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

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.

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			Y	Y
Vifor Intl	KORSUVA	difelikefalin acetate	SOLUTION;INTRAVENOUS	214916-001	Aug 23, 2021		RX	Yes	Yes
Vifor Intl	KORSUVA	difelikefalin acetate	SOLUTION;INTRAVENOUS	214916-001	Aug 23, 2021		RX	Yes	Yes
Vifor Intl	KORSUVA	difelikefalin acetate	SOLUTION;INTRAVENOUS	214916-001	Aug 23, 2021		RX	Yes	Yes			Y	Y
Vifor Intl	KORSUVA	difelikefalin acetate	SOLUTION;INTRAVENOUS	214916-001	Aug 23, 2021		RX	Yes	Yes
Vifor Intl	KORSUVA	difelikefalin acetate	SOLUTION;INTRAVENOUS	214916-001	Aug 23, 2021		RX	Yes	Yes

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	20140056396
Canada	2667460
Denmark	2064228
Portugal	2064228
Luxembourg	C00282
World Intellectual Property Organization (WIPO)	2008060552

Supplementary Protection Certificates for KORSUVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2064228	C02064228/01	Switzerland		FORMER OWNER: CARA THERAPEUTICS, INC., US
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	PA2022522,C2064228	Lithuania		PRODUCT NAME: DIFELIKEFALINAS, BET KOKIA FORMA, KURIAI TAIKOMA PAGRINDINIO PATENTO APSAUGA ; REGISTRATION NO/DATE: EU/1/22/1643 20220425
2064228	43/2022	Austria		PRODUCT NAME: DIFELIKEFALIN ODER EIN STEREOISOMER, EINE MISCHUNG VON STEREOISOMEREN, EIN PHARMAZEUTISCH ANNEHMBARES SALZ, HYDRAT, SOLVAT, SAEURESALZHYDRAT, N-OXID, ODER EINE ISOMORPHE KRISTALLINE FORM DAVON; REGISTRATION NO/DATE: EU/1/22/1643 (MITTEILUNG) 20220427
2064228	22C1054	France		PRODUCT NAME: DIFELIKEFALINE DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/22/1643 20220427
2064228	LUC00282	Luxembourg		PRODUCT NAME: DIFELIKEFALIN IN ALL FORMS COVERED BY THE BASIC PATENT; AUTHORISATION NUMBER AND DATE: EU/1/22/1643 20220427

Market Dynamics and Financial Trajectory for KORSUVA

Last updated: February 20, 2026

What is KORSUVA?

KORSUVA (difelikefalin) is a peripherally restricted kappa-opioid receptor agonist approved by the U.S. Food and Drug Administration (FDA) in August 2021 for treating pruritus in adult patients with chronic kidney disease (CKD) on dialysis. It is marketed by Cara Therapeutics. The drug's mechanism targets non-histaminergic itch pathways, addressing unmet needs in this specific patient population.

Market Size and Prevalence

The CKD with dialysis subset represents approximately 750,000 patients in the U.S. as of 2022 [1]. Chronic pruritus affects an estimated 60-80% of dialysis patients, translating to a potential market of 450,000–600,000 patients domestically.

Globally, chronic kidney disease affects over 700 million individuals, with a significant portion receiving dialysis and experiencing pruritus. The worldwide prevalence of CKD-related pruritus is less precisely estimated but is deemed a substantial unmet medical need.

Key Market Drivers

• High Unmet Need: No approved non-opioid therapies specifically for CKD-associated pruritus. Current treatments include off-label use of antihistamines, gabapentinoids, and corticosteroids, with limited efficacy.
• Regulatory Approval: KORSUVA’s approval provides a first-in-class therapeutic option, potentially capturing significant market share.
• Market Penetration Potential: Limited competition at launch increases revenue potential. Several off-label treatments have variable success, but specific data on theirs market share remains sparse.
• Physician Adoption: Dialysis centers and nephrologists are primary prescribers. Direct-to-consumer marketing is limited; adoption depends heavily on formulary inclusion and clinical guidelines.

