Details for Patent: 9,750,726

Which drugs does patent 9,750,726 protect, and when does it expire?

Patent 9,750,726 protects ANORO ELLIPTA and TRELEGY ELLIPTA and is included in two NDAs.

This patent has sixty-six patent family members in forty countries.

Summary for Patent: 9,750,726

Title:	Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist
Abstract:	Combinations of a muscarinic acetylcholine receptor antagonist and a beta 2 agonist for inhaled administration via the nose or mouth, and methods of using them are provided.
Inventor(s):	Baker; Darrell (Middlesex, GB), Bruce; Mark (Stevenage, GB), Crater; Glenn (Mississauga, CA), Noga; Brian (Durham, NC), Thomas; Marian (Ware, GB), Wire; Patrick (Durham, NC)
Assignee:	Glaxo Group Limited (Brentford, Middlesex, GB)
Application Number:	14/970,945
Patent Claim Types: see list of patent claims	Composition; Compound; Delivery; Dosage form;

Detailed Analysis of the Scope and Claims of United States Patent 9,750,726

Introduction

United States Patent 9,750,726, assigned to Glaxo Group Limited, is a significant patent in the pharmaceutical industry, particularly in the treatment of respiratory diseases such as Chronic Obstructive Pulmonary Disease (COPD) and asthma. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Patent Overview

Patent Number: 9,750,726 Issued: September 5, 2017 Inventors: Baker Darrell, Bruce Mark, Crater Glenn, Noga Brian, Thomas Marian, Wire Patrick Assignee: Glaxo Group Limited

Field of the Invention

This patent pertains to pharmaceutical products and compositions designed for the treatment of chronic obstructive pulmonary disease (COPD), asthma, and related respiratory diseases. It specifically focuses on the combination of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist[5].

Scope of the Invention

The scope of this patent is broad and encompasses several key aspects:

Combination Therapy

The patent describes combinations of a muscarinic acetylcholine receptor antagonist and a beta-2 adrenoreceptor agonist for inhaled administration via the nose or mouth. This combination is indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema[2][5].

Active Ingredients

The muscarinic receptor antagonist typically used in this combination is umeclidinium, while the beta-2 adrenoreceptor agonist is often vilanterol. These ingredients work synergistically to improve lung function and reduce symptoms of COPD[2].

Dosage and Administration

The patent details the formulation and dosage of the combination, which is typically administered via an inhaler. The specific doses and administration methods are critical components of the patent claims[5].

Claims of the Patent

The patent includes several claims that define the scope of the invention:

Independent Claims

• The patent claims the combination of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist for inhaled administration.
• It specifies the use of this combination for treating COPD and asthma.
• The claims also cover the methods of using these combinations, including the dosage forms and administration routes[5].

Dependent Claims

• These claims further detail the specific formulations, such as the ratio of the muscarinic receptor antagonist to the beta-2 adrenoreceptor agonist.
• They also cover various aspects of the inhaler device used for administration, including the medicament dispenser and manifold designs[2][5].

Patent Expiration

The patent is set to expire on November 29, 2030. This date is crucial as it marks the earliest possible entry point for generic versions of the drug, assuming no patent challenges or licensing agreements alter this timeline[2][4].

Patent Landscape

The patent landscape surrounding U.S. Patent 9,750,726 is complex and involves multiple related patents:

Related Patents

• Other patents, such as U.S. Patent 8,183,257 and U.S. Patent 8,309,572, also cover muscarinic acetylcholine receptor antagonists and their use in treating COPD. These patents expire at various dates between 2025 and 2030[2][4].
• Patents like U.S. Patent 8,511,304 and U.S. Patent 8,534,281 focus on the medicament dispenser and manifold designs, which are integral to the administration of the drug combination[2].

Patent Litigation and Challenges

The patent landscape is also influenced by potential litigation and challenges to the existing patents. Any successful challenges could alter the expiration dates or the scope of protection for these patents[3].

Impact on the Pharmaceutical Industry

This patent has significant implications for the pharmaceutical industry:

Market Dominance

Glaxo Group Limited, through this patent, maintains market dominance for the combination therapy until the patent expires. This protects their product, ANORO ELLIPTA, from generic competition during this period[1][2].

Innovation and Research

The patent encourages continued innovation in respiratory disease treatments. It sets a standard for combination therapies and prompts further research into similar or improved treatments[3].

Key Takeaways

• Combination Therapy: The patent covers a combination of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist for treating COPD and asthma.
• Expiration Date: The patent is set to expire on November 29, 2030.
• Related Patents: Several related patents cover various aspects of the drug and its administration.
• Impact on Industry: The patent maintains Glaxo Group Limited's market dominance and encourages continued innovation in respiratory disease treatments.

FAQs

1. What is the primary use of the combination therapy described in U.S. Patent 9,750,726?

   • The primary use is for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema.

2. Who is the assignee of U.S. Patent 9,750,726?

   • The assignee is Glaxo Group Limited.

3. When is the patent set to expire?

   • The patent is set to expire on November 29, 2030.

4. What are the active ingredients in the combination therapy?

   • The active ingredients are typically umeclidinium (a muscarinic receptor antagonist) and vilanterol (a beta-2 adrenoreceptor agonist).

5. How does this patent impact the pharmaceutical industry?

   • It maintains Glaxo Group Limited's market dominance for the combination therapy and encourages continued innovation in respiratory disease treatments.

Cited Sources

1. Drug Patent Watch - ANORO ELLIPTA Patents
2. Drugs.com - Generic Anoro Ellipta Availability
3. Hoover Institution - Patent Claims and Patent Scope
4. Drug Patent Watch - TRELEGY ELLIPTA Patents
5. Justia Patents - Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist

Drugs Protected by US Patent 9,750,726

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes			Y
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017		RX	Yes	Yes			Y
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020		RX	Yes	Yes			Y

Foreign Priority and PCT Information for Patent: 9,750,726

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	0921075.8	Dec 1, 2009

International Family Members for US Patent 9,750,726

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2506844		300942	Netherlands
European Patent Office	2506844		PA2018011	Lithuania
European Patent Office	2506844		122018000060	Germany
European Patent Office	2506844		CA 2018 00023	Denmark
European Patent Office	2506844		LUC00077	Luxembourg
European Patent Office	2506844		2018C/022	Belgium