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Last Updated: April 18, 2024

Difelikefalin acetate - Generic Drug Details

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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 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

Generic Entry Date for difelikefalin acetate^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Cara Therap	KORSUVA	difelikefalin acetate	SOLUTION;INTRAVENOUS	214916-001	Aug 23, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Cara Therap	KORSUVA	difelikefalin acetate	SOLUTION;INTRAVENOUS	214916-001	Aug 23, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Cara Therap	KORSUVA	difelikefalin acetate	SOLUTION;INTRAVENOUS	214916-001	Aug 23, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Cara Therap	KORSUVA	difelikefalin acetate	SOLUTION;INTRAVENOUS	214916-001	Aug 23, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for difelikefalin acetate

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Country	Patent Number	Title	Estimated Expiration
Canada	2667155	AMIDES PEPTIDIQUES SYNTHETIQUES (SYNTHETIC PEPTIDE AMIDES)	⤷ Try a Trial
South Korea	101513842		⤷ Try a Trial
South Korea	20090085097	SYNTHETIC PEPTIDE AMIDES AND DIMERS THEREOF	⤷ Try a Trial
Malaysia	153678	SYNTHETIC PEPTIDE AMIDES AND DIMERS THEREOF	⤷ Try a Trial
France	22C1054		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for difelikefalin acetate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2064228	C02064228/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: DIFELIKEFALIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68653 16.08.2022
2064228	301199	Netherlands	⤷ Try a Trial	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	122022000071	Germany	⤷ Try a Trial	PRODUCT NAME: DIFELIKEFALIN IN ALLEN DURCH DAS GRUNDPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/22/1643 20220425
2064228	43/2022	Austria	⤷ Try a Trial	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	⤷ Try a Trial	PRODUCT NAME: DIFELIKEFALINE DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/22/1643 20220427
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Summary for difelikefalin acetate

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

Pharmacology for difelikefalin acetate

Anatomical Therapeutic Chemical (ATC) Classes for difelikefalin acetate

Make Better Decisions: Try a trial or see plans & pricing

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