FDA Orange Book
Is there a generic for Tosymra?
Tosymra 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 Tosymra (sumatriptan). The Orange Book shows its last listed patent expires July 19, 2031.
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Tosymra products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| spray, nasal | 10MG/SPRAY | Marketed (Rx) | None | 0 | None |
NDA 210884, 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.
Tosymra patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8440631 | May 9, 2026 | Drug product | U-1719 | 210884 |
| 9283280 | May 9, 2026 | Drug product | None | 210884 |
| 8268791 | May 9, 2026 | Drug product | None | 210884 |
| 9974770 | June 16, 2030 | Drug product | U-1719 | 210884 |
| 11337962 | June 16, 2030 | Drug product | U-1719 | 210884 |
| 10603305 | June 16, 2030 | Drug product | U-1719 | 210884 |
| 9610280 | June 16, 2030 | Drug product | U-1719 | 210884 |
| 12090139 | June 16, 2030 | Drug product | None | 210884 |
| 9211282 | July 19, 2031 | Drug product | U-1719 | 210884 |
Tosymra NDC codes
Questions
Is there a generic for Tosymra?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tosymra (sumatriptan). The Orange Book shows its last listed patent expires July 19, 2031.
What is the generic name for Tosymra?
The active ingredient in Tosymra is sumatriptan, per the FDA Orange Book.
When does the Tosymra patent expire?
The last patent listed for Tosymra in the Orange Book expires July 19, 2031. 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 Tosymra and Sumatriptan
- What is Sumatriptan used for?FDA label uses
- Is Sumatriptan a controlled substance?Federal schedule
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- Serotonin-1b and Serotonin-1d Receptor Agonists listFDA drug class
- NDC 0245-0812Tosymra NDC record
- NDC 70792-812Tosymra NDC record