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POSLUMA Drug Patent Profile

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When do Posluma patents expire, and when can generic versions of Posluma launch?

Posluma is a drug marketed by Blue Earth and is included in one NDA. There is one patent protecting this drug.

This drug has seventeen patent family members in thirteen countries.

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

DrugPatentWatch^® Generic Entry Outlook for Posluma

Posluma will be eligible for patent challenges on May 25, 2027. 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 May 25, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for POSLUMA

International Patents:	17
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for POSLUMA
What excipients (inactive ingredients) are in POSLUMA?	POSLUMA excipients list
DailyMed Link:	POSLUMA at DailyMed

Drug patent expirations by year for POSLUMA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for POSLUMA

Generic Entry Date for POSLUMA^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: NEW CHEMICAL ENTITY NDA: 216023 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.

Pharmacology for POSLUMA

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

US Patents and Regulatory Information for POSLUMA

POSLUMA is protected by two US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of POSLUMA is ⤷ Try a Trial.

This potential generic entry date is based on NEW CHEMICAL ENTITY.
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 POSLUMA

Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: POSITRON EMISSION TOMOGRAPHY (PET) OF PROSTATE-SPECIFIC MEMBRANE ANTIGEN (PSMA) POSITIVE LESIONS IN MEN WITH PROSTATE CANCER WITH SUSPECTED METASTASIS WHO ARE CANDIDATES FOR INITIAL DEFINITIVE THERAPY

Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: POSITRON EMISSION TOMOGRAPHY (PET) OF PROSTATE-SPECIFIC MEMBRANE ANTIGEN (PSMA) POSITIVE LESIONS IN MEN WITH PROSTATE CANCER WITH SUSPECTED RECURRENCE BASED ON ELEVATED SERUM PROSTATE-SPECIFIC ANTIGEN (PSA) LEVEL

FDA Regulatory Exclusivity protecting POSLUMA

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Blue Earth	POSLUMA	flotufolastat f-18 gallium	SOLUTION;INTRAVENOUS	216023-001	May 25, 2023		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial		Y		⤷ Try a Trial
Blue Earth	POSLUMA	flotufolastat f-18 gallium	SOLUTION;INTRAVENOUS	216023-001	May 25, 2023		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 POSLUMA

See the table below for patents covering POSLUMA around the world.

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Country	Patent Number	Title	Estimated Expiration
Australia	2024200440	Dual mode radiotracer and -therapeutics	⤷ Try a Trial
European Patent Office	3658194	AGENTS À DEUX MODES RADIOTRACEURS ET THÉRAPEUTIQUES (DUAL MODE RADIOTRACER AND -THERAPEUTICS)	⤷ Try a Trial
Japan	2020528461	デュアルモードの放射性トレーサーおよび療法剤	⤷ Try a Trial
Israel	272291	חומרים המסומנים ברדיואיזוטופים דו אופניים ותרופות (Dual mode radiotracer and -therapeutics)	⤷ Try a Trial
Canada	3071315	AGENTS A DEUX MODES RADIOTRACEURS ET THERAPEUTIQUES (DUAL MODE RADIOTRACER AND -THERAPEUTICS)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration