KORSUVA Drug Patent Profile
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When do Korsuva patents expire, and what generic alternatives are available?
Korsuva is a drug marketed by Cara Therap and is included in one NDA. There are twelve patents protecting this drug.
This drug has fifty patent family members in twenty-five countries.
The generic ingredient in KORSUVA is difelikefalin acetate. One supplier is listed for this compound. Additional details are available on the difelikefalin acetate profile page.
DrugPatentWatch® Generic Entry Outlook for Korsuva
Korsuva will be eligible for patent challenges on August 23, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be November 12, 2027. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Summary for KORSUVA
| International Patents: | 50 |
| US Patents: | 12 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 21 |
| Drug Prices: | Drug price information for KORSUVA |
| What excipients (inactive ingredients) are in KORSUVA? | KORSUVA excipients list |
| DailyMed Link: | KORSUVA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for KORSUVA
*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 KORSUVA
| Drug Class | Kappa Opioid Receptor Agonist |
| Mechanism of Action | Opioid kappa Receptor Agonists |
US Patents and Regulatory Information for KORSUVA
KORSUVA is protected by twelve US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of KORSUVA is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting KORSUVA
Synthetic peptide amides and dimers thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF MODERATE-TO-SEVERE PRURITUS ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD-AP) IN ADULTS UNDERGOING HEMODIALYSIS (HD)
Synthetic peptide amides
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF MODERATE-TO-SEVERE PRURITUS ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD-AP) IN ADULTS UNDERGOING HEMODIALYSIS (HD)
Synthetic peptide amides
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF MODERATE-TO-SEVERE PRURITUS ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD-AP) IN ADULTS UNDERGOING HEMODIALYSIS (HD)
Synthetic peptide amides
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF MODERATE-TO-SEVERE PRURITUS ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD-AP) IN ADULTS UNDERGOING HEMODIALYSIS (HD)
Synthetic peptide amides and dimeric forms thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF MODERATE-TO-SEVERE PRURITUS ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD-AP) IN ADULTS UNDERGOING HEMODIALYSIS (HD)
Synthetic peptide amides
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF MODERATE-TO-SEVERE PRURITUS ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD-AP) IN ADULTS UNDERGOING HEMODIALYSIS (HD)
Synthetic peptide amides
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF MODERATE-TO-SEVERE PRURITUS ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD-AP) IN ADULTS UNDERGOING HEMODIALYSIS (HD)
Uses of synthetic peptide amides
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF MODERATE-TO-SEVERE PRURITUS ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD-AP) IN ADULTS UNDERGOING HEMODIALYSIS (HD)
Synthetic peptide amides and dimeric forms thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF MODERATE-TO-SEVERE PRURITUS ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD-AP) IN ADULTS UNDERGOING HEMODIALYSIS (HD)
Synthetic peptide amides and dimers thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF MODERATE-TO-SEVERE PRURITUS ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD-AP) IN ADULTS UNDERGOING HEMODIALYSIS (HD)
Synthetic peptide amides and dimers thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF MODERATE-TO-SEVERE PRURITUS ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD-AP) IN ADULTS UNDERGOING HEMODIALYSIS (HD)
Synthetic peptide amides
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF MODERATE-TO-SEVERE PRURITUS ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD-AP) IN ADULTS UNDERGOING HEMODIALYSIS (HD)
FDA Regulatory Exclusivity protecting KORSUVA
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
| 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 | ||||
| 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 | ||||
| >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 KORSUVA
When does loss-of-exclusivity occur for KORSUVA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 07317817
Patent: Synthetic peptide amides
Estimated Expiration: ⤷ Sign Up
Patent: 07319831
Patent: Synthetic peptide amides and dimers thereof
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0718651
Patent: AMIDAS PEPTÍDICAS SINTÉTICAS.
