DIFELIKEFALIN ACETATE - Generic Drug Details

What are the generic sources for difelikefalin acetate and what is the scope of patent protection?

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 forty-nine patent family members in twenty-five countries.

One supplier is listed for this compound.

Summary for DIFELIKEFALIN ACETATE

International Patents:	49
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

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
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			Y	Y
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			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
Russian Federation	2009121298	СИНТЕТИЧЕСКИЕ ПЕПТИДНЫЕ АМИДЫ И ИХ ДИМЕРЫ
Australia	2007319831	Synthetic peptide amides and dimers thereof
South Africa	200903053	SYNTHETIC PEPTIDE AMIDES AND DIMERS THEREOF
Israel	197924	אמידים פפטידים סינתטיים, תכשירים רוקחים המכילים אותם ושימושים שלהם (Synthetic peptide amides, pharmaceutical compositions comprising the same and uses thereof)
Malaysia	153678	SYNTHETIC PEPTIDE AMIDES AND DIMERS THEREOF
European Patent Office	2064228	AMIDES PEPTIDIQUES SYNTHETIQUES (SYNTHETIC PEPTIDE AMIDES)
Poland	2064228

Supplementary Protection Certificates for DIFELIKEFALIN ACETATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2064228	PA2022522	Lithuania		PRODUCT NAME: DIFELIKEFALINAS, BET KOKIA FORMA, KURIAI TAIKOMA PAGRINDINIO PATENTO APSAUGA ; REGISTRATION NO/DATE: EU/1/22/1643 20220425
2064228	CR 2022 00045	Denmark		PRODUCT NAME: DIFELIKEFALIN; REG. NO/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	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	C20220035 00379	Estonia		PRODUCT NAME: DIFELIKEFALIIN;REG NO/DATE: EU/1/22/1643 27.04.2022
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	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