FDA Orange Book
Is there a generic for Zembrace Symtouch (autoinjector)?
Zembrace Symtouch (autoinjector) contains sumatriptan. 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 Zembrace Symtouch (autoinjector) (sumatriptan). The Orange Book shows its last listed patent expires January 29, 2036.
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Zembrace Symtouch (autoinjector) products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, subcutaneous | EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) | Marketed (Rx) | None | 0 | None |
NDA 208223, held by TONIX MEDICINES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Zembrace Symtouch (autoinjector) patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10537554 | January 29, 2036 | Method of use | U-72 | 208223 |
| 11364224 | January 29, 2036 | Method of use | U-72 | 208223 |
| 12097183 | January 29, 2036 | Drug product | None | 208223 |
Zembrace Symtouch (autoinjector) NDC codes
Questions
Is there a generic for Zembrace Symtouch (autoinjector)?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zembrace Symtouch (autoinjector) (sumatriptan). The Orange Book shows its last listed patent expires January 29, 2036.
What is the generic name for Zembrace Symtouch (autoinjector)?
The active ingredient in Zembrace Symtouch (autoinjector) is sumatriptan, per the FDA Orange Book.
When does the Zembrace Symtouch (autoinjector) patent expire?
The last patent listed for Zembrace Symtouch (autoinjector) in the Orange Book expires January 29, 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.