TPOXX — FDA application NDA214518
Listed sponsor: SIGA TECHNOLOGIES · SIGA company profile · 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 |
Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.
Orange Book patent and exclusivity listings
| Listing | Product | Descriptive date | Flags/code |
|---|---|---|---|
| Patent 8039504 | 001 | listed patent expiry date: 2027-07-23 | drug product |
| Patent 10576165 | 001 | listed patent expiry date: 2031-08-02 | drug product |
| Patent 9233097 | 001 | listed patent expiry date: 2031-08-02 | drug product |
| Patent 9907859 | 001 | listed patent expiry date: 2031-08-02 | U-3377 |
| Patent 7737168 | 001 | listed patent expiry date: 2031-09-04 | U-3377 |
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 · CHEMBL1257073
- TECOVIRIMAT MONOHYDRATE · UNII SB96YO2BR8 · lmmol compound QRHXYGPOQKLBJP-NPIFKJBVSA-N · CHEMBL5315121
Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.
Related pages
Sponsor company · FDA-approved application index
Peer clusters: No published peer-cluster link for this sponsor.
Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.
Regulatory listing data as published by FDA; not medical or investment advice.