Nepafenac - Generic Drug Details

What are the generic sources for nepafenac and what is the scope of freedom to operate?

Nepafenac is the generic ingredient in two branded drugs marketed by Harrow Eye and is included in two NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Nepafenac has eighty-two patent family members in twenty-nine countries.

There are eight drug master file entries for nepafenac. One supplier is listed for this compound.

Summary for nepafenac

International Patents:	82
US Patents:	5
Tradenames:	2
Applicants:	1
NDAs:	2
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	47
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for nepafenac
What excipients (inactive ingredients) are in nepafenac?	nepafenac excipients list
DailyMed Link:	nepafenac at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for nepafenac

Dosage:

SUSPENSION/DROPS;OPHTHALMIC

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for nepafenac

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

Sponsor	Phase
Nemocnice Koln	NA
Kafrelsheikh University	Phase 4
Virginia Polytechnic Institute and State University	N/A

See all nepafenac clinical trials

Pharmacology for nepafenac

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

Anatomical Therapeutic Chemical (ATC) Classes for nepafenac

S01BC	Antiinflammatory agents, non-steroids
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for NEPAFENAC

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ILEVRO	Ophthalmic Suspension	nepafenac	0.3%	203491	1	2015-12-21

US Patents and Regulatory Information for nepafenac

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Harrow Eye	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012		RX	Yes	Yes			Y
Harrow Eye	NEVANAC	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	021862-001	Aug 19, 2005		RX	Yes	Yes
Harrow Eye	NEVANAC	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	021862-001	Aug 19, 2005		RX	Yes	Yes			Y
Harrow Eye	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012		RX	Yes	Yes			Y
Harrow Eye	NEVANAC	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	021862-001	Aug 19, 2005		RX	Yes	Yes			Y

Expired US Patents for nepafenac

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Harrow Eye	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012
Harrow Eye	NEVANAC	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	021862-001	Aug 19, 2005
Harrow Eye	NEVANAC	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	021862-001	Aug 19, 2005
Harrow Eye	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012
Harrow Eye	NEVANAC	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	021862-001	Aug 19, 2005
Harrow Eye	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012

EU/EMA Drug Approvals for nepafenac

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Novartis Europharm Limited	Nevanac	nepafenac	EMEA/H/C/000818Nevanac is indicated for:, , , prevention and treatment of postoperative pain and inflammation associated with cataract surgery;, reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients., ,	Authorised	no	no	no	2007-12-11

International Patents for nepafenac

Country	Patent Number	Title	Estimated Expiration
Chile	2012001402
Slovenia	2965749
Denmark	2586426
Russian Federation	2007124638	ПРЕПАРАТЫ НЕПАФЕНАКА ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ
Poland	2586426
Japan	2016106155

Supplementary Protection Certificates for nepafenac

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0999825	92301	Luxembourg		PRODUCT NAME: NEPAFENAC-SUSPENSION OPHTALMIQUE
0999825	CA 2013 00055	Denmark		PRODUCT NAME: NEPAFENAC (3 MG/ML), HERUNDER NEPAFENAC I KOMBINATION MED GLACTOMANNANPOLYMERER, ISAER 3 MG/ML NEPAFENAC I KOMBINATION MED GALACTOMANNANPOLYMERER, SAMT OFTALMISKE SAMMENSAETNINGER DERAF; REG. NO/DATE: EU1/07/433/002 20130503
0999825	122013000085	Germany		PRODUCT NAME: NEPAFENAC (OPHTHALMISCHE SUSPENSION); REGISTRATION NO/DATE: EU 1/07/433/002 20130503
0999825	C300622	Netherlands		PRODUCT NAME: NEPAFENAC; REGISTRATION NO/DATE: EU/1/07/433/002 20130503
0716600	C00716600/01	Switzerland		PRODUCT NAME: NEPAFENAC; REGISTRATION NUMBER/DATE: SWISSMEDIC 58745 24.09.2008

Market Dynamics and Financial Trajectory for NEPAFENAC

Last updated: July 28, 2025

Introduction

Nepafenac, a non-steroidal anti-inflammatory drug (NSAID), has carved a significant niche within ophthalmology, particularly for its role in managing postoperative inflammation and pain associated with cataract surgery. As a prodrug converting into amfenac, it penetrates ocular tissues effectively, offering targeted relief with a favorable safety profile. Understanding its market dynamics and financial trajectory involves examining its clinical role, competitive landscape, regulatory environment, and growth catalysts shaping its commercial potential.

