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Last Updated: April 8, 2025

Details for Patent: 10,143,665


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Which drugs does patent 10,143,665 protect, and when does it expire?

Patent 10,143,665 protects PROCYSBI and is included in two NDAs.

Protection for PROCYSBI has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

Summary for Patent: 10,143,665
Title:Methods for storing cysteamine formulations and related methods of treatment
Abstract: Methods of storing and methods of stabilizing pharmaceutical compositions comprising cysteamine, or a pharmaceutically acceptable salt thereof, are provided. Methods of distributing pharmaceutical compositions comprising cysteamine, or a pharmaceutically acceptable salt thereof, and methods of treating cystinosis also are provided.
Inventor(s): DesJardin; Michael (Aptos, CA), Johnson; Mark (Fort Collins, CO)
Assignee: Horizon Orphan LLC (Lake Forest, IL)
Application Number:15/238,037
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,143,665
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 10,143,665

Introduction

United States Patent 10,143,665, titled "Methods for storing cysteamine formulations and related methods of treatment," is a significant patent in the field of pharmaceuticals, particularly for the treatment of cystinosis. This patent, issued to Horizon Orphan LLC, covers innovative methods for storing, stabilizing, distributing, and treating conditions using cysteamine formulations.

Patent Overview

  • Issuance Date: December 4, 2018
  • Inventors: Michael DesJardin and Mark Johnson
  • Assignee: Horizon Orphan LLC
  • Patent Expiration Date: August 16, 2036[1][4][5].

Scope of the Patent

The patent encompasses several key areas:

Methods of Storing Cysteamine Formulations

The patent describes specific methods for storing pharmaceutical compositions that include cysteamine or its pharmaceutically acceptable salts. These methods are designed to maintain the stability and efficacy of the cysteamine formulations over time, which is crucial for the treatment of cystinosis, a rare genetic disorder characterized by the accumulation of cystine within cells[1][4].

Methods of Stabilizing Cysteamine Formulations

In addition to storage methods, the patent outlines techniques for stabilizing cysteamine formulations. This includes maintaining the chemical integrity of cysteamine, which is prone to degradation, thereby ensuring that the medication remains effective for its intended use[1][4].

Methods of Distributing Cysteamine Formulations

The patent also covers methods for distributing these pharmaceutical compositions. This involves ensuring that the formulations are transported and stored under conditions that preserve their stability and potency, which is vital for maintaining the quality of the medication from the manufacturer to the patient[1][4].

Methods of Treating Cystinosis

The core of the patent is the application of these cysteamine formulations in the treatment of cystinosis. Cysteamine is a critical medication for managing this condition by reducing cystine levels in cells. The patent provides detailed methods for administering these formulations to achieve optimal therapeutic outcomes[1][4].

Claims of the Patent

The claims of the patent are comprehensive and detailed, covering various aspects of the invention:

Independent Claims

  • The patent includes multiple independent claims that define the scope of the invention. These claims are focused on the specific methods of storing, stabilizing, and distributing cysteamine formulations, as well as the methods of treatment using these formulations[4].

Dependent Claims

  • Dependent claims further elaborate on the independent claims, providing additional details and specifications. These claims help to narrow down the scope and ensure that the patent covers all necessary aspects of the invention[4].

Patent Landscape

The patent landscape surrounding US Patent 10,143,665 is complex and involves several related patents:

Related Patents

  • There are several other patents issued to Horizon Orphan LLC that are related to this patent. These include patents with numbers 10,328,037, 10,548,859, and 10,905,662, all of which deal with similar methods for storing, stabilizing, and treating cystinosis using cysteamine formulations. These patents have overlapping but distinct claims and expiration dates, ensuring a broad and extended protection for the inventions[1].

Patent Expiration Dates

  • The patent expiration dates for these related patents range from August 16, 2036, to February 16, 2037, providing a long-term protection for the intellectual property related to cysteamine formulations[1].

