FDA Orange Book
Generic for Korlym
Korlym contains mifepristone. 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
Yes. The generic name for Korlym is mifepristone. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Korlym products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 300MG | Marketed (Rx) | AB | 1 | AB |
NDA 202107, 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.
Approved generic mifepristone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 211436 | AB (A-rated, therapeutically equivalent) | August 3, 2020 | 300MG |
Korlym patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8921348 | August 27, 2028 | Method of use | U-1643 | 202107 |
| 10842801 | November 15, 2032 | Method of use | U-1643 | 202107 |
| 10500216 | March 5, 2033 | Method of use | U-1643 | 202107 |
| 10166243 | April 20, 2036 | Method of use | U-1643 | 202107 |
| 9943526 | April 20, 2036 | Method of use | U-1643 | 202107 |
| 10166242 | April 20, 2036 | Method of use | U-1643 | 202107 |
| 10660904 | April 20, 2036 | Method of use | U-1643 | 202107 |
| 10495650 | August 12, 2036 | Method of use | U-1643 | 202107 |
| 10006924 | August 12, 2036 | Method of use | U-1643 | 202107 |
| 9829495 | August 15, 2036 | Method of use | U-1643 | 202107 |
| 10151763 | January 18, 2037 | Method of use | U-1643 | 202107 |
| 11969435 | June 19, 2037 | Method of use | U-1643 | 202107 |
| 12097210 | June 19, 2037 | Method of use | U-1643 | 202107 |
| 10195214 | June 19, 2037 | Method of use | U-1643 | 202107 |
| 10842800 | June 19, 2037 | Method of use | U-1643 | 202107 |
| 10231983 | August 22, 2038 | Method of use | U-1643 | 202107 |
| 10314850 | August 22, 2038 | Method of use | U-1643 | 202107 |
| 10780097 | August 22, 2038 | Method of use | U-1643 | 202107 |
Korlym NDC codes
Questions
Is there a generic for Korlym?
Yes. The generic name for Korlym is mifepristone. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Korlym?
The active ingredient in Korlym is mifepristone, per the FDA Orange Book.
When does the Korlym patent expire?
The last patent listed for Korlym in the Orange Book expires August 22, 2038. 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.