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NDA

FLORBETABEN F-18 | N204677 | LANTHEUS BIOSCIENCES LTD

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2027

2028

2029

2030

2031

2032

Today

Mar. 18, 2029

Jul. 14, 2032

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

3 trials from ClinicalTrials.gov — 2 recruiting, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)NCT07169630	Phase 1	Recruiting	National Institute of Mental Health (NIMH)	90	2026-07-07 → 2030-04-11
PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease NCT04396873	Phase 1	Recruiting	National Institute of Mental Health (NIMH)	184	2021-08-17 → 2030-10-03
Brain Amyloid- Retention During Wakefulness and Following Emergence From Sleep in Healthy People NCT02669225	Early Phase 1	Completed	National Institute on Alcohol Abuse and Alcoholism (NIAAA)	22	2016-05-02 → 2018-07-11

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

Approval Letters

10 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 1.4-135mCi/ML

RLD

2 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Mar 19, 2014

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7807135	Mar 18, 2029	—	Yes	Yes		—
9308284	Jul 14, 2032	—	—	Yes	—	—