Pharmacological Profile and Clinical Utility

Nepafenac's unique prodrug formulation enhances corneal penetration, enabling efficient delivery of active metabolites to intraocular tissues. Its primary indications include reducing ocular pain and inflammation post-cataract surgery, supported by clinical evidence demonstrating substantial efficacy and safety. The FDA-approved formulations—such as NEVANAC—and similar products by leading pharmaceutical players underpin its widespread clinical adoption. Its once-daily dosing regimen favorably impacts patient compliance, further boosting its market acceptance.

Competitive Landscape and Market Position

Nepafenac faces competition from other NSAIDs like bromfenac, ketorolac, and diclofenac, which also serve postoperative ocular inflammation. However, its distinct pharmacokinetic properties and proven tolerability position it favorably within the intraocular NSAID segment. Key players such as Alcon, Novartis, and Santen Pharmaceutical have invested in patent protections, marketing campaigns, and product differentiations that sustain its competitive advantage.

The patent expiration and emergence of biosimilars or generics could influence pricing strategies and market share. Nonetheless, the clinical reputation and established safety profile for nepafenac underpin sustained demand. Additionally, expanding indications—such as for diabetic macular edema—could diversify its application and further enhance its market position.

Regulatory Environment and Market Access

Regulatory agencies globally, including FDA (U.S.), EMA (Europe), and other regional authorities, have approved nepafenac, affirming its safety and efficacy profile. Regulatory approval facilitates market access but also necessitates ongoing compliance with post-market surveillance and pharmacovigilance regulations, which can influence market stability and profitability.

In emerging markets, regulatory timelines and approval processes may pose hurdles or provide opportunities for early adoption through dedicated health initiatives or orphan drug designations. Reimbursement policies and pricing negotiations significantly impact sales trajectories, especially within highly competitive healthcare systems.

Market Drivers and Growth Catalysts

Aging Populations

The global increase in cataract surgeries, driven by aging demographics, directly correlates with heightened demand for postoperative NSAIDs like nepafenac. The World Health Organization estimates the global cataract surgery volume exceeds 20 million annually, signaling robust growth potential [1].

Advancements in Surgical Techniques

Minimally invasive surgical procedures and enhanced postoperative care protocols increase reliance on effective anti-inflammatory agents to improve visual outcomes and patient satisfaction.

Rising Prevalence of Chronic Ocular Conditions

Growing incidences of diabetic retinopathy and macular degeneration necessitate adjunctive anti-inflammatory therapy, expanding nepafenac's market beyond postoperative use.

Emerging Markets

Developing economies with expanding healthcare infrastructure present untapped markets with substantial growth opportunities. The affordability and familiarity of nepafenac can facilitate market penetration in these regions.

Pharmaceutical Innovation

Formulation improvements, such as sustained-release devices and combination therapies, can extend nepafenac's application scope, multiply revenue streams, and reinforce market dominance.

Market Challenges and Risks

• Patent Expiry and Generic Competition: Patent landscapes strongly influence pricing and profit margins. The entrance of generics could depreciate revenue streams if pricing strategies are not strategically managed.
• Pricing Pressures and Reimbursement Hurdles: Health systems seeking cost reductions may impose strict reimbursement policies, constraining profit margins.
• Regulatory Barriers: Divergences in regulatory approval criteria across regions can delay market entry or expand costs.
• Competition from Novel Therapies: Emerging drug candidates, gene therapies, or alternative anti-inflammatory agents could challenge nepafenac's market share.

Financial Trajectory and Market Forecast

Predicting nepafenac's financial trajectory involves analyzing current sales data, pipeline developments, regulatory trends, and macroeconomic factors influencing healthcare expenditure.

