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Last Updated: June 5, 2020

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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

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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
Drug patent expirations by year for TPOXX
Generic Entry Opportunity Date for TPOXX
Generic Entry Date for TPOXX*:
Constraining patent/regulatory exclusivity:
NDA:
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   Start Trial   Start Trial   Start Trial
Siga Technologies TPOXX tecovirimat CAPSULE;ORAL 208627-001 Jul 13, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Siga Technologies TPOXX tecovirimat CAPSULE;ORAL 208627-001 Jul 13, 2018 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Siga Technologies TPOXX tecovirimat CAPSULE;ORAL 208627-001 Jul 13, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Siga Technologies TPOXX tecovirimat CAPSULE;ORAL 208627-001 Jul 13, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Siga Technologies TPOXX tecovirimat CAPSULE;ORAL 208627-001 Jul 13, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Medtronic
Dow
Baxter
Boehringer Ingelheim
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.