FDA Orange Book
Is there a generic for Orserdu?
Orserdu contains elacestrant. 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 Orserdu (elacestrant). The Orange Book shows its last listed patent expires January 5, 2038 and its last listed exclusivity ends January 27, 2028.
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Orserdu products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 345MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 86MG BASE | Marketed (Rx) | None | 0 | None |
NDA 217639, held by STEMLINE THERAPEUTICS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Orserdu patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7612114 | August 18, 2026 | Drug substance, Drug product | U-3523 | 217639 |
| 10071066 | October 10, 2034 | Method of use | U-3524 | 217639 |
| 11779552 | October 10, 2034 | Method of use | U-3524 | 217639 |
| 10420734 | October 3, 2036 | Method of use | U-3524 | 217639 |
| 11819480 | February 28, 2037 | Method of use | U-3523 | 217639 |
| 10745343 | January 5, 2038 | Method of use | U-3523 | 217639 |
| 10385008 | January 5, 2038 | Drug substance, Drug product | None | 217639 |
Orserdu exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | January 27, 2028 | 217639 |
Orserdu NDC codes
Questions
Is there a generic for Orserdu?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Orserdu (elacestrant). The Orange Book shows its last listed patent expires January 5, 2038 and its last listed exclusivity ends January 27, 2028.
What is the generic name for Orserdu?
The active ingredient in Orserdu is elacestrant, per the FDA Orange Book.
When does the Orserdu patent expire?
The last patent listed for Orserdu in the Orange Book expires January 5, 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.