KORSUVA Drug Patent Profile

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

Korsuva is a drug marketed by Cara Therap and is included in one NDA. There are twelve patents protecting this drug.

This drug has fifty-two 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 will be eligible for patent challenges on August 23, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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.

Indicators of Generic Entry

Summary for KORSUVA

International Patents:	52
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
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

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
Cara Therap	KORSUVA	difelikefalin acetate	SOLUTION;INTRAVENOUS	214916-001	Aug 23, 2021		RX	Yes	Yes			Y	Y
Cara Therap	KORSUVA	difelikefalin acetate	SOLUTION;INTRAVENOUS	214916-001	Aug 23, 2021		RX	Yes	Yes
Cara Therap	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
European Patent Office	2064228	AMIDES PEPTIDIQUES SYNTHETIQUES (SYNTHETIC PEPTIDE AMIDES)
South Korea	20090085096
Spain	2394377

Supplementary Protection Certificates for KORSUVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2064228	2022C/546	Belgium		PRODUCT NAME: DIFELIKEFALINE SOUS TOUTES LES FORMES COUVERTES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND 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	CR 2022 00045	Denmark		PRODUCT NAME: DIFELIKEFALIN; REG. NO/DATE: EU/1/22/1643 20220427

Market Dynamics and Financial Trajectory for KORSUVA (Difelikefalin) Injection

Introduction

KORSUVA (difelikefalin) injection, developed by Cara Therapeutics, is a groundbreaking treatment for pruritus, particularly in patients with chronic kidney disease (CKD) undergoing hemodialysis. This article delves into the market dynamics and financial trajectory of KORSUVA, highlighting its commercial performance, international expansion, and the company's strategic decisions.

Commercial Launch and Performance

Initial Success

The commercial launch of KORSUVA in the U.S. marked a significant milestone for Cara Therapeutics. In the third quarter of 2022, KORSUVA generated net sales of $16.2 million, along with $7.4 million in profit-sharing revenue from its partner CSL Vifor[1].

• This strong start was driven by large dialysis organizations, with approximately 180,000 vials shipped during the third quarter of 2022.

Quarterly Sales Trends

• In the second quarter of 2023, KORSUVA injection sales continued to grow, with net sales of $11.4 million and collaborative revenue of $5.4 million. Vial orders increased by 46% quarter-over-quarter, indicating accelerating demand[4].
• However, by the first quarter of 2024, net sales had decreased to approximately $1.8 million, reflecting a slower pace compared to previous quarters[5].

International Expansion

European and Asian Markets

Cara Therapeutics has been actively expanding the reach of KORSUVA globally.

• In Europe, Kapruvia (the brand name for KORSUVA outside the U.S.) was launched in Austria and Germany in the third quarter of 2022. Approvals were also secured in Canada, Singapore, and Switzerland during the same period[1].
• By the second quarter of 2023, Kapruvia had been launched in seven EU countries, with additional launches anticipated[4].
• In Japan, Maruishi Pharmaceutical Co., Ltd. submitted a New Drug Application for KORSUVA in September 2022, with a decision expected in the second half of 2023. A regulatory milestone payment was received from Maruishi in September 2023 following the marketing approval in Japan[1][2].

Revenue Streams

Collaborative Revenue

Cara Therapeutics generates revenue through a collaborative agreement with CSL Vifor.

• In the fourth quarter of 2023, the company recorded $1.1 million in collaborative revenue related to its share of the profit from CSL Vifor’s sales of KORSUVA injection in the U.S.[2].
• For the full year 2023, collaborative revenue totaled $12.9 million, down from $16.6 million in 2022[2].

Commercial Supply Revenue

• The company also earns revenue from the sale of KORSUVA injection to CSL Vifor.
• In 2023, commercial supply revenue was $5.8 million, compared to $10.2 million in 2022[2].

Royalty and Milestone Payments

• Royalty revenue from the sales of Kapruvia in Europe was $415,000 in 2023, up from $72,000 in 2022[2].
• Milestone payments, such as the $15 million license fee from Maruishi for the development of KORSUVA in Japan, contribute to other revenue streams[3].

