US Patent

US12427114 — Orodispersible dosage unit containing an estetrol component

Method of Use · Assigned to Estetra SRL · Expires 2036-06-17 · 10y remaining

Vulnerability score 75/100 Vulnerable — likely target for IPR or design-around

What this patent protects

This patent protects an orodispersible solid pharmaceutical dosage unit containing estetrol, which can be obtained through a specific manufacturing process.

USPTO 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.

Drugs covered by this patent

FDA Patent Use Codes

When a patent is method-of-use, FDA lists it once per applicable indication ("U-code"). Each U-code carves out a specific therapeutic use that generic filers must either license or design around.

CodeDescriptionDrug
U-3152 Slynd

Patent Metadata

Patent number
US12427114
Jurisdiction
US
Classification
Method of Use
Expires
2036-06-17
Drug substance claim
No
Drug product claim
Yes
Assignee
Estetra SRL
Source
FDA Orange Book + USPTO grounding via Google Patents

Bibliographic data sourced from FDA Orange Book + USPTO public records. Plain-English summary generated by AI grounded in source text. Patent term extensions (PTR, SPC, pediatric) may shift the effective expiry. Not legal advice.

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