NEVANAC Drug Patent Profile

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Which patents cover Nevanac, and when can generic versions of Nevanac launch?

Nevanac is a drug marketed by Harrow Eye and is included in one NDA. There is one patent protecting this drug.

The generic ingredient in NEVANAC is nepafenac. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the nepafenac profile page.

DrugPatentWatch^® Generic Entry Outlook for Nevanac

Nevanac was eligible for patent challenges on August 19, 2009.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 31, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for NEVANAC

US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	25
Patent Applications:	2,951
Drug Prices:	Drug price information for NEVANAC
What excipients (inactive ingredients) are in NEVANAC?	NEVANAC excipients list
DailyMed Link:	NEVANAC at DailyMed

See drug prices for NEVANAC

See drug sales revenues for NEVANAC

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

NDA:

021862

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 NEVANAC

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

Sponsor	Phase
Kafrelsheikh University	Phase 4
Ifocus Oyeklinikk	Phase 4
The Research Council of Norway	Phase 4

See all NEVANAC clinical trials

Pharmacology for NEVANAC

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

US Patents and Regulatory Information for NEVANAC

NEVANAC is protected by one US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Expired US Patents for NEVANAC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	NEVANAC	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	021862-001	Aug 19, 2005

EU/EMA Drug Approvals for NEVANAC

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 NEVANAC

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

Country	Patent Number	Title	Estimated Expiration
Austria	215366
Australia	2818495
Australia	689277
Canada	2167524	COMPOSITIONS ADMINISTRABLES PAR VOIE LOCALE CONTENANT DES DERIVES D'ACIDE 3-BENZOYLPHENYLACETIQUE POUR LE TRAITEMENT DE TROUBLES INFLAMMATOIRES OPHTALMIQUES (TOPICALLY ADMINISTRABLE COMPOSITIONS CONTAINING 3-BENZOYLPHENYLACETIC ACID DERIVATIVES FOR TREATMENT OF OPHTHALMIC INFLAMMATORY DISORDERS)
China	1088992

Supplementary Protection Certificates for NEVANAC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0999825	C300622	Netherlands		PRODUCT NAME: NEPAFENAC; REGISTRATION NO/DATE: EU/1/07/433/002 20130503
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
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

NEVANAC Market Dynamics, Patent Exclusivity, and Financial Trajectory

Last updated: September 26, 2026

NEVANAC is Alcon’s branded nepafenac ophthalmic suspension 0.1% for postoperative ocular inflammation and pain after cataract surgery. The product received FDA approval in 2005 and later faced generic competition after core market exclusivity expired. Its commercial trajectory has shifted from branded volume growth to price-sensitive maintenance revenue, with Alcon’s higher-concentration nepafenac product, ILEVRO 0.3%, supporting portfolio retention. Alcon does not disclose standalone NEVANAC revenue in its public financial statements, so product-level sales and margins cannot be calculated from reported filings.[1][2]

What is NEVANAC and how is it used?

NEVANAC contains nepafenac, a nonsteroidal anti-inflammatory drug delivered as an ophthalmic suspension. Ocular tissues convert nepafenac to amfenac, the pharmacologically active metabolite that inhibits cyclooxygenase-mediated prostaglandin synthesis.

Attribute	NEVANAC
Active ingredient	Nepafenac
Strength	0.1% ophthalmic suspension
Dosage form	Topical eye drops
FDA indication	Treatment of pain and inflammation associated with cataract surgery
Original sponsor	Alcon Laboratories
FDA approval	2005
NDA	21-284
Primary market	Postoperative cataract care
Main competitors	ILEVRO, Prolensa, Bromday, Acular LS, generic nepafenac
Regulatory category	Small-molecule prescription ophthalmic product

The labeled regimen is one drop in the affected eye three times daily, beginning one day before cataract surgery and continuing on the day of surgery and for the first 14 days after surgery.[3]

NEVANAC competes in a procedure-driven market. Demand depends mainly on cataract surgery volumes, physician prescribing habits, payer coverage, and generic substitution rather than chronic patient adherence.

