Details for New Drug Application (NDA): 220641
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NDA 220641 describes LIFYORLI (COPACKAGED), which is a drug marketed by Corcept Therap and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the LIFYORLI (COPACKAGED) profile page.
The generic ingredient in LIFYORLI (COPACKAGED) is relacorilant. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the relacorilant profile page.
The generic ingredient in LIFYORLI (COPACKAGED) is relacorilant. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the relacorilant profile page.
Summary for 220641
| Tradename: | LIFYORLI (COPACKAGED) |
| Applicant: | Corcept Therap |
| Ingredient: | relacorilant |
| Patents: | 10 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 220641
Generic Entry Date for 220641*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL |
*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.
Suppliers and Packaging for NDA: 220641
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LIFYORLI (COPACKAGED) | relacorilant | CAPSULE;ORAL | 220641 | NDA | Corcept Therapeutics Incorporated | 76346-425 | 76346-425-01 | 1 BLISTER PACK in 1 CARTON (76346-425-01) / 1 KIT in 1 BLISTER PACK (76346-425-11) * 1 CAPSULE in 1 PACKAGE, COMBINATION (76346-025-01) * 1 CAPSULE in 1 PACKAGE, COMBINATION (76346-100-01) |
| LIFYORLI (COPACKAGED) | relacorilant | CAPSULE;ORAL | 220641 | NDA | Corcept Therapeutics Incorporated | 76346-450 | 76346-450-01 | 1 BLISTER PACK in 1 CARTON (76346-450-01) / 1 KIT in 1 BLISTER PACK (76346-450-11) * 1 CAPSULE in 1 PACKAGE, COMBINATION (76346-025-01) * 1 CAPSULE in 1 PACKAGE, COMBINATION (76346-100-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG;25MG | ||||
| Approval Date: | Mar 25, 2026 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 25, 2031 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | May 24, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PLATINUM-RESISTANT EPITHELIAL OVARIAN CANCER WITH LIFYORLI IN COMBINATION WITH NAB-PACLITAXEL, IN ADULTS WHO HAVE RECEIVED ONE TO THREE PRIOR SYSTEMIC TREATMENT REGIMENS, AT LEAST ONE OF WHICH INCLUDED BEVACIZUMAB | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | May 26, 2041 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PLATINUM-RESISTANT EPITHELIAL OVARIAN CANCER WITH LIFYORLI IN COMBINATION WITH NAB-PACLITAXEL, IN ADULTS WHO HAVE RECEIVED ONE TO THREE PRIOR SYSTEMIC TREATMENT REGIMENS, AT LEAST ONE OF WHICH INCLUDED BEVACIZUMAB | ||||||||
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