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Last Updated: February 23, 2024

PYLARIFY Drug Patent Profile


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

Pylarify is a drug marketed by Progenics Pharms Inc and is included in one NDA. There are four patents protecting this drug.

This drug has ninety-two patent family members in twenty-three countries.

The generic ingredient in PYLARIFY is piflufolastat f-18. One supplier is listed for this compound. Additional details are available on the piflufolastat f-18 profile page.

DrugPatentWatch® Generic Entry Outlook for Pylarify

Pylarify will be eligible for patent challenges on May 26, 2025. 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 September 21, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for PYLARIFY
International Patents:92
US Patents:4
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 3
Clinical Trials: 2
Patent Applications: 36
Drug Prices: Drug price information for PYLARIFY
What excipients (inactive ingredients) are in PYLARIFY?PYLARIFY excipients list
DailyMed Link:PYLARIFY at DailyMed
Drug patent expirations by year for PYLARIFY
Drug Prices for PYLARIFY

See drug prices for PYLARIFY

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

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

SponsorPhase
M.D. Anderson Cancer CenterEarly Phase 1
Lantheus Medical ImagingEarly Phase 1
Sirisha Nandalur, MDPhase 4

See all PYLARIFY clinical trials

Pharmacology for PYLARIFY

US Patents and Regulatory Information for PYLARIFY

PYLARIFY is protected by four US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of PYLARIFY 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 PYLARIFY

Synthesis of the radiolabeled prostate-specific membrane antigen (PSMA) inhibitor [.sup.18F]DCFPyL
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF POSITRON EMISSION TOMOGRAPHY (PET) IN MEN WITH PROSTATE CANCER

Heterodimers of glutamic acid
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

PSMA-binding agents and uses thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF POSITRON EMISSION TOMOGRAPHY (PET) IN MEN WITH PROSTATE CANCER

PSMA-binding agents and uses thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF POSITRON EMISSION TOMOGRAPHY (PET) IN MEN WITH PROSTATE CANCER

FDA Regulatory Exclusivity protecting PYLARIFY

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
Progenics Pharms Inc PYLARIFY piflufolastat f-18 SOLUTION;INTRAVENOUS 214793-001 May 26, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Progenics Pharms Inc PYLARIFY piflufolastat f-18 SOLUTION;INTRAVENOUS 214793-001 May 26, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Progenics Pharms Inc PYLARIFY piflufolastat f-18 SOLUTION;INTRAVENOUS 214793-001 May 26, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Progenics Pharms Inc PYLARIFY piflufolastat f-18 SOLUTION;INTRAVENOUS 214793-001 May 26, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Progenics Pharms Inc PYLARIFY piflufolastat f-18 SOLUTION;INTRAVENOUS 214793-001 May 26, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  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 PYLARIFY

When does loss-of-exclusivity occur for PYLARIFY?

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

Australia

Patent: 09276423
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 32632
Estimated Expiration: ⤷  Try a Trial

Patent: 87744
Estimated Expiration: ⤷  Try a Trial

China

Patent: 2171187
Estimated Expiration: ⤷  Try a Trial

Patent: 7382846
Estimated Expiration: ⤷  Try a Trial

Patent: 3563262
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0171133
Estimated Expiration: ⤷  Try a Trial

Patent: 0220742
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 19367
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 18366
Estimated Expiration: ⤷  Try a Trial

Patent: 22615
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 18366
Estimated Expiration: ⤷  Try a Trial

Patent: 22615
Estimated Expiration: ⤷  Try a Trial

Patent: 89074
Estimated Expiration: ⤷  Try a Trial

Finland

Patent: 0230033
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 47197
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 34027
Estimated Expiration: ⤷  Try a Trial

Patent: 59436
Estimated Expiration: ⤷  Try a Trial

Patent: 300039
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 88441
Estimated Expiration: ⤷  Try a Trial

Patent: 06765
Estimated Expiration: ⤷  Try a Trial

Patent: 30724
Estimated Expiration: ⤷  Try a Trial

Patent: 24046
Estimated Expiration: ⤷  Try a Trial

Patent: 19497
Estimated Expiration: ⤷  Try a Trial

Patent: 77113
Estimated Expiration: ⤷  Try a Trial

Patent: 11529919
Estimated Expiration: ⤷  Try a Trial

Patent: 15007058
Estimated Expiration: ⤷  Try a Trial

Patent: 16053025
Estimated Expiration: ⤷  Try a Trial

Patent: 17048204
Estimated Expiration: ⤷  Try a Trial

Patent: 19055973
Estimated Expiration: ⤷  Try a Trial

Patent: 21095407
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 18366
Estimated Expiration: ⤷  Try a Trial

Patent: 22615
Estimated Expiration: ⤷  Try a Trial

Netherlands

Patent: 1250
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 18366
Estimated Expiration: ⤷  Try a Trial

Patent: 22615
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 18366
Estimated Expiration: ⤷  Try a Trial

Patent: 22615
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 94096
Estimated Expiration: ⤷  Try a Trial

Patent: 11107752
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 18366
Estimated Expiration: ⤷  Try a Trial

Patent: 22615
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1664855
Estimated Expiration: ⤷  Try a Trial

Patent: 110038725
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 34894
Estimated Expiration: ⤷  Try a Trial

Patent: 14593
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 PYLARIFY around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 3699162 HÉTÉRODIMÈRES D'ACIDE GLUTAMIQUE (HETERODIMERS OF GLUTAMIC ACID) ⤷  Try a Trial
Russian Federation 2494096 АГЕНТЫ, СВЯЗЫВАЮЩИЕСЯ С PSMA, И ИХ ПРИМЕНЕНИЕ (PSMA-BINDING AGENTS AND USING THEM) ⤷  Try a Trial
Japan 2019521104 放射線標識した前立腺特異的膜抗原(PSMA)阻害剤 [18F]DCFPyL の改良合成 ⤷  Try a Trial
Portugal 3222615 ⤷  Try a Trial
Spain 2914593 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PYLARIFY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2318366 LUC00323 Luxembourg ⤷  Try a Trial PRODUCT NAME: PIFLUFOLASTAT (18F) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/23/1746 20230725
2318366 PA2023534 Lithuania ⤷  Try a Trial PRODUCT NAME: PIFLUFOLASTATAS (18F) ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/23/1746 20230724
2318366 301250 Netherlands ⤷  Try a Trial PRODUCT NAME: PIFLUFOLASTAT (18F) OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1746 20230725
2318366 2023C/540 Belgium ⤷  Try a Trial PRODUCT NAME: PIFLUFOLASTAT (18F) OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1746 20230725
2318366 37/2023 Austria ⤷  Try a Trial PRODUCT NAME: PIFLUFOLASTAT (18F) ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1746 (MITTEILUNG) 20230725
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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