Details for Patent: 10,039,804

Which drugs does patent 10,039,804 protect, and when does it expire?

Patent 10,039,804 protects VANCOMYCIN HYDROCHLORIDE and VANCOMYCIN and is included in two NDAs.

This patent has forty-seven patent family members in twenty-nine countries.

Summary for Patent: 10,039,804

Title:	Glycopeptide compositions
Abstract:	Solutions comprising a glycopeptide antibiotic, for example Vancomycin, and an amino acid or amino acid derivative such as N-acetyl-Glycine or N-acetyl-D-Alanine are provided. These solutions are stable or stabilized for long-term periods at conditions of normal use and storage, and can be formulated as pharmaceutical solutions for use in subjects. Methods of manufacturing and using these solutions are also provided, as are methods of stabilizing a glycopeptide antibiotic, for example Vancomycin, using amino acids or amino acid derivatives such as N-acetyl-Glycine or N-acetyl-D-Alanine.
Inventor(s):	Jasprica; Ivona (Zagreb, HR), Keser; Sabina (Zagreb, HR), Pindric; Katarina (Sesvete, HR)
Assignee:	XELLIA PHARMACEUTICALS APS (Copenhagen S., DK)
Application Number:	15/827,719
Patent Claim Types: see list of patent claims	Use; Composition;

Detailed Analysis of the Scope and Claims of United States Patent 10,039,804

Introduction

The United States Patent 10,039,804, titled "Glycopeptide compositions," is a significant patent in the field of pharmaceuticals, particularly focusing on glycopeptide antibiotics. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Patent Overview

Publication Details

• Publication Number: US10039804B2
• Authority: United States
• Prior Art Date: The patent is based on an application filed on October 27, 2017[4].

Scope of the Patent

Glycopeptide Antibiotics

The patent pertains to glycopeptide antibiotic compositions, which are crucial in the treatment of bacterial infections. Glycopeptide antibiotics, such as vancomycin, are known for their effectiveness against Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA)[4].

Key Components

The compositions described in the patent include glycopeptide antibiotics combined with specific amino acids or their derivatives. Notably, the patent mentions the use of N-acetyl-D-Alanine or N-acetyl-Glycine, which are added to enhance the stability and efficacy of the glycopeptide antibiotics[4].

Claims of the Patent

Composition Claims

The patent includes several claims related to the composition of the glycopeptide antibiotic formulations. These claims specify:

• The presence of a glycopeptide antibiotic, such as vancomycin.
• The inclusion of N-acetyl-D-Alanine or N-acetyl-Glycine.
• The molar ratio of the glycopeptide antibiotic to the amino acid or its derivative[4].

Method Claims

In addition to composition claims, the patent also covers methods for preparing these glycopeptide antibiotic compositions. These methods involve mixing the glycopeptide antibiotic with the specified amino acids or their derivatives under controlled conditions to ensure stability and efficacy[4].

Use Claims

The patent further includes claims related to the use of these compositions in treating bacterial infections. These claims highlight the therapeutic applications of the glycopeptide antibiotic compositions, emphasizing their effectiveness against various bacterial strains[4].

Patent Landscape

Related Patents

The patent landscape for glycopeptide antibiotics is complex and involves multiple patents and patent applications. Here are some relevant patents and their contributions:

• US20220133845A1: This patent application discusses liquid formulations and methods for glycopeptide antibiotics, including the use of solubilizing and stabilizing agents[1].
• WO2001/82971A2: This international patent application describes pharmaceutical compositions containing a cyclodextrin and a glycopeptide antibiotic, which enhances the solubility and stability of the antibiotic[1].

Patent Expiration and Generic Launch

The patent US10039804B2 is one of several patents protecting vancomycin and its formulations. These patents are set to expire in November 2035, which will pave the way for the launch of generic versions of vancomycin[2].

