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USPTO Patent Grant for API Crystalline Form Preparation

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Published March 24th, 2026
Detected March 24th, 2026
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Summary

The USPTO has granted patent US12583860B2 to Apotex Inc. for processes to prepare multicomponent crystalline forms of active pharmaceutical ingredients using solvent vapour. The patent covers methods involving mixing a solid API with a liquid or solid pharmaceutically acceptable entity in the presence of solvent vapour, utilizing standard rotary apparatus.

What changed

The United States Patent and Trademark Office (USPTO) has issued patent US12583860B2 to Apotex Inc. This patent details novel processes for preparing specific crystalline forms of active pharmaceutical ingredients (APIs). The described methods involve mixing a solid API with a pharmaceutically acceptable high-boiling liquid or solid in the presence of solvent vapour, and specifically mentions the use of rotary apparatus like rotary cone dryers.

This patent grant represents a new intellectual property right for Apotex Inc. in the area of pharmaceutical manufacturing. Companies involved in the synthesis and formulation of APIs, particularly those seeking to control crystalline forms for improved stability, bioavailability, or manufacturing efficiency, should be aware of this granted patent. While this is a patent grant and not a regulatory rule imposing direct compliance obligations, it may impact freedom to operate for competitors in this specific area of chemical process development.

Source document (simplified)

← USPTO Patent Grants

Processes for the preparation of multicomponent crystalline forms of active pharmaceutical ingredients using solvent vapour

Grant US12583860B2 Kind: B2 Mar 24, 2026

Assignee

Apotex Inc.

Inventors

Alexander J. Stirk, Fabio E. S. Souza, Avedis Karadeolian, Allan W. Rey, Fatemeh Mohammadpourmir

Abstract

The present invention provides solvent-limited processes for the preparation of an existing crystalline solid form of an active pharmaceutical ingredient comprising mixing, in the presence of solvent vapour, of a solid active pharmaceutical ingredient and a pharmaceutically acceptable entity that is either a high-boiling liquid or a solid. Also provided is the use of a standard rotary apparatus, such as a rotary cone dryer, for application of the processes herein.

CPC Classifications

C07D 487/04 C07B 2200/13 A61K 31/10 A61K 31/4985 A61K 2300/00

Filing Date

2021-02-24

Application No.

17802203

Claims

14

View original document →

Classification

Agency
USPTO
Published
March 24th, 2026
Instrument
Rule
Legal weight
Binding
Stage
Final
Change scope
Minor
Document ID
US12583860B2

Who this affects

Applies to
Drug manufacturers Pharmaceutical companies
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
API Synthesis Pharmaceutical Manufacturing
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
R&D
Topics
Intellectual Property Manufacturing

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