Tpoxx is a drug owned by Siga Technologies Inc. It is protected by 10 US drug patents filed from 2018 to 2024. Out of these, 7 drug patents are active and 3 have expired. Tpoxx's patents have been open to challenges since 13 July, 2022. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 08, 2032. Details of Tpoxx's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US9339466 | Polymorphic forms of ST-246 and methods of preparation |
Mar, 2031
(6 years from now) | Active |
| US8124643 | Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases |
Jun, 2024
(6 months ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11890270 | Polymorphic forms of ST-246 and methods of preparation |
Aug, 2032
(7 years from now) | Active |
| US7737168 | Compounds, compositions, and methods for treatment and prevention of orthopoxvirus infections and associated diseases |
Sep, 2031
(6 years from now) | Active |
| US9233097 | ST-246 liquid formulations |
Aug, 2031
(6 years from now) | Active |
| US9907859 | ST-246 liquid formulations and methods |
Aug, 2031
(6 years from now) | Active |
| US10576165 | ST-246 liquid formulations and methods |
Aug, 2031
(6 years from now) | Active |
| US8039504 | Chemicals, compositions, and methods for treatment and prevention of orthopoxvirus infections and associated diseases |
Jul, 2027
(2 years from now) | Active |
| US8802714 | Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases |
Jun, 2024
(6 months ago) |
Expired
|
| US8530509 | Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases |
Jun, 2024
(6 months ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Tpoxx's patents.
Latest Legal Activities on Tpoxx's Patents
Given below is the list of recent legal activities going on the following patents of Tpoxx.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent eGrant Notification | 06 Feb, 2024 | US11890270 |
| Mail Patent eGrant Notification | 06 Feb, 2024 | US11890270 |
| Email Notification Critical | 06 Feb, 2024 | US11890270 |
| Recordation of Patent Grant Mailed Critical | 06 Feb, 2024 | US11890270 |
| Recordation of Patent eGrant | 06 Feb, 2024 | US11890270 |
| Patent Issue Date Used in PTA Calculation Critical | 06 Feb, 2024 | US11890270 |
| Email Notification Critical | 18 Jan, 2024 | US11890270 |
| Issue Notification Mailed Critical | 17 Jan, 2024 | US11890270 |
| Application Is Considered Ready for Issue Critical | 21 Dec, 2023 | US11890270 |
| Dispatch to FDC | 21 Dec, 2023 | US11890270 |
FDA has granted several exclusivities to Tpoxx. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tpoxx, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Tpoxx.
Exclusivity Information
Tpoxx holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Tpoxx's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 13, 2023 |
| Orphan Drug Exclusivity(ODE-200) | Jul 13, 2025 |
US patents provide insights into the exclusivity only within the United States, but Tpoxx is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Tpoxx's family patents as well as insights into ongoing legal events on those patents.
Tpoxx's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Tpoxx's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 08, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tpoxx Generics:
There are no approved generic versions for Tpoxx as of now.
About Tpoxx
Tpoxx is a drug owned by Siga Technologies Inc. It is used for treating human smallpox disease caused by variola virus in adults and pediatric patients. Tpoxx uses Tecovirimat as an active ingredient. Tpoxx was launched by Siga Technologies in 2018.
Approval Date:
Tpoxx was approved by FDA for market use on 13 July, 2018.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Tpoxx is 13 July, 2018, its NCE-1 date is estimated to be 13 July, 2022.
Active Ingredient:
Tpoxx uses Tecovirimat as the active ingredient. Check out other Drugs and Companies using Tecovirimat ingredient
Treatment:
Tpoxx is used for treating human smallpox disease caused by variola virus in adults and pediatric patients.
Dosage:
Tpoxx is available in the following dosage forms - capsule form for oral use, solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 200MG | CAPSULE | Prescription | ORAL |
| 200MG/20ML (10MG/ML) | SOLUTION | Prescription | INTRAVENOUS |