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Last Updated: May 24, 2024

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PLUVICTO Drug Patent Profile


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Which patents cover Pluvicto, and when can generic versions of Pluvicto launch?

Pluvicto is a drug marketed by Novartis and is included in one NDA. There are three patents protecting this drug.

This drug has ninety-one patent family members in twenty-nine countries.

The generic ingredient in PLUVICTO is lutetium lu-177 vipivotide tetraxetan. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lutetium lu-177 vipivotide tetraxetan profile page.

DrugPatentWatch® Generic Entry Outlook for Pluvicto

Pluvicto will be eligible for patent challenges on March 23, 2026. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 17, 2034. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for PLUVICTO
International Patents:91
US Patents:3
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 1
Drug Prices: Drug price information for PLUVICTO
What excipients (inactive ingredients) are in PLUVICTO?PLUVICTO excipients list
DailyMed Link:PLUVICTO at DailyMed
Drug patent expirations by year for PLUVICTO
Drug Prices for PLUVICTO

See drug prices for PLUVICTO

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for PLUVICTO
Generic Entry Date for PLUVICTO*:
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.

Recent Clinical Trials for PLUVICTO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
OncoC4, Inc.Phase 2
Prostate Cancer Clinical Trials ConsortiumPhase 2

See all PLUVICTO clinical trials

Pharmacology for PLUVICTO

US Patents and Regulatory Information for PLUVICTO

PLUVICTO is protected by three US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of PLUVICTO is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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 PLUVICTO

Labeled inhibitors of prostate specific membrane antigen (PSMA), their use as imaging agents and pharmaceutical agents for the treatment of prostate cancer
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

PSMA binding ligand-linker conjugates and methods for using
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: FOR TREATMENT OF ADULT PATIENTS WITH PROSTATE-SPECIFIC MEMBRANE ANTIGEN (PSMA)-POSITIVE METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) WHO HAVE BEEN TREATED WITH ANDROGEN RECEPTOR (AR) PATHWAY INHIBITION AND TAXANE-BASED CHEMOTHERAPY

PSMA binding ligand-linker conjugates and methods for using
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: FOR TREATMENT OF ADULT PATIENTS WITH PROSTATE-SPECIFIC MEMBRANE ANTIGEN (PSMA)-POSITIVE METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) WHO HAVE BEEN TREATED WITH ANDROGEN RECEPTOR (AR) PATHWAY INHIBITION AND TAXANE-BASED CHEMOTHERAPY

FDA Regulatory Exclusivity protecting PLUVICTO

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis PLUVICTO lutetium lu-177 vipivotide tetraxetan SOLUTION;INTRAVENOUS 215833-001 Mar 23, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Novartis PLUVICTO lutetium lu-177 vipivotide tetraxetan SOLUTION;INTRAVENOUS 215833-001 Mar 23, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis PLUVICTO lutetium lu-177 vipivotide tetraxetan SOLUTION;INTRAVENOUS 215833-001 Mar 23, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Novartis PLUVICTO lutetium lu-177 vipivotide tetraxetan SOLUTION;INTRAVENOUS 215833-001 Mar 23, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
>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 PLUVICTO

When does loss-of-exclusivity occur for PLUVICTO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 14336638
Estimated Expiration: ⤷  Sign Up

Patent: 18200419
Estimated Expiration: ⤷  Sign Up

Patent: 20201086
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 24360
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 16000883
Estimated Expiration: ⤷  Sign Up

China

Patent: 5636924
Estimated Expiration: ⤷  Sign Up

Patent: 9053616
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 7778
Estimated Expiration: ⤷  Sign Up

Patent: 1690495
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 62857
Estimated Expiration: ⤷  Sign Up

