Orange Book product · Brand (NDA)
LIFYORLI (COPACKAGED)
RELACORILANT
At a glance
Mar 25, 2026
Approved
Brand (NDA)
Application
Not listed
TE code
20
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 25, 2026
3 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Mar 25, 2031
in 4 yr 10 mo
Patent 10456392 expires
Listed method-of-use patent (U-4457) expiration.
May 24, 2033
in 7 yr
Patent 11576907 expires
Listed drug substance patent expiration.
May 24, 2033
in 7 yr
Patent 11576907 expires
Listed drug substance patent expiration.
May 24, 2033
in 7 yr
Patent 11576907 expires
Listed drug substance patent expiration.
May 24, 2033
in 7 yr
Patent 8859774 expires
Listed drug substance patent expiration.
May 24, 2033
in 7 yr
Patent 9273047 expires
Listed method-of-use patent (U-4457) expiration.
May 24, 2033
in 7 yr
Patent 9273047 expires
Listed method-of-use patent (U-4458) expiration.
May 24, 2033
in 7 yr
Patent 9273047 expires
Listed method-of-use patent (U-4459) expiration.
May 24, 2033
in 7 yr
Patent 11925626 expires
Listed drug product patent expiration.
Dec 18, 2039
in 13 yr 8 mo
Patent 12514849 expires
Listed drug product patent expiration.
Dec 18, 2039
in 13 yr 8 mo
Patent 11464764 expires
Listed drug product patent expiration.
Apr 14, 2040
in 14 yr
Patent 11285145 expires
Listed method-of-use patent (U-4458) expiration.
May 26, 2041
in 15 yr 2 mo
Patent 11285145 expires
Listed method-of-use patent (U-4457) expiration.
May 26, 2041
in 15 yr 2 mo
Patent 11285145 expires
Listed method-of-use patent (U-4459) expiration.
May 26, 2041
in 15 yr 2 mo
Patent 12589094 expires
Listed method-of-use patent (U-4457) expiration.
May 26, 2041
in 15 yr 2 mo
Patent 12589094 expires
Listed method-of-use patent (U-4458) expiration.
May 26, 2041
in 15 yr 2 mo
Patent 12589094 expires
Listed method-of-use patent (U-4459) expiration.
May 26, 2041
in 15 yr 2 mo
Patent 12152028 expires
Listed drug product patent expiration.
Dec 22, 2041
in 15 yr 9 mo
Patent 12152028 expires
Listed drug product patent expiration.
Dec 22, 2041
in 15 yr 9 mo
Patent 12152028 expires
Listed drug product patent expiration.
Dec 22, 2041
in 15 yr 9 mo
Pharmaceutical detail
Active ingredient
RELACORILANT
Strength
100MG;25MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 220641
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (1)
- NCENew chemical entity exclusivity (5 years)
Mar 25, 2031
in 4 yr 10 mo
Listed patents (20)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10456392 | May 24, 2033 | in 7 yr | U-4457 |
| 11576907 | May 24, 2033 | in 7 yr | SubstanceProductU-4458 |
| 11576907 | May 24, 2033 | in 7 yr | SubstanceProductU-4457 |
| 11576907 | May 24, 2033 | in 7 yr | SubstanceProductU-4459 |
| 8859774 | May 24, 2033 | in 7 yr | SubstanceProduct |
| 9273047 | May 24, 2033 | in 7 yr | U-4457 |
| 9273047 | May 24, 2033 | in 7 yr | U-4458 |
| 9273047 | May 24, 2033 | in 7 yr | U-4459 |
| 11925626 | Dec 18, 2039 | in 13 yr 8 mo | Product |
| 12514849 | Dec 18, 2039 | in 13 yr 8 mo | Product |
| 11464764 | Apr 14, 2040 | in 14 yr | Product |
| 11285145 | May 26, 2041 | in 15 yr 2 mo | U-4458 |
| 11285145 | May 26, 2041 | in 15 yr 2 mo | U-4457 |
| 11285145 | May 26, 2041 | in 15 yr 2 mo | U-4459 |
| 12589094 | May 26, 2041 | in 15 yr 2 mo | U-4457 |
| 12589094 | May 26, 2041 | in 15 yr 2 mo | U-4458 |
| 12589094 | May 26, 2041 | in 15 yr 2 mo | U-4459 |
| 12152028 | Dec 22, 2041 | in 15 yr 9 mo | ProductU-4457 |
| 12152028 | Dec 22, 2041 | in 15 yr 9 mo | ProductU-4458 |
| 12152028 | Dec 22, 2041 | in 15 yr 9 mo | ProductU-4459 |