Legal Activities and Oppositions

Recent legal activities on vancomycin's patents include changes in power of attorney and email notifications. Additionally, oppositions filed on European patents can impact the timeline for the generic launch of vancomycin. For instance, the revocation of certain European patents could shorten the exclusivity period, allowing generic versions to enter the market earlier[2].

Strategic Implications

Patent Analytics

Understanding the scope and claims of this patent, along with the broader patent landscape, is crucial for strategic planning. Patent analytics tools can help in categorizing patents by claims and scope concepts, identifying gaps or opportunities in the intellectual property portfolio[3].

Market Entry

The expiration of these patents and the potential for earlier generic entry due to oppositions on European patents need to be carefully monitored. Companies can identify markets with weaker patent protection as ideal entry points for generic versions of vancomycin[2].

Key Takeaways

• Glycopeptide Compositions: The patent focuses on glycopeptide antibiotic compositions, including vancomycin, combined with N-acetyl-D-Alanine or N-acetyl-Glycine.
• Claims: The patent includes claims related to the composition, preparation methods, and therapeutic uses of these glycopeptide antibiotic formulations.
• Patent Landscape: The patent is part of a complex landscape involving multiple patents and patent applications related to glycopeptide antibiotics.
• Expiration and Generic Launch: The patents protecting vancomycin are set to expire in November 2035, allowing for the launch of generic versions.
• Strategic Implications: Understanding the patent landscape and monitoring legal activities are essential for strategic planning and market entry.

FAQs

What is the main focus of United States Patent 10,039,804?

The main focus of this patent is on glycopeptide antibiotic compositions, specifically those including vancomycin combined with N-acetyl-D-Alanine or N-acetyl-Glycine.

What are the key components of the glycopeptide antibiotic compositions described in the patent?

The key components include a glycopeptide antibiotic (such as vancomycin) and N-acetyl-D-Alanine or N-acetyl-Glycine.

When are the patents protecting vancomycin set to expire?

The patents protecting vancomycin are set to expire in November 2035.

How do oppositions on European patents impact the generic launch of vancomycin?

Oppositions on European patents can result in the revocation or amendment of patents, potentially shortening the exclusivity period and allowing generic versions to enter the market earlier.

What is the significance of patent analytics in understanding this patent?

Patent analytics helps in categorizing patents by claims and scope concepts, identifying gaps or opportunities in the intellectual property portfolio, and aiding in strategic planning and market entry decisions.

Sources

1. US20220133845A1 - Glycopeptide antibiotics liquid formulations and methods and uses thereof - Google Patents
2. Vancomycin patent expiration - Pharsight
3. Patent Analytics | Intellectual Property Law - SLWIP
4. US10039804B2 - Glycopeptide compositions - Google Patents
5. Glycopeptide compositions - Patent US-10039804-B2 - PubChem

Drugs Protected by US Patent 10,039,804

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Xellia Pharms Aps	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	SOLUTION;INTRAVENOUS	211962-002	Feb 15, 2019		RX	Yes	Yes			Y			METHOD OF TREATING BACTERIAL INFECTIONS
Xellia Pharms Aps	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	SOLUTION;INTRAVENOUS	211962-006	May 13, 2020		RX	Yes	Yes			Y			METHOD OF TREATING BACTERIAL INFECTIONS
Xellia Pharms Aps	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	SOLUTION;INTRAVENOUS	211962-003	Feb 15, 2019		RX	Yes	Yes			Y			METHOD OF TREATING BACTERIAL INFECTIONS
Xellia Pharms Aps	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	SOLUTION;INTRAVENOUS	211962-007	May 13, 2020		RX	Yes	Yes			Y			METHOD OF TREATING BACTERIAL INFECTIONS
Xellia Pharms Aps	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	SOLUTION;INTRAVENOUS	211962-004	Feb 15, 2019		RX	Yes	Yes			Y			METHOD OF TREATING BACTERIAL INFECTIONS

International Family Members for US Patent 10,039,804

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015341763
Brazil	112017009405
Canada	2964524
Chile	2017001139
China	107073072