Patent: 38996
Estimated Expiration: ⤷  Sign Up

Patent: 15489
Estimated Expiration: ⤷  Sign Up

Patent: 56700
Estimated Expiration: ⤷  Sign Up

Patent: 95355
Estimated Expiration: ⤷  Sign Up

Patent: 95130
Estimated Expiration: ⤷  Sign Up

Georgia, Republic of

Patent: 0217330
Estimated Expiration: ⤷  Sign Up

Patent: 0237479
Estimated Expiration: ⤷  Sign Up

Patent: 0237496
Estimated Expiration: ⤷  Sign Up

Patent: 0237497
Estimated Expiration: ⤷  Sign Up

Germany

Patent: 2014011593
Estimated Expiration: ⤷  Sign Up

Patent: 2014011600
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 21711
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 5113
Estimated Expiration: ⤷  Sign Up

Patent: 8974
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 56805
Estimated Expiration: ⤷  Sign Up

Patent: 01451
Estimated Expiration: ⤷  Sign Up

Patent: 36774
Estimated Expiration: ⤷  Sign Up

Patent: 94161
Estimated Expiration: ⤷  Sign Up

Patent: 93485
Estimated Expiration: ⤷  Sign Up

Patent: 16535013
Estimated Expiration: ⤷  Sign Up

Patent: 18058847
Estimated Expiration: ⤷  Sign Up

Patent: 19011368
Estimated Expiration: ⤷  Sign Up

Patent: 19218351
Estimated Expiration: ⤷  Sign Up

Patent: 21059557
Estimated Expiration: ⤷  Sign Up

Patent: 22159345
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 8934
Estimated Expiration: ⤷  Sign Up

Patent: 4484
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 16005013
Estimated Expiration: ⤷  Sign Up

Patent: 21008976
Estimated Expiration: ⤷  Sign Up

Patent: 21008977
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 986
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 8812
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 160678
Estimated Expiration: ⤷  Sign Up

Patent: 211760
Estimated Expiration: ⤷  Sign Up

Philippines

Patent: 016500656
Estimated Expiration: ⤷  Sign Up

Saudi Arabia

Patent: 6370842
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 201602249R
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1603380
Estimated Expiration: ⤷  Sign Up

Patent: 1907607
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1947053
Estimated Expiration: ⤷  Sign Up

Patent: 2210931
Estimated Expiration: ⤷  Sign Up

Patent: 2282378
Estimated Expiration: ⤷  Sign Up

Patent: 160063398
Estimated Expiration: ⤷  Sign Up

Patent: 190016133
Estimated Expiration: ⤷  Sign Up

Patent: 210013350
Estimated Expiration: ⤷  Sign Up

Tunisia

Patent: 16000137
Estimated Expiration: ⤷  Sign Up

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 PLUVICTO around the world.

Country Patent Number Title Estimated Expiration
China 109053616 前列腺特异性膜抗原(PSMA)的标记的抑制剂及其用途 (Labeled inhibitors of prostate specific membrane antigen (PSMA), and use thereof) ⤷  Sign Up
European Patent Office 3388086 CONJUGUÉS COMPRENANT UN LIGAND DU PSMA ET UN LIEUR ET PROCÉDÉS POUR LEUR UTILISATION (PSMA BINDING LIGAND-LINKER CONJUGATES AND METHODS FOR USING) ⤷  Sign Up
Georgia, Republic of P20237496 LABELED INHIBITORS OF PROSTATE SPECIFIC MEMBRANE ANTIGEN (PSMA), THEIR USE AS IMAGING AGENTS AND PHARMACEUTICAL AGENTS FOR THE TREATMENT OF PROSTATE CANCER ⤷  Sign Up
Japan 2010536790 ⤷  Sign Up
Japan 2019218351 前立腺特異的膜抗原(PSMA)の標識インヒビター、前立腺癌の治療のための画像化剤および薬剤としてのその使用 (LABELED INHIBITORS OF PROSTATE SPECIFIC MEMBRANE ANTIGEN (PSMA), AND THEIR USE AS IMAGING AGENTS AND PHARMACEUTICAL AGENTS FOR TREATMENT OF PROSTATE CANCER) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.