FDA Orange Book
Is there a generic for Dojolvi?
Dojolvi contains triheptanoin. 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 Dojolvi (triheptanoin). The Orange Book shows its last listed patent expires November 14, 2034 and its last listed exclusivity ends June 30, 2027.
Run it in Rivvi
Map Dojolvi and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Dojolvi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| liquid, oral | 100% w/w | Marketed (Rx) | None | 0 | None |
NDA 213687, held by ULTRAGENYX PHARMACEUTICAL INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Dojolvi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8697748 | April 28, 2029 | Drug product | None | 213687 |
| 12551461 | November 14, 2034 | Drug product | None | 213687 |
Dojolvi exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-311 | Orphan drug exclusivity | June 30, 2027 | 213687 |
Dojolvi NDC codes
Questions
Is there a generic for Dojolvi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Dojolvi (triheptanoin). The Orange Book shows its last listed patent expires November 14, 2034 and its last listed exclusivity ends June 30, 2027.
What is the generic name for Dojolvi?
The active ingredient in Dojolvi is triheptanoin, per the FDA Orange Book.
When does the Dojolvi patent expire?
The last patent listed for Dojolvi in the Orange Book expires November 14, 2034. 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.