Difelikefalin acetate - Generic Drug Details

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

Difelikefalin acetate is the generic ingredient in one branded drug marketed by Vifor Intl and is included in one NDA. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Difelikefalin acetate has fifty-three patent family members in twenty-seven countries.

One supplier is listed for this compound.

Summary for difelikefalin acetate

International Patents:	53
US Patents:	12
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for difelikefalin acetate
DailyMed Link:	difelikefalin acetate at DailyMed

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

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 difelikefalin acetate

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

Anatomical Therapeutic Chemical (ATC) Classes for difelikefalin acetate

V03AX	Other therapeutic products
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

Paragraph IV (Patent) Challenges for DIFELIKEFALIN ACETATE

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 difelikefalin acetate

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
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

International Patents for difelikefalin acetate

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2510399	СИНТЕТИЧЕСКИЕ ПЕПТИДНЫЕ АМИДЫ И ИХ ДИМЕРЫ (SYNTHETIC PEPTIDE AMIDES AND THEIR DIMERS)
Russian Federation	2009121297	СИНТЕТИЧЕСКИЕ ПЕПТИДНЫЕ АМИДЫ
China	101627049

Supplementary Protection Certificates for difelikefalin acetate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2064228	PA2022522,C2064228	Lithuania		PRODUCT NAME: DIFELIKEFALINAS, BET KOKIA FORMA, KURIAI TAIKOMA PAGRINDINIO PATENTO APSAUGA ; REGISTRATION NO/DATE: EU/1/22/1643 20220425
2064228	SPC/GB22/048	United Kingdom		PRODUCT NAME: DIFELIKEFALIN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, SOLVATE, ACID-SALT-HYDRATE OR N-OXIDE; REGISTERED: UK EU/1/22/1643(FOR NI) 20220427; UK MORE ON HISTORY TAB 20220427
2064228	CR 2022 00045	Denmark		PRODUCT NAME: DIFELIKEFALIN; REG. NO/DATE: EU/1/22/1643 20220427

Market Dynamics and Financial Trajectory for Difelikefalin Acetate

Last updated: July 27, 2025

Introduction

Difelikefalin acetate, marketed under the brand name Korsuva, represents a novel peptide-based pharmacotherapy targeted predominantly at managing specific symptoms associated with chronic kidney disease (CKD) and dialysis-related pruritus. As a selective kappa-opioid receptor (KOR) agonist, its unique mechanism offers a promising approach in a market historically underserved by effective therapies. This analysis evaluates the current market landscape, key drivers, competitive environment, and forecasted financial trajectory of difelikefalin acetate, providing strategic insights for stakeholders.

Market Landscape and Therapeutic Indications

Difelikefalin acetate's primary indication is the alleviation of moderate-to-severe pruritus in adult patients undergoing hemodialysis or peritoneal dialysis, a condition often resistant to conventional therapies. The prevalence of pruritus among dialysis patients hovers around 60-90%, representing a substantial unmet medical need in the nephrology sphere (source: KDIGO 2017 guidelines). This high prevalence coupled with limited existing options positions difelikefalin as a first-in-class agent with significant commercial potential.

Additional off-label or exploratory indications are being evaluated, including potential applications for other pruritic conditions and neurological disorders involving KOR modulation, though these remain speculative absent formal approvals.

Market Drivers

1. Unmet Clinical Need in Dialysis Patients

Chronic pruritus significantly impairs quality of life, correlates with increased depression, and complicates dialysis compliance. The lack of approved, effective treatments amplifies demand for innovative therapies like difelikefalin.

2. Regulatory Approvals and Reimbursement

The FDA approved difelikefalin in August 2021 for dialysis-associated pruritus, shortly thereafter receiving regulatory clearance in the European Union. The approvals catalyzed market entry, especially in North America, with reimbursement pathways enabled through CMS and private insurers. Strong payer positioning relies on demonstrating substantial improvements in patient-reported outcomes.

3. Growing CKD and Dialysis Population

The global burden of CKD is intensifying, with estimates exceeding 850 million affected worldwide (source: WHO). As the CKD progression leads to increased dialysis needs, the incorporate of pruritus management in treatment standards propels market expansion.

4. Increasing Physician Acceptance

Post-approval, clinical trials and real-world evidence have bolstered physician confidence, leading to greater prescription rates. The favorable safety profile, characterized by minimal central nervous system effects, supports sustained use.

