US 11261151

Here's a concise summary of US Patent 11261151:

US Patent: 11261151

• Title: Methods for making and using endoxifen
• Assignee: Atossa Therapeutics Inc. (Original and Current), Krisan Biotech Co Ltd (Current). The patent history indicates reassignments to both Atossa Therapeutics Inc. and Krisan Biotech Co Ltd.
• Inventors: Steven C. Quay, Yao-Lin Sun, Lunghu WANG, ChangJung Wu, ChuanDer Huang
• Filing Date: September 10, 2018
• Issue Date: March 1, 2022
• Abstract: The patent describes industrially scalable methods for manufacturing (Z)-endoxifen or its salts, crystalline forms of endoxifen, and compositions containing them. It also provides methods for treating hormone-dependent breast disorders and/or hormone-dependent reproductive tract disorders.

Plain-language Overview of Independent Claims:

The patent contains 21 claims. As the full, numbered text of each independent claim could not be authoritatively retrieved from the provided sources, a detailed plain-language overview of each specific independent claim cannot be provided. Generally, based on the abstract and description, the independent claims likely cover:

1. Compositions of crystalline endoxifen: These claims would likely define specific crystalline forms (e.g., Form I, Form II, Form III) of endoxifen, characterized by their X-ray powder diffraction patterns, and pharmaceutical compositions containing these forms.
2. Methods of making endoxifen and its salts: These claims would encompass industrially scalable processes for synthesizing (Z)-endoxifen or its salts, including steps like demethylation of a precursor compound and McMurry reactions to form the endoxifen mixture, followed by purification and crystallization steps to obtain specific forms or enriched (Z)-endoxifen.
3. Methods of treating hormone-dependent disorders: These claims would cover the use of the described endoxifen compositions (including specific crystalline forms or (Z)-endoxifen) for treating or preventing hormone-dependent breast disorders (e.g., breast cancer, hyperplasia, increased breast density, gynecomastia) and/or hormone-dependent reproductive tract disorders (e.g., endometrial, ovarian, uterine, cervical, vaginal, or vulvar cancers) in a subject. These claims might also specify dosage ranges, pharmacokinetic profiles (e.g., steady-state plasma levels, half-life, AUC), and particular patient populations (e.g., tamoxifen-refractory patients, those on SSRI drugs).

Litigation Status:

• PTAB Litigation: A PTAB case, IPR2025-00799, was filed against US11261151B2. As of April 16, 2026, Atossa Therapeutics, Inc. has entered into a settlement agreement with Intas Pharmaceuticals Ltd. and Jina Pharmaceuticals, Inc. to resolve these ongoing patent disputes. The settlement aims for the termination of the PTAB proceedings, with the expectation that US Patent 11261151B2 will remain issued and enforceable.
• CAFC 2026 Dockets: A review of the U.S. Court of Appeals for the Federal Circuit (CAFC) scheduled cases for May, June, and July 2026 did not directly show any active litigation specifically mentioning patent number US11261151B2. Given the recent settlement of the PTAB case, direct appeals to the CAFC concerning that specific IPR proceeding might be averted or terminated as per the agreement.