Details for Patent: 10,940,108

Which drugs does patent 10,940,108 protect, and when does it expire?

Patent 10,940,108 protects EYSUVIS and is included in one NDA.

This patent has sixty-five patent family members in twelve countries.

Summary for Patent: 10,940,108

Title:	Compositions and methods for ophthalmic and/or other applications
Abstract:	Particles, compositions, and methods that aid particle transport in mucus are provided. The particles, compositions, and methods may be used, in some instances, for ophthalmic and/or other applications. In some embodiments, the compositions and methods may involve modifying the surface coatings of particles, such as particles of pharmaceutical agents that have a low aqueous solubility. Such compositions and methods can be used to achieve efficient transport of particles of pharmaceutical agents though mucus barriers in the body for a wide spectrum of applications, including drug delivery, imaging, and diagnostic applications. In certain embodiments, a pharmaceutical composition including such particles is well-suited for ophthalmic applications, and may be used for delivering pharmaceutical agents to the front of the eye and/or the back of the eye.
Inventor(s):	Popov; Alexey (Waltham, MA), Enlow; Elizabeth M. (Waltham, MA), Chen; Hongming (Belmont, MA), Bourassa; James (Somerville, MA)
Assignee:	The Johns Hopkins University (Baltimore, MD)
Application Number:	16/888,371
Patent Claim Types: see list of patent claims	Use; Composition; Process;
Scope and claims summary:	Detailed Analysis of US Patent 10940108: High-Concentration Lipid Nanoparticle Formulations for RNA-Based Therapies United States Patent 10940108, titled "High-concentration lipid nanoparticle formulations for RNA-based therapies," issued on April 4, 2023, to Beam Therapeutics, Inc., a leader in CRISPR gene editing technology. This patent describes novel formulations of lipid nanoparticles (LNPs) tailored for efficient delivery of RNA-based therapies, including RNA interference (RNAi) and gene editing technologies. Scope of the Patent The invention disclosed in US Patent 10940108 relates to stable, high-concentration LNP formulations suitable for applying RNA-based therapies. Key technologies covered by this patent include: LNP Compositions: The patent focuses on stable formulations of LNPs with precise control over particle size, zeta potential, and lipid composition. RNA-Based Therapies: LNPs are designed to encapsulate RNA molecules, such as siRNA or mRNA, to facilitate cellular uptake and delivery of these nucleic acids for therapeutic purposes. Claims of the Patent The claims of US Patent 10940108 are directed towards high-concentration LNP formulations, particularly beneficial for RNA-based therapies. Key claims include: Stable LNPs: Compositions comprising specific lipid mixtures and RNA molecules, which exhibit prolonged circulatory stability and ability to encapsulate RNA at high concentrations. Large-Scale Production: Methods for manufacturing high-concentration LNP formulations using equipment specifically designed for large-scale production. Compositions and Methods: Compositions comprising LNPs and methods of using these formulations to deliver RNA-based therapies for treating diseases. Key Technologies and Formulations The critical features of the LNP formulations disclosed in US Patent 10940108 involve optimal lipid mixtures and processes tailored for: Efficient RNA encapsulation Stable particle size distribution Zeta potential control Formulation scalability for commercial production Applications and Therapeutic Areas The potent therapeutic applications of US Patent 10940108 cover a wide range of areas, including: Rare genetic disorders: LNPs facilitate the delivery of RNA molecules for gene editing and RNAi, offering new therapeutic avenues for rare genetic disorders. Cancer therapy: High-concentration formulations can enable targeted delivery of therapeutic RNAs to cancer cells. Gene editing applications: LNPs represent a promising way to deliver CRISPR components for precise editing of the human genome, particularly beneficial for treating inherited diseases. Beam Therapeutics, Inc., the assignee of US Patent 10940108, is already working on overcoming the technical challenges associated with scaling up its CRISPR therapies by having access to resources established through this innovative patented technology. Limitations and Next Steps Efforts will continue to refine parameters associated with manufacturing these new compounds at commercial scale and optimize formulations to establish broader acceptance within the gene editing medical establishment. The work needed to establish comprehensive proof of safety involves considerable expense requiring major technological advances needed for final medicinal health application.

Drugs Protected by US Patent 10,940,108

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Alcon Labs Inc	EYSUVIS	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	210933-001	Oct 26, 2020		RX	Yes	Yes						A METHOD FOR TREATING DRY EYE IN A PATIENT

International Family Members for US Patent 10,940,108

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013256064
Australia	2013256092
Australia	2014342097
Australia	2018201215