FDA Orange Book
Is there a generic for Auvi-Q?
Auvi-Q 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 Auvi-Q (epinephrine). The Orange Book shows its last listed patent expires December 21, 2037.
Run it in Rivvi
Map Auvi-Q 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.
Auvi-Q products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intramuscular, subcutaneous | EQ 0.15MG/DELIVERY | Marketed (Rx) | BX | 0 | None |
| solution, intramuscular, subcutaneous | EQ 0.1MG/DELIVERY | Marketed (Rx) | None | 0 | None |
| solution, intramuscular, subcutaneous | EQ 0.3MG/DELIVERY | Marketed (Rx) | BX | 0 | None |
NDA 201739, held by KALEO INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Auvi-Q patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11590286 | December 12, 2026 | Drug product | None | 201739 |
| 8206360 | February 27, 2027 | Drug product | None | 201739 |
| 7947017 | March 12, 2028 | Drug product | None | 201739 |
| 8231573 | November 25, 2028 | Drug product | None | 201739 |
| 8226610 | April 10, 2029 | Drug product | None | 201739 |
| 8021344 | November 2, 2029 | Drug product | None | 201739 |
| 10688244 | December 21, 2037 | Drug product | U-2980 | 201739 |
| 10842938 | December 21, 2037 | Drug product | U-2980 | 201739 |
| 11771830 | December 21, 2037 | Drug product | U-2980 | 201739 |
Auvi-Q NDC codes
Questions
Is there a generic for Auvi-Q?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Auvi-Q (epinephrine). The Orange Book shows its last listed patent expires December 21, 2037.
What is the generic name for Auvi-Q?
The active ingredient in Auvi-Q is epinephrine, per the FDA Orange Book.
When does the Auvi-Q patent expire?
The last patent listed for Auvi-Q in the Orange Book expires December 21, 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.
More on Auvi-Q and Epinephrine
- What is Epinephrine used for?FDA label uses
- Is Epinephrine a controlled substance?Federal schedule
- Generic for AdrenaclickFDA Orange Book
- Generic for EpipenFDA Orange Book
- Generic for Epipen JrFDA Orange Book
- Generic for AdrenalinFDA Orange Book
- Generic for SymjepiFDA Orange Book
- Generic for neffyFDA Orange Book
- Catecholamines listFDA drug class
- Alpha-Adrenergic Agonists listFDA drug class
- Beta-Adrenergic Agonists listFDA drug class
- NDC 60842-021Auvi-Q NDC record
- NDC 60842-022Auvi-Q NDC record
- NDC 60842-023Auvi-Q NDC record