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TPOXX

NDA

TECOVIRIMAT | N214518 | SIGA TECHNOLOGIES INC

1 strength5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

Expiring < 1yr (1)Active (4)Today

2027

2028

2029

2030

2031

Today

Sep. 4, 2031

Jul. 23, 2027

Aug. 2, 2031

Aug. 2, 2031

Aug. 2, 2031

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

6 trials from ClinicalTrials.gov, 4 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Tecovirimat (ST-246) Treatment for Orthopox Virus Exposure NCT02080767	—	AVAILABLE	U.S. Army Medical Research and Development Command	—	—
Phase I, Escalating, Multiple-Dose, ST-246 Safety, Tolerability and Pharmacokinetics 21-Day Trial in Healthy Volunteers NCT00431951	Phase 1	Completed	SIGA Technologies	30	2007-02 → 2008-02
Phase I Trial of an Investigational Small Pox Medication NCT00728689	Phase 1	Completed	SIGA Technologies	12	2008-08 → 2008-10
A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of the Anti-Orthopoxvirus Compound Tecovirimat NCT02474589	Phase 3	Completed	SIGA Technologies	449	2015-06-19 → 2016-08-24
Safety, Tolerability, Pharmacokinetics (PK) of the Anti-Orthopox Drug, ST-246 NCT00907803	Phase 2	Completed	SIGA Technologies	107	2009-06 → 2010-01
Study of Tecovirimat for Human Mpox Virus NCT05534984	Phase 3	Terminated	National Institute of Allergy and Infectious Diseases (NIAID)	719	2022-09-08 → 2025-02-22

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

API Supply Chain2 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

ANHUI POLY PHARM CO LTDTECOVIRIMAT MONOHYDRATE

DMF 388522023

TOPHARMAN SHANDONG CO LTDTECOVIRIMAT

DMF 393082024

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jul 2, 2024	SUPPL -3	View Letter (PDF)
May 19, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 200MG/20ML (10MG/ML)

RLD

5 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: May 18, 2022

Patents (5) · 2 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7737168	Sep 4, 2031	—	—	—		—
8039504	Jul 23, 2027	—	—	Yes	—	—
9233097	Aug 2, 2031	—	—	Yes	—	—
9907859	Aug 2, 2031	—	—	—		—
10576165	Aug 2, 2031	—	—	Yes	—	—