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Last Updated: June 24, 2024

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TPOXX Drug Patent 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 two NDAs. There are ten patents protecting this drug.

This drug has ninety-five patent family members in twenty-three countries.

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

DrugPatentWatch® Generic Entry Outlook for Tpoxx

Tpoxx was eligible for patent challenges on July 13, 2022.

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:95
US Patents:10
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 29
Patent Applications: 33
What excipients (inactive ingredients) are in TPOXX?TPOXX excipients list
DailyMed Link:TPOXX at DailyMed
Drug patent expirations by year for TPOXX
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TPOXX
Generic Entry Dates for TPOXX*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL
Generic Entry Dates for TPOXX*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INTRAVENOUS

*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.

US Patents and Regulatory Information for TPOXX

TPOXX is protected by eleven US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TPOXX is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting TPOXX

ST-246 liquid formulations and methods
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF HUMAN SMALLPOX DISEASE CAUSED BY VARIOLA VIRUS IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 13 KG

Compounds, compositions, and methods for treatment and prevention of orthopoxvirus infections and associated diseases
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF HUMAN SMALLPOX DISEASE CAUSED BY VARIOLA VIRUS IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 13 KG

Compounds, compositions, and methods for treatment and prevention of orthopoxvirus infections and associated diseases
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TPOXX IS INDICATED FOR THE TREATMENT OF HUMAN SMALLPOX DISEASE IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 3 KG

Chemicals, compositions, and methods for treatment and prevention of orthopoxvirus infections and associated diseases
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TPOXX IS INDICATED FOR THE TREATMENT OF HUMAN SMALLPOX DISEASE IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 3 KG

ST-246 liquid formulations
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Polymorphic forms of ST-246 and methods of preparation
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

ST-246 liquid formulations and methods
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TPOXX IS INDICATED FOR THE TREATMENT OF HUMAN SMALLPOX DISEASE IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 3 KG

FDA Regulatory Exclusivity protecting TPOXX

INDICATED FOR THE TREATMENT OF HUMAN SMALLPOX DISEASE CAUSED BY VARIOLA VIRUS IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 13 KG
Exclusivity Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Siga Technologies TPOXX tecovirimat SOLUTION;INTRAVENOUS 214518-001 May 18, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Siga Technologies TPOXX tecovirimat CAPSULE;ORAL 208627-001 Jul 13, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Siga Technologies TPOXX tecovirimat SOLUTION;INTRAVENOUS 214518-001 May 18, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for TPOXX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Siga Technologies TPOXX tecovirimat SOLUTION;INTRAVENOUS 214518-001 May 18, 2022 ⤷  Sign Up ⤷  Sign Up
Siga Technologies TPOXX tecovirimat CAPSULE;ORAL 208627-001 Jul 13, 2018 ⤷  Sign Up ⤷  Sign Up
Siga Technologies TPOXX tecovirimat CAPSULE;ORAL 208627-001 Jul 13, 2018 ⤷  Sign Up ⤷  Sign Up
Siga Technologies TPOXX tecovirimat SOLUTION;INTRAVENOUS 214518-001 May 18, 2022 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for TPOXX

When does loss-of-exclusivity occur for TPOXX?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Patent: 21
Patent: Polymorphic forms ST-246 and methods of preparation
Estimated Expiration: ⤷  Sign Up

Argentina

Patent: 2566
Patent: FORMULACIONES LIQUIDAS DE ST-246 Y METODOS RELACIONADOS, PROCESO
Estimated Expiration: ⤷  Sign Up

Patent: 3435
Patent: FORMAS POLIMORFICAS DE 4-TRIFLUOROMETIL-N-(3,3A,4,4A,5,5A,6,6A-OCTAHIDRO-1,3-DIOXO-4,6-ETENCICLOPROP[F]ISOINDOL-2(1H)-IL)-BENZAMIDA
Estimated Expiration: ⤷  Sign Up

Patent: 2178
Patent: COMPOSICIÓN FARMACÉUTICA LÍQUIDA Y PROCESO PARA PREPARARLA
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 11232551
Patent: Polymorphic forms ST-246 and methods of preparation
Estimated Expiration: ⤷  Sign Up

Patent: 11285871
Patent: ST-246 liquid formulations and methods
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2012023743
Patent: formas polimórficas st-246 e métodos de preparação
Estimated Expiration: ⤷  Sign Up

Patent: 2013002646
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 93533
Patent: FORMES POLYMORPHES ST-246 ET PROCEDES DE PREPARATION (POLYMORPHIC FORMS OF ST-246 AND METHODS OF PREPARATION)
Estimated Expiration: ⤷  Sign Up

Patent: 07528
Patent: PREPARATIONS LIQUIDES DE ST-246 ET PROCEDES (ST-246 LIQUID FORMULATIONS AND METHODS)
Estimated Expiration: ⤷  Sign Up

