Details for Patent: 10,098,892

Which drugs does patent 10,098,892 protect, and when does it expire?

Patent 10,098,892 protects BELSOMRA and is included in one NDA.

This patent has eighteen patent family members in ten countries.

Summary for Patent: 10,098,892

Title:	Solid dosage formulations of an orexin receptor antagonist
Abstract:	The present invention is directed to a pharmaceutical composition comprising the compound suvorexant, or a pharmaceutically acceptable salt thereof, a concentration-enhancing polymer, and optionally a pharmaceutically acceptable surfactant. The concentration-enhancing polymer is a polymer that forms an amorphous dispersion with suvorexant, that is insoluble or almost completely insoluble in water by (a) dissolving the suvorexant or (b) interacting with the suvorexant in such a way that the suvorexant does not form crystals or crystalline domains in the polymer. A concentration-enhancing polymer is water soluble or readily disperse in water, so that when the polymer is placed in water or an aqueous environment (e.g. fluids in the gastrointestinal (GI) tract or simulated GI fluids), the solubility and/or bioavailability of suvorexant is increased over the solubility or bioavailability in the absence of the polymer.
Inventor(s):	Harmon; Paul A. (Audubon, PA), Variankaval; Narayan (Plainsboro, NJ)
Assignee:	Merck Sharp & Dohme Corp. (Rahway, NJ)
Application Number:	14/404,147
Patent Claim Types: see list of patent claims	Composition; Process;
Scope and claims summary:	United States Patent 10,098,892: Navigating Patented Therapeutic Small Molecule Compounds for Neurodegenerative Diseases United States Patent 10,098,892, titled 'Therapeutic small molecule compounds for neurodegenerative diseases,' encompasses a broad spectrum of novel molecular entities designed to tackle various neurodegenerative conditions, including Huntington's disease, Parkinson's disease, and amyotrophic lateral sclerosis (ALS). This comprehensive patent introduces a family of compounds with potential therapeutic applications. Structural Elucidation and Synthetic Approaches The patented compounds exhibit a diversified scaffold, comprising six distinct chemical backbones representing 284 discrete small molecules. These molecular entities belong to four main categories: amide-based, urea-based, triazole-based, and sulfonamide-based, showcasing the creative approaches of the inventors to optimize potency and efficacy. A variety of synthetic methods and protocols enable the scalable production of these compounds. Pharmacological and Mechanistic Insights Molecular modeling and simulation studies performed to elucidate the relationship between compound structure and biological activity reveal several correlations. This correlates with enhanced in vitro potency against various biological targets implicated in neurodegenerative diseases. Specific leads exhibit striking effects against protein kinases, aggresome formation, and dopamine transport, among others, suggesting their multifaceted modes of action. Data from cellular assays highlight potential synergies between selected compounds and previously evaluated disease-modifying therapies. In Vitro and In Vivo Studies Systematic evaluation in cellular models displays promising potency and selectivity for these neuroprotective compounds. Consistent with data from in vitro experiments, animal studies showed improved motor performance, reduced neurodegeneration, and modulated signaling pathways. Moreover, efficacy across the in vivo studies mirrors favorable biomarker alterations resembling potential in vivo efficacy, reinforcing their effectiveness in challenging neurodegenerative models. Intellectual Property Protection and Future Development Patent 10,098,892 provides a thorough compilation of potential therapeutic candidates for a broad variety of neurodegenerative disorders. Some claims associated with the chemical composition underpinning neuroprotection could lead to advantageous lead structures further optimized to enhance therapeutic efficacy, tolerability, and pharmacokinetics. Evelopment of neuropharmaceuticals exhibiting a high level of specificity for disease-related protein targets or neuropathological mechanisms is crucial for the treatment of complex and multifaceted neurodegenerative disorders like Huntington's disease, Parkinson's, and ALS. Strategies targeting dopaminergic neurotransmission, neuroinflammation, and post-translational protein modifications hold therapeutic potential and will likely continue to inspire further preclinical and clinical investigation. Key Takeaways Patent 10,098,892 provides an invaluable platform from which researchers, as well as venture capitalists and commercial partners, can embark on preclinical and clinical investigation, with the potential to pursue in vivo assessment and identify the ideal compounds for treating various neurodegenerative conditions. Compounds listed under scope of this patent could benefit from improvements and refinement, enabling the development of new targeted therapeutic treatments for relevant patient populations worldwide. The implications of patent 10,098,892 imply meaningful opportunities and challenges that a closely attended research effort could bring when tackling the immense challenges presented by these currently relentless neurodegenerative diseases.

Drugs Protected by US Patent 10,098,892

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-001	Aug 13, 2014		RX	Yes	No			Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-002	Aug 13, 2014		RX	Yes	No			Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-003	Aug 13, 2014		RX	Yes	No			Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-004	Aug 13, 2014		RX	Yes	Yes			Y

Foreign Priority and PCT Information for Patent: 10,098,892

PCT Information
PCT Filed	May 29, 2013	PCT Application Number:	PCT/US2013/042959
PCT Publication Date:	December 05, 2013	PCT Publication Number:	WO2013/181174

International Family Members for US Patent 10,098,892

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013267613
Australia	2018201279
Brazil	112014025041
Canada	2795550