Piflufolastat f-18 - Generic Drug Details

What are the generic sources for piflufolastat f-18 and what is the scope of freedom to operate?

Piflufolastat f-18 is the generic ingredient in one branded drug marketed by Progenics Pharms Inc and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Piflufolastat f-18 has ninety-three patent family members in twenty-three countries.

One supplier is listed for this compound.

Summary for piflufolastat f-18

International Patents:	93
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	1
Patent Applications:	77
What excipients (inactive ingredients) are in piflufolastat f-18?	piflufolastat f-18 excipients list
DailyMed Link:	piflufolastat f-18 at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for piflufolastat f-18

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 piflufolastat f-18

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

Sponsor	Phase
M.D. Anderson Cancer Center	Early Phase 1
Lantheus Medical Imaging	Early Phase 1

See all piflufolastat f-18 clinical trials

Pharmacology for piflufolastat f-18

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

US Patents and Regulatory Information for piflufolastat f-18

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

International Patents for piflufolastat f-18

Country	Patent Number	Title	Estimated Expiration
Poland	2318366
South Korea	20230111272	방사성 표지된 전립선-특이적 막 항원(PSMA) 억제제[18F]DCFPyL의 개선된 합성 (- PSMA [18F]DCFPyL IMPROVED SYNTHESIS OF THE RADIOLABELED PROSTATE-SPECIFIC MEMBRANE ANTIGEN PSMA INHIBITOR [18F]DCFPyL)
Japan	2015044807	グルタミン酸のヘテロダイマー (HETERODIMERS OF GLUTAMIC ACID)
Japan	6030724
Japan	2021095407	ＰＳＭＡ結合剤及びその使用 (PSMA-BINDING AGENTS AND USES THEREOF)

Supplementary Protection Certificates for piflufolastat f-18

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2318366	LUC00323	Luxembourg		PRODUCT NAME: PIFLUFOLASTAT (18F) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/23/1746 20230725
2318366	301250	Netherlands		PRODUCT NAME: PIFLUFOLASTAT (18F) OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1746 20230725
2318366	PA2023534	Lithuania		PRODUCT NAME: PIFLUFOLASTATAS (18F) ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/23/1746 20230724
2318366	2023C/540	Belgium		PRODUCT NAME: PIFLUFOLASTAT (18F) OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1746 20230725
2318366	C20230027 00410	Estonia		PRODUCT NAME: PIFLUFOLASTAAT (18F);REG NO/DATE: EU/1/23/1746 25.07.2023