Patent: 30671
Patent: FORMES POLYMORPHES ST-246 ET PROCEDES DE PREPARATION (POLYMORPHIC FORMS OF ST-246 AND METHODS OF PREPARATION)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 12002621
Patent: Polimorfo forma i, ii, iii, iv y vi de 4-trifluorometil-n-(3,3a,4,4a,5,5a,6,6a-octahidro-1,3-dioxo-4,6-etenocicloprop[f]isoindol-2(1h)-il)-benzamida (st-246); metodo para producirlas; composicion farmaceutica; forma de dosificacion unitaria; y metodo de tratamiento de infecciones por ortopoxvirus y de eczema vacunal.
Estimated Expiration: ⤷  Sign Up

China

Patent: 3068232
Patent: Polymorphic forms st-246 and methods of preparation
Estimated Expiration: ⤷  Sign Up

Patent: 3281898
Patent: St-246 liquid formulations and methods
Estimated Expiration: ⤷  Sign Up

Patent: 5111130
Patent: Polymorphic forms of ST-246 and methods of preparation
Estimated Expiration: ⤷  Sign Up

Patent: 5111131
Patent: Polymorphic forms of ST-246 and methods of preparation
Estimated Expiration: ⤷  Sign Up

Patent: 5175311
Patent: Polymorphic Forms of ST-246 and Methods of Preparation
Estimated Expiration: ⤷  Sign Up

Patent: 6074370
Patent: ST‑246液体配制物以及方法 (ST-246 LIQUID FORMULATIONS AND METHODS)
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 49871
Estimated Expiration: ⤷  Sign Up

Patent: 00715
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 49871
Patent: FORME POLYMORPHE ST-246 ET PROCÉDÉS DE PRÉPARATION (POLYMORPHIC FORM ST-246 AND METHODS OF PREPARATION)
Estimated Expiration: ⤷  Sign Up

Patent: 00715
Patent: PRÉPARATIONS LIQUIDES DE ST-246 ET PROCÉDÉS (ST-246 LIQUID FORMULATIONS AND METHODS)
Estimated Expiration: ⤷  Sign Up

France

Patent: C1023
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 1991
Patent: תצורות פולימורפיות של 246-st ושיטות להכנתן (Polymorphic forms st-246 and methods of preparation)
Estimated Expiration: ⤷  Sign Up

Patent: 4430
Patent: Liquid pharmaceutical formulation comprising st-246 and a beta-cyclodextrin, a process of making the liquid formulation, a unit dosage liquid formulation and a process for preparing a water-soluble solid st-246 pharmaceutical formulation
Estimated Expiration: ⤷  Sign Up

Patent: 8239
Patent: ושיטות st-תוצרות פולימורפיות של 246 להכנתן (Polymorphic forms st-246 and methods of preparation)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 98196
Estimated Expiration: ⤷  Sign Up

Patent: 18041
Estimated Expiration: ⤷  Sign Up

Patent: 13522371
Estimated Expiration: ⤷  Sign Up

Patent: 13532729
Estimated Expiration: ⤷  Sign Up

Patent: 16040323
Patent: ST−246の多形型および調製方法 (POLYMORPHIC FORMS OF ST-246 AND METHODS OF PREPARATION)
Estimated Expiration: ⤷  Sign Up

Patent: 18012735
Patent: ST−246の多形型および調製方法 (POLYMORPHIC FORMS OF ST-246 AND METHODS OF PREPARATION)
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 7795
Patent: FORMULACIONES LIQUIDAS DE ST-246 Y METODOS. (ST-246 LIQUID FORMULATIONS AND METHODS.)
Estimated Expiration: ⤷  Sign Up

Patent: 1428
Patent: FORMAS POLIMORFICAS ST-246 Y METODOS DE PREPARACION. (POLYMORPHIC FORMS ST-246 AND METHODS OF PREPARATION.)
Estimated Expiration: ⤷  Sign Up

Patent: 8106
Patent: FORMULACIONES LIQUIDAS DE ST-246 Y METODOS. (ST-246 LIQUID FORMULATIONS AND METHODS.)
Estimated Expiration: ⤷  Sign Up

Patent: 12010859
Patent: FORMAS POLIMORFICAS ST-246 Y METODOS DE PREPARACION. (POLYMORPHIC FORMS ST-246 AND METHODS OF PREPARATION.)
Estimated Expiration: ⤷  Sign Up

Patent: 13001389
Patent: FORMULACIONES LIQUIDAS DE ST-246 Y METODOS. (ST-246 LIQUID FORMULATIONS AND METHODS.)
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 2578
Patent: Polymorphic forms st-246 and methods of preparation
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 130212
Patent: FORMAS POLIMORFICAS DE ST-246 Y METODOS DE PREPARACION
Estimated Expiration: ⤷  Sign Up

Patent: 170944
Patent: FORMAS POLIMORFICAS DE ST-246 Y METODOS DE PREPARACION
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 78606
Patent: ПОЛИМОРФНЫЕ ФОРМЫ СОЕДИНЕНИЯ ST-246 И СПОСОБЫ ПОЛУЧЕНИЯ (POLYMORPHIC FORMS OF ST-246 COMPOUND AND METHODS FOR PRODUCING)
Estimated Expiration: ⤷  Sign Up

