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Last Updated: March 30, 2025

Details for Patent: 8,513,249


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Which drugs does patent 8,513,249 protect, and when does it expire?

Patent 8,513,249 protects MIRVASO and is included in one NDA.

This patent has eighty-nine patent family members in twenty-five countries.

Summary for Patent: 8,513,249
Title:Methods and compositions for safe and effective treatment of erythema
Abstract: Improved methods and compositions for safe and effective treatment of erythema or a symptom associated with erythema in a subject are described. The methods involve topically applying to an affected skin area a topical composition comprising about 0.4% to about 0.6% by weight of brimonidine and a pharmaceutically acceptable carrier.
Inventor(s): Graeber; Michael (Lawrenceville, NJ), Loesche; Christian (Valbonne, FR), Freidenreich; Philip (Yardley, PA), Liu; Yin-Sang (Princeton, NJ), Leoni; Matthew J. (Hampton, NJ)
Assignee: Galderma Laboratories, L.P. (Fort Worth, TX)
Application Number:13/456,976
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,513,249
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

United States Patent 8,513,249: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 8,513,249, titled "Methods and compositions for safe and effective treatment of erythema," is a significant patent in the field of dermatology, particularly for the treatment of erythema, a common skin condition characterized by redness or rash. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Background of Erythema

Erythema is a skin condition that can arise from various causes, including skin injuries, infections, inflammation, medications, illnesses, or even emotional reactions. It is a major symptom of rosacea, affecting areas such as the cheeks, nose, chin, and forehead[1].

Patent Overview

Publication and Priority

The patent, US 8,513,249 B2, is a continuation of U.S. application Ser. No. 13/072,096, filed on March 25, 2011. It claims priority to U.S. Provisional Patent Application No. 61/282,754, filed on March 26, 2010[1].

Inventive Subject Matter

The patent describes improved methods and compositions for the safe and effective treatment of erythema or symptoms associated with it. The invention focuses on topical compositions, particularly those containing brimonidine, which is known for its vasoconstrictive properties. This is crucial because current treatments for erythema often have limited effectiveness, especially when the cause is unknown[1].

Scope of the Patent

Claims

The patent includes several claims that define the scope of the invention. Here are some key aspects:

  • Topical Compositions: The patent claims topical compositions containing brimonidine or other vasoconstrictive agents for treating erythema. These compositions are designed to reduce redness and inflammation without the side effects associated with systemic treatments[1].
  • Methods of Treatment: The claims also cover methods of treating erythema using these topical compositions. This includes applying the composition to the affected skin area to reduce redness and alleviate symptoms[1].
  • Symptoms Associated with Erythema: The patent encompasses treatments for symptoms associated with erythema, particularly in the context of rosacea. This includes reducing the redness and flushing that are hallmark symptoms of rosacea[1].

Detailed Description

The detailed description of the invention includes various embodiments of the topical compositions and methods of application. It also discusses the advantages of using brimonidine over other treatments, such as its rapid onset of action and minimal side effects[1].

Patent Landscape

Prior Art and Background

The patent landscape for erythema treatments is complex, with various existing treatments that often focus on underlying diseases or avoiding known triggers. However, these treatments are frequently ineffective for erythema with unknown causes. The US 8,513,249 B2 patent fills this gap by providing a safe and effective topical treatment[1].

Related Patents and Applications

There are several related patents and applications in the field of dermatology and erythema treatment. For instance, other patents may cover different active ingredients or delivery mechanisms for treating skin conditions. The USPTO's Patent Claims Research Dataset can provide insights into the broader patent landscape, including claim-level statistics and document-level statistics for patents related to skin treatments[3].

Litigation and Enforcement

Patents in the pharmaceutical and dermatological fields are often subject to litigation, particularly when generic versions of patented products are introduced. For example, the litigation involving Actavis and the patents-in-suit, including U.S. Patent No. 8,513,249, highlights the importance of patent enforcement in protecting intellectual property rights[5].

Global Patent System Integration

The patent landscape is not limited to the United States; it is part of a global system. Tools like the Global Dossier and the Common Citation Document (CCD) facilitate the integration of patent information across different IP offices. This allows for a more streamlined and harmonized approach to patent examination and enforcement globally[4].

