Details for Patent: 9,415,009

Which drugs does patent 9,415,009 protect, and when does it expire?

Patent 9,415,009 protects AIRSUPRA, BEVESPI AEROSPHERE, BREZTRI AEROSPHERE, and SYMBICORT AEROSPHERE, and is included in four NDAs.

This patent has one hundred and eighty-four patent family members in thirty-one countries.

Summary for Patent: 9,415,009

Title:	Compositions, methods and systems for respiratory delivery of two or more active agents
Abstract:	Compositions, methods and systems are provided for pulmonary or nasal delivery of two or more active agents via a metered dose inhaler. In one embodiment, the compositions include a suspension medium, active agent particles, and suspending particles, in which the active agent particles and suspending particles form a co-suspension within the suspension medium.
Inventor(s):	Vehring; Reinhard (Edmonton, CA), Hartman; Michael Steven (Millbrae, CA), Lechuga-Ballesteros; David (San Jose, CA), Smith; Adrian Edward (Emerald Hills, CA), Joshi; Vidya B. (Redwood City, CA), Dwivedi; Sarvajna Kumar (Redwood City, CA)
Assignee:	Pearl Therapeutics, Inc. (Redwood City, CA)
Application Number:	14/334,503
Patent Claim Types: see list of patent claims	Use; Delivery; Composition;

United States Patent 9,415,009: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 9,415,009, issued on August 16, 2016, is a significant patent in the field of respiratory medicine, particularly focusing on the delivery of two or more active agents via metered dose inhalers (MDIs). This patent is assigned to Pearl Therapeutics, Inc., and it encompasses compositions, methods, and systems for pulmonary or nasal delivery of these active agents.

Inventors and Assignees

The patent was invented by a team of researchers including Reinhard Vehring, Michael Steven Hartman, David Lechuga-Ballesteros, Adrian Edward Smith, Vidya B. Joshi, and Sarvajna Kumar Dwivedi. The assignee of the patent is Pearl Therapeutics, Inc., based in Redwood City, California[2][4][5].

Scope of the Patent

Compositions and Methods

The patent describes compositions and methods for the respiratory delivery of two or more active agents. These compositions typically include a suspension medium, active agent particles, and suspending particles. The active agent particles and suspending particles form a co-suspension within the suspension medium, which is crucial for the stable and effective delivery of the active agents via MDIs[2][4][5].

Active Agents

The patent covers a wide range of active agents, including but not limited to long-acting muscarinic antagonists (LAMAs), long-acting beta2-adrenergic receptor agonists (LABAs), and corticosteroids. Specific examples of active agents mentioned include glycopyrrolate and formoterol[4].

Claims of the Patent

Independent Claims

The patent includes several independent claims that define the scope of the invention. These claims cover:

• The composition itself, including the suspension medium, active agent particles, and suspending particles.
• The method of preparing these compositions.
• The system for delivering these compositions via MDIs.
• Specific embodiments where the active agents are delivered in a co-suspension format[4].

Dependent Claims

Dependent claims further specify the details of the independent claims, such as the types of suspension media, the characteristics of the active agent and suspending particles, and the propellants used in the MDIs[4].

Patent Landscape

Related Patents

The patent is part of a broader landscape of respiratory drug delivery patents held by Pearl Therapeutics, Inc. Other related patents include:

• Patent 8,324,266, issued on December 4, 2012, which also covers compositions and methods for respiratory delivery of two or more active agents[5].
• Patent 8,703,806, issued on April 22, 2014, focusing on propellant-based systems for delivering glycopyrrolate and other active agents[5].

Patent Expiration Dates

The patent is set to expire on May 28, 2030. This expiration date is significant as it marks the end of the exclusive rights granted to Pearl Therapeutics, Inc. for this specific invention[2][5].

Drug Patents and Exclusivity

Drug Patents

Drug patents, like US 9,415,009, are assigned by the U.S. Patent and Trademark Office and grant exclusive legal rights to the patent holder. These patents protect the proprietary chemical formulation, dosage form, ingredient formulation, or manufacturing process. Typically, drug patents expire 20 years from the date of filing, but this can vary due to factors such as new formulations and patent infringement litigation[2][5].