Patent: 12144818
Patent: ПОЛИМОРФНЫЕ ФОРМЫ СОЕДИНЕНИЯ ST-246 И СПОСОБЫ ПОЛУЧЕНИЯ
Estimated Expiration: ⤷  Sign Up

Patent: 15146899
Patent: ПОЛИМОРФНЫЕ ФОРМЫ СОЕДИНЕНИЯ ST-246 И СПОСОБЫ ПОЛУЧЕНИЯ
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 4201
Patent: POLYMORPHIC FORMS ST-246 AND METHODS OF PREPARATION
Estimated Expiration: ⤷  Sign Up

Patent: 7243
Patent: ST-246 LIQUID FORMULATIONS AND METHODS
Estimated Expiration: ⤷  Sign Up

Patent: 201501936P
Patent: POLYMORPHIC FORMS ST-246 AND METHODS OF PREPARATION
Estimated Expiration: ⤷  Sign Up

Patent: 201506031U
Patent: ST-246 LIQUID FORMULATIONS AND METHODS
Estimated Expiration: ⤷  Sign Up

Patent: 202105262Q
Patent: ST-246 LIQUID FORMULATIONS AND METHODS
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1207141
Patent: POLYMORPHIC FORMS ST-246 AND METHODS OF PREPARATION
Estimated Expiration: ⤷  Sign Up

Patent: 1300930
Patent: ST-246 LIQUID FORMULATIONS AND METHODS
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1868117
Estimated Expiration: ⤷  Sign Up

Patent: 130018271
Patent: POLYMORPHIC FORMS ST-246 AND METHODS OF PREPARATION
Estimated Expiration: ⤷  Sign Up

Patent: 130135836
Patent: ST-246 LIQUID FORMULATIONS AND METHODS
Estimated Expiration: ⤷  Sign Up

Patent: 150011016
Patent: POLYMORPHIC FORMS ST-246 AND METHODS OF PREPARATION
Estimated Expiration: ⤷  Sign Up

Patent: 150092354
Patent: POLYMORPHIC FORMS ST-246 AND METHODS OF PREPARATION
Estimated Expiration: ⤷  Sign Up

Patent: 160028489
Patent: 다형체 형태 ST―246 및 제조방법 (POLYMORPHIC FORMS ST-246 AND METHODS OF PREPARATION)
Estimated Expiration: ⤷  Sign Up

Patent: 160062208
Patent: 다형체 형태 ST―246 및 제조방법 (POLYMORPHIC FORMS ST-246 AND METHODS OF PREPARATION)
Estimated Expiration: ⤷  Sign Up

Patent: 170102070
Patent: 다형체 형태 ST―246 및 제조방법 (POLYMORPHIC FORMS ST-246 AND METHODS OF PREPARATION)
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TPOXX around the world.

Country Patent Number Title Estimated Expiration
Mexico 363189 PRODUCTOS QUÍMICOS, COMPOSICIONES Y MÉTODOS PARA TRATAMIENTO Y PREVENCIÓN DE INFECCIONES DE VIRUS ORTHOPOX Y ENFERMEDADES ASOCIADAS. (CHEMICALS, COMPOSITIONS, AND METHODS FOR TREATMENT AND PREVENTION OF ORTHOPOXVIRUS INFECTIONS AND ASSOCIATED DISEASES.) ⤷  Sign Up
Mexico 368106 FORMULACIONES LIQUIDAS DE ST-246 Y METODOS. (ST-246 LIQUID FORMULATIONS AND METHODS.) ⤷  Sign Up
Canada 2966466 PRODUITS CHIMIQUES, COMPOSITIONS ET PROCEDES DE TRAITEMENT ET DE PREVENTION DES INFECTIONS A ORTHOPOXVIRUS ET DES MALADIES ASSOCIEES (CHEMICALS, COMPOSITIONS, AND METHODS FOR TREATMENT AND PREVENTION OF ORTHOPOXVIRUS INFECTIONS AND ASSOCIATED DISEASES) ⤷  Sign Up
Australia 2004249250 Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TPOXX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2549871 22C1023 France ⤷  Sign Up PRODUCT NAME: TECOVIRIMAT, SOUS TOUTES LES FORMES RELEVANT DE LA PROTECTION DU BREVET DE BASE; REGISTRATION NO/DATE: EU/1/21/1600/001 20220106
1638938 2022C/521 Belgium ⤷  Sign Up PRODUCT NAME: TECOVIRIMAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1600 20220107
1638938 2290024-5 Sweden ⤷  Sign Up PRODUCT NAME: TECOVIRIMAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/21/1600/001 20220107
2549871 122022000033 Germany ⤷  Sign Up PRODUCT NAME: TECOVIRIMAT ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1600 20220106
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.