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 67155
Patent: AMIDES PEPTIDIQUES SYNTHETIQUES (SYNTHETIC PEPTIDE AMIDES)
Estimated Expiration: ⤷ Sign Up
Patent: 67460
Patent: AMIDES PEPTIDIQUES SYNTHETIQUES ET DIMERES DE CES AMIDES (SYNTHETIC PEPTIDE AMIDES AND DIMERS THEREOF)
Estimated Expiration: ⤷ Sign Up
Patent: 98514
Patent: AMIDES PEPTIDIQUES SYNTHETIQUES ET DIMERES DE CES AMIDES (SYNTHETIC PEPTIDE AMIDES AND DIMERS THEREOF)
Estimated Expiration: ⤷ Sign Up
China
Patent: 1535336
Patent: Synthetic peptide amides and dimers thereof
Estimated Expiration: ⤷ Sign Up
Patent: 1627049
Patent: Synthetic peptide amides
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 16760
Estimated Expiration: ⤷ Sign Up
Patent: 22032
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 64228
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 64228
Patent: AMIDES PEPTIDIQUES SYNTHETIQUES (SYNTHETIC PEPTIDE AMIDES)
Estimated Expiration: ⤷ Sign Up
Patent: 79756
Patent: AMIDES PEPTIDIQUES SYNTHÉTIQUES ET DIMÈRES DE SES AMIDES (SYNTHETIC PEPTIDE AMIDES AND DIMERS THEREOF)
Estimated Expiration: ⤷ Sign Up
France
Patent: C1054
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 30814
Patent: SYNTHETIC PEPTIDE AMIDES
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 200045
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 7923
Patent: אמידים פפטידים סינתטיים, תכשירים רוקחיים המכילים אותם ושימושים שלהם (Synthetic peptide amides, pharmaceutical compositions comprising the same and uses thereof)
Estimated Expiration: ⤷ Sign Up
Patent: 7924
Patent: אמידים פפטידים סינתטיים, תכשירים רוקחים המכילים אותם ושימושים שלהם (Synthetic peptide amides, pharmaceutical compositions comprising the same and uses thereof)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 44810
Estimated Expiration: ⤷ Sign Up
Patent: 64583
Estimated Expiration: ⤷ Sign Up
Patent: 20180
Estimated Expiration: ⤷ Sign Up
Patent: 10509343
Estimated Expiration: ⤷ Sign Up
Patent: 10510966
Estimated Expiration: ⤷ Sign Up
Patent: 13241447
Patent: SYNTHETIC PEPTIDE AMIDES AND DIMERS THEREOF
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 2022522
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 8144
Patent: SYNTHETIC PEPTIDE AMIDES
Estimated Expiration: ⤷ Sign Up
Patent: 3678
Patent: SYNTHETIC PEPTIDE AMIDES AND DIMERS THEREOF
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 09004999
Patent: AMIDAS DE PEPTIDOS SINTETICOS Y DIMEROS DE LAS MISMAS. (SYNTHETIC PEPTIDE AMIDES AND DIMERS THEREOF.)
Estimated Expiration: ⤷ Sign Up
Patent: 09005000
Patent: AMIDAS DE PEPTIDOS SINTETICOS. (SYNTHETIC PEPTIDE AMIDES.)
Estimated Expiration: ⤷ Sign Up
Netherlands
Patent: 1199
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 7107
Patent: Synthetic peptide amide ligands of the kappa opiod receptor
Estimated Expiration: ⤷ Sign Up
Patent: 7108
Patent: Synthetic peptide amides and dimers thereof of the kappa opioid receptor
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 64228
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 64228
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 00685
Patent: СИНТЕТИЧЕСКИЕ ПЕПТИДНЫЕ АМИДЫ (SYNTHETIC PEPTIDE AMIDES)
Estimated Expiration: ⤷ Sign Up
Patent: 10399
Patent: СИНТЕТИЧЕСКИЕ ПЕПТИДНЫЕ АМИДЫ И ИХ ДИМЕРЫ (SYNTHETIC PEPTIDE AMIDES AND THEIR DIMERS)
Estimated Expiration: ⤷ Sign Up
Patent: 09121297
Patent: СИНТЕТИЧЕСКИЕ ПЕПТИДНЫЕ АМИДЫ
Estimated Expiration: ⤷ Sign Up
Patent: 09121298
Patent: СИНТЕТИЧЕСКИЕ ПЕПТИДНЫЕ АМИДЫ И ИХ ДИМЕРЫ
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 64228
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 0903053
Patent: SYNTHETIC PEPTIDE AMIDES AND DIMERS THEREOF
Estimated Expiration: ⤷ Sign Up
Patent: 0903054
Patent: SYNTHETIC PEPTIDE AMIDES
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1513736
Estimated Expiration: ⤷ Sign Up
Patent: 1513737
Estimated Expiration: ⤷ Sign Up
Patent: 1513842
Estimated Expiration: ⤷ Sign Up
Patent: 090085096
Patent: SYNTHETIC PEPTIDE AMIDES
Estimated Expiration: ⤷ Sign Up
Patent: 090085097
Patent: SYNTHETIC PEPTIDE AMIDES AND DIMERS THEREOF
Estimated Expiration: ⤷ Sign Up
Patent: 140056396
Patent: SYNTHETIC PEPTIDE AMIDES AND DIMERS THEREOF
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 94377
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering KORSUVA around the world.
| 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 |
| Hong Kong | 1130814 | SYNTHETIC PEPTIDE AMIDES | ⤷ Sign Up |
| France | 22C1054 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for KORSUVA
| 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 |
| 2064228 | C20220035 00379 | Estonia | ⤷ Sign Up | PRODUCT NAME: DIFELIKEFALIIN;REG NO/DATE: EU/1/22/1643 27.04.2022 |
| 2064228 | CA 2022 00045 | Denmark | ⤷ Sign Up | PRODUCT NAME: DIFELIKEFALIN IN ALL FORMS COVERED BY THE BASIC PATENT; REG. 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.
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