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Last Updated: January 31, 2023

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 eighty-three patent family members in twenty-two 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:83
US Patents:4
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 2
Patent Applications: 44
What excipients (inactive ingredients) are in PYLARIFY?PYLARIFY excipients list
DailyMed Link:PYLARIFY at DailyMed
Drug patent expirations by year for PYLARIFY
DrugPatentWatch® Estimated Generic Entry Opportunity 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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF POSITRON EMISSION TOMOGRAPHY (PET) IN MEN WITH PROSTATE CANCER

Heterodimers of glutamic acid
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

PSMA-binding agents and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF POSITRON EMISSION TOMOGRAPHY (PET) IN MEN WITH PROSTATE CANCER

PSMA-binding agents and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF POSITRON EMISSION TOMOGRAPHY (PET) IN MEN WITH PROSTATE CANCER

FDA Regulatory Exclusivity protecting PYLARIFY

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Progenics Pharms Inc PYLARIFY piflufolastat f-18 SOLUTION;INTRAVENOUS 214793-001 May 26, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Progenics Pharms Inc PYLARIFY piflufolastat f-18 SOLUTION;INTRAVENOUS 214793-001 May 26, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Progenics Pharms Inc PYLARIFY piflufolastat f-18 SOLUTION;INTRAVENOUS 214793-001 May 26, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Progenics Pharms Inc PYLARIFY piflufolastat f-18 SOLUTION;INTRAVENOUS 214793-001 May 26, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Canada

Patent: 32632
Estimated Expiration: See Plans and Pricing

Patent: 87744
Estimated Expiration: See Plans and Pricing

China

Patent: 2171187
Estimated Expiration: See Plans and Pricing

Patent: 7382846
Estimated Expiration: See Plans and Pricing

Patent: 3563262
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0171133
Estimated Expiration: See Plans and Pricing

Patent: 0220742
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 19367
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 18366
Estimated Expiration: See Plans and Pricing

Patent: 22615
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 18366
Estimated Expiration: See Plans and Pricing

Patent: 22615
Estimated Expiration: See Plans and Pricing

Patent: 89074
Estimated Expiration: See Plans and Pricing

Finland

Patent: 22615
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 47197
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 34027
Estimated Expiration: See Plans and Pricing

Japan

Patent: 88441
Estimated Expiration: See Plans and Pricing

Patent: 06765
Estimated Expiration: See Plans and Pricing

Patent: 30724
Estimated Expiration: See Plans and Pricing

Patent: 24046
Estimated Expiration: See Plans and Pricing

Patent: 11529919
Estimated Expiration: See Plans and Pricing

Patent: 15007058
Estimated Expiration: See Plans and Pricing

Patent: 16053025
Estimated Expiration: See Plans and Pricing

Patent: 17048204
Estimated Expiration: See Plans and Pricing

Patent: 19055973
Estimated Expiration: See Plans and Pricing

Patent: 21095407
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 18366
Estimated Expiration: See Plans and Pricing

Patent: 22615
Estimated Expiration: See Plans and Pricing

Poland

Patent: 18366
Estimated Expiration: See Plans and Pricing

Patent: 22615
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 18366
Estimated Expiration: See Plans and Pricing

Patent: 22615
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 94096
Estimated Expiration: See Plans and Pricing

Patent: 11107752
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 18366
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1664855
Estimated Expiration: See Plans and Pricing

Patent: 110038725
Estimated Expiration: See Plans and Pricing

Spain

Patent: 34894
Estimated Expiration: See Plans and Pricing

Patent: 14593
Estimated Expiration: See Plans and Pricing

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
Japan 2019055973 PSMA結合剤及びその使用 (PSMA-BINDING AGENTS AND USES THEREOF) See Plans and Pricing
Portugal 3222615 See Plans and Pricing
Denmark 3222615 See Plans and Pricing
Japan 2016053025 PSMA結合剤及びその使用 (PSMA-BINDING AGENTS AND USES THEREOF) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2017214470 See Plans and Pricing
European Patent Office 2942065 HÉTÉRODIMÈRES D'ACIDE GLUTAMIQUE (HETERODIMERS OF GLUTAMIC ACID) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2008058192 See Plans and Pricing
>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.