Impact on Innovation and Industry

The issuance of this patent and its related patents has significant implications for innovation and the pharmaceutical industry:

Encouraging Innovation

  • By providing a clear and protected method for storing, stabilizing, and treating cystinosis, these patents encourage further innovation in the field. Researchers and manufacturers can build upon these methods, knowing that their intellectual property is protected[3].

Market Dominance

  • Horizon Orphan LLC, with its suite of patents, holds a strong position in the market for cystinosis treatments. This dominance can influence the development and availability of similar treatments, as other companies may need to navigate around these patents or seek licenses to use the protected methods[3].

Critiques and Challenges

While the patent provides significant advancements, there are also critiques and challenges associated with its scope and claims:

Patent Scope and Quality

  • The debate over patent scope and quality is ongoing. Some argue that broad patents can stifle innovation by increasing licensing and litigation costs. However, narrower claims, as seen in this patent, can mitigate these issues by providing clear boundaries and reducing the complexity of the examination process[3].

Litigation and Licensing

  • The clarity and specificity of the claims in this patent can help reduce the likelihood of litigation and make licensing agreements more straightforward. This is particularly important in the pharmaceutical industry, where the stakes are high and the need for clear intellectual property rights is paramount[3].

Conclusion

United States Patent 10,143,665 is a pivotal patent in the treatment of cystinosis, offering innovative methods for storing, stabilizing, distributing, and treating this rare genetic disorder. The patent's scope and claims are detailed and comprehensive, ensuring a strong protection for Horizon Orphan LLC's intellectual property. Understanding the patent landscape and the implications of this patent is crucial for both innovators and industry stakeholders.

Key Takeaways

  • Innovative Methods: The patent introduces novel methods for storing, stabilizing, and distributing cysteamine formulations.
  • Treatment of Cystinosis: It provides specific methods for treating cystinosis, a rare genetic disorder.
  • Patent Protection: The patent and its related patents offer long-term protection for Horizon Orphan LLC’s intellectual property.
  • Industry Impact: The patent influences innovation and market dynamics in the pharmaceutical industry.
  • Critiques and Challenges: The patent’s scope and claims are subject to ongoing debates about patent quality and innovation.

FAQs

Q: What is the main focus of United States Patent 10,143,665? A: The main focus is on methods for storing, stabilizing, distributing, and treating cystinosis using cysteamine formulations.

Q: Who are the inventors of this patent? A: The inventors are Michael DesJardin and Mark Johnson.

Q: What is the expiration date of this patent? A: The patent expires on August 16, 2036.

Q: Are there related patents to US Patent 10,143,665? A: Yes, there are several related patents issued to Horizon Orphan LLC, including patents 10,328,037, 10,548,859, and 10,905,662.

Q: How does this patent impact the pharmaceutical industry? A: It encourages innovation, provides market dominance to Horizon Orphan LLC, and influences the development and availability of similar treatments.

Sources

  1. Drugs.com: Generic Procysbi Availability - Drugs.com
  2. PubChem: Enterically coated cysteamine, cystamine and derivatives thereof ...
  3. Hoover Institution: Patent Claims and Patent Scope
  4. Google Patents: US10143665B2 - Methods for storing cysteamine formulations and related methods of treatment
  5. Unified Patents Portal: US-9192590-B2 - Unified Patents Portal

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Drugs Protected by US Patent 10,143,665

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Patented / Exclusive UseSubmissiondate
Horizon PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-001 Apr 30, 2013 RX Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Horizon PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-002 Apr 30, 2013 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Horizon PROCYSBI cysteamine bitartrate GRANULE, DELAYED RELEASE;ORAL 213491-001 Feb 14, 2020 RX Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Horizon PROCYSBI cysteamine bitartrate GRANULE, DELAYED RELEASE;ORAL 213491-002 Feb 14, 2020 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Patented / Exclusive Use>Submissiondate
Showing 1 to 4 of 4 entries

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