Competitive Environment

Major competitors include:

• Gabapentin and Pregabalin: Off-label drugs with limited efficacy evidence.
• Serlopitant and related NK1 receptor antagonists: Trials underway but limited by inconsistent outcomes.
• Traditional anti-pruritic agents: Limited effectiveness and adverse effect concerns.

Difelikefalin’s specificity for KOR and its demonstrated efficacy position it as a differentiated asset, tapping into a niche with scant effective alternatives. Nonetheless, emerging therapies and off-label options could present future challenges.

Financial Trajectory

1. Revenue Generation Timeline

Initial market penetration was modest in the first year post-approval, constrained by supply chain scaling and payer reimbursement negotiations. However, recent data indicate accelerated adoption as awareness increases; sales in the US reached approximately $50 million in 2022 (source: IQVIA). Forecasts project revenues surpassing $300 million by 2026, driven by expanded formulary access and broader physician adoption.

2. Pricing and Market Access

The average wholesale price (AWP) for difelikefalin approximates $1,200 per month per patient. Payer negotiations and value-based agreements influence net pricing, potentially impacting margins. Early reimbursement success has been favorable, likely due to demonstrated clinical benefit and cost-offsets from reduced secondary complications.

3. Cost Structure and Margins

Manufacturing costs are moderate due to peptide synthesis complexity. Pilot commercialization costs, including sales force expansion and educational campaigns, are balancing against steady revenue growth. Gross margins are projected to range between 65-70%, with operational margins improving as scale economies mature.

4. Investment and R&D Outlook

Current revenues facilitate incremental investment in pipeline development, exploring expanded indications like neurodegenerative conditions. Competitive pressures and patent protections (expected to extend until 2030) influence long-term investment outlook.

Future Market Opportunities and Challenges

Opportunities

• Expansion of Indications: Clinical trials for other pruritic or neuromodulatory conditions could unlock new markets.
• Global Access: Emerging markets face rising CKD burdens, presenting compelling growth opportunities.
• Combination Therapies: Use with other dialysis medications could enhance therapeutic outcomes.

Challenges

• Market Penetration: Limited awareness among primary care and nephrology specialists necessitates intensive educational outreach.
• Pricing Pressures: Payers’ push for cost-effective therapies might constrain revenue growth.
• Competitive Innovations: Emerging therapies from biotech competitors could threaten market share.

Regulatory and Policy Impact

Regulatory agencies’ focus on patient-centered outcomes bolsters difelikefalin’s positioning. Future approvals for additional indications hinge upon positive trial outcomes, influencing long-term financial trajectories. Policy shifts towards value-based care models could further enhance or restrict revenue streams.

Conclusion

Difelikefalin acetate’s market dynamics are strongly influenced by its unique mechanism, high unmet need, and evolving clinical acceptance. Financial performance to date exhibits promising growth, with forecasts projecting sustained expansion through 2026. Strategic focus on expanded indications, global access, and payer negotiations will be crucial for maximizing its commercial potential.

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Key Takeaways

• Market Opportunity: The substantial dialysis patient population and limited effective options position difelikefalin as a high-growth asset.
• Revenue Potential: Sales are expected to escalate sharply through market penetration, with forecasts exceeding $300 million in five years.
• Competitive Edge: Differentiation as a selective KOR agonist offers clinical advantages over existing off-label therapies.
• Challenges: Pricing pressures, market awareness, and emergent competitors require strategic navigation.
• Expansion Prospects: Broader indications and geographic expansion remain vital for sustained growth.

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FAQs

1. What differentiates difelikefalin acetate from other pruritus treatments?
Difelikefalin’s selectivity for kappa-opioid receptors and its targeted mechanism provide superior efficacy and safety profiles compared to off-label options like gabapentin, which have limited evidence and safety concerns.

2. How has regulatory approval influenced its market trajectory?
FDA and EMA approvals have catalyzed market entry, facilitating reimbursement pathways, which, combined with clinical validation, underpin rapid adoption growth.

3. What are the main barriers to increasing difelikefalin’s market share?
Key barriers include payer reimbursement negotiations, physician awareness, and competing therapies’ development.

4. Are there any legal or patent issues affecting difelikefalin’s market stability?
Patent protections extending into the 2030s mitigate generic competition, supporting pricing power and revenue stability.

5. How could global health trends impact future demand?
Rising CKD prevalence worldwide, especially in emerging markets, promises increased demand, provided regulatory and pricing strategies align.

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Sources:
[1] KDIGO 2017 Clinical Practice Guidelines.
[2] IQVIA sales data, 2022.
[3] WHO Global Health Observatory.
[4] FDA and EMA regulatory filings.