Pluvicto is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 4 US drug patents filed from 2022 to 2024 out of which none have expired yet. Pluvicto's patents will be open to challenges from 23 March, 2026. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 12, 2035. Details of Pluvicto'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. | |||
| US10398791 | Labeled inhibitors of prostate specific membrane antigen (PSMA), their use as imaging agents and pharmaceutical agents for the treatment of prostate cancer |
Oct, 2034
(9 years from now) | Active |
| US11318121 | PSMA binding ligand-linker conjugates and methods for using |
Aug, 2028
(3 years from now) | Active |
| US10406240 | PSMA binding ligand-linker conjugates and methods for using |
Aug, 2028
(3 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). | |||
| US11951190 | Use of labeled inhibitors of prostate specific membrane antigen (PSMA), as agents for the treatment of prostate cancer |
Nov, 2035
(10 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 Pluvicto's patents.
Latest Legal Activities on Pluvicto's Patents
Given below is the list of recent legal activities going on the following patents of Pluvicto.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Second letter to regulating agency to determine regulatory review period | 06 Mar, 2024 | US10398791 |
| Letter from FDA or Dept of Agriculture re PTE application | 19 Oct, 2023 | US10398791 |
| Email Notification Critical | 22 Aug, 2023 | US10398791 |
| Change in Power of Attorney (May Include Associate POA) Critical | 22 Aug, 2023 | US10398791 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 10 Mar, 2023 | US10406240 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 22 Feb, 2023 | US10398791 |
| Initial letter Re: PTE Application to regulating agency | 28 Dec, 2022 | US10398791 |
| Patent Issue Date Used in PTA Calculation Critical | 03 May, 2022 | US11318121 |
| Recordation of Patent Grant Mailed Critical | 03 May, 2022 | US11318121 |
| Change in Power of Attorney (May Include Associate POA) Critical | 20 Apr, 2022 | US10398791 |
FDA has granted several exclusivities to Pluvicto. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Pluvicto, 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 Pluvicto.
Exclusivity Information
Pluvicto holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Pluvicto's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Mar 23, 2027 |
Several oppositions have been filed on Pluvicto'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 Pluvicto's generic, the next section provides detailed information on ongoing and past EP oppositions related to Pluvicto patents.
Pluvicto's Oppositions Filed in EPO
Pluvicto has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jul 07, 2020, by Boult Wade Tennant Llp. This opposition was filed on patent number EP08798020A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP08798020A | Jul, 2020 | Orano Med | Revoked |
| EP08798020A | Jul, 2020 | Boult Wade Tennant LLP | Revoked |
US patents provide insights into the exclusivity only within the United States, but Pluvicto 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 Pluvicto's family patents as well as insights into ongoing legal events on those patents.
Pluvicto's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Pluvicto's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 12, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Pluvicto Generics:
There are no approved generic versions for Pluvicto as of now.
About Pluvicto
Pluvicto is a drug owned by Novartis Pharmaceuticals Corp. It is used for treating metastatic castration-resistant prostate cancer in adult patients with PSMA-positive tumors who have failed previous treatments with androgen receptor inhibition and taxane-based chemotherapy. Pluvicto uses Lutetium Lu-177 Vipivotide Tetraxetan as an active ingredient. Pluvicto was launched by Novartis in 2022.
Approval Date:
Pluvicto was approved by FDA for market use on 23 March, 2022.
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 Pluvicto is 23 March, 2022, its NCE-1 date is estimated to be 23 March, 2026.
Active Ingredient:
Pluvicto uses Lutetium Lu-177 Vipivotide Tetraxetan as the active ingredient. Check out other Drugs and Companies using Lutetium Lu-177 Vipivotide Tetraxetan ingredient
Treatment:
Pluvicto is used for treating metastatic castration-resistant prostate cancer in adult patients with PSMA-positive tumors who have failed previous treatments with androgen receptor inhibition and taxane-based chemotherapy.
Dosage:
Pluvicto is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 27mCi/ML | SOLUTION | Prescription | INTRAVENOUS |