Difelikefalin acetate - Generic Drug Details

What are the generic drug 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 Cara Therap 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 patent family members in twenty-five countries.

One supplier is listed for this compound.

Summary for difelikefalin acetate

International Patents:	50
US Patents:	12
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
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

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
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
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

International Patents for difelikefalin acetate

Country	Patent Number	Title	Estimated Expiration
Mexico	2009004999	AMIDAS DE PEPTIDOS SINTETICOS Y DIMEROS DE LAS MISMAS. (SYNTHETIC PEPTIDE AMIDES AND DIMERS THEREOF.)
Japan	6220180
Mexico	2009005000	AMIDAS DE PEPTIDOS SINTETICOS. (SYNTHETIC PEPTIDE AMIDES.)
Hong Kong	1130814	SYNTHETIC PEPTIDE AMIDES
France	22C1054
Cyprus	1116760

Supplementary Protection Certificates for difelikefalin acetate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2064228	CR 2022 00045	Denmark		PRODUCT NAME: DIFELIKEFALIN; REG. 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
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	C20220035 00379	Estonia		PRODUCT NAME: DIFELIKEFALIIN;REG NO/DATE: EU/1/22/1643 27.04.2022
2064228	CA 2022 00045	Denmark		PRODUCT NAME: DIFELIKEFALIN IN ALL FORMS COVERED BY THE BASIC PATENT; REG. NO/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