PLUVICTO Drug Patent Profile
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When do Pluvicto patents expire, 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
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 |
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
| Sponsor | Phase |
|---|---|
| OncoC4, Inc. | Phase 2 |
| Prostate Cancer Clinical Trials Consortium | Phase 2 |
Pharmacology for PLUVICTO
| Drug Class | Radioligand Therapeutic Agent |
| Mechanism of Action | Radioligand Activity |
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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
PSMA binding ligand-linker conjugates and methods for using
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Novartis | PLUVICTO | lutetium lu-177 vipivotide tetraxetan | SOLUTION;INTRAVENOUS | 215833-001 | Mar 23, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Novartis | PLUVICTO | lutetium lu-177 vipivotide tetraxetan | SOLUTION;INTRAVENOUS | 215833-001 | Mar 23, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Novartis | PLUVICTO | lutetium lu-177 vipivotide tetraxetan | SOLUTION;INTRAVENOUS | 215833-001 | Mar 23, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| >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: ⤷ Try a Trial
Patent: 18200419
Estimated Expiration: ⤷ Try a Trial
Patent: 20201086
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 24360
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 16000883
Estimated Expiration: ⤷ Try a Trial
China
Patent: 5636924
Estimated Expiration: ⤷ Try a Trial
Patent: 9053616
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 7778
Estimated Expiration: ⤷ Try a Trial
Patent: 1690495
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 62857
Estimated Expiration: ⤷ Try a Trial
Patent: 38996
Estimated Expiration: ⤷ Try a Trial
Patent: 15489
Estimated Expiration: ⤷ Try a Trial
Patent: 56700
Estimated Expiration: ⤷ Try a Trial
Patent: 95355
Estimated Expiration: ⤷ Try a Trial
Patent: 95130
Estimated Expiration: ⤷ Try a Trial
Georgia, Republic of
Patent: 0217330
Estimated Expiration: ⤷ Try a Trial
Patent: 0237479
Estimated Expiration: ⤷ Try a Trial
Patent: 0237496
Estimated Expiration: ⤷ Try a Trial
Patent: 0237497
Estimated Expiration: ⤷ Try a Trial
Germany
Patent: 2014011593
Estimated Expiration: ⤷ Try a Trial
Patent: 2014011600
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 21711
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 5113
Estimated Expiration: ⤷ Try a Trial
Patent: 8974
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 56805
Estimated Expiration: ⤷ Try a Trial
Patent: 01451
Estimated Expiration: ⤷ Try a Trial
Patent: 36774
Estimated Expiration: ⤷ Try a Trial
Patent: 94161
Estimated Expiration: ⤷ Try a Trial
Patent: 93485
Estimated Expiration: ⤷ Try a Trial
Patent: 16535013
Estimated Expiration: ⤷ Try a Trial
Patent: 18058847
Estimated Expiration: ⤷ Try a Trial
Patent: 19011368
Estimated Expiration: ⤷ Try a Trial
Patent: 19218351
Estimated Expiration: ⤷ Try a Trial
Patent: 21059557
Estimated Expiration: ⤷ Try a Trial
Patent: 22159345
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 8934
Estimated Expiration: ⤷ Try a Trial
Patent: 4484
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 16005013
Estimated Expiration: ⤷ Try a Trial
Patent: 21008976
Estimated Expiration: ⤷ Try a Trial
Patent: 21008977
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 986
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 8812
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 160678
Estimated Expiration: ⤷ Try a Trial
Patent: 211760
Estimated Expiration: ⤷ Try a Trial
Philippines
Patent: 016500656
Estimated Expiration: ⤷ Try a Trial
Saudi Arabia
Patent: 6370842
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 201602249R
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1603380
Estimated Expiration: ⤷ Try a Trial
Patent: 1907607
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1947053
Estimated Expiration: ⤷ Try a Trial
Patent: 2210931
Estimated Expiration: ⤷ Try a Trial
Patent: 2282378
Estimated Expiration: ⤷ Try a Trial
Patent: 160063398
Estimated Expiration: ⤷ Try a Trial
Patent: 190016133
Estimated Expiration: ⤷ Try a Trial
Patent: 210013350
Estimated Expiration: ⤷ Try a Trial
Tunisia
Patent: 16000137
Estimated Expiration: ⤷ Try a Trial
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 |
|---|---|---|---|
| Japan | 7393485 | ⤷ Try a Trial | |
| European Patent Office | 3415489 | INHIBITEURS MARQUÉS DE L'ANTIGÈNE MEMBRANAIRE SPÉCIFIQUE DE LA PROSTATE (PSMA), LEUR UTILISATION COMME AGENTS D'IMAGERIE ET AGENTS PHARMACEUTIQUES POUR LE TRAITEMENT DU CANCER DE LA PROSTATE (LABELED INHIBITORS OF PROSTATE SPECIFIC MEMBRANE ANTIGEN (PSMA), THEIR USE AS IMAGING AGENTS AND PHARMACEUTICAL AGENTS FOR THE TREATMENT OF PROSTATE CANCER) | ⤷ Try a Trial |
| Eurasian Patent Organization | 201690495 | МЕЧЕНЫЕ ИНГИБИТОРЫ ПРОСТАТИЧЕСКОГО СПЕЦИФИЧЕСКОГО МЕМБРАННОГО АНТИГЕНА (ПСМА), ИХ ПРИМЕНЕНИЕ В КАЧЕСТВЕ АГЕНТОВ ДЛЯ ВИЗУАЛИЗАЦИИ И ФАРМАЦЕВТИЧЕСКИХ АГЕНТОВ ДЛЯ ЛЕЧЕНИЯ РАКА ПРЕДСТАТЕЛЬНОЙ ЖЕЛЕЗЫ | ⤷ Try a Trial |
| 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) | ⤷ Try a Trial |
| Japan | 6625690 | ⤷ Try a Trial | |
| Portugal | 2187965 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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