grepcent public filings, reorganized for comparison

TPOXX — FDA application NDA208627

Application NDA208627 · type NDA · FDA status: approved · original approval 2018-07-13

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

ProductFDA-listed trade nameActive ingredientDosage formRouteStrengthMarketing statusTE codeRLD
001TPOXXTECOVIRIMATCAPSULEORAL200MGPrescriptionnot listedYes

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

ListingProductDescriptive dateFlags/code
Patent 8039504001listed patent expiry date: 2027-07-23drug product
Patent 12433868001listed patent expiry date: 2031-03-23drug product
Patent 9339466001listed patent expiry date: 2031-03-23drug substance, drug product
Patent 7737168001listed patent expiry date: 2031-09-04U-2346
Patent 11890270001listed patent expiry date: 2032-08-08U-2346
NDA208627 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA208627 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA208627 FDA listing datesDescriptive regulatory dates only; no relationship to revenue or future sales is stated or implied.Source: Drugs@FDA and FDA Orange Book.Listed dateDated listing marker0.001.002.002018-07-131.002027-07-231.002031-03-231.002031-09-041.002032-08-081.00

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

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.