Application 220641

Type: NDA
Sponsor: CORCEPT THERAP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIFYORLI (COPACKAGED)	RELACORILANT	CAPSULE;ORAL	100MG;25MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N220641-001	LIFYORLI (COPACKAGED)	RELACORILANT	100MG;25MG	CAPSULE / ORAL		RLD, RS	2026-03-25

Orange Book patents#

Current patent rows page 1 of 1 · 20 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N220641-001	10456392	2033-05-24	U-4457		2026-04-21
N220641-001	11576907	2033-05-24	U-4457	Drug substance, Drug product	2026-04-21
N220641-001	11576907	2033-05-24	U-4458	Drug substance, Drug product	2026-04-21
N220641-001	11576907	2033-05-24	U-4459	Drug substance, Drug product	2026-04-21
N220641-001	8859774	2033-05-24		Drug substance, Drug product	2026-04-21
N220641-001	9273047	2033-05-24	U-4457		2026-04-21
N220641-001	9273047	2033-05-24	U-4458		2026-04-21
N220641-001	9273047	2033-05-24	U-4459		2026-04-21
N220641-001	11925626	2039-12-18		Drug product	2026-04-21
N220641-001	12514849	2039-12-18		Drug product	2026-04-21
N220641-001	11464764	2040-04-14		Drug product	2026-04-21
N220641-001	11285145	2041-05-26	U-4457		2026-04-21
N220641-001	11285145	2041-05-26	U-4458		2026-04-21
N220641-001	11285145	2041-05-26	U-4459		2026-04-21
N220641-001	12589094	2041-05-26	U-4457		2026-04-21
N220641-001	12589094	2041-05-26	U-4458		2026-04-21
N220641-001	12589094	2041-05-26	U-4459		2026-04-21
N220641-001	12152028	2041-12-22	U-4457	Drug product	2026-04-21
N220641-001	12152028	2041-12-22	U-4458	Drug product	2026-04-21
N220641-001	12152028	2041-12-22	U-4459	Drug product	2026-04-21

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N220641-001	NCE	2031-03-25

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220641-001	LIFYORLI (COPACKAGED)	100MG;25MG	CAPSULE / ORAL		RLD, RS	2026-03-25	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220641-001	10456392	2033-05-24	U-4457		2026-04-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220641-001	11576907	2033-05-24	U-4458	Drug substance, Drug product	2026-04-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220641-001	11576907	2033-05-24	U-4457	Drug substance, Drug product	2026-04-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220641-001	11576907	2033-05-24	U-4459	Drug substance, Drug product	2026-04-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220641-001	8859774	2033-05-24		Drug substance, Drug product	2026-04-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220641-001	9273047	2033-05-24	U-4457		2026-04-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220641-001	9273047	2033-05-24	U-4458		2026-04-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220641-001	9273047	2033-05-24	U-4459		2026-04-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220641-001	11925626	2039-12-18		Drug product	2026-04-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220641-001	12514849	2039-12-18		Drug product	2026-04-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220641-001	11464764	2040-04-14		Drug product	2026-04-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220641-001	11285145	2041-05-26	U-4458		2026-04-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220641-001	11285145	2041-05-26	U-4457		2026-04-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220641-001	11285145	2041-05-26	U-4459		2026-04-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220641-001	12589094	2041-05-26	U-4457		2026-04-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220641-001	12589094	2041-05-26	U-4458		2026-04-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220641-001	12589094	2041-05-26	U-4459		2026-04-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220641-001	12152028	2041-12-22	U-4457	Drug product	2026-04-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220641-001	12152028	2041-12-22	U-4458	Drug product	2026-04-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220641-001	12152028	2041-12-22	U-4459	Drug product	2026-04-21	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220641-001	NCE	2031-03-25	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lifyorli	RELACORILANT	Corcept Therapeutics Incorporated	6fcebfb5-19d6-4f63-b852-999d68a13729	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 220641 application number: NDA220641

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85997	ORIG	2026-05-21
85778	ORIG	2026-04-28
85548	ORIG	2026-03-27