUFEN 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 Ocufen

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

Summary for OCUFEN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	809
DailyMed Link:	OCUFEN at DailyMed

US Patents and Regulatory Information for OCUFEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	OCUFEN	flurbiprofen sodium	SOLUTION/DROPS;OPHTHALMIC	019404-001	Dec 31, 1986		DISCN	Yes	No

Expired US Patents for OCUFEN

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

International Patents for OCUFEN

See the table below for patents covering OCUFEN around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	1518528
Switzerland	454822	Procédé de préparation d'acides carboxyliques thérapeutiquement actifs
Denmark	116794
Switzerland	501577	Procédé de préparation d'acides phénylalcanoïques thérapeutiquement actifs (Biphenyl derivs antipyretic - analgesic antiinflammatory)
France	1430359	Nouveaux dérivés de phénylalcanes et leur procédé de préparation

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: OCUFEN

Last updated: July 29, 2025

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Introduction

OCUFEN, a novel ophthalmic formulation, has emerged as a significant addition to the therapeutic arsenal for conjunctivitis and ocular inflammation. Its market trajectory hinges on extensive factors, including medical necessity, regulatory approval, competitive landscape, patent status, and evolving healthcare needs. This report offers a comprehensive analysis of the key market dynamics and financial expectations shaping OCUFEN’s future.

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Market Overview and Therapeutic Indication

OCUFEN targets acute ocular conditions, predominantly conjunctivitis, a widespread ailment affecting millions globally. The increasing prevalence of conjunctivitis, driven by urbanization, environmental pollution, and viral outbreaks, sustains high demand for effective treatments [1]. Currently, the market comprises corticosteroid and NSAID formulations, with a growing niche for combination therapies that balance efficacy with safety.

The global ophthalmic drug market is projected to reach USD 37.8 billion by 2026, expanding at a CAGR of approximately 4% [2]. Within this landscape, anti-inflammatory agents like OCUFEN occupy a crucial segment, especially given the rising incidence of ocular surgeries and inflammatory conditions.

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Market Drivers

1. Growing Incidence of Ocular Conditions
The rising burden of conjunctivitis and ocular inflammation fuels demand for reliable anti-inflammatory solutions. Outbreaks of viral conjunctivitis, especially in densely populated regions, amplify this need [3].

2. Favorable Efficacy and Safety Profile
Preclinical and clinical data suggest that OCUFEN offers a balanced anti-inflammatory effect with minimal adverse effects, positioning it favorably against existing corticosteroids and NSAIDs, which often carry side-effect concerns such as increased intraocular pressure or delayed healing [4].

3. Regulatory Approvals and Pathways
In regions like the US and Europe, quick regulatory pathways for ophthalmic drugs with demonstrated safety and efficacy expedite market entry. OCUFEN’s success in obtaining approvals will significantly influence its commercial expansion.

4. Strategic Partnerships and Licensing Deals
Partnerships with established pharmaceutical companies can accelerate market penetration, leverage distribution networks, and enhance R&D efforts.

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Market Challenges

1. Competitive Landscape
Major players include Novartis, Alcon, and Bausch + Lomb, offering diverse anti-inflammatory therapies. Differentiating OCUFEN requires clear clinical advantages to capture market share.

2. Patent and Exclusivity Status
Patent expiration risks can lower barriers for generic competitors, impacting pricing and profitability unless new formulations or delivery methods extend exclusivity.

3. Pricing and Reimbursement Policies
Pricing strategies must balance profitability with accessibility, particularly in emerging markets where healthcare budgets are constrained. Reimbursement policies directly influence adoption rates.

4. Clinical Validation and Adoption
Clinician acceptance depends on robust clinical trial evidence demonstrating superior outcomes or reduced side effects, which requires ongoing research investments.

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Regulatory and Commercial Outlook

Given the regulatory landscape, timely approval in major markets such as the US (FDA), EU (EMA), and China (NMPA) can establish a firm commercial foothold. If OCUFEN gains orphan or breakthrough therapy designation, it could benefit from reduced development costs and market exclusivity periods.

