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POSLUMA

NDA

FLOTUFOLASTAT F-18 GALLIUM | N216023 | BLUE EARTH DIAGNOSTICS LTD

1 strength6 unique patents1 unique exclusivity

Patent Timeline

6 unique patents, 1 exclusivity by expiration date

Active (6)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

Today

Nov. 22, 2038

Nov. 27, 2041

Nov. 22, 2038

Nov. 22, 2038

Aug. 23, 2038

Nov. 27, 2041

NCE

May. 25, 2028

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

2 trials from ClinicalTrials.gov — 2 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
An Investigational Scan (rhPSMA-7.3 PET/CT) for Detecting Biochemically Recurrent Prostate Cancer, ENLIGHTEN Trial NCT06813898	Early Phase 1	Recruiting	Northwestern University	27	2025-04-11 → 2032-02-01
rhPSMA-73 PET-MRI Imaging for the Detection of Prostate Cancer Among Men Who Are Otherwise Candidates for Active Surveillance NCT05852041	Early Phase 1	Recruiting	Northwestern University	40	2023-06-07 → 2035-06-07

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jan 10, 2025	SUPPL -4	View Letter (PDF)
May 26, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 25ML (8-158mCi/ML)

RLD

6 patents1 exclusivity▴

SOLUTION;INTRAVENOUS | Approved: May 25, 2023

Patents (6)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11413360	Nov 22, 2038	—	Yes	—		—
12036290	Nov 27, 2041	—	—	Yes		—
12357711	Nov 22, 2038	—	Yes	—	—	—
12377176	Nov 22, 2038	—	Yes	—	—	—
12390540	Aug 23, 2038	—	Yes	—	—	—
12427207	Nov 27, 2041	—	—	Yes	—	—

Exclusivities (1)

Code	Date	Status
NCE	May 25, 2028	Active