Revenue Projections and Financial Trajectory

Initial Sales Estimates

Cara Therapeutics projected first-year sales of approximately $50 million in the U.S. for KORSUVA in 2022 [2]. The rapid uptake was limited by factors such as insurance coverage delays and physician awareness.

Growth Factors

• Pricing Strategy: The drug’s wholesale acquisition cost (WAC) is approximately $850 per dose, administered weekly.
• Patient Volume Growth: Based on prevalence estimates, expanding access to dialysis patients can increase treated populations by 15-20% annually if market penetration increases.
• Reimbursement Dynamics: CMS (Centers for Medicare & Medicaid Services) has approved coverage with specifics still evolving; private insurers' adoption correlates with evidence of clinical benefit.
• Global Expansion: Regulatory filings are underway in the EU and Japan, targeting approval in 2024-2025. Commercialization outside the U.S. could add significant revenue streams.

Long-Term Financial Outlook

Based on conservative assumptions:

Year	Estimated U.S. Sales	Key Assumptions
2022	$50 million	Initial market penetration
2023	$125 million	50% volume growth, increased formulary coverage
2024	$250 million	Global expansion, higher dosing rates
2025	$400 million	Dominant market share, broader payer coverage

These projections depend heavily on clinical adoption, pricing negotiations, and regulatory timing.

Competitive Landscape

No direct competitors with identical mechanisms of action exist. Off-label therapies include:

• Antihistamines (limited efficacy)
• Gabapentin or pregabalin (variable success)
• Immunosuppressants (off-label and limited data)

Potential future competitors include emerging biologics or small molecules targeting itch pathways.

Market Entry Barriers

• Pricing and Reimbursement: Negotiating coverage in a cost-sensitive environment is crucial.
• Physician Awareness: Education on efficacy and safety profiles influences prescriber willingness.
• Regulatory Hurdles: Additional indications or extension to other pruritus conditions face regulatory timelines.

Risks and Challenges

• Market Adoption: Slow physician uptake could delay revenue realization.
• Insurance Coverage: Delays or restrictions could limit patient access.
• Competition: Future drugs targeting similar pathways could erode market share.
• Manufacturing and Supply Chain: Consistency and scalable production are necessary to meet demand.

Conclusion

KORSUVA's commercial success hinges on rapid adoption within dialysis centers, favorable reimbursement, and expansion into international markets. Its potential aligns with a significant unmet medical need, but market penetration is contingent on overcoming barriers relating to awareness, pricing, and clinical evidence.

Key Takeaways

• KORSUVA faces a sizable but specialized market of CKD patients on dialysis experiencing pruritus.
• Initial revenue estimates suggest $50 million in 2022, with potential to reach $400 million by 2025.
• Expansion into global markets and broader indications could enhance long-term commercial prospects.
• Market entry depends on reimbursement, physician education, and competitive positioning.
• Ongoing monitoring of clinical uptake and regulatory developments remains essential.

FAQs

1. How does KORSUVA differ from existing treatments for pruritus?
KORSUVA is a selective kappa-opioid receptor agonist targeting non-histaminergic itch pathways, offering a mechanism distinct from antihistamines or corticosteroids.

2. What is the primary patient population for KORSUVA?
Adults with chronic kidney disease on dialysis experiencing moderate to severe pruritus.

3. What are the main barriers to market penetration?
Reimbursement delays, physician awareness, and formulary approval pose significant hurdles.

4. Are there broader indications being explored for KORSUVA?
Yes, clinical trials investigate use in other pruritus conditions, including atopic dermatitis and liver disease-related itch.

5. How does pricing influence market adoption?
High WAC (~$850 per dose) necessitates favorable reimbursement and demonstrates the importance of demonstrating cost-effectiveness.

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References

[1] U.S. Renal Data System. (2022). USRDS Annual Data Report. Retrieved from https://usrds.org/annual-data-report/

[2] Cara Therapeutics. (2021). KORSUVA FDA Approval Announcement. Retrieved from https://www.caratherapeutics.com/news/press-release-details/2021/KORSUVA-Approved-by-FDA-for-Pruritus-in-CKD-Dialysis-Patients/default.aspx