When did NEVANAC lose exclusivity?

NEVANAC’s principal commercial exclusivity expired after the product’s early patent and regulatory protection periods, allowing generic nepafenac ophthalmic suspension to enter the U.S. market. The FDA approved generic versions of nepafenac ophthalmic suspension 0.1%, creating direct substitution pressure against NEVANAC.[4]

The commercial exclusivity timeline is:

Event	Approximate date	Commercial effect
FDA approval of NEVANAC	August 2005	Originator launch
NEVANAC branded lifecycle period	2005-2012	Branded ophthalmic NSAID growth
ILEVRO approval	2012	Higher-concentration product introduced
Generic nepafenac approvals	2012 onward	Direct price and volume pressure
Alcon separation from Novartis	2019	Alcon became independent ophthalmic company
Current market	2024-2025	Generic-led, branded-retention market

The exact launch timing of individual generic products depends on the ANDA sponsor and patent certifications. Generic entry was not blocked indefinitely by NEVANAC’s original product protection.

What patents protect NEVANAC?

NEVANAC’s historical patent protection covered nepafenac chemistry, ophthalmic compositions, and related use claims. The relevant patent estate is no longer a material barrier to ordinary generic nepafenac 0.1% suspension entry in the United States.

The FDA Orange Book is the controlling source for listed patents and regulatory exclusivity associated with NDA 21-284. Patent listings may change as products are updated, discontinued, or transferred between sponsors. Public financial filings from Alcon do not identify NEVANAC patent numbers, patent-by-patent expiry dates, or a continuing enforceable patent position that would prevent generic substitution.[1][5]

What formulation patents protect nepafenac eye drops?

Formulation protection historically focused on:

• Nepafenac suspension stability.
• Particle-size control.
• Ophthalmic vehicles and preservatives.
• Delivery of nepafenac to ocular tissues.
• Dosing and treatment of postoperative inflammation.

These features can support regulatory differentiation, but they do not necessarily block an ANDA referencing the same active ingredient, strength, dosage form, and route of administration. A generic sponsor can challenge listed patents through a Paragraph IV certification or wait for patent expiry and file under another certification pathway.

Are method-of-use patents still commercially important?

Method-of-use claims can cover treatment of postoperative inflammation and pain, dosing schedules, or use around cataract surgery. Their commercial value is limited when the indication is already established and generic applicants can use a section viii statement to carve out patented indications, where legally available.

For NEVANAC, method-of-use protection is less significant than generic substitution, payer behavior, and physician familiarity. The product’s core indication is a standard ophthalmic postoperative use, and the market has multiple non-infringing treatment alternatives.

What is the Orange Book status of NEVANAC?

NEVANAC is an FDA-approved prescription product associated with NDA 21-284. The FDA Orange Book identifies approved drug products, therapeutic equivalence information, and, where applicable, listed patents and exclusivity data.[5]

The relevant commercial point is that generic nepafenac ophthalmic suspension has entered the market. Orange Book listing does not guarantee that a listed patent blocks all generic entry. The practical questions are whether patents remain listed, whether a generic applicant certified under Paragraph IV, whether the NDA holder filed suit within the statutory period, and whether any litigation triggered a 30-month stay.

No widely reported, currently material NEVANAC patent litigation has created a durable barrier to generic 0.1% nepafenac entry.

Which companies challenge NEVANAC through generic competition?

The competitive threat comes from generic ophthalmic manufacturers rather than a single high-profile challenger. Generic ophthalmic companies commonly active in this market include Bausch + Lomb, Sandoz, Mylan or Viatris, Apotex, and other ANDA sponsors, depending on product availability and time period.

The market also includes branded or authorized alternatives:

Product	Active ingredient	Strength	Competitive position
NEVANAC	Nepafenac	0.1%	Original branded product
ILEVRO	Nepafenac	0.3%	Alcon lifecycle product
Prolensa	Bromfenac	0.07%	Branded postoperative NSAID
Bromday	Bromfenac	0.09%	Earlier bromfenac product
ACULAR LS	Ketorolac	0.4%	Established generic and branded class competitor
Generic ketorolac	Ketorolac	Multiple strengths	Low-cost alternative
Generic nepafenac	Nepafenac	0.1%	Direct NEVANAC substitute

How does NEVANAC compare with ILEVRO?