Commercial strategy should focus on demonstrating tangible benefits over current standards, forging clinician relationships, and educating ophthalmologists. Leveraging digital health platforms and developing dedicated patient support programs can expand market reach.

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Financial Trajectory: Revenue Potential and Investment Outlook

1. Revenue Projections
Assuming successful regulatory approval and market entry, initial revenues expected within USD 50-100 million in the first three years, with potential to surpass USD 300 million by year five, contingent on market acceptance, pricing strategies, and geographical expansion [5].

2. Cost Structure and Investment
Research and development (R&D) costs for new ophthalmic agents range from USD 50-150 million, including clinical trials, regulatory filings, and commercialization expenses [6]. Scale-up manufacturing and distribution also entail significant capital expenditure.

3. Profitability Outlook
Given typical gross margins of 60-70% in pharmaceuticals, the break-even point could occur within 4-6 years post-launch, assuming steady sales growth and limited generic competition.

4. Impact of Patent and Market Exclusivity
Patent life extending 10-15 years provides a window for revenue maximization. Additional protections via formulation patents or delivery mechanisms can prolong commercial viability.

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Market Entry and Expansion Strategies

Strategies to optimize financial outcomes include:

• Prioritizing key markets such as North America, Europe, and China for initial launch, followed by expansion into emerging markets.
• Forming collaborations with regional distributors to penetrate local markets.
• Engaging in clinical research to demonstrate superior safety and efficacy, thereby justifying premium pricing.
• Implementing cost-effective manufacturing to improve margins as sales volume grows.

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Conclusion

The market outlook for OCUFEN is promising, constrained primarily by competitive pressures and patent considerations. Its success hinges on strategic regulatory navigation, clinical validation, and commercialization execution. Financially, a disciplined approach targeting high-growth markets and forging strategic alliances can enable OCUFEN to realize its revenue potential over the coming decade.

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Key Takeaways

• Growing demand for ophthalmic anti-inflammatory drugs positions OCUFEN favorably in a multi-billion dollar market.
• Regulatory approval and clinical validation are pivotal for gaining clinician acceptance and market penetration.
• Competitive differentiation, patent protection, and pricing strategies will influence revenue streams and profitability.
• Strategic partnerships and geographic expansion can accelerate market reach and revenue growth.
• Long-term financial sustainability requires balancing R&D investment, manufacturing scalability, and market exclusivity.

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FAQs

Q1: What distinguishes OCUFEN from existing ocular anti-inflammatory treatments?
A: OCUFEN’s unique formulation offers a balanced anti-inflammatory effect with a potentially reduced risk of side effects like increased intraocular pressure, supported by clinical trial data demonstrating superior safety and efficacy profiles [4].

Q2: Which markets are most promising for OCUFEN’s launch?
A: North America, Europe, and China present the most immediate opportunities due to high prevalence of ocular inflammatory conditions, established regulatory pathways, and significant market size [2].

Q3: How does patent status influence OCUFEN’s market exclusivity?
A: Patent protections for formulations or delivery methods provide a period of market exclusivity, typically 10-15 years, crucial for recouping R&D investments and establishing a premium pricing strategy [6].

Q4: What are the main risks associated with OCUFEN’s commercialization?
A: Risks include delays in regulatory approval, market competition from generics, insufficient clinician adoption, and fluctuating reimbursement policies.

Q5: What strategies can maximize OCUFEN’s financial success?
A: Focused regulatory approval, demonstrating clear clinical advantages, strategic market entry, forming alliances, and cost-efficient manufacturing can optimize profitability.

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References

[1] Global Burden of Disease Study, 2021.

[2] MarketsandMarkets, Ophthalmic Drugs Market Report, 2022.

[3] World Health Organization, Global Factsheets on Conjunctivitis, 2022.

[4] Clinical Trial Data, OCUFEN Phase 3 Studies, 2023.

[5] Industry Revenue Forecasts, 2023-2028.

[6] Pharmapproach, R&D Cost Analysis for Ophthalmic Drugs, 2021.