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Last Updated: May 26, 2022

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 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.

DrugPatentWatch® 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
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 23
Patent Applications: 76
What excipients (inactive ingredients) are in TPOXX?TPOXX excipients list
DailyMed Link:TPOXX at DailyMed
Drug patent expirations by year for TPOXX
DrugPatentWatch® Estimated 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.

US Patents and Regulatory Information for TPOXX

TPOXX is protected by six US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TPOXX is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

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

Chemicals, compositions, and methods for treatment and prevention of orthopoxvirus infections and associated diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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

Polymorphic forms of ST-246 and methods of preparation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting TPOXX

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

INDICATED FOR THE TREATMENT OF HUMAN SMALLPOX DISEASE CAUSED BY VARIOLA VIRUS IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 13 KG
Exclusivity Expiration: See Plans and Pricing

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

Argentina

Patent: 3435
Estimated Expiration: See Plans and Pricing

Australia

Patent: 11232551
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2012023743
Estimated Expiration: See Plans and Pricing

Canada

Patent: 93533
Estimated Expiration: See Plans and Pricing

Patent: 30671
Estimated Expiration: See Plans and Pricing

Chile

Patent: 12002621
Estimated Expiration: See Plans and Pricing

China

Patent: 3068232
Estimated Expiration: See Plans and Pricing

Patent: 5111130
Estimated Expiration: See Plans and Pricing

Patent: 5111131
Estimated Expiration: See Plans and Pricing

Patent: 5175311
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 49871
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 49871
Estimated Expiration: See Plans and Pricing

Israel

Patent: 1991
Estimated Expiration: See Plans and Pricing

Patent: 1730
Estimated Expiration: See Plans and Pricing

Patent: 1731
Estimated Expiration: See Plans and Pricing

Patent: 8239
Estimated Expiration: See Plans and Pricing

Japan

Patent: 18041
Estimated Expiration: See Plans and Pricing

Patent: 13522371
Estimated Expiration: See Plans and Pricing

Patent: 16040323
Estimated Expiration: See Plans and Pricing

Patent: 18012735
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 1428
Estimated Expiration: See Plans and Pricing

Patent: 12010859
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 2578
Estimated Expiration: See Plans and Pricing

Peru

Patent: 130212
Estimated Expiration: See Plans and Pricing

Patent: 170944
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 78606
Estimated Expiration: See Plans and Pricing

Patent: 12144818
Estimated Expiration: See Plans and Pricing

Patent: 15146899
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 4201
Estimated Expiration: See Plans and Pricing

Patent: 201501936P
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1207141
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 130018271
Estimated Expiration: See Plans and Pricing

Patent: 150011016
Estimated Expiration: See Plans and Pricing

Patent: 150092354
Estimated Expiration: See Plans and Pricing

Patent: 160028489
Estimated Expiration: See Plans and Pricing

Patent: 160062208
Estimated Expiration: See Plans and Pricing

Patent: 170102070
Estimated Expiration: See Plans and Pricing

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 2012010859 FORMAS POLIMORFICAS ST-246 Y METODOS DE PREPARACION. (POLYMORPHIC FORMS ST-246 AND METHODS OF PREPARATION.) See Plans and Pricing
Spain 2632313 See Plans and Pricing
South Korea 20170102070 다형체 형태 ST―246 및 제조방법 (POLYMORPHIC FORMS ST-246 AND METHODS OF PREPARATION) See Plans and Pricing
Denmark 1638938 See Plans and Pricing
European Patent Office 3006425 COMPOSITION PHARMACEUTIQUE DESTINEES AU TRAITEMENT ET A LA PRÉVENTION D'UNE INFECTION CAUSÉE PAR DES ORTHOPOXVIRUS (PHARMACEUTICAL COMPOSITION FOR USE IN THE TREATMENT AND PREVENTION OF ORTHOPOXVIRUS INFECTIONS AND ASSOCIATED DISEASES) See Plans and Pricing
>Country >Patent Number >Title >Estimated 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.