Tembexa is a drug owned by Emergent Biodefense Operations Lansing Inc. It is protected by 5 US drug patents filed in 2021 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 10, 2034. Details of Tembexa'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. | |||
| US8962829 | Morphic forms of hexadecyloxypropyl-phosphonate esters and methods of synthesis thereof |
Oct, 2034
(9 years from now) | Active |
| US9303051 | Phosphonate ester derivatives and methods of synthesis thereof |
Aug, 2031
(6 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10112909 | Morphic forms of hexadecyloxypropyl-phosphonate esters and methods of synthesis thereof |
Oct, 2034
(9 years from now) | Active |
| US9371344 | Morphic forms of hexadecyloxypropyl-phosphonate esters and methods of synthesis thereof |
Oct, 2034
(9 years from now) | Active |
| US10487061 | Morphic forms of hexadecyloxypropyl-phosphonate esters and methods of synthesis thereof |
Oct, 2034
(9 years from now) | Active |
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 Tembexa's patents.
Latest Legal Activities on Tembexa's Patents
Given below is the list of recent legal activities going on the following patents of Tembexa.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| transaction for FDA Determination of Regulatory Review Period | 29 Feb, 2024 | US9303051 |
| transaction for FDA Determination of Regulatory Review Period | 07 Feb, 2024 | US9303051 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 06 Dec, 2023 | US9371344 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Sep, 2023 | US9303051 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 10 May, 2023 | US10487061 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 14 Feb, 2023 | US10112909 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 14 Feb, 2023 | US9371344 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 14 Feb, 2023 | US8962829 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 14 Feb, 2023 | US9303051 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 08 Feb, 2023 | US10487061 |
FDA has granted several exclusivities to Tembexa. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tembexa, 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 Tembexa.
Exclusivity Information
Tembexa holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Tembexa's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Jun 04, 2024 |
| Orphan Drug Exclusivity(ODE-354) | Jun 04, 2028 |
US patents provide insights into the exclusivity only within the United States, but Tembexa 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 Tembexa's family patents as well as insights into ongoing legal events on those patents.
Tembexa's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Tembexa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 10, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tembexa Generics:
There are no approved generic versions for Tembexa as of now.
About Tembexa
Tembexa is a drug owned by Emergent Biodefense Operations Lansing Inc. It is used for treating human smallpox disease. Tembexa uses Brincidofovir as an active ingredient. Tembexa was launched by Emergent Biodefense in 2021.
Approval Date:
Tembexa was approved by FDA for market use on 04 June, 2021.
Active Ingredient:
Tembexa uses Brincidofovir as the active ingredient. Check out other Drugs and Companies using Brincidofovir ingredient
Treatment:
Tembexa is used for treating human smallpox disease.
Dosage:
Tembexa is available in the following dosage forms - suspension form for oral use, tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG | TABLET | Prescription | ORAL |
| 10MG/ML | SUSPENSION | Prescription | ORAL |