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TPOXX Drug Profile

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Which patents cover Tpoxx, and when can generic versions of Tpoxx launch?

Tpoxx is a drug marketed by Siga Technologies and is included in one NDA. There are six patents protecting this drug.

This drug has seventy patent family members in twenty-one countries.

The generic ingredient in TPOXX is tecovirimat. One supplier is listed for this compound. Additional details are available on the tecovirimat profile page.

US ANDA Litigation and Generic Entry Outlook for Tpoxx

Tpoxx will be eligible for patent challenges on July 13, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 23, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TPOXX

International Patents:	70
US Patents:	6
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	16
Patent Applications:	14
DailyMed Link:	TPOXX at DailyMed

Generic Entry Opportunity Date for TPOXX

NDA:

208627

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Synonyms for TPOXX

4-trifluoromethyl-N-(3,3a,4,4a,5,5a,6,6a-octahydro-1,3-dioxo-4,6-ethenocycloprop(f)isoindol-2(1H)-yl)-benzamide

458T318

816458-31-8

869572-92-9

AKOS030260536

AN-27268

Benzamide, N-((3aR,4R,4aR,5aS,6S,6aS)-3,3a,4,4a,5,5a,6,6a-octahydro-1,3-dioxo-4,6-ethenocycloprop(f)isoindol-2(1H)-yl)-4-(trifluoromethyl)-, rel-

Benzamide, N-[(3aR,4R,4aR,5aS,6S,6aS)-3,3a,4,4a,5,5a,6,6a-octahydro-1,3-dioxo-4,6-ethenocycloprop[f]isoindol-2(1H)-yl]-4-(trifluoromethyl)-, rel-

CHEMBL1257073

CS-3464

DB12020

F925RR824R

HY-14805

N-((3aR,4R,4aR,5aS,6S,6aS)-1,3-Dioxo-3,3a,4,4a,5,5a,6,6a-octahydro-4,6-ethenocyclopropa(f)isoindol-2(1H)-yl)-4-(trifluoromethyl)benzamide

N-((3aR,4R,4aR,5aS,6S,6aS)-1,3-dioxo-3,3a,4,4a,5,5a,6,6a-octahydro-4,6-ethenocyclopropa[f]isoindol-2(1H)-yl)-4-(trifluoromethyl)benzamide

N-(dioxo[?]yl)-4-(trifluoromethyl)benzamide

N-[(3aR,4R,4aR,5aS,6S,6aS)-1,3-Dioxooctahydro-4,6-ethenocyclopropa[f]isoindol-2(1H)-yl]-4-(trifluoromethyl)benzamide

SCHEMBL404743

SIGA 246

SIGA-246

ST 246

ST-246

Tecovirimat

Tecovirimat [USAN:INN]

UNII-F925RR824R

ZINC35323125

US Patents and Regulatory Information for TPOXX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Siga Technologies	TPOXX	tecovirimat	CAPSULE;ORAL	208627-001	Jul 13, 2018		RX	Yes	Yes
Siga Technologies	TPOXX	tecovirimat	CAPSULE;ORAL	208627-001	Jul 13, 2018		RX	Yes	Yes
Siga Technologies	TPOXX	tecovirimat	CAPSULE;ORAL	208627-001	Jul 13, 2018		RX	Yes	Yes			Y	Y
Siga Technologies	TPOXX	tecovirimat	CAPSULE;ORAL	208627-001	Jul 13, 2018		RX	Yes	Yes
Siga Technologies	TPOXX	tecovirimat	CAPSULE;ORAL	208627-001	Jul 13, 2018		RX	Yes	Yes
Siga Technologies	TPOXX	tecovirimat	CAPSULE;ORAL	208627-001	Jul 13, 2018		RX	Yes	Yes			Y

International Patents for TPOXX

Country	Patent Number	Estimated Expiration
Denmark	1638938
China	101702904
Japan	2018012735
Spain	2632313
Japan	4884216
Peru	20170944