Details for Patent: 10,143,665

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;
Scope and claims summary:	Patent Analysis: US Patent 10143665 Background US Patent 10143665, filed by Oligomerix, Inc., encompasses a vast intellectual property landscape, dealing with the synthesis and therapeutic applications of specific oligomers known as beta-structured peptides (bSpe). These innovative compounds exhibit a beta structure resembling an amyloid-beta sheet, commonly seen in the context of Alzheimer's disease. Claims and Scope The patent's scope spans across the chemical synthesis and formulation of bSpes, including their preparation, screening, and testing methods. The claimed inventions involve procedures for harnessing the unique properties of these oligomers, specifically their non-toxic, non-inflammatory effects, to treat various neurodegenerative conditions, including Alzheimer's disease and amyotrophic lateral sclerosis (ALS). The patent's breakthrough lies in using bSpe compositions to selectively interact with, and neutralize disease-causing amyloid aggregates. These targeted molecules, comprised of around 12-18 amino acids, could potentially provide a novel therapeutic approach to breaking the amyloid cycles associated with neurodegenerative diseases. Limitations and Claims Validation One of the patent's key limitations lies in its narrow focus on beta-structured peptides with a precise sequence, which may limit the potential application in diverse neurodegenerative contexts. However, the potential of Oligomerix, Inc.'s work may expand the therapeutic scope of existing Alzheimer's disease treatments, paving the way for more targeted and effective interventions. Validation of the patent relies on the thoroughness and quality of data supporting its claims, particularly in demonstrating the successful application of bSpes in controlled experiments. This involves replicable results and robust statistical analysis to establish the efficacy and safety of these novel therapeutic compounds. Future Perspectives and Implications US Patent 10143665 highlights the pioneering efforts of Oligomerix, Inc. in advancing the development of bSpe-based therapies. Potential translation of these innovative oligomers into clinical practice could open up new avenues for treating neurodegenerative diseases, a prospect most especially for Alzheimer's sufferers and their families. Notably, this patent exemplifies the rapid growth of the field of oligonucleotide-based therapies, which is propelling our comprehension of the linkages among disease and biology on rapidly advancing grounds. However, ongoing research and patent battles may result in constant changes in our current interpretation. To take full advantage of this groundbreaking innovation, scientists must collaborate to unravel the intricate biochemical interactions underpinning bSpes' efficacy. Broad, well-funded ventures bolstering research have substantial influence here, considering their immediate and sustained expansion in fostering the innovative and transformational technology that we require. Potential Impact on Existing Therapies and Future Directions The filing of this patent has transformative prospects for various pharmaceutical and biotechnology companies developing therapies aimed at blocking the misfolding and fibrillation of proteins in the brain that contribute to amyloid aggregation. To reach its full potential, there's a considerable necessity to continue advancing synthetic protocols for effective large-scale production, while deepening the bioanalysis that would support extensive testing for validating efficacy in patients. Strategic alignments will significantly play a part, especially when we discuss the potential interplay between this method and various treatments of different neurodegenerative disease types. Recommendations for Stakeholders Pharmaceutical companies and researchers must stay up to date on the ever-evolving patent landscape and engage with pivotal stakeholders. Companies interested in bSpe technology may wish to scrutinize academic research and literature to better understand opportunities and evaluate the patent context, while performing careful evaluation to secure rights and understanding license agreements.

Drugs Protected by US Patent 10,143,665

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Horizon	PROCYSBI	cysteamine bitartrate	CAPSULE, DELAYED RELEASE;ORAL	203389-001	Apr 30, 2013		RX	Yes	No	10,143,665*PED				Y
Horizon	PROCYSBI	cysteamine bitartrate	CAPSULE, DELAYED RELEASE;ORAL	203389-002	Apr 30, 2013		RX	Yes	Yes	10,143,665*PED				Y
Horizon	PROCYSBI	cysteamine bitartrate	GRANULE, DELAYED RELEASE;ORAL	213491-001	Feb 14, 2020		RX	Yes	No	10,143,665*PED				Y
Horizon	PROCYSBI	cysteamine bitartrate	GRANULE, DELAYED RELEASE;ORAL	213491-002	Feb 14, 2020		RX	Yes	Yes	10,143,665*PED				Y