Cost Structure and Expenses

Cost of Goods Sold

• The cost of goods sold for KORSUVA injection has been significant, reflecting the commercial supply to CSL Vifor. In the third quarter of 2022, this cost was $3.1 million[1].
• By the first quarter of 2024, the cost of goods sold had decreased to $0.6 million, aligning with the reduced commercial supply revenue[5].

Research and Development (R&D) Expenses

• R&D expenses have been a major component of Cara Therapeutics' operational costs. In the third quarter of 2022, R&D expenses were $24.7 million, including a $5.0 million milestone payment to Enteris Biopharma, Inc.[1].
• For the first quarter of 2024, R&D expenses remained high at $21.9 million[5].

Strategic Decisions and Market Impact

Pipeline Focus

Cara Therapeutics has had to make critical decisions about which pipelines to continue funding and which to discontinue.

• The company has focused on the pruritus treatment pipeline, given the positive data from clinical trials and the significant market need[3].

Partnerships and Collaborations

• Partnerships with companies like CSL Vifor and Maruishi Pharmaceutical Co., Ltd. have been instrumental in the global expansion and commercial success of KORSUVA.
• These collaborations have not only provided financial support through licensing fees and milestone payments but also facilitated regulatory approvals and market access[1][3].

Regulatory Environment

FDA and International Approvals

• The FDA has played a crucial role in the approval process of KORSUVA. An FDA meeting was scheduled for the fourth quarter of 2022 to discuss a potential pivotal program in notalgia paresthetica[1].
• International approvals, such as those from Health Canada, the European Commission, and the Swiss Agency for Therapeutic Products, have expanded the drug's market reach[1][4].

Financial Outlook

Cash Position and Funding

• As of the first quarter of 2024, Cara Therapeutics' current unrestricted cash and cash equivalents, along with available-for-sale marketable securities, are expected to fund the company's operating plan for at least the next 12 months[4].

Revenue Projections

• Despite the fluctuating sales figures, the company remains optimistic about the long-term potential of KORSUVA. The acceleration in vial orders and the expansion into new markets suggest a positive outlook for future revenue[4].

Key Takeaways

• Strong Initial Launch: KORSUVA generated significant revenue in its initial quarters, driven by demand from large dialysis organizations.
• Global Expansion: The drug has been approved and launched in several countries, including those in Europe and Asia.
• Diverse Revenue Streams: Revenue comes from collaborative agreements, commercial supply, royalties, and milestone payments.
• High R&D Expenses: Research and development costs remain a significant component of the company's expenses.
• Strategic Partnerships: Collaborations with other pharmaceutical companies have been crucial for the drug's commercial success and global reach.

FAQs

What is KORSUVA (difelikefalin) injection used for?

KORSUVA (difelikefalin) injection is used to treat pruritus in patients with chronic kidney disease (CKD) undergoing hemodialysis.

How has KORSUVA performed commercially since its launch?

KORSUVA generated $16.2 million in net sales in the third quarter of 2022 but saw a decline to $1.8 million in the first quarter of 2024. Despite this, the drug has shown strong demand and expansion into international markets.

Which companies are Cara Therapeutics' key partners for KORSUVA?

Cara Therapeutics' key partners include CSL Vifor for global commercialization and Maruishi Pharmaceutical Co., Ltd. for the Japanese market.

What are the main revenue streams for Cara Therapeutics from KORSUVA?

The main revenue streams include collaborative revenue from CSL Vifor, commercial supply revenue, royalty payments, and milestone payments.

How does the cost structure of Cara Therapeutics impact its financial performance?

High research and development expenses, along with costs of goods sold, significantly impact the company's financial performance. However, the company's cash position and funding from partnerships help sustain its operations.

Sources

1. Cara Therapeutics Reports Third Quarter 2022 Financial Results. Biospace.
2. Cara Therapeutics Announces Fourth Quarter and Full Year 2023 Financial Results. Cara Therapeutics Investor Relations.
3. KORSUVA: The Decisions Cara Therapeutics INC. made to potentially revolutionize pain and pruritus relief. eCampusOntario.
4. Cara Therapeutics Reports Second Quarter 2023 Financial Results. Cara Therapeutics Investor Relations.
5. Cara Therapeutics Reports First Quarter 2024 Financial Results. Cara Therapeutics Investor Relations.