Current Market Valuation

As of 2023, the ophthalmic anti-inflammatory market, inclusive of nepafenac and its competitors, is valued at approximately $3 billion globally, with a CAGR of around 5% predicted over the next five years [2].

Revenue Drivers

• Increasing cataract surgeries, especially in Asia-Pacific and Latin America.
• Rising adoption rates in emerging markets due to improved healthcare access.
• Incremental launches of extended-release formulations and combination products.
• Potential approval for additional indications, such as retinal edema.

Growth Projections

Industry analysts forecast that nepafenac's segment within ophthalmic NSAIDs could grow at a CAGR of 4-6% over the next five years, driven primarily by clinical adoption, market expansion, and pipeline innovations. Established pharmaceutical companies' investments in clinical trials and marketing strategies will further influence this trajectory.

Profitability Outlook

Profit margins are expected to remain stable, contingent upon patent protections and competitive pricing strategies. A shift towards biosimilar proliferation could necessitate aggressive marketing and cost-efficiency initiatives to maintain profitability.

Strategic Opportunities

• Pipeline Expansion: Investing in clinical trials for new indications such as diabetic macular edema could diversify revenue streams.
• Geographic Expansion: Accelerating entry into emerging markets with high cataract surgical volumes.
• Formulation Innovations: Developing sustained-release formulations could enhance patient adherence and differentiate products.
• Partnerships and Licensing: Collaborative agreements with regional distributors can accelerate market penetration.

Regulatory and Strategic Risks

• Patent Litigation: Potential patent disputes could disrupt product availability.
• Regulatory Delays: Time-consuming approval processes may postpone revenue streams.
• Market Saturation: Intense competition may lead to pricing pressures and reduced market shares.

Conclusion

Nepafenac’s market dynamics are shaped by its pharmacological profile, expanding surgical procedures, and evolving healthcare needs. Its financial trajectory appears favorable, supported by increasing procedural volumes and ongoing innovation. Nonetheless, the landscape requires vigilant navigation of patent rights, competition, and regulatory hurdles. Strategic investments in pipeline expansion, geographic diversification, and formulation technology will be essential for sustained growth.

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Key Takeaways

• The global ophthalmic NSAID market is expanding, driven by demographic shifts, surgical advancements, and emerging therapeutic indications.
• Nepafenac benefits from a strong clinical position owing to its effective intraocular penetration and safety profile.
• Patent expirations and biosimilar emergence pose significant challenges, necessitating innovation and strategic market expansion.
• Rising cataract surgery volumes, particularly in emerging markets, underpin robust growth prospects for nepafenac.
• Firms investing in pipeline development and formulation innovations will better position themselves to capitalize on market opportunities.

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FAQs

Q1: What are the primary clinical advantages of nepafenac over other NSAIDs?

A1: Nepafenac’s prodrug design enhances corneal penetration, leading to effective intraocular concentrations, reducing postoperative inflammation and pain efficiently with a favorable safety profile, and allowing once-daily dosing, which improves patient compliance.

Q2: How might patent expirations impact nepafenac’s market share?

A2: Patent expirations could invite generic competitors, exerting downward pressure on prices, reducing profit margins, and potentially diminishing market share unless the innovator invests in differentiation and new indications.

Q3: What opportunities exist for nepafenac in emerging markets?

A3: Growing cataract surgery volumes, increasing healthcare infrastructure, and demand for effective, affordable postoperative care create substantial opportunities for market expansion with strategic localization and distribution partnerships.

Q4: Are there any recent pipeline developments that could influence nepafenac’s future sales?

A4: Yes, ongoing research into extended-release formulations, combination therapies, and novel indications such as diabetic macular edema could broaden its application and sustain sales growth.

Q5: How do regulatory differences across regions affect nepafenac’s global market potential?

A5: Variations in approval processes, regulatory requirements, and reimbursement policies can delay or facilitate market entry. Tailored regulatory strategies and early engagement are essential to maximize access and commercial success.

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References

[1] World Health Organization. (2020). Global Data on Cataract Surgery Volume. WHO Reports.

[2] Market Research Future. (2022). Ophthalmic Anti-Inflammatory Drugs Market Analysis. MRFR.