Drug Exclusivity

In addition to patent protection, the FDA grants drug exclusivity, which provides sole marketing rights to the manufacturer upon drug approval. Exclusivity periods can range from 180 days to seven years, depending on the circumstances of the exclusivity grant. This exclusivity can run concurrently with the patent protection[2][5].

Impact on Innovation and Competition

The scope and claims of this patent can influence innovation and competition in the respiratory drug delivery market. By protecting specific compositions and delivery methods, the patent encourages further research and development within the field while preventing direct competition for the patented inventions until the patent expires.

Metrics for Patent Scope

Research on patent scope suggests that metrics such as independent claim length and independent claim count can be used to measure the breadth of a patent. Narrower claims are often associated with a higher probability of grant and a shorter examination process, which can be relevant for understanding the strategic positioning of US 9,415,009 within the patent landscape[3].

Key Takeaways

• Compositions and Methods: The patent covers compositions and methods for delivering two or more active agents via MDIs, using a co-suspension format.
• Active Agents: Includes LAMAs, LABAs, and corticosteroids.
• Claims: Defines the composition, method of preparation, and delivery system.
• Patent Landscape: Part of a broader set of respiratory drug delivery patents held by Pearl Therapeutics, Inc.
• Expiration Date: Set to expire on May 28, 2030.
• Drug Patents and Exclusivity: Protects proprietary formulations and grants exclusive marketing rights.

FAQs

What is the main focus of United States Patent 9,415,009?

The main focus of this patent is on compositions, methods, and systems for the pulmonary or nasal delivery of two or more active agents via metered dose inhalers (MDIs).

Who are the inventors of this patent?

The inventors include Reinhard Vehring, Michael Steven Hartman, David Lechuga-Ballesteros, Adrian Edward Smith, Vidya B. Joshi, and Sarvajna Kumar Dwivedi.

What types of active agents are covered by this patent?

The patent covers a variety of active agents, including long-acting muscarinic antagonists (LAMAs), long-acting beta2-adrenergic receptor agonists (LABAs), and corticosteroids.

When is the patent set to expire?

The patent is set to expire on May 28, 2030.

How does this patent impact innovation and competition in the respiratory drug delivery market?

By protecting specific compositions and delivery methods, the patent encourages further research and development while preventing direct competition for the patented inventions until the patent expires.

Cited Sources:

1. United States Patent and Trademark Office. Compositions, methods and systems for pulmonary delivery of long-acting muscarinic antagonists and long-acting B2 adrenergic receptor agonists and associated methods and systems. US10716753B2, July 21, 2020.
2. Drugs.com. Generic Airsupra Availability. Retrieved November 6, 2024.
3. SSRN. Patent Claims and Patent Scope. Retrieved September 29, 2016.
4. Google Patents. Compositions, methods and systems for respiratory delivery of two or more active agents. US9415009B2, August 16, 2016.
5. Drugs.com. Generic Bevespi Aerosphere Availability. Retrieved November 6, 2024.

Drugs Protected by US Patent 9,415,009

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Astrazeneca	AIRSUPRA	albuterol sulfate; budesonide	AEROSOL, METERED;INHALATION	214070-001	Jan 10, 2023		RX	Yes	Yes						AS-NEEDED TREATMENT OR PREVENTION OF BRONCHOCONSTRICTION AND REDUCTION OF THE RISK OF EXACERBATIONS IN PATIENTS WITH ASTHMA 18 YEARS OF AGE AND OLDER
Astrazeneca	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes						USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Astrazeneca Ab	BREZTRI AEROSPHERE	budesonide; formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	212122-001	Jul 23, 2020		RX	Yes	Yes						USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Astrazeneca	SYMBICORT AEROSPHERE	budesonide; formoterol fumarate	AEROSOL, METERED;INHALATION	216579-001	Apr 28, 2023		RX	Yes	Yes						MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

International Family Members for US Patent 9,415,009

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2435025		300995	Netherlands
European Patent Office	2435025		PA2019014	Lithuania
European Patent Office	2435025		122019000068	Germany
European Patent Office	2435025		2019C/532	Belgium