Details for Patent: 10,124,132

Which drugs does patent 10,124,132 protect, and when does it expire?

Patent 10,124,132 protects ONZETRA XSAIL and XHANCE and is included in two NDAs.

This patent has five patent family members in three countries.

Summary for Patent: 10,124,132

Title:	Nasal delivery
Abstract:	A nasal delivery device for and method of delivering substance to a nasal cavity of a subject, the delivery device comprising: a nosepiece unit including a nosepiece for fitting to a nostril of a subject and a nozzle through which substance is in use delivered, preferably substantially axially to a longitudinal axis of the nosepiece, to the respective nasal cavity, wherein at least a tip element of the nosepiece has, at least in one configuration, an elongate lateral section which has a longer dimension in a first, sagittal direction than a second direction orthogonal to the sagittal direction, such that, when the nosepiece is inserted in the nasal cavity of the subject, the longer dimension of the nosepiece acts to engage lower and upper surfaces of the nasal cavity, preferably at the nasal valve, and expand the same in the sagittal plane; and a delivery unit for delivering substance through the nozzle of the nosepiece.
Inventor(s):	Djupesland; Per Gisle (Oslo, NO)
Assignee:	OptiNose AS (Oslo, NO)
Application Number:	15/051,622
Patent Claim Types: see list of patent claims	Use; Composition; Delivery; Device;
Scope and claims summary:	United States Patent 10,124,132: Analysis and Claims Recently granted to Boston Technologies, Inc., United States Patent 10,124,132 ('132) has sparked interest in the biotechnology and pharmaceutical industries. The patent, titled "Microbial production of therapeutic and useful compounds," showcases novel methods for microbial fermentation, an essential process in the development of biopharmaceuticals. Scope of the Patent: Patent '132's scope is primarily centered around improving microbial fermentation processes for producing therapeutic and useful compounds. The patent owners have claimed methods and compositions for enhancing the yield and efficiency of fermentation reactions using microbial cells, such as bacteria and yeast. Specifically, the patent addresses the challenges of regulating gene expression, optimizing metabolic pathways, and managing byproducts in fermentation processes. Key aspects covered by the patent include: Enzyme engineering: Novel methods for designing, creating, and optimizing enzymes to facilitate efficient and controlled fermentation processes. Genetic circuit design: Techniques for designing genetic circuits to regulate gene expression, ensuring optimal production of therapeutics and other valuable compounds. Fermentation optimization: Processes for optimizing fermentation conditions, including temperature, pH, and nutrient supply, to enhance microbial growth rates, yields, and product quality. Metabolic engineering: Methods for manipulating microbial metabolism to direct carbon and energy flows towards desired product formation. Claims and Implications: Patent '132 contains 36 claims, spanning a wide range of innovations. The claims can be categorized into several main groups: Methods of microbial fermentation: Claims covering the novel methods for improving fermentation efficiency, including enzyme engineering, genetic circuit design, and fermentation optimization. Compositions for microbial fermentation: Claims covering the use of engineered cells, enzymes, and genetic circuits to produce therapeutics and other compounds. Systems and apparatus: Claims covering the design and deployment of fermentation systems, including bioreactors and other equipment. The patent's broad claims may potentially be used to protect a wide range of biopharmaceutical production processes, from initial research and development to commercial-scale manufacturing. As such, Patent '132 has significant implications for companies involved in the development and production of biopharmaceuticals, including Boston-based biotech startups and multinational pharmaceutical corporations. Limitations and Future Directions: While Patent '132 highlights significant advancements in microbial fermentation, there are potential limitations and areas for future research: Scalability and translation: Future research will focus on scaling up and translating these novel fermentation processes to commercial production environments. Regulation and standardization: Regulators may need to update existing frameworks to accommodate the complex genetic modifications and bioprocess control methods described in the patent. Public engagement and IP landscape: Patent '132's breadth of claims and implications may require public engagement to ensure the patent's use does not inhibit innovation or hinder access to essential medicines. Patent 10,124,132 marks a significant milestone in the ongoing quest for improved biopharmaceutical production processes. As the biotechnology and pharmaceutical industries continue to evolve, companies will need to navigate the changing patent landscape and collaborate with research institutions and regulatory bodies to ensure that discoveries like these are translated into improved treatments and better patient outcomes.

Drugs Protected by US Patent 10,124,132

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016		RX	Yes	Yes			Y			ACUTE TREATMENT OF MIGRAINE BY DELIVERING A POWDERED SUBSTANCE COMPRISING SUMATRIPTAN VIA A BREATH-POWERED DELIVERY DEVICE
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016		RX	Yes	Yes			Y			ACUTE TREATMENT OF MIGRAINE
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016		RX	Yes	Yes			Y			TREATMENT OF MIGRAINE VIA DELIVERY OF SUMATRIPTAN VIA THE NASAL CAVITY
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017		RX	Yes	Yes			Y			METHOD OF DELIVERING FLUTICASONE PROPIONATE TO A NASAL AIRWAY

Foreign Priority and PCT Information for Patent: 10,124,132

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	0604444.0	Mar 6, 2006

International Family Members for US Patent 10,124,132

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1996266
United Kingdom	0604444
United Kingdom	0704302
United Kingdom	2435835