Tauvid is a drug owned by Avid Radiopharmaceuticals Inc. It is protected by 1 US drug patent filed in 2022 out of which none have expired yet. Tauvid's patents have been open to challenges since 28 May, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be May 26, 2032. Details of Tauvid'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. | |||
| US8932557 | Imaging agents for detecting neurological dysfunction |
May, 2032
(7 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 Tauvid's patents.
Latest Legal Activities on Tauvid's Patents
Given below is the list of recent legal activities going on the following patents of Tauvid.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent Term Extension Certificate Critical | 18 Oct, 2023 | US8932557 |
| Notice of Final Determination -Eligible | 01 Sep, 2023 | US8932557 |
| FDA Final Eligibility Letter Critical | 26 Apr, 2023 | US8932557 |
| transaction for FDA Determination of Regulatory Review Period | 30 Jun, 2022 | US8932557 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Jun, 2022 | US8932557 |
| Second letter to regulating agency to determine regulatory review period | 05 Nov, 2021 | US8932557 |
| Letter from FDA or Dept of Agriculture re PTE application | 14 Dec, 2020 | US8932557 |
| Initial letter Re: PTE Application to regulating agency | 05 Nov, 2020 | US8932557 |
| Patent Term Extension Application under 35 USC 156 Filed | 28 Aug, 2020 | US8932557 |
| Patent Term Extension Application under 35 USC 156 Filed | 16 Jul, 2020 | US8932557 |
FDA has granted several exclusivities to Tauvid. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tauvid, 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 Tauvid.
Exclusivity Information
Tauvid holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Tauvid's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 28, 2025 |
Several oppositions have been filed on Tauvid's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Tauvid's generic, the next section provides detailed information on ongoing and past EP oppositions related to Tauvid patents.
Tauvid's Oppositions Filed in EPO
Tauvid has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Oct 31, 2022, by Life Molecular Imaging Ltd.. This opposition was filed on patent number EP09711194A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP09711194A | Oct, 2022 | Life Molecular Imaging Ltd. | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Tauvid 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 Tauvid's family patents as well as insights into ongoing legal events on those patents.
Tauvid's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Tauvid's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 26, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tauvid Generics:
There are no approved generic versions for Tauvid as of now.
About Tauvid
Tauvid is a drug owned by Avid Radiopharmaceuticals Inc. Tauvid uses Flortaucipir F-18 as an active ingredient. Tauvid was launched by Avid Radiopharms Inc in 2020.
Approval Date:
Tauvid was approved by FDA for market use on 28 May, 2020.
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 Tauvid is 28 May, 2020, its NCE-1 date is estimated to be 28 May, 2024.
Active Ingredient:
Tauvid uses Flortaucipir F-18 as the active ingredient. Check out other Drugs and Companies using Flortaucipir F-18 ingredient
Dosage:
Tauvid is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 50ML (8.1-51mCi/ML) | SOLUTION | Discontinued | INTRAVENOUS |
| 30ML (8.1-51mCi/ML) | SOLUTION | Discontinued | INTRAVENOUS |
| 100ML (8.1-100mCi/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 50ML (8.1-100mCi/ML) | SOLUTION | Prescription | INTRAVENOUS |