FDA Orange Book
Is there a generic for Symjepi?
Symjepi contains epinephrine. 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 Symjepi (epinephrine). The Orange Book shows its last listed patent expires October 20, 2036.
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Symjepi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intramuscular, subcutaneous | 0.15MG/0.3ML (0.15MG/0.3ML) | Discontinued | None | 0 | None |
| solution, intramuscular, subcutaneous | 0.3MG/0.3ML (0.3MG/0.3ML) | Marketed (Rx) | None | 0 | None |
NDA 207534, held by ADAMIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Symjepi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11141540 | October 20, 2036 | Drug product | U-3379 | 207534 |
Questions
Is there a generic for Symjepi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Symjepi (epinephrine). The Orange Book shows its last listed patent expires October 20, 2036.
What is the generic name for Symjepi?
The active ingredient in Symjepi is epinephrine, per the FDA Orange Book.
When does the Symjepi patent expire?
The last patent listed for Symjepi in the Orange Book expires October 20, 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.