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TPOXX

NDA

TECOVIRIMAT | N208627 | SIGA TECHNOLOGIES INC

1 strength5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

Active (5)Today

2027

2028

2029

2030

2031

2032

Today

Sep. 4, 2031

Jul. 23, 2027

Mar. 23, 2031

Aug. 8, 2032

Mar. 23, 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

1 trial from ClinicalTrials.gov

Trial	Phase	Status	Sponsor	Enrollment	Dates
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.

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

4 letters from Drugs@FDA

Date	Submission	Document
Jul 2, 2024	SUPPL -8	View Letter (PDF)
May 19, 2022	SUPPL -7	View Letter (PDF)
Nov 24, 2021	SUPPL -6	View Letter (PDF)
Jul 13, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 200MG

RLD

5 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jul 13, 2018

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7737168	Sep 4, 2031	—	—	—		—
8039504	Jul 23, 2027	—	—	Yes	—	—
9339466	Mar 23, 2031	—	Yes	Yes	—	—
11890270	Aug 8, 2032	—	—	—		—
12433868	Mar 23, 2031	—	—	Yes	—	—