Generic entry timeline

Posluma generics — when can they launch?

Posluma (FLOTUFOLASTAT F-18 GALLIUM) · Blue Earth · 6 active US patents · 0 expired

Earliest patent expiry

2038-08-23

12 years remaining

Full patent estate to

2041-11-27

complete protection through 2041

FDA approval

2023

Blue Earth

Where Posluma sits in the generic timeline

Long-dated protection: earliest active US patent for Posluma extends to 2038 (~12 years out). Generic competition is at least 4 years away. Lifecycle moves (new formulations, label extensions, combination filings) typically execute 18-36 months ahead of cliff.

Under US Hatch-Waxman, a generic enters via an ANDA (Abbreviated New Drug Application) and may file with one of four Paragraph IV certifications attacking the brand's listed patents. If the brand sues within 45 days, a 30-month FDA approval stay is triggered. First Para IV filer typically gets 180-day market exclusivity.

Patent estate by type — active patents

Method-of-use patents only carve out specific indications; generics can launch with a "skinny label" omitting those uses. Composition-of-matter patents block the molecule itself.

Composition of Matter — 3 patents
Method of Use — 2 patents
Formulation — 1 patent

FDA U-codes carved out by Posluma patents

Method-of-use patents are listed against specific FDA Patent Use Codes ("U-codes") representing carved-out indications. Generics can launch with a label that omits these uses.

U-code	Description
`U-3614`	(no description)

Sample patent estate

Showing 6 of 6 active US patents. View full estate on the Posluma drug page →

US12390540 Composition of Matter · expires 2038-08-23

This patent protects a single molecule that combines a disease-targeting ligand, a silicon-fluoride acceptor, and one or more chelating groups.

USPTO title: Dual mode radiotracer and -therapeutics
US12377176 Composition of Matter · expires 2038-11-22

This patent protects a single molecule that combines a binding agent for PSMA, a silicon-fluoride acceptor, and a chelating group.

USPTO title: Cancer diagnostic imaging agents
US12357711 Composition of Matter · expires 2038-11-22

This patent protects a compound according to formula (V) or a pharmaceutically acceptable salt thereof, optionally containing a chelated radioactive cation and 18 F.

USPTO title: PSMA binding dual mode radiotracer and therapeutic
US11413360 Method of Use · expires 2038-11-22

This patent protects a ligand-SIFA-chelator conjugate, a single molecule with three separate moieties for binding to a disease-relevant target and chelating a cation.

USPTO title: Dual mode radiotracer andâtherapeutics
US12427207 Formulation · expires 2041-11-27

This patent protects a pharmaceutical composition containing a radiohybrid agent with specific components and pH range.

USPTO title: Pharmaceutical formulations
US12036290 Method of Use · expires 2041-11-27

This patent protects a pharmaceutical composition containing a radiohybrid agent with specific components and pH range.

USPTO title: Pharmaceutical formulations

Sources

FDA Orange Book — patents listed against Posluma (NDA filed 2023)
Posluma drug profile — full patent estate, indications, clinical trials, pricing
Blue Earth patent portfolio
Patent cliff 2038 — every drug losing US exclusivity that year

Patent term extensions (PTR, pediatric exclusivity), Hatch-Waxman 30-month stays, and FDA regulatory exclusivity (NCE/ODE/PED) may shift the effective generic entry date. Not legal advice.

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