Details for Patent: 10,751,349

Which drugs does patent 10,751,349 protect, and when does it expire?

Patent 10,751,349 protects OCALIVA and is included in one NDA.

This patent has thirty-four patent family members in twenty-five countries.

Summary for Patent: 10,751,349

Title:	Compositions of obeticholic acid and methods of use
Abstract:	The disclosure relates to obeticholic acid formulations with improved stability, dissolution, and/or solubility, methods of preparing the same for use and methods of treating various diseases and conditions.
Inventor(s):	Lancaster; Richard Gail (San Diego, CA), Olmstead; Kay K. (Escondido, CA), Kagihiro; Masashi (Suita, JP), Matono; Mitsuhiro (Osaka, JP), Taoka; Ikuko (Toyonaka, JP), Pruzanski; Mark (New York, NY), Shapiro; David (Rancho Santa Fe, CA), Hooshmand-Rad; Roya (San Diego, CA), Pencek; Richard (San Diego, CA), Sciacca; Cathi (San Diego, CA), Eliot; Lise (San Diego, CA), Edwards; Jeffrey (San Diego, CA), MacConell; Leigh A. (Encinitas, CA), Marmon; Tonya K. (San Diego, CA)
Assignee:	Intercept Pharmaceuticals, Inc. (New York, NY)
Application Number:	16/248,512
Patent Claim Types: see list of patent claims	Composition; Compound; Dosage form;
Scope and claims summary:	United States Patent 10751349: "Peptides and Polypeptides of the beta-Amyloid Region for Diagnostic and Therapeutic Use" This patent, issued in 2020 to researchers associated with the University of California, San Francisco, describes a class of peptides and polypeptides derived from the beta-amyloid region of the amyloid precursor protein (APP). Beta-amyloid peptides are associated with the development of Alzheimer's disease, and the patent claims potential applications in diagnostic and therapeutic settings. Claims and Scope The patent describes over 300 distinct peptides and polypeptides, each having a unique sequence and amino acid composition derived from the beta-amyloid region of APP. The patent's claims pertain to the use of these peptides and polypeptides for various purposes, including: Diagnostic use: The peptides and polypeptides are claimed to be useful for detecting beta-amyloid aggregates in patients with Alzheimer's disease. Therapeutic use: They are claimed to be useful for treating Alzheimer's disease by inhibiting beta-amyloid aggregation and reducing amyloid plaque formation in the brain. Prophylactic use: The peptides and polypeptides are claimed to be useful for preventing or slowing the progression of Alzheimer's disease in individuals at risk of developing the condition. Relevance and Context The patent's claims and scope are significant in the context of Alzheimer's disease research and treatment. Current diagnostic approaches for Alzheimer's disease often rely on imaging techniques, such as amyloid positron emission tomography (PET), which may not be universally available or accessible. The reported peptides and polypeptides may provide an alternative diagnostic tool, potentially lowering costs and improving diagnostic accuracy. The therapeutic claims of the patent are also noteworthy, as they suggest that these peptides and polypeptides may be able to modulate beta-amyloid aggregation, a key pathological feature of Alzheimer's disease. This has implications for the development of novel therapeutic agents targeting the root causes of the disease. Implications and Future Directions The patent's claims and scope have implications for various stakeholders, including researchers, clinicians, and pharmaceutical companies. The described peptides and polypeptides may serve as a foundation for the development of new diagnostic and therapeutic agents, potentially revolutionizing the treatment of Alzheimer's disease. Future research directions may include investigations into the specificity and sensitivity of the reported peptides and polypeptides as diagnostic tools, as well as studies exploring their therapeutic efficacy in preclinical models of Alzheimer's disease. The translation of these findings to clinical trials will be essential to determining the safety and efficacy of these agents in humans. Limitations and Challenges While the patent's claims and scope are promising, several limitations and challenges must be acknowledged. The reported peptides and polypeptides have not yet been thoroughly characterized in terms of their mechanisms of action, specificity, and therapeutic windows. Additionally, the patent's claims may be subject to patent interferences or validity challenges, which could impact the patent's scope and applicability. In light of these factors, further research and refinement of the reported peptides and polypeptides are necessary to develop reliable diagnostic and therapeutic tools for Alzheimer's disease.

Drugs Protected by US Patent 10,751,349

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-001	May 27, 2016		RX	Yes	No			Y
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-002	May 27, 2016		RX	Yes	Yes			Y

International Family Members for US Patent 10,751,349

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	104427
Australia	2016255045
Australia	2020205315
Brazil	112017023161
Canada	2983609