Difelikefalin acetate - Generic Drug Details

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What are the generic 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-seven patent family members in twenty-three countries.

One supplier is listed for this compound.

Summary for difelikefalin acetate

International Patents:	47
US Patents:	12
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	difelikefalin acetate at DailyMed

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	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
Cara Therap	KORSUVA	difelikefalin acetate	SOLUTION;INTRAVENOUS	214916-001	Aug 23, 2021		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
Cara Therap	KORSUVA	difelikefalin acetate	SOLUTION;INTRAVENOUS	214916-001	Aug 23, 2021		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
Cara Therap	KORSUVA	difelikefalin acetate	SOLUTION;INTRAVENOUS	214916-001	Aug 23, 2021		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
Cara Therap	KORSUVA	difelikefalin acetate	SOLUTION;INTRAVENOUS	214916-001	Aug 23, 2021		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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
Japan	2010510966		See Plans and Pricing
South Korea	101513842		See Plans and Pricing
European Patent Office	2064228	AMIDES PEPTIDIQUES SYNTHETIQUES (SYNTHETIC PEPTIDE AMIDES)	See Plans and Pricing
South Korea	20140056396	SYNTHETIC PEPTIDE AMIDES AND DIMERS THEREOF	See Plans and Pricing
South Africa	200903053	SYNTHETIC PEPTIDE AMIDES AND DIMERS THEREOF	See Plans and Pricing
>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	301199	Netherlands	See Plans and Pricing	PRODUCT NAME: DIFELIKEFALIN IN ALLE VORMEN ZOALS BESCHERMD DOOR HET BASISOCTROOI; REGISTRATION NO/DATE: EU/1/22/1643 20220427
2064228	2022C/546	Belgium	See Plans and Pricing	PRODUCT NAME: DIFELIKEFALINE SOUS TOUTES LES FORMES COUVERTES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/22/1643 20220427
2064228	LUC00282	Luxembourg	See Plans and Pricing	PRODUCT NAME: DIFELIKEFALIN IN ALL FORMS COVERED BY THE BASIC PATENT; AUTHORISATION NUMBER AND DATE: EU/1/22/1643 20220427
2064228	122022000071	Germany	See Plans and Pricing	PRODUCT NAME: DIFELIKEFALIN IN ALLEN DURCH DAS GRUNDPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/22/1643 20220425
2064228	C20220035 00379	Estonia	See Plans and Pricing	PRODUCT NAME: DIFELIKEFALIIN;REG NO/DATE: EU/1/22/1643 27.04.2022
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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