Orodispersible Estetrol Dosage Unit Patent

ChangeBridge: Patent Apps - Therapeutics (A61P)

Published April 2nd, 2026

Detected April 2nd, 2026

Summary

USPTO published patent application US20260090995A1 by ESTETRA SRL covering an orodispersible solid pharmaceutical dosage unit containing estetrol particles (0.1-25 wt.%) for sublingual, buccal, or sublabial administration. The dosage unit weighs 30-1,000 mg, contains at least 100 μg of estetrol component, and is manufactured via wet granulation of particles sized 2-50 μm. Application No. 19340502 was filed September 25, 2025.

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What changed

USPTO published a patent application (US20260090995A1) filed by ESTETRA SRL covering an orodispersible solid pharmaceutical dosage unit formulation. The invention comprises 0.1-25 wt.% estetrol particles (containing at least 80 wt.% estetrol component or esters) combined with 75-99.9 wt.% pharmaceutical ingredients, weighing 30-1,000 mg total with minimum 100 μg estetrol content. The formulation uses wet granulation processing of estetrol particles having 2-50 μm volume-weighted average particle size.

This is a routine patent publication with no compliance requirements. Pharmaceutical companies developing hormone-based therapeutics may wish to review for potential freedom-to-operate implications if developing competing products in the estetrol or orodispersible delivery space.

Source document (simplified)

← USPTO Patent Applications

ORODISPERSIBLE DOSAGE UNIT CONTAINING AN ESTETROL COMPONENT

Application US20260090995A1 Kind: A1 Apr 02, 2026

Assignee

ESTETRA SRL

Inventors

Séverine Francine Isabelle JASPART, Johannes Jan PLATTEEUW, Denny Johan Marijn VAN DEN HEUVEL

Abstract

The invention provides an orodispersible solid pharmaceutical dosage unit having a weight between 30 and 1,000 mg, said dosage unit consisting of:
0.1-25 wt. % of estetrol particles containing at least 80 wt. % of an estetrol component selected from estetrol, estetrol esters and combinations thereof; and75-99.9 wt. % of one or more pharmaceutically acceptable ingredients;the solid dosage unit comprising at least 100 μg of the estetrol component; and wherein the solid dosage unit can be obtained by a process comprising wet granulation of estetrol particles having a volume weighted average particle size of 2 μm to 50 μm.
The solid dosage unit is easy to manufacture and perfectly suited for sublingual, buccal or sublabial administration.