Question 1

Is there a generic for Tecovirimat?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Tecovirimat. It is available as 2 brand (NDA) applications.

Question 2

What is the reference-listed drug for Tecovirimat?

Accepted Answer

TPOXX (NDA 214518, SIGA TECHNOLOGIES) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Tecovirimat?

Accepted Answer

The Orange Book lists 8 patents against Tecovirimat products, with the earliest listed expiry in 2027. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

What dosage forms of Tecovirimat are approved?

Accepted Answer

Tecovirimat is approved in the following dosage forms: capsule, solution.

Product	Applicant	Application	TE	Approved
TPOXXRLD	SIGA TECHNOLOGIES	NDA 214518	—	May 18, 2022
TPOXXRLD	SIGA TECHNOLOGIES	NDA 208627	—	Jul 13, 2018

Patent	Expires	In	Type
8039504	Jul 23, 2027	in 1 yr 1 mo	Product
9339466	Mar 23, 2031	in 4 yr 10 mo	SubstanceProduct
12433868	Mar 23, 2031	in 4 yr 10 mo	Product
9907859	Aug 02, 2031	in 5 yr 2 mo	U-3377
10576165	Aug 02, 2031	in 5 yr 2 mo	Product
9233097	Aug 02, 2031	in 5 yr 2 mo	Product
7737168	Sep 04, 2031	in 5 yr 3 mo	U-2346
11890270	Aug 08, 2032	in 6 yr 3 mo	U-2346

Tecovirimat

Brand (NDA) products · capsule, solution

Listed patents (8)

Tecovirimat — frequently asked questions

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