PYLARIFY Drug Patent Profile
✉ Email this page to a colleague
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 five patents protecting this drug.
This drug has ninety-three 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
Summary for PYLARIFY
International Patents: | 93 |
US Patents: | 5 |
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 |
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
Sponsor | Phase |
---|---|
M.D. Anderson Cancer Center | Early Phase 1 |
Lantheus Medical Imaging | Early Phase 1 |
Sirisha Nandalur, MD | Phase 4 |
Pharmacology for PYLARIFY
Drug Class | Radioactive Diagnostic Agent |
Mechanism of Action | Positron Emitting Activity |
US Patents and Regulatory Information for PYLARIFY
PYLARIFY is protected by five 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
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 | 2097111 | HÉTÉRODIMÈRES D'ACIDE GLUTAMIQUE (HETERODIMERS OF GLUTAMIC ACID) | ⤷ Try a Trial |
South Korea | 101664855 | ⤷ Try a Trial | |
South Korea | 102558962 | ⤷ 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 |
Hong Kong | 1257260 | 谷氨酸的異質二聚體 (HETERODIMERS OF GLUTAMIC ACID) | ⤷ 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 | 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 |
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 | CR 2023 00032 | Denmark | ⤷ Try a Trial | PRODUCT NAME: PIFLUFOLASTAT (18F) ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/23/1746 20230725 |
2318366 | C20230027 00410 | Estonia | ⤷ Try a Trial | PRODUCT NAME: PIFLUFOLASTAAT (18F);REG NO/DATE: EU/1/23/1746 25.07.2023 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |