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Last Updated: November 22, 2024

DIFELIKEFALIN ACETATE - Generic Drug Details


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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 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
Generic Entry Date for DIFELIKEFALIN ACETATE*:
Constraining patent/regulatory exclusivity:
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
Anatomical Therapeutic Chemical (ATC) Classes for DIFELIKEFALIN ACETATE

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

Country Patent Number Title Estimated Expiration
Mexico 2009004999 AMIDAS DE PEPTIDOS SINTETICOS Y DIMEROS DE LAS MISMAS. (SYNTHETIC PEPTIDE AMIDES AND DIMERS THEREOF.) ⤷  Sign Up
Japan 6220180 ⤷  Sign Up
Mexico 2009005000 AMIDAS DE PEPTIDOS SINTETICOS. (SYNTHETIC PEPTIDE AMIDES.) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DIFELIKEFALIN ACETATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2064228 CR 2022 00045 Denmark ⤷  Sign Up PRODUCT NAME: DIFELIKEFALIN; REG. NO/DATE: EU/1/22/1643 20220427
2064228 LUC00282 Luxembourg ⤷  Sign Up PRODUCT NAME: DIFELIKEFALIN IN ALL FORMS COVERED BY THE BASIC PATENT; AUTHORISATION NUMBER AND DATE: EU/1/22/1643 20220427
2064228 43/2022 Austria ⤷  Sign Up 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
>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.