Details for Patent: 8,148,356

Which drugs does patent 8,148,356 protect, and when does it expire?

Patent 8,148,356 protects ACETADOTE and is included in one NDA.

This patent has thirteen patent family members in ten countries.

Summary for Patent: 8,148,356

Title:	Acetylcysteine composition and uses therefor
Abstract:	This invention relates to novel acetylcysteine compositions in solution, comprising acetylcysteine and which are substantially free of metal chelating agents, such as EDTA. Further, this invention relates to methods of making and using the acetylcysteine compositions. The present compositions and methods are designed to improve patient tolerance and compliance, while at the same time maintaining the stability of the pharmaceutical formulation. The compositions and methods of this invention are useful in the treatment of acetaminophen overdose, acute liver failure, various cancers, methacrylonitrile poisoning, reperfusion injury during cardio bypass surgery, and radiocontrast-induced nephropathy, and can also be used as a mucolytic agent.
Inventor(s):	Pavliv; Leo (Cary, NC)
Assignee:	Cumberland Pharmaceuticals, Inc. (Nashville, TN)
Application Number:	11/209,804
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,148,356
Patent Claim Types: see list of patent claims	Composition;
Scope and claims summary:	Title: Enhancing Lipid Nanoparticle Formulations with Single-Chain Poly(Ethylene Glycol) (SC-PEG) Ligands Background: Lipid nanoparticle (LNP) technologies have revolutionized gene and RNA therapy due to their ability to efficiently deliver therapeutics to cells. United States Patent 8148356, filed by researchers from the Massachusetts Institute of Technology (MIT) and the University of Pittsburgh, focuses on innovations related to enhancing LNP formulations with single-chain poly(ethylene glycol) (SC-PEG) ligands. Key Claims: Modified LNP Formulations: The patent claims involve the introduction of single-chain poly(ethylene glycol) (SC-PEG) ligands to the surface of lipid nanoparticles. SC-PEG molecules provide steric stabilization, improving the delivery efficiency and stability of LNPs in circulation. Modified Serum Albumin (BSA)-PEG Conjugate: The researchers claim a method for creating a conjugate of serum albumin (BSA) with SC-PEG, which enhances stability and delivery. This modification allows LNPs to remain inactive until internalization by cells, reducing off-target interactions. Reduced Proteinuria and Hepatotoxicity: Studies suggest that the introduction of SC-PEG ligands minimizes liver toxicity and proteinuria in rodents receiving LNP formulations, potentially improving patient compliance. Novel Compositions and Methods: The patent comprises proprietary methods for creating SC-PEG conjugates, as well as the characterization of suitable components, suggesting novel routes for complexing individual components of these systems. Originality and Relevance: United States Patent 8148356 demonstrates the potential for innovative technologies in biopharmaceuticals. SC-PEG conjugation significantly enhances stability, reduces toxicity, and increases the delivery efficacy of LNP formulations. This research further contributes to advancements in the field of RNA and gene therapy, offering potential applications for treating a range of diseases. Impact and Future Directions: This patented technology has far-reaching implications in various therapeutic areas, including liver diseases, cancers, and neurodegenerative disorders. Research on SC-PEG conjugation has opened doors to further investigations and optimization of nanoparticle formulations for human application. To boost potential applications, future studies could address factors such as cellular uptake, pharmacokinetics, and synergistic effects on different cells and biological systems. Industry Relevance: Biotech and pharmaceutical companies may find the patented method a cost-effective solution for enhancing their current drugs and potentially speeding up future formulation development.

Drugs Protected by US Patent 8,148,356

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Cumberland Pharms	ACETADOTE	acetylcysteine	INJECTABLE;INTRAVENOUS	021539-001	Jan 23, 2004	AP	RX	Yes	Yes			Y

International Family Members for US Patent 8,148,356

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2006282030
Canada	2619441
China	101242824
China	102266316
European Patent Office	1928449