Invalidity dossier
US 11623920
Process for preparing pitolisant hydrochloride and solid-state forms thereof
Current assignee: Harmony Biosciences Management Inc, Novitium Pharma LLC
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Patent summary
Title, assignee, inventors, filing/issue dates, abstract, and a plain-language overview of the claims.
Patent Analyst Report: US 11,623,920 B2
Date of Analysis: 2026-05-05
Subject: United States Patent 11,623,920 B2
This report provides a concise summary of US patent 11,623,920, including its key bibliographic data and a plain-language overview of its independent claims. A search of the United States Patent and Trademark Office (USPTO) database and the 2026 dockets of the Court of Appeals for the Federal Circuit (CAFC) was conducted. No records of litigation involving this patent were found in the CAFC dockets for the current year.
I. Bibliographic Information
| Patent Number | 11,623,920 B2 |
| Title | Process for preparing pitolisant hydrochloride and solid-state forms thereof |
| Assignee | Novitium Pharma LLC |
| Inventors | Ramasamy Venkatragavan, Erugu Balaiah, Paramanandam Senthilkumaran, Guttha Jayaprasad, Manniyam Kailasam Selvam, Noti Krishnareddy, Sorakka Pichandi Parthipan, Murugan Arunkumar, Palaniswamy Premkumar, Salamuthu Kaliraj, Shanmugam Arumugam, Singavarapu Ajay Madhukar, Raman Silambarasan, Saminathan Karthick, Kudumudi Jayaraman Parthiban, Ravi Silambarasan |
| Filing Date | 2022-05-24 |
| Issue Date | 2023-04-11 |
| Abstract | The present disclosure relates to a process for preparing pitolisant hydrochloride of Formula-(I) and solid-state forms thereof. |
II. Plain-Language Overview of Independent Claims
An independent claim represents the broadest definition of the invention protected by the patent. Infringement of an independent claim is sufficient for a finding of patent infringement. US Patent 11,623,920 has one independent claim.
Independent Claim 1:
This claim protects a new crystalline form of pitolisant hydrochloride, specifically referred to as pitolisant hydrochloride sesquihydrate. A "sesquihydrate" means that for every two molecules of pitolisant hydrochloride, there are three molecules of water integrated into the crystal structure.
The claim defines this specific crystalline form by its unique fingerprint when analyzed with Powder X-ray Diffraction (PXRD), a standard analytical technique. It specifies that this form is characterized by having prominent peaks at certain angles (5.3, 7.3, 10.0, 11.8, and 26.1 ±0.2° two-theta). This unique pattern distinguishes it from other known forms of pitolisant hydrochloride.
In essence, this claim grants the patent holder exclusive rights to this particular stable, hydrated crystal form of the active pharmaceutical ingredient pitolisant hydrochloride.
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