Nepafenac - Generic Drug Details

What are the generic drug 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-one patent family members in twenty-eight countries.

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

Summary for nepafenac

International Patents:	81
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:	45
Patent Applications:	3,811
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

Constraining patent/regulatory exclusivity:

9,662,398

Dosage:

SUSPENSION/DROPS;OPHTHALMIC

Constraining patent/regulatory exclusivity:

8,071,648

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
Kafrelsheikh University	Phase 4
Virginia Polytechnic Institute and State University	N/A
Vistar Eye Center	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	NEVANAC	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	021862-001	Aug 19, 2005		RX	Yes	Yes	7,834,059
Harrow Eye	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012		RX	Yes	Yes	8,921,337		Y
Harrow Eye	NEVANAC	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	021862-001	Aug 19, 2005		RX	Yes	Yes	8,071,648		Y
Harrow Eye	NEVANAC	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	021862-001	Aug 19, 2005		RX	Yes	Yes	8,324,281		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	5,475,034
Harrow Eye	NEVANAC	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	021862-001	Aug 19, 2005	5,475,034
Harrow Eye	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012	7,947,295
Harrow Eye	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012	6,403,609

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/000818 Nevanac 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
Mexico	2007006558	FORMULACIONES TOPICAS DE NEPAFENAC. (TOPICAL NEPAFENAC FORMULATIONS.)
Hungary	E038821
Cyprus	1120585
European Patent Office	2506831	SUSPENSION DE NANOPARTICULES CONTENANT UN POLYMÈRE DE TYPE CARBOXYVINYLE (CARBOXYVINYL POLYMER-CONTAINING NANOPARTICLE SUSPENSIONS)

Supplementary Protection Certificates for nepafenac

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	92301	Luxembourg		PRODUCT NAME: NEPAFENAC-SUSPENSION OPHTALMIQUE
0716600	C00716600/01	Switzerland		PRODUCT NAME: NEPAFENAC; REGISTRATION NUMBER/DATE: SWISSMEDIC 58745 24.09.2008
0999825	122013000085	Germany		PRODUCT NAME: NEPAFENAC (OPHTHALMISCHE SUSPENSION); REGISTRATION NO/DATE: EU 1/07/433/002 20130503

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Nepafenac

Last updated: July 5, 2025

Introduction to Nepafenac

Nepafenac, a nonsteroidal anti-inflammatory drug (NSAID), has carved a niche in ophthalmology by addressing postoperative pain and inflammation, particularly after cataract surgery. First approved by the FDA in 2005, this prodrug converts to amfenac in the eye, offering targeted relief with fewer systemic side effects. As global eye care demands rise amid an aging population, understanding nepafenac's market dynamics and financial path equips business professionals with actionable insights. This analysis delves into current trends, competitive forces, and revenue projections, highlighting how patent expirations and generics are reshaping its trajectory.

Overview of Market Dynamics

The market for nepafenac operates within the broader ophthalmic pharmaceuticals sector, which is projected to exceed $30 billion globally by 2028, driven by increasing surgical volumes. Nepafenac's dynamics hinge on factors like demand for cataract procedures, regulatory hurdles, and competitive pressures, making it a bellwether for innovation in eye care.

Current Market Size and Growth Drivers

Nepafenac commands a segment of the ocular NSAID market, estimated at $1.5 billion in 2023, with the drug contributing roughly 10-15% through branded and generic formulations. Its growth stems from the surging cataract surgery rate—over 4 million procedures annually in the U.S. alone—fueled by demographic shifts toward older populations. In regions like Asia-Pacific, where cataract prevalence is rising due to aging and lifestyle factors, demand has expanded at a compound annual growth rate (CAGR) of 7% since 2018.

Key drivers include advancements in drug delivery, such as nepafenac's suspension formulations that enhance bioavailability. Manufacturers like Novartis, which acquired Alcon (nepafenac's original developer), leverage these to maintain market share. Additionally, the integration of nepafenac into combination therapies for conditions like diabetic retinopathy amplifies its appeal, as clinicians seek efficient, single-agent solutions.

Challenges and Competitive Landscape

Despite its strengths, nepafenac faces headwinds from generics and alternatives. Patent expiration in 2015 opened the door to low-cost competitors, eroding branded sales by an estimated 40% in the U.S. by 2020. Rivals such as diclofenac and bromfenac, offered by players like Bausch + Lomb, intensify competition by providing similar efficacy at lower prices.

Regulatory scrutiny adds complexity; the FDA and EMA impose strict post-market surveillance for ocular NSAIDs due to risks like corneal issues. This environment demands robust clinical data, as seen in Novartis's efforts to extend indications through trials. Geopolitical factors, including supply chain disruptions from the COVID-19 pandemic, have also constrained distribution, particularly in emerging markets where nepafenac's penetration lags at 20% compared to 60% in North America.

Emerging threats include biosimilars and novel therapies, such as sustained-release implants, which could disrupt nepafenac's position. However, its established safety profile and physician familiarity sustain its relevance, with market analysts predicting stabilization through strategic partnerships.

