FDA Orange Book
Is there a generic for Tryngolza (autoinjector)?
Tryngolza (autoinjector) contains olezarsen. 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 Tryngolza (autoinjector) (olezarsen). The Orange Book shows its last listed patent expires May 1, 2034 and its last listed exclusivity ends December 19, 2031.
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Tryngolza (autoinjector) products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, subcutaneous | EQ 50MG BASE/0.8ML (EQ 50MG BASE/0.8ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML) | Marketed (Rx) | None | 0 | None |
NDA 218614, held by IONIS PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Tryngolza (autoinjector) patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9157082 | April 27, 2032 | Method of use | U-4580 | 218614 |
| 9157082 | April 27, 2032 | Method of use | U-4050 | 218614 |
| 9593333 | February 14, 2034 | Method of use | U-4050 | 218614 |
| 12509684 | May 1, 2034 | Method of use | U-4580 | 218614 |
| 9181549 | May 1, 2034 | Drug substance | None | 218614 |
| 9127276 | May 1, 2034 | Drug substance | None | 218614 |
| 9163239 | May 1, 2034 | Drug substance | None | 218614 |
| 12509684 | May 1, 2034 | Method of use | U-4050 | 218614 |
Tryngolza (autoinjector) exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NS | New strength | June 24, 2029 | 218614 |
| I-992 | New indication | June 24, 2029 | 218614 |
| ODE-515 | Orphan drug exclusivity | December 19, 2031 | 218614 |
Tryngolza (autoinjector) NDC codes
Questions
Is there a generic for Tryngolza (autoinjector)?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tryngolza (autoinjector) (olezarsen). The Orange Book shows its last listed patent expires May 1, 2034 and its last listed exclusivity ends December 19, 2031.
What is the generic name for Tryngolza (autoinjector)?
The active ingredient in Tryngolza (autoinjector) is olezarsen, per the FDA Orange Book.
When does the Tryngolza (autoinjector) patent expire?
The last patent listed for Tryngolza (autoinjector) in the Orange Book expires May 1, 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.