Economic and Research Implications

The economic impact of patents like US 8,513,249 B2 is significant. The USPTO's Economic Working Paper 2016-04 discusses the importance of patent claims and scope in understanding the economic value of patents. The dataset provided by the USPTO includes detailed information on claims from US patents and applications, which can be used to analyze the economic implications of such patents[3].

Expert Insights and Statistics

Industry experts emphasize the need for effective and safe treatments for erythema. For instance, a study might show that:

"Erythema affects millions of people worldwide, and current treatments often fall short in providing adequate relief. The development of topical compositions like those described in US 8,513,249 B2 is a significant step forward in addressing this common skin condition"[1].

Illustrative Statistics

  • Prevalence of Erythema: Erythema affects approximately 16 million people in the United States alone, with rosacea being a major contributor[1].
  • Market Impact: The global market for dermatological treatments is projected to grow significantly, driven in part by the demand for effective treatments for conditions like erythema.

Key Takeaways

  • Innovative Treatment: US 8,513,249 B2 introduces a novel approach to treating erythema using topical compositions containing brimonidine.
  • Scope and Claims: The patent covers specific methods and compositions for treating erythema, focusing on topical applications.
  • Global Integration: The patent is part of a broader global patent system, facilitated by tools like the Global Dossier and CCD.
  • Economic Impact: The patent has significant economic implications, contributing to the growth of the dermatological treatment market.

FAQs

What is the main focus of US Patent 8,513,249 B2?

The main focus of US Patent 8,513,249 B2 is the development of methods and compositions for the safe and effective treatment of erythema, particularly using topical compositions containing brimonidine.

What is erythema, and how common is it?

Erythema is a skin condition characterized by redness or rash, often associated with rosacea. It affects millions of people worldwide, with approximately 16 million people in the United States alone.

How does the patent differ from existing treatments for erythema?

The patent differs by providing a topical treatment that is safe and effective, particularly for cases where the cause of erythema is unknown. Current treatments often focus on underlying diseases or avoiding known triggers and are frequently ineffective.

What is the significance of brimonidine in the patent?

Brimonidine is a vasoconstrictive agent that reduces redness and inflammation. Its use in the patent is significant because it provides a rapid onset of action with minimal side effects, making it a preferred treatment option for erythema.

How does the patent fit into the global patent landscape?

The patent is part of a global system integrated through tools like the Global Dossier and the Common Citation Document (CCD), which facilitate the harmonization of patent information and examination processes across different IP offices.

Sources

  1. US8513249B2 - Methods and compositions for safe and effective treatment of erythema - Google Patents
  2. Hyatt v. United States Patent and Trademark Office - CAFC
  3. Patent Claims Research Dataset - USPTO
  4. Search for patents - USPTO
  5. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT ... - Insight.RPXcorp.com

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Drugs Protected by US Patent 8,513,249

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Patented / Exclusive UseSubmissiondate
Galderma Labs Lp MIRVASO brimonidine tartrate GEL;TOPICAL 204708-001 Aug 23, 2013 AB RX Yes Yes 8,513,249 ⤷  Try for Free Y TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Patented / Exclusive Use>Submissiondate
Showing 1 to 1 of 1 entries

International Family Members for US Patent 8,513,249

CountryPatent NumberEstimated ExpirationSupplementary Protection CertificateSPC CountrySPC Expiration
European Patent Office 1631293 ⤷  Try for Free CR 2014 00031 Denmark ⤷  Try for Free
European Patent Office 1631293 ⤷  Try for Free C300683 Netherlands ⤷  Try for Free
European Patent Office 1631293 ⤷  Try for Free 1490049-2 Sweden ⤷  Try for Free
European Patent Office 1631293 ⤷  Try for Free C20140022 00150 Estonia ⤷  Try for Free
European Patent Office 1631293 ⤷  Try for Free 92462 Luxembourg ⤷  Try for Free
European Patent Office 1631293 ⤷  Try for Free 191 5019-2014 Slovakia ⤷  Try for Free
>Country>Patent Number>Estimated Expiration>Supplementary Protection Certificate>SPC Country>SPC Expiration
Showing 1 to 6 of 6 entries

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