Details for New Drug Application (NDA): 214916
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NDA 214916 describes KORSUVA, which is a drug marketed by Cara Therap and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug. Additional details are available on the KORSUVA profile page.
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.
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.
Summary for 214916
| Tradename: | KORSUVA |
| Applicant: | Cara Therap |
| Ingredient: | difelikefalin acetate |
| Patents: | 12 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214916
Generic Entry Date for 214916*:
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 NDA: 214916
| Mechanism of Action | Opioid kappa Receptor Agonists |
Suppliers and Packaging for NDA: 214916
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KORSUVA | difelikefalin acetate | SOLUTION;INTRAVENOUS | 214916 | NDA | Vifor (International) Inc. | 59353-065 | 59353-065-12 | 12 VIAL, SINGLE-USE in 1 TRAY (59353-065-12) / 1.3 mL in 1 VIAL, SINGLE-USE (59353-065-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) | ||||
| Approval Date: | Aug 23, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 23, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 10,017,536 | Patent Expiration: | Nov 12, 2027 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patented Use: | TREATMENT OF MODERATE-TO-SEVERE PRURITUS ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD-AP) IN ADULTS UNDERGOING HEMODIALYSIS (HD) | ||||||||
| Patent: | 10,138,270 | Patent Expiration: | Nov 12, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF MODERATE-TO-SEVERE PRURITUS ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD-AP) IN ADULTS UNDERGOING HEMODIALYSIS (HD) | ||||||||
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