# TPOXX — FDA application NDA214518

Informational only - not investment advice.

Application NDA214518 · type NDA · FDA status: approved · original approval 2022-05-18

Listed sponsor: SIGA TECHNOLOGIES · [SIGA company profile](/company/SIGA/) · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

## FDA application facts

| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 001 | TPOXX | TECOVIRIMAT | SOLUTION | INTRAVENOUS | 200MG/20ML (10MG/ML) | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 8039504, product 001; listed patent expiry date: 2027-07-23.
- Patent 10576165, product 001; listed patent expiry date: 2031-08-02.
- Patent 9233097, product 001; listed patent expiry date: 2031-08-02.
- Patent 9907859, product 001; listed patent expiry date: 2031-08-02.
- Patent 7737168, product 001; listed patent expiry date: 2031-09-04.

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

## Compound cross-links

- TECOVIRIMAT · UNII F925RR824R · [lmmol compound CSKDFZIMJXRJGH-VWLPUNTISA-N](https://lmmol.com/compound/CSKDFZIMJXRJGH-VWLPUNTISA-N)
- TECOVIRIMAT MONOHYDRATE · UNII SB96YO2BR8 · [lmmol compound QRHXYGPOQKLBJP-NPIFKJBVSA-N](https://lmmol.com/compound/QRHXYGPOQKLBJP-NPIFKJBVSA-N)

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

## Related pages

- [Sponsor company](/company/SIGA/)
- [FDA-approved application index](/drug/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA214518. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.