FDA Orange Book
Is there a generic for Onivyde?
Onivyde contains irinotecan. 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 Onivyde (irinotecan). The Orange Book shows its last listed patent expires October 15, 2036 and its last listed exclusivity ends February 13, 2031.
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Onivyde products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, liposomal, intravenous | EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) | Marketed (Rx) | None | 0 | None |
NDA 207793, held by IPSEN BIOPHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Onivyde patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8329213 | January 6, 2027 | Drug substance, Drug product | None | 207793 |
| 8147867 | August 29, 2028 | Drug substance, Drug product | None | 207793 |
| 9717724 | June 12, 2033 | Method of use | U-2091 | 207793 |
| 9492442 | June 12, 2033 | Method of use | U-1917 | 207793 |
| 9364473 | June 12, 2033 | Method of use | U-1856 | 207793 |
| 12364691 | June 12, 2033 | Method of use | U-1848 | 207793 |
| 11369597 | June 12, 2033 | Method of use | U-1848 | 207793 |
| 9339497 | June 12, 2033 | Method of use | U-1848 | 207793 |
| 9452162 | June 12, 2033 | Method of use | U-1899 | 207793 |
| 9492442 | June 12, 2033 | Method of use | U-1899 | 207793 |
| 9717724 | June 12, 2033 | Method of use | U-1848 | 207793 |
| 9492442 | June 12, 2033 | Method of use | U-1848 | 207793 |
| 10980795 | June 12, 2033 | Method of use | U-1848 | 207793 |
| 11344552 | August 19, 2036 | Method of use | U-3824 | 207793 |
| 12059497 | October 15, 2036 | Drug product | None | 207793 |
| 10456360 | October 15, 2036 | Drug product | None | 207793 |
| 10993914 | October 15, 2036 | Drug product | None | 207793 |
Onivyde exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-932 | New indication | February 13, 2027 | 207793 |
| ODE-463 | Orphan drug exclusivity | February 13, 2031 | 207793 |
Onivyde NDC codes
Questions
Is there a generic for Onivyde?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Onivyde (irinotecan). The Orange Book shows its last listed patent expires October 15, 2036 and its last listed exclusivity ends February 13, 2031.
What is the generic name for Onivyde?
The active ingredient in Onivyde is irinotecan, per the FDA Orange Book.
When does the Onivyde patent expire?
The last patent listed for Onivyde in the Orange Book expires October 15, 2036. 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.