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 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
| Drug Class | Kappa Opioid Receptor Agonist |
| Mechanism of Action | Opioid kappa Receptor Agonists |
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 | 8,236,766 | ⤷ Subscribe | ⤷ Subscribe | ||||
| Cara Therap | KORSUVA | difelikefalin acetate | SOLUTION;INTRAVENOUS | 214916-001 | Aug 23, 2021 | RX | Yes | Yes | 8,217,007 | ⤷ Subscribe | ⤷ Subscribe | ||||
| Cara Therap | KORSUVA | difelikefalin acetate | SOLUTION;INTRAVENOUS | 214916-001 | Aug 23, 2021 | RX | Yes | Yes | 8,486,894 | ⤷ Subscribe | ⤷ Subscribe | ||||
| Cara Therap | KORSUVA | difelikefalin acetate | SOLUTION;INTRAVENOUS | 214916-001 | Aug 23, 2021 | RX | Yes | Yes | 8,536,131 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
| >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 |
|---|---|---|---|
| Canada | 2667155 | AMIDES PEPTIDIQUES SYNTHETIQUES (SYNTHETIC PEPTIDE AMIDES) | ⤷ Subscribe |
| New Zealand | 577108 | Synthetic peptide amides and dimers thereof of the kappa opioid receptor | ⤷ Subscribe |
| Japan | 6220180 | ⤷ Subscribe | |
| Canada | 2667460 | AMIDES PEPTIDIQUES SYNTHETIQUES ET DIMERES DE CES AMIDES (SYNTHETIC PEPTIDE AMIDES AND DIMERS THEREOF) | ⤷ Subscribe |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for difelikefalin acetate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2064228 | C02064228/01 | Switzerland | ⤷ Subscribe | PRODUCT NAME: DIFELIKEFALIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68653 16.08.2022 |
| 2064228 | 43/2022 | Austria | ⤷ Subscribe | 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 | 122022000071 | Germany | ⤷ Subscribe | PRODUCT NAME: DIFELIKEFALIN IN ALLEN DURCH DAS GRUNDPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/22/1643 20220425 |
| 2064228 | C20220035 00379 | Estonia | ⤷ Subscribe | 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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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.
ISSN: 2162-2639
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