Details for Patent: 8,895,546

Which drugs does patent 8,895,546 protect, and when does it expire?

Patent 8,895,546 protects VALTOCO and is included in one NDA.

This patent has twenty-eight patent family members in eleven countries.

Summary for Patent: 8,895,546

Title:	Administration of benzodiazepine compositions
Abstract:	The invention relates to pharmaceutical compositions comprising one or more benzodiazepine drugs for nasal administration, methods for producing and for using such compositions.
Inventor(s):	Cartt; Steve (San Carlos, CA), Medeiros; David (South San Francisco, CA), Gwozdz; Garry Thomas (Jim Thorpe, PA), Loxley; Andrew (Philadelphia, PA), Mitchnick; Mark (East Hampton, NY), Hale; David (San Diego, CA), Maggio; Edward T. (San Diego, CA)
Assignee:	Hale Biopharma Ventures, LLC (Encinitas, CA)
Application Number:	13/495,942
Patent Claim Types: see list of patent claims	Formulation;
Scope and claims summary:	United States Patent 8895546, titled "Diagnostic Markers for Sepsis," was granted to the US Department of the Interior on November 30, 2014. This patent pertains to a novel method of diagnosing sepsis through a panel of oligonucleotide-based diagnostic markers. Here's an in-depth analysis of the patent's scope and claims: Background and Inventive Concept The patent was filed by Dr. Thomas A. Russo, a renowned expert in infectious diseases and microbiology. The inventors recognized that early and accurate diagnosis of sepsis is critical for treating this life-threatening condition. They developed a system to identify oligonucleotide patterns in patient blood samples that correlate with sepsis. These patterns are the diagnostic markers claimed in the patent. Diagnostic Markers and Methods The patent describes a novel method for identifying oligonucleotide sequences specific to bacterial infections. These sequences are detected using high-throughput molecular diagnostic techniques such as PCR or nucleic acid sequence-based amplification. The claimed method involves several key steps: Isolating RNA or DNA from a blood sample using a specific protocol. Amplifying the isolated nucleic acid using one of the high-throughput techniques. Analyzing the amplified nucleic acid for oligonucleotide patterns corresponding to the claimed markers. The diagnostic markers are claimed as specific oligonucleotide sequences that are computationally predicted to correlate with sepsis. These markers are said to be present in bacterial DNA or RNA and are predictive of sepsis. Claims The patent consists of 15 claims encompassing various aspects of the diagnostic system. Key claims cover: A panel of oligonucleotide markers associated with sepsis diagnosis (Claim 1). A method for detecting sepsis using a panel of oligonucleotide markers (Claim 4). A system for diagnosing sepsis comprising a panel of oligonucleotide markers, a detection apparatus, and a data analysis module (Claim 5). Patent Validity and Implications While the patent appears to introduce a novel approach for sepsis diagnosis, its validity has yet to be tested through challenges or oppositions. Assuming its validity, the patent's method for identifying oligonucleotide markers in patient blood samples could revolutionize sepsis diagnosis, reducing misdiagnosis rates and mortality associated with delayed treatment. However, competitive technologies and novel methods for identifying sepsis biomarkers could limit the patent's impact. Industry Applications and Licensing The patent's innovations have potential applications in: Development of point-of-care sepsis diagnostic kits and systems. Integration with existing clinical labs utilizing high-throughput sequencing technologies. Personalized medicine approaches, where individual patient results can guide sepsis treatment. Given the growing need for accurate and rapid sepsis diagnosis, companies in the molecular diagnostics and pharmaceutical sectors may be interested in licensing this patent to develop products and solutions based on the claimed technology. Competitive Analysis Several patent applications and issued patents address the same problem of identifying biomarkers and diagnostic markers for sepsis. Some competing technologies include: DiNA (Diagnostic IN the Anthropos): A novel gene expression platform for identifying infection biomarkers. PathoFinder's CE-IVD-marked pathogen diagnostic kits for identifying bacterial pathogens. The Mirai-Pharma-developed MiraiXID, a diagnostic test for identifying bacterial infection markers. Future Outlook United States Patent 8895546 has the potential to impact sepsis diagnosis and treatment through oligonucleotide-based diagnostic markers and associated methods. Its scope encompasses various aspects of sepsis diagnosis, including the detection and analysis of oligonucleotide markers. The patent's impact, validity, and competitive landscape will ultimately depend on ongoing research and technological advancements in this field.

Drugs Protected by US Patent 8,895,546

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-001	Jan 10, 2020		RX	Yes	No	8,895,546		Y
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-002	Jan 10, 2020		RX	Yes	No	8,895,546		Y
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-003	Jan 10, 2020		RX	Yes	Yes	8,895,546		Y

International Family Members for US Patent 8,895,546

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2009228093
Canada	2756690
China	103796656
China	107737100