Prescription medicine
Tecovirimat Brand names: Tpoxx
Tecovirimat (Tpoxx) is a prescription medicine with an FDA approval on record since 2018. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the tecovirimat FDA label on DailyMed (effective December 31, 2025, SIGA Technologies, Inc.); the NDA 208627 record on Drugs@FDA; every tecovirimat label on DailyMed.
Highlights of the record
FDA label of December 31, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageTPOXX is an inhibitor of the orthopoxvirus VP37 envelope wrapping protein and is indicated for the treatment of human smallpox disease in adults and pediatric patients weighing at least 3 kg.
Forms and strengths
- 200 mg
- 10 mg/ml
Capsule; injection (solution) (concentrate).
On the market
- Earliest approval on file
- July 13, 2018 Tpoxx, Siga Technologies; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- August 8, 2032 Tpoxx capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 103 through July 30, 2026
What is tecovirimat used for?
From the label: indications and usageTPOXX is an inhibitor of the orthopoxvirus VP37 envelope wrapping protein and is indicated for the treatment of human smallpox disease in adults and pediatric patients weighing at least 3 kg. ( 1.1 ) Limitations of Use: The effectiveness of TPOXX for treatment of smallpox disease has not been determined in humans because adequate and well-controlled field trials have not been feasible, and inducing smallpox disease in humans to study the drug’s efficacy is not ethical. ( 1.2 ) TPOXX efficacy may be reduced in immunocompromised patients based on studies demonstrating reduced efficacy in immunocompromised animal models. […]
FDA pharmacologic class: Orthopoxvirus VP37 Envelope Wrapping Protein Inhibitor.
Source: FDA drug label (TPOXX), SIGA Technologies, Inc., effective December 31, 2025 (SPL set fce826ab-4d6a-4139-a2ee-a304a913a253), via openFDA; the full label on DailyMed
Is there a generic for tecovirimat (Tpoxx)?
No generic tecovirimat is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 5 patents for Tpoxx capsules: the compound patent runs to March 23, 2031, and the last listed entry to August 8, 2032. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2018 earliest approval on file
- 2032 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the tecovirimat label say about other medicines?
The tecovirimat label names 8 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Bupropion | drug interactions | Based on a drug interaction study, no clinically significant drug interactions have been observed when TPOXX is co-administered with bupropion, flurbiprofen, or omeprazole [see Clinical Pharmacology ( 12.3 )]. |
| Calcium acetate | drug interactions | Concomitant Drug Class/Drug Name: Calcium acetate Lanthanum carbonate Sevelamer carbonate Sucroferric oxyhydroxide; Effect on Concentration a: ↑ tecovirimat; Clinical Effect/Recommendation: Monitor for signs or symptoms of adverse effects when TPOXX is co-administered with phosphate binders [see Overdose ()]. |
| Flurbiprofen | drug interactions | Based on a drug interaction study, no clinically significant drug interactions have been observed when TPOXX is co-administered with bupropion, flurbiprofen, or omeprazole [see Clinical Pharmacology ( 12.3 )]. |
| Lanthanum | drug interactions | Concomitant Drug Class/Drug Name: Calcium acetate Lanthanum carbonate Sevelamer carbonate Sucroferric oxyhydroxide; Effect on Concentration a: ↑ tecovirimat; Clinical Effect/Recommendation: Monitor for signs or symptoms of adverse effects when TPOXX is co-administered with phosphate binders [see Overdose ()]. |
| Midazolam | drug interactions | Concomitant Drug Class/Drug Name: Midazolam b; Effect on Concentration a: ↓ midazolam; Clinical Effect/Recommendation: Monitor for effectiveness of midazolam. |
| Omeprazole | drug interactions | Based on a drug interaction study, no clinically significant drug interactions have been observed when TPOXX is co-administered with bupropion, flurbiprofen, or omeprazole [see Clinical Pharmacology ( 12.3 )]. |
| Repaglinide | drug interactions | Concomitant Drug Class/Drug Name: Repaglinide b; Effect on Concentration a: ↑ repaglinide; Clinical Effect/Recommendation: Monitor blood glucose and monitor for hypoglycemic symptoms in patients when TPOXX is co-administered with repaglinide [see Warnings and Precautions ()]. |
| Sevelamer | drug interactions | Concomitant Drug Class/Drug Name: Calcium acetate Lanthanum carbonate Sevelamer carbonate Sucroferric oxyhydroxide; Effect on Concentration a: ↑ tecovirimat; Clinical Effect/Recommendation: Monitor for signs or symptoms of adverse effects when TPOXX is co-administered with phosphate binders [see Overdose ()]. |
Source: FDA drug label (TPOXX), SIGA Technologies, Inc., effective December 31, 2025 (SPL set fce826ab-4d6a-4139-a2ee-a304a913a253), via openFDA; the full label on DailyMed
What do FAERS reports show for tecovirimat?
The FDA Adverse Event Reporting System holds 103 reports that list tecovirimat among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 13 are coded as a death and 23 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Tecovirimat side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other