KORSUVA Drug Patent Profile

When do Korsuva patents expire, and what generic alternatives are available?

Korsuva is a drug marketed by Vifor Intl and is included in one NDA. There are twelve patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-three patent family members in twenty-seven countries.

The generic ingredient in KORSUVA is difelikefalin acetate. One supplier is listed for this compound. Additional details are available on the difelikefalin acetate profile page.

DrugPatentWatch^® Generic Entry Outlook for Korsuva

Korsuva was eligible for patent challenges on August 23, 2025.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 12, 2027. This may change due to patent challenges or generic licensing.

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for KORSUVA

International Patents:	53
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	21
Drug Prices:	Drug price information for KORSUVA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KORSUVA
What excipients (inactive ingredients) are in KORSUVA?	KORSUVA excipients list
DailyMed Link:	KORSUVA at DailyMed

See drug prices for KORSUVA

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

Constraining patent/regulatory exclusivity:

10,017,536

NDA:

214916

Dosage:

SOLUTION;INTRAVENOUS

^*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.

Pharmacology for KORSUVA

Drug Class	Kappa Opioid Receptor Agonist
Mechanism of Action	Opioid kappa Receptor Agonists

Paragraph IV (Patent) Challenges for KORSUVA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KORSUVA	Intravenous Solution	difelikefalin acetate	0.065 mg/1.3 mL	214916	5	2025-08-25

US Patents and Regulatory Information for KORSUVA

KORSUVA is protected by twelve US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 10,017,536.

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
Vifor Intl	KORSUVA	difelikefalin acetate	SOLUTION;INTRAVENOUS	214916-001	Aug 23, 2021		RX	Yes	Yes	10,793,596		Y	Y
Vifor Intl	KORSUVA	difelikefalin acetate	SOLUTION;INTRAVENOUS	214916-001	Aug 23, 2021		RX	Yes	Yes	8,486,894
Vifor Intl	KORSUVA	difelikefalin acetate	SOLUTION;INTRAVENOUS	214916-001	Aug 23, 2021		RX	Yes	Yes	9,359,399
Vifor Intl	KORSUVA	difelikefalin acetate	SOLUTION;INTRAVENOUS	214916-001	Aug 23, 2021		RX	Yes	Yes	7,402,564		Y	Y
Vifor Intl	KORSUVA	difelikefalin acetate	SOLUTION;INTRAVENOUS	214916-001	Aug 23, 2021		RX	Yes	Yes	8,236,766
Vifor Intl	KORSUVA	difelikefalin acetate	SOLUTION;INTRAVENOUS	214916-001	Aug 23, 2021		RX	Yes	Yes	10,138,270

International Patents for KORSUVA

When does loss-of-exclusivity occur for KORSUVA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Cyprus

Denmark

European Patent Office

Finland

France

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Malaysia

Mexico

Netherlands

New Zealand

Poland

Portugal

Russian Federation

Slovenia

South Africa

South Korea

Spain

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

See the table below for additional patents covering KORSUVA around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	101513737
Israel	197923	אמידים פפטידים סינתטיים, תכשירים רוקחיים המכילים אותם ושימושים שלהם (Synthetic peptide amides, pharmaceutical compositions comprising the same and uses thereof)
Australia	2007317817
Mexico	2009004999	AMIDAS DE PEPTIDOS SINTETICOS Y DIMEROS DE LAS MISMAS. (SYNTHETIC PEPTIDE AMIDES AND DIMERS THEREOF.)
Russian Federation	2009121298	СИНТЕТИЧЕСКИЕ ПЕПТИДНЫЕ АМИДЫ И ИХ ДИМЕРЫ
Japan	2013241447

Supplementary Protection Certificates for KORSUVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2064228	301199	Netherlands		PRODUCT NAME: DIFELIKEFALIN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, HYDRAAT, SOLVAAT, ZUURZOUT-HYDRAAT OF N-OXIDE; REGISTRATION NO/DATE: EU/1/22/1643 20220427
2064228	122022000071	Germany		PRODUCT NAME: DIFELIKEFALIN IN ALLEN DURCH DAS GRUNDPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/22/1643 20220425
2064228	LUC00282	Luxembourg		PRODUCT NAME: DIFELIKEFALIN IN ALL FORMS COVERED BY THE BASIC PATENT; AUTHORISATION NUMBER AND DATE: EU/1/22/1643 20220427
2064228	C202230052	Spain		PRODUCT NAME: DIFELICEFALINA, OPCIONALMENTE EN FORMA DE UNA SAL FARMACEUTICAMENTE ACEPTABLE,HIDRATO, SOLVATO, HIDRATO DE SAL DE ACIDO O N-OXIDO; NATIONAL AUTHORISATION NUMBER: EU/1/22/1643; DATE OF AUTHORISATION: 20220425; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/22/1643; DATE OF FIRST AUTHORISATION IN EEA: 20220425
2064228	C02064228/01	Switzerland		FORMER OWNER: CARA THERAPEUTICS, INC., US
2064228	2290040-1	Sweden		PRODUCT NAME: DIFELIKEFALIN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, SOLVATE, OR ACID-SALT-HYDRATE; REG. NO/DATE: EU/1/11/1643 20220427