ILEVRO is the most important Alcon lifecycle product in the nepafenac franchise. It uses a 0.3% nepafenac suspension and is dosed once daily, compared with NEVANAC’s 0.1% formulation administered three times daily.[3][6]

Commercial factor	NEVANAC	ILEVRO
Nepafenac concentration	0.1%	0.3%
Typical dosing	Three times daily	Once daily
FDA approval	2005	2012
Lifecycle position	Mature originator product	Later-generation branded product
Generic exposure	High	Lower historically, but increasing with patent maturity
Differentiation	Established brand familiarity	Convenience and higher concentration

ILEVRO allowed Alcon to migrate some prescribing from an older product exposed to generic substitution toward a newer branded product. That strategy can preserve revenue per treated patient, but it also creates a later patent and generic-entry cycle.

What is NEVANAC’s financial trajectory?

Alcon does not report NEVANAC as a separate revenue line. The company reports ophthalmic pharmaceutical sales at a broader portfolio level, combining multiple products and markets.[1][2]

The product’s financial trajectory can therefore be analyzed by market stage:

2005-2011: Originator expansion

NEVANAC benefited from:

• Growth in cataract procedures.
• Physician adoption of topical NSAID therapy.
• Alcon’s ophthalmology sales force and surgical-channel relationships.
• Limited direct generic substitution.

Revenue quality during this period was favorable because the product had branded pricing and established clinical familiarity.

2012-2018: Lifecycle management and generic erosion

The launch of ILEVRO gave Alcon a higher-concentration nepafenac product with a differentiated dosing profile. At the same time, generic nepafenac reduced the price ceiling for NEVANAC 0.1%.

The likely financial pattern was a decline in NEVANAC unit economics, partly offset by:

• Continued cataract-procedure growth.
• Institutional and physician loyalty.
• Brand prescriptions where reimbursement permitted.
• Portfolio substitution into ILEVRO.
• International sales in markets with different generic-entry timing.

2019 onward: Mature, lower-growth portfolio contribution

After Alcon’s 2019 separation from Novartis, NEVANAC became part of Alcon’s independent pharmaceutical portfolio. The product remained commercially relevant but no longer had the characteristics of a protected growth asset.

Current economic drivers are:

1. Procedure volume.
2. Generic dispensing rates.
3. Net price and rebates.
4. ILEVRO conversion.
5. Competitive branded NSAID promotion.
6. Formulary and pharmacy substitution rules.

Standalone NEVANAC revenue, gross margin, and operating profit are not disclosed. Any precise product-level revenue estimate would be unsupported by Alcon’s reported segment data.

What generic entry risks exist for NEVANAC?

NEVANAC faces high generic-entry risk because:

• The product is a small molecule.
• The dosage form is an ophthalmic suspension rather than a complex biologic.
• The indication is mature and well understood.
• Generic nepafenac products are commercially available.
• Cataract surgeons have several topical NSAID alternatives.
• Payers can encourage substitution through formularies and pharmacy benefit controls.

The main residual barriers are technical rather than fundamental patent barriers. Ophthalmic suspensions require control of particle size, uniformity, sterility, preservative performance, container closure, and physical stability. These requirements can delay or complicate development, but they do not create the same barriers associated with biologics or complex injectables.

What litigation and settlement agreements affect NEVANAC?

There is no publicly prominent, current NEVANAC litigation campaign comparable to major patent disputes involving oncology, immunology, or high-value biologic products. Generic entry has occurred, and no publicly disclosed settlement has preserved a broad U.S. monopoly for NEVANAC 0.1%.

Potential litigation issues historically would have included:

• Paragraph IV patent certifications.
• Infringement claims against ANDA sponsors.
• 30-month stays under the Hatch-Waxman Act.
• Patent-listing disputes.
• Formulation and method-of-use claims.

