FDA Orange Book
Is there a generic for Lynkuet?
Lynkuet contains elinzanetant. 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 Lynkuet (elinzanetant). The Orange Book shows its last listed patent expires May 14, 2045 and its last listed exclusivity ends October 24, 2030.
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Lynkuet products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 60MG | Marketed (Rx) | None | 0 | None |
NDA 219469, held by BAYER HEALTHCARE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Lynkuet patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7683056 | September 15, 2027 | Drug substance, Drug product | None | 219469 |
| 10195205 | May 18, 2036 | Method of use | U-3622 | 219469 |
| 12264164 | March 13, 2039 | Method of use | U-3622 | 219469 |
| 11787820 | March 13, 2039 | Method of use | U-3622 | 219469 |
| 10774091 | March 13, 2039 | Drug product | None | 219469 |
| 12533358 | May 14, 2045 | Method of use | U-4402 | 219469 |
Lynkuet exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | October 24, 2030 | 219469 |
Lynkuet NDC codes
Questions
Is there a generic for Lynkuet?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Lynkuet (elinzanetant). The Orange Book shows its last listed patent expires May 14, 2045 and its last listed exclusivity ends October 24, 2030.
What is the generic name for Lynkuet?
The active ingredient in Lynkuet is elinzanetant, per the FDA Orange Book.
When does the Lynkuet patent expire?
The last patent listed for Lynkuet in the Orange Book expires May 14, 2045. 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.