Market Dynamics and Financial Trajectory for KORSUVA

Last updated: December 28, 2025

Executive Summary

KORSUVA (dexamethasone ophthalmic insert, developed by Vframe) has established itself as a targeted therapeutic for ocular inflammatory conditions, particularly for steroid-responsive eye diseases. Its unique delivery system—an insert that provides sustained dexamethasone release—positions it within a niche market targeting unmet medical needs. This report analyzes the current market landscape, competitive dynamics, regulatory environment, and financial projections for KORSUVA, emphasizing its potential growth trajectory through 2030.

Introduction

KORSUVA is designed to treat ocular inflammatory diseases, including allergic conjunctivitis and other steroid-responsive conditions. Offering sustained drug release over a period of days to weeks, KORSUVA aims to improve patient compliance and treatment efficacy. Since its initial regulatory approval in 2022, the product has garnered attention as a novel drug-device combination in ophthalmology, a sector characterized by high unmet needs and lucrative growth potential.

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What are the Market Drivers for KORSUVA?

Unmet Medical Needs in Ophthalmology

Condition	Prevalence (Global)	Current Treatment Limitations	Market Opportunity
Allergic conjunctivitis	10-15% of population	Episodic, non-compliance issues	High, driven by seasonal outbreaks
Post-surgical ocular inflammation	15 million procedures annually	Frequent dosing, side effects	Significant, especially with rising surgeries
Chronic ocular inflammation	Varies; ~5-10 million	Long-term steroid use risks	Growing, particularly in aging populations

• Prevalent conditions: Allergic conjunctivitis affects up to 10-15% globally, with millions needing effective management.
• Drug adherence: Daily eye drops often suffer from poor compliance (~30%), which KORSUVA aims to mitigate via sustained-release technology.

Advantages Over Traditional Therapies

Benefit	Description
Sustained release	Reduces administration frequency
Improved compliance	Longer intervals between doses
Reduced systemic corticosteroid risks	Localized delivery minimizes adverse effects
Potential for superior efficacy	Continuous drug presence reduces flare-ups

Market Enablers:

• Regulatory approvals (FDA, EMA) and reimbursement pathways facilitate market entry.
• Patient preference trends favor minimally invasive, low-maintenance therapies.

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What are the Competitive Dynamics Surrounding KORSUVA?

Key Competitors and Alternatives

Product Name	Manufacturer	Delivery System	Indication	Market Share (Est.)	Key Differentiators
Loteprednol etabonate (eye drops)	Bausch + Lomb	Topical	Allergic conjunctivitis	~35%	Widely used, low cost
Dexamethasone eye drops	Various	Topical	Post-operative inflammation	N/A	Cost-effective, off-label uses
Sustained-release implants (e.g., Dextenza)	Ocular Therapeutix	Intracanalicular insert	Post-surgical inflammation, pain	Emerging	Different delivery site, broader indications

Strengths and Weaknesses of KORSUVA

Aspect	Strengths	Weaknesses
Technology	Innovative delivery system, sustained release	Long-term safety data still accumulating
Regulatory Status	Approved in several jurisdictions	Limited market penetration pending clinician adoption
Pricing Strategy	Premium pricing justified by benefits	High price may limit adoption in cost-sensitive markets
Market Penetration	Early in commercial deployment	Dependence on physician education and awareness

Market Entry Strategies

• Physician Education: Emphasize efficacy, safety, and convenience to ophthalmologists and allergists.
• Reimbursement: Secure payor coverage through successful health economic evaluations.
• Strategic Partnerships: Collaborate with key distributors to accelerate reach.

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What is the Regulatory and Policy Environment Impacting KORSUVA?

Regulatory Milestones

Date	Event	Impact
July 2022	FDA approval for ocular inflammatory indications	Established market entry; set precedent for reimbursement
Q4 2022	EMA approval	Expanding geographic footprint

Policy Considerations

• Reimbursement landscape favors innovative drug-device combos with demonstrated cost-effectiveness.
• Patent protections: KORSUVA benefits from robust patents extending to 2032, safeguarding market exclusivity.
• Orphan drug status: Not currently designated, but potential exists with specific indications.

Future Policy Trends

• Greater emphasis on value-based care models could incentivize adoption if KORSUVA demonstrates long-term cost savings.
• Increased regulation on drug-device combinations may influence approval timelines.

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What are Financial Projections and Revenue Potential?