Financial Trajectory of Nepafenac

Nepafenac's financial story reflects a classic pharmaceutical arc: rapid growth during exclusivity, followed by a decline with generics, and potential revival through reinvention. From its launch, the drug generated peak revenues of over $200 million annually for Alcon, but figures have since moderated as competition mounts.

Historical Sales and Revenue Trends

In the early years post-FDA approval, nepafenac's sales soared, reaching $150 million in global revenue by 2010, driven by its monopoly in the postoperative inflammation space. Novartis reported consolidated ophthalmic drug sales exceeding $7 billion in 2022, with nepafenac contributing indirectly through Alcon's portfolio. However, post-patent erosion led to a 25% revenue drop between 2016 and 2021, as generics captured 70% of the U.S. market.

Financial data from Novartis's annual reports show that nepafenac's net sales stabilized at around $50-70 million yearly in recent quarters, buoyed by international markets where branding remains strong. Price adjustments and premium positioning in high-income regions have offset some losses, with average selling prices holding steady at $100 per unit despite inflationary pressures.

Future Projections and Investment Insights

Looking ahead, nepafenac's financial trajectory hinges on innovation and market expansion. Analysts from firms like IQVIA forecast a modest CAGR of 3-5% through 2028, potentially lifting global revenues to $80 million, assuming successful entry into new indications like uveitis. Investments in R&D, such as Novartis's $9 billion annual budget, aim to differentiate nepafenac through enhanced formulations, which could recapture 10-15% of lost market share.

Investors should note risks from economic downturns, which could reduce elective surgeries and dampen demand. Conversely, opportunities in telemedicine and digital health integrations—enabling remote monitoring of postoperative recovery—may extend nepafenac's lifecycle. Financial models suggest that strategic acquisitions or licensing deals could yield returns exceeding 15% for stakeholders positioning in emerging economies.

Regulatory and Patent Landscape

Patents form the backbone of nepafenac's financial narrative, with the original composition-of-matter patent expiring in 2015, triggering a generics influx. Subsequent patents on formulations and methods of use have provided partial protection, as evidenced by Novartis's extensions granted by the USPTO in 2019 for improved delivery systems.

Regulatory bodies like the FDA continue to influence dynamics through approvals for generic entrants, with over 10 ANDA filings processed since 2016. This landscape demands vigilance; companies must navigate abbreviated new drug applications (ANDAs) and potential litigation to safeguard intellectual property. In Europe, the EMA's centralized procedures have expedited generic approvals, further compressing profit margins.

For business professionals, monitoring patent databases like the USPTO or EPO is essential, as ongoing litigation could sway nepafenac's market value. Recent trends indicate a shift toward patent thickets, where layered protections help sustain revenue streams amid commoditization.

Conclusion

Nepafenac's market dynamics and financial trajectory underscore the pharmaceutical industry's volatility, where innovation meets inevitable competition. As demand for ocular treatments grows, the drug's ability to adapt through R&D and strategic alliances will define its future. Business leaders can leverage these insights to anticipate shifts, optimize investments, and navigate regulatory complexities for sustained profitability.

Key Takeaways

• Nepafenac's market growth relies on rising cataract surgeries, but generics have reduced its global share by 40% since 2015.
• Financial revenues peaked at $200 million annually pre-expiration, now stabilizing at $50-70 million with potential for 5% CAGR growth.
• Patent strategies and regulatory compliance remain critical for countering competition and extending product lifecycles.
• Opportunities in emerging markets and new indications could revitalize nepafenac's trajectory despite economic challenges.
• Investors should prioritize R&D investments to mitigate risks from alternatives like diclofenac.

FAQs

1. What factors are driving the current demand for nepafenac?
Demand is primarily fueled by the increasing volume of cataract surgeries worldwide, with an aging population and improved access to eye care services playing key roles.

2. How have generics impacted nepafenac's financial performance?
Generics have eroded branded sales by about 40% since 2015, leading to revenue declines, though international markets and premium formulations have helped stabilize figures.

3. What regulatory challenges does nepafenac face today?
The drug contends with stringent FDA and EMA oversight on safety and efficacy, particularly for new indications, alongside patent disputes that affect market exclusivity.

4. Are there investment opportunities in nepafenac's future?
Yes, potential growth in emerging markets and advancements in drug delivery systems offer returns, especially for companies investing in R&D to differentiate the product.

5. How does nepafenac compare financially to its competitors?
Nepafenac's revenues have lagged behind diclofenac due to generics, but its targeted efficacy in ophthalmology maintains a competitive edge in specific therapeutic segments.

Sources

1. U.S. Food and Drug Administration. "FDA Approval Letter for Nepafenac," accessed via FDA website, 2005.
2. Novartis Annual Report 2022, available on Novartis investor relations page.
3. IQVIA Institute for Human Data Science. "Global Use of Medicines Report 2023," IQVIA publications.
4. United States Patent and Trademark Office. "Patent Database Search for Nepafenac," USPTO records, 2019.