FDA Orange Book
Is there a generic for Lifyorli (copackaged)?
Lifyorli (copackaged) contains relacorilant. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Lifyorli (copackaged) (relacorilant). The Orange Book shows its last listed patent expires December 22, 2041 and its last listed exclusivity ends March 25, 2031.
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Lifyorli (copackaged) products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 100MG;25MG | Marketed (Rx) | None | 0 | None |
NDA 220641, held by CORCEPT THERAPEUTICS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Lifyorli (copackaged) patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10456392 | May 24, 2033 | Method of use | U-4457 | 220641 |
| 9273047 | May 24, 2033 | Method of use | U-4457 | 220641 |
| 9273047 | May 24, 2033 | Method of use | U-4458 | 220641 |
| 9273047 | May 24, 2033 | Method of use | U-4459 | 220641 |
| 11576907 | May 24, 2033 | Drug substance, Drug product | U-4458 | 220641 |
| 11576907 | May 24, 2033 | Drug substance, Drug product | U-4457 | 220641 |
| 11576907 | May 24, 2033 | Drug substance, Drug product | U-4459 | 220641 |
| 8859774 | May 24, 2033 | Drug substance, Drug product | None | 220641 |
| 11925626 | December 18, 2039 | Drug product | None | 220641 |
| 12514849 | December 18, 2039 | Drug product | None | 220641 |
| 11464764 | April 14, 2040 | Drug product | None | 220641 |
| 11285145 | May 26, 2041 | Method of use | U-4458 | 220641 |
| 11285145 | May 26, 2041 | Method of use | U-4457 | 220641 |
| 11285145 | May 26, 2041 | Method of use | U-4459 | 220641 |
| 12589094 | May 26, 2041 | Method of use | U-4457 | 220641 |
| 12589094 | May 26, 2041 | Method of use | U-4458 | 220641 |
| 12589094 | May 26, 2041 | Method of use | U-4459 | 220641 |
| 12152028 | December 22, 2041 | Drug product | U-4457 | 220641 |
| 12152028 | December 22, 2041 | Drug product | U-4458 | 220641 |
| 12152028 | December 22, 2041 | Drug product | U-4459 | 220641 |
Lifyorli (copackaged) exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | March 25, 2031 | 220641 |
Questions
Is there a generic for Lifyorli (copackaged)?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Lifyorli (copackaged) (relacorilant). The Orange Book shows its last listed patent expires December 22, 2041 and its last listed exclusivity ends March 25, 2031.
What is the generic name for Lifyorli (copackaged)?
The active ingredient in Lifyorli (copackaged) is relacorilant, per the FDA Orange Book.
When does the Lifyorli (copackaged) patent expire?
The last patent listed for Lifyorli (copackaged) in the Orange Book expires December 22, 2041. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.