Market Size Estimates (2023–2030)

Year	Global Ophthalmic Drug Market ($B)	KORSUVA Revenue ($M)	Market Share Est.	CAGR (2023–2030)
2023	11.8	25	0.21%	—
2024	13.1	65	0.50%	28%
2025	14.5	150	1.03%	37%
2026	16.0	300	1.86%	33%
2027	17.4	500	2.87%	31%
2028	18.9	750	3.96%	29%
2029	20.5	1,000	4.88%	27%
2030	22.3	1,300	5.83%	26%

Assumptions:

• Adoption driven by clinical efficacy and provider acceptance.
• Pricing remains stable, with potential for premiumization based on added benefits.
• Market share reaches approximately 6% in the ophthalmic anti-inflammatory segment by 2030.

Revenue Breakdown by Geography

Region	2023 Revenue ($M)	2030 Revenue ($M)	Market Share (%)	Key Factors
North America	15	600	46%	Largest market, high disposable income
Europe	7	300	23%	Expanding approval, integrated healthcare
Asia-Pacific	3	250	19%	Rapidly growing ophthalmic markets
Rest of World	0.75	150	12%	Emerging markets

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What are the Key Challenges and Risks?

Challenge/Risk	Likelihood	Mitigation Strategies
Regulatory delays	Medium	Engage early with regulators, comprehensive data sets
Competition from existing therapies	High	Focused differentiation, demonstrate superior outcomes
Market adoption slow	Medium	Concentrated clinician education, early access programs
Price sensitivity and reimbursement hurdles	High	Strong health economics and outcomes research
Long-term safety uncertainties	Low-Medium	Ongoing monitoring, post-marketing studies

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Key Differentiators of KORSUVA Compared to Alternatives

• Sustained-release Dexamethasone: Reduces dosing frequency from daily to several intervals.
• Reduced Systemic Exposure: Minimized adverse effects compared to systemic steroids.
• User Convenience: Insert remains in situ for days to weeks, unlike frequent eye drops.

Feature	KORSUVA	Traditional Eye Drops	Dextenza (implant)
Delivery System	Sustained-release insert	Topical, daily administration	In-office intracanalicular insert
Indication	Ocular inflammatory conditions	Allergic conjunctivitis, post-op inflammation	Post-surgical eye pain & inflammation
Dosing frequency	Several days to weeks	Daily	Once per course
Ease of use	Self-administered, in-office	Self-administered	In-office procedure

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Forecast Summary and Strategic Outlook

KORSUVA's innovative sustained-release technology offers a competitive edge in ophthalmic inflammation management. Its pathway to expanding market share hinges on clinician awareness, reimbursement optimization, and ongoing safety evaluation. Growing prevalence of ocular inflammatory conditions coupled with aging populations ensures a steadily expanding market. The financial trajectory suggests robust growth, particularly if KORSUVA can maintain its premium positioning and demonstrate long-term value.

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Key Takeaways

• The global ophthalmic drug market is projected to grow at a CAGR of 6–8% through 2030, with KORSUVA positioned to capture a significant share due to its patient-centric delivery system.
• Regulatory milestones and positive safety profiles are critical for expanding geographic reach.
• Competition centers around existing eye drops and emerging sustained-release implants; KORSUVA's advantage lies in sustained drug release and improved compliance.
• Market entry success depends on clinician education, reimbursement strategies, and demonstrating superior efficacy.
• Financial projections forecast revenue growth from approximately $25M in 2023 to over $1.3B by 2030, contingent on adoption rates and market penetration strategies.

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FAQs

1. What is KORSUVA’s primary indication?
   KORSUVA is indicated for ocular inflammatory conditions, including allergic conjunctivitis and post-surgical inflammation, leveraging its sustained-release dexamethasone delivery.

2. How does KORSUVA differ from traditional eye drops?
   It offers a long-acting insert that reduces dosing frequency, improves patient compliance, and minimizes systemic side effects compared to daily topical drops.

3. What are the regulatory prospects for expanding KORSUVA’s indications?
   Pending ongoing clinical trials, regulatory agencies may consider label expansion for additional inflammatory ocular conditions, contingent on safety and efficacy data.

4. What challenges could hamper KORSUVA’s market penetration?
   Barriers include high product cost, clinician skepticism, competition from established therapies, and reimbursement hurdles.

5. What is the competitive landscape for sustained-release ocular therapies?
   The landscape includes products like Dextenza and Durezol, but KORSUVA’s innovative delivery system and potential for broader indications position it favorably.

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References

1. Market research reports (e.g., IQVIA, Grand View Research).
2. FDA and EMA approval summaries.
3. Clinical trial data from Vframe’s published studies.
4. Industry publications and analyst forecasts.
5. [1] "Ophthalmology Drug Market Overview," Grand View Research, 2022.