FDA Orange Book
Is there a generic for Akynzeo?
Akynzeo contains netupitant and palonosetron. 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 Akynzeo (netupitant and palonosetron). The Orange Book shows its last listed patent expires June 2, 2037.
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Akynzeo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 300MG;EQ 0.5MG BASE | Marketed (Rx) | None | 0 | None |
| powder, intravenous | EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL | Discontinued | None | 0 | None |
| solution, intravenous | EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML) | Marketed (Rx) | None | 0 | None |
NDA 205718, 210493, held by HELSINN HEALTHCARE SA. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Akynzeo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9943515 | November 18, 2030 | Method of use | U-2293 | 205718 |
| 8623826 | November 18, 2030 | Method of use | U-2293 | 205718 |
| 9186357 | November 18, 2030 | Method of use | U-2293 | 205718 |
| 11559523 | November 18, 2030 | Drug product | U-3522 | 205718 |
| 12042494 | November 18, 2030 | Drug product | U-3522 | 205718 |
| 8951969 | November 18, 2030 | Drug product | None | 205718 |
| 9186357 | November 18, 2030 | Method of use | U-2301 | 210493 |
| 10828297 | December 17, 2030 | Method of use | U-2293 | 205718 |
| 10828297 | December 17, 2030 | Method of use | U-2301 | 210493 |
| 9271975 | September 9, 2031 | Method of use | U-2293 | 205718 |
| 10208073 | May 23, 2032 | Method of use | U-2301 | 210493 |
| 8895586 | May 23, 2032 | Method of use | U-2301 | 210493 |
| 9403772 | May 23, 2032 | Drug substance | U-2301 | 210493 |
| 11312698 | May 23, 2032 | Drug substance, Drug product | None | 210493 |
| 8426450 | May 23, 2032 | Drug substance, Drug product | None | 210493 |
| 9908907 | May 23, 2032 | Drug substance, Drug product | None | 210493 |
| 10717721 | May 23, 2032 | Drug substance | None | 210493 |
| 9951016 | September 25, 2035 | Drug substance, Drug product | None | 205718 |
| 10676440 | September 25, 2035 | Drug substance, Drug product | None | 205718 |
| 10961195 | September 25, 2035 | Drug substance, Drug product | None | 205718 |
| 10233154 | September 25, 2035 | Drug substance | None | 205718 |
| 12208109 | June 2, 2037 | Drug product | None | 210493 |
| 11529362 | June 2, 2037 | Drug product | None | 210493 |
| 10624911 | June 2, 2037 | Drug product | None | 210493 |
Akynzeo NDC codes
Questions
Is there a generic for Akynzeo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Akynzeo (netupitant and palonosetron). The Orange Book shows its last listed patent expires June 2, 2037.
What is the generic name for Akynzeo?
The active ingredient in Akynzeo is netupitant and palonosetron, per the FDA Orange Book.
When does the Akynzeo patent expire?
The last patent listed for Akynzeo in the Orange Book expires June 2, 2037. 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.