The commercial significance of any legacy dispute is limited unless it affects ILEVRO or another later-generation nepafenac product.

How strong is the NEVANAC patent estate?

The NEVANAC patent estate is weak as a current market-exclusion mechanism and moderate as a historical lifecycle-management tool.

Factor	Assessment
Active-ingredient complexity	Low
Generic development difficulty	Moderate
Core patent barrier today	Low
Formulation differentiation	Moderate
Method-of-use protection	Limited
Biosimilar risk	None
Generic substitution risk	High
Revenue durability	Low to moderate
Dependence on cataract volumes	High

NEVANAC is not a biosimilar product. Biosimilar risk applies to biologics and certain complex biological products, while NEVANAC is a conventional small-molecule ophthalmic drug. Its primary competitive threat is generic substitution under the ANDA pathway.

What is the outlook for NEVANAC and the ophthalmic NSAID market?

The U.S. cataract market provides a stable demand base. Population aging and improved surgical access support procedure growth, but those gains do not fully offset generic price erosion.

NEVANAC’s likely future profile is:

• Stable or declining branded unit volume.
• Continued price compression.
• Limited standalone revenue growth.
• Persistent use where surgeons prefer the original brand.
• Portfolio substitution toward ILEVRO where dosing convenience supports reimbursement.
• Ongoing competition from bromfenac and ketorolac.
• Greater pressure from generic nepafenac as payer controls expand.

Geographic performance will vary. Generic entry and reimbursement substitution generally occur earlier in the United States than in some international markets, but local patent, registration, tender, and reimbursement systems determine the timing in each country.

Key Takeaways

• NEVANAC is Alcon’s nepafenac 0.1% ophthalmic suspension for cataract-surgery pain and inflammation.
• FDA approval occurred in 2005 under NDA 21-284.
• Generic nepafenac has entered the U.S. market, making direct substitution the primary commercial risk.
• ILEVRO 0.3% is Alcon’s principal nepafenac lifecycle product and offers once-daily dosing.
• NEVANAC’s current patent estate is not a material barrier to ordinary generic competition.
• No biosimilar risk applies because NEVANAC is a small-molecule drug.
• Alcon does not disclose standalone NEVANAC sales, margins, or product-level revenue forecasts.
• Future value depends on cataract procedure growth, brand retention, pricing, generic penetration, and conversion to ILEVRO.

FAQs About NEVANAC Exclusivity and Commercial Risk

Is NEVANAC still under patent protection?

Generic nepafenac ophthalmic suspension is commercially available, so NEVANAC no longer has effective broad market exclusivity for its core 0.1% product.

Does NEVANAC have a generic equivalent?

Yes. Generic nepafenac ophthalmic suspension 0.1% products have received FDA approval and compete directly with NEVANAC.

Is ILEVRO the same drug as NEVANAC?

Both contain nepafenac, but ILEVRO is a 0.3% ophthalmic suspension generally dosed once daily, while NEVANAC is a 0.1% suspension generally dosed three times daily.

Who owns NEVANAC?

Alcon is the current commercial owner and marketer of NEVANAC in its ophthalmic pharmaceutical portfolio.

Can NEVANAC revenue be calculated from Alcon’s annual reports?

No. Alcon reports ophthalmic pharmaceutical performance at an aggregated portfolio or segment level and does not provide a standalone NEVANAC revenue line.

References

1. Alcon Inc. (2024). Annual report for the fiscal year ended December 31, 2023.
2. Novartis AG. (2019). Annual report 2018 and Alcon separation disclosures.
3. U.S. Food and Drug Administration. (2023). NEVANAC (nepafenac ophthalmic suspension) prescribing information.
4. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations.
5. U.S. Food and Drug Administration. (n.d.). Orange Book: Approved drug products with therapeutic equivalence evaluations.
6. U.S. Food and Drug Administration. (2012). ILEVRO (nepafenac ophthalmic suspension) prescribing information.

DrugChatter Q&A for NEVANAC

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