FDA Orange Book
Is there a generic for Tpoxx?
Tpoxx contains tecovirimat. 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 Tpoxx (tecovirimat). The Orange Book shows its last listed patent expires August 8, 2032.
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Tpoxx products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 200MG | Marketed (Rx) | None | 0 | None |
| solution, intravenous | 200MG/20ML (10MG/ML) | Marketed (Rx) | None | 0 | None |
NDA 208627, 214518, held by SIGA TECHNOLOGIES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Tpoxx patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8039504 | July 23, 2027 | Drug product | None | 208627 |
| 9339466 | March 23, 2031 | Drug substance, Drug product | None | 208627 |
| 12433868 | March 23, 2031 | Drug product | None | 208627 |
| 9907859 | August 2, 2031 | Method of use | U-3377 | 214518 |
| 10576165 | August 2, 2031 | Drug product | None | 214518 |
| 9233097 | August 2, 2031 | Drug product | None | 214518 |
| 7737168 | September 4, 2031 | Method of use | U-2346 | 208627 |
| 7737168 | September 4, 2031 | Method of use | U-3377 | 214518 |
| 11890270 | August 8, 2032 | Method of use | U-2346 | 208627 |
Tpoxx NDC codes
Questions
Is there a generic for Tpoxx?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tpoxx (tecovirimat). The Orange Book shows its last listed patent expires August 8, 2032.
What is the generic name for Tpoxx?
The active ingredient in Tpoxx is tecovirimat, per the FDA Orange Book.
When does the Tpoxx patent expire?
The last patent listed for Tpoxx in the Orange Book expires August 8, 2032. 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.