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 nine patents protecting this drug.
This drug has ninety-three patent family members in twenty-two 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
Summary for TPOXX
International Patents: | 93 |
US Patents: | 9 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 24 |
Patent Applications: | 53 |
What excipients (inactive ingredients) are in TPOXX? | TPOXX excipients list |
DailyMed Link: | TPOXX at DailyMed |

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.
Pharmacology for TPOXX
Anatomical Therapeutic Chemical (ATC) Classes for TPOXX
US Patents and Regulatory Information for TPOXX
TPOXX is protected by eleven US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of TPOXX is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compounds, compositions, and methods for treatment and prevention of orthopoxvirus infections and associated diseases
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Polymorphic forms of ST-246 and methods of preparation
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
ST-246 liquid formulations and methods
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
INDICATED FOR THE TREATMENT OF HUMAN SMALLPOX DISEASE CAUSED BY VARIOLA VIRUS IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 13 KG
Exclusivity Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Siga Technologies | TPOXX | tecovirimat | CAPSULE;ORAL | 208627-001 | Jul 13, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Siga Technologies | TPOXX | tecovirimat | CAPSULE;ORAL | 208627-001 | Jul 13, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Siga Technologies | TPOXX | tecovirimat | SOLUTION;INTRAVENOUS | 214518-001 | May 18, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Siga Technologies | TPOXX | tecovirimat | CAPSULE;ORAL | 208627-001 | Jul 13, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Siga Technologies | TPOXX | tecovirimat | SOLUTION;INTRAVENOUS | 214518-001 | May 18, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>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: ⤷ Try a Trial
Argentina
Patent: 2566
Estimated Expiration: ⤷ Try a Trial
Patent: 3435
Estimated Expiration: ⤷ Try a Trial
Patent: 2178
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 11232551
Estimated Expiration: ⤷ Try a Trial
Patent: 11285871
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2012023743
Estimated Expiration: ⤷ Try a Trial
Patent: 2013002646
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 93533
Estimated Expiration: ⤷ Try a Trial
Patent: 07528
Estimated Expiration: ⤷ Try a Trial
Patent: 30671
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 12002621
Estimated Expiration: ⤷ Try a Trial
China
Patent: 3068232
Estimated Expiration: ⤷ Try a Trial
Patent: 3281898
Estimated Expiration: ⤷ Try a Trial
Patent: 5111130
Estimated Expiration: ⤷ Try a Trial
Patent: 5111131
Estimated Expiration: ⤷ Try a Trial
Patent: 5175311
Estimated Expiration: ⤷ Try a Trial
Patent: 6074370
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 49871
Estimated Expiration: ⤷ Try a Trial
Patent: 00715
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 49871
Estimated Expiration: ⤷ Try a Trial
Patent: 00715
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 1991
Estimated Expiration: ⤷ Try a Trial
Patent: 4430
Estimated Expiration: ⤷ Try a Trial
Patent: 8239
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 98196
Estimated Expiration: ⤷ Try a Trial
Patent: 18041
Estimated Expiration: ⤷ Try a Trial
Patent: 13522371
Estimated Expiration: ⤷ Try a Trial
Patent: 13532729
Estimated Expiration: ⤷ Try a Trial
Patent: 16040323
Estimated Expiration: ⤷ Try a Trial
Patent: 18012735
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 7795
Estimated Expiration: ⤷ Try a Trial
Patent: 1428
Estimated Expiration: ⤷ Try a Trial
Patent: 8106
Estimated Expiration: ⤷ Try a Trial
Patent: 12010859
Estimated Expiration: ⤷ Try a Trial
Patent: 13001389
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 2578
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 130212
Estimated Expiration: ⤷ Try a Trial
Patent: 170944
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 78606
Estimated Expiration: ⤷ Try a Trial
Patent: 12144818
Estimated Expiration: ⤷ Try a Trial
Patent: 15146899
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 4201
Estimated Expiration: ⤷ Try a Trial
Patent: 7243
Estimated Expiration: ⤷ Try a Trial
Patent: 201501936P
Estimated Expiration: ⤷ Try a Trial
Patent: 201506031U
Estimated Expiration: ⤷ Try a Trial
Patent: 202105262Q
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1207141
Estimated Expiration: ⤷ Try a Trial
Patent: 1300930
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1868117
Estimated Expiration: ⤷ Try a Trial
Patent: 130018271
Estimated Expiration: ⤷ Try a Trial
Patent: 130135836
Estimated Expiration: ⤷ Try a Trial
Patent: 150011016
Estimated Expiration: ⤷ Try a Trial
Patent: 150092354
Estimated Expiration: ⤷ Try a Trial
Patent: 160028489
Estimated Expiration: ⤷ Try a Trial
Patent: 160062208
Estimated Expiration: ⤷ Try a Trial
Patent: 170102070
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
Argentina | 083435 | ⤷ Try a Trial | |
China | 105175311 | ⤷ Try a Trial | |
Argentina | 122178 | COMPOSICIÓN FARMACÉUTICA LÍQUIDA Y PROCESO PARA PREPARARLA | ⤷ Try a Trial |
South Korea | 20170102070 | ⤷ Try a Trial | |
Peru | 20170944 | ⤷ Try a Trial | |
Canada | 3030671 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TPOXX
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2549871 | 122022000033 | Germany | ⤷ Try a Trial | PRODUCT NAME: TECOVIRIMAT ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1600 20220106 |
1638938 | 2022C/521 | Belgium | ⤷ Try a Trial | PRODUCT NAME: TECOVIRIMAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1600 20220107 |
1638938 | 2290024-5 | Sweden | ⤷ Try a Trial | PRODUCT NAME: TECOVIRIMAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/21/1600/001 20220107 |
1638938 | 301177 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: TECOVIRIMAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1600/001 20220107 |
1638938 | C202230021 | Spain | ⤷ Try a Trial | PRODUCT NAME: TECOVIRIMAT O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/21/1600; DATE OF AUTHORISATION: 20220106; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1600; DATE OF FIRST AUTHORISATION IN EEA: 20220106 |
1638938 | 122022000032 | Germany | ⤷ Try a Trial | 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 |