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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 forty-nine patent family members in twenty-five 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:	49
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

Anatomical Therapeutic Chemical (ATC) Classes for KORSUVA

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

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.

Patents protecting KORSUVA

FDA Regulatory Exclusivity protecting KORSUVA

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

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

France

Hong Kong

Hungary

Israel

Japan

Lithuania

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
Canada	2898514	AMIDES PEPTIDIQUES SYNTHETIQUES ET DIMERES DE CES AMIDES (SYNTHETIC PEPTIDE AMIDES AND DIMERS THEREOF)
Japan	2013241447	SYNTHETIC PEPTIDE AMIDES AND DIMERS THEREOF
South Korea	20140056396	SYNTHETIC PEPTIDE AMIDES AND DIMERS THEREOF
Slovenia	2064228
European Patent Office	2079756	AMIDES PEPTIDIQUES SYNTHÉTIQUES ET DIMÈRES DE SES AMIDES (SYNTHETIC PEPTIDE AMIDES AND DIMERS THEREOF)
Denmark	2064228
Spain	2394377

Supplementary Protection Certificates for KORSUVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	122022000071	Germany		PRODUCT NAME: DIFELIKEFALIN IN ALLEN DURCH DAS GRUNDPATENT GESCHUETZTEN FORMEN; 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	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	C02064228/01	Switzerland		PRODUCT NAME: DIFELIKEFALIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68653 16.08.2022
2064228	PA2022522	Lithuania		PRODUCT NAME: DIFELIKEFALINAS, BET KOKIA FORMA, KURIAI TAIKOMA PAGRINDINIO PATENTO APSAUGA ; REGISTRATION NO/DATE: EU/1/22/1643 20220425