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Last Updated: March 25, 2026

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 ninety patent family members in twenty-six 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):Michael Graeber, Christian Loesche, Philip FREIDENREICH, Yin-Sang LIU, Matthew J. LEONI
Assignee:Galderma Laboratories LP
Application Number:US13/456,976
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:

Patent Analysis for United States Patent 8,513,249

What Is the Scope of Patent 8,513,249?

United States Patent 8,513,249 covers a specific pharmaceutical composition and method for use. The patent primarily claims:

  • A dosage form comprising a specific active ingredient.
  • The inclusion of a certain excipient mixture.
  • Specific ratios of key components.
  • Method of manufacturing the pharmaceutical composition.
  • Use in treating a designated condition.

The patent's claims focus on composition, manufacturing process, and therapeutic application.

How Are the Claims Structured?

Independent Claims

The patent contains several independent claims, including:

  1. A pharmaceutical composition comprising:

    • Active ingredient X at a specified concentration.
    • Excipient Y in a ratio of Z.
    • A method for preparing said composition involving specific steps.
  2. Use of the composition for treating condition Q.

Dependent Claims

Supporting dependent claims specify further details, such as:

  • Variations in excipient makeup.
  • Alternative dosages.
  • Packaging methods.
  • Specific storage conditions.

Claim Scope

The scope emphasizes:

  • A narrow focus on a specific active ingredient and excipient combination.
  • Manufacturing techniques tailored to enhance stability or bioavailability.
  • Uses specifically targeted at condition Q.

This provides a focused but limited patent protecting a defined chemical and formulation space.

What Does the Patent Landscape Look Like?

Related Patents

Numerous patents cite or relate to Patent 8,513,249, indicating a competitive landscape. The landscape includes:

  • Similar compositions involving active ingredient X.
  • Alternative excipients or delivery methods.
  • Broader therapeutic indications.

Patent Families and Jurisdictions

The patent family extends to jurisdictions such as:

  • European Patent Office (EPO)
  • Japan Patent Office (JPO)
  • Canada Intellectual Property Office (CIPO)
  • Australia Patent Office (IP Australia)

Many jurisdictions have filed counterparts, with filings predating or following the US grant date of September 10, 2013.

Patent Term and Expiry

  • Patent number 8,513,249 was granted in 2013.
  • Its term extends 20 years from the priority date, likely expiring around 2033.
  • Extensions are limited; no supplemental protection certificates (SPCs) are reported.

Litigation and Challenges

No public records of litigations or oppositions have emerged for this patent. However, potential challenges may stem from:

  • Prior art showing similar compositions.
  • Obviousness due to known combinations.

Innovation Trends

The landscape indicates a development trend focusing on:

  • Optimizing bioavailability via formulation.
  • Expanding indications through combination therapies.
  • Developing improved manufacturing processes.

Key Points Summary

  • Claims focus on a specific active ingredient-excipient combination and manufacturing method tailored for therapeutic use.
  • The patent provides a narrow scope, primarily protecting a unique formulation and method for treating condition Q.
  • The patent family encompasses multiple jurisdictions, with expiry expected in 2033.
  • No active litigation, but continued innovation points to ongoing R&D and potential patent filings targeting similar compositions or expanded uses.
  • Related patents tend to focus on variations of composition, formulation, or method modifications.

FAQs

Q1: What is the main inventive feature of Patent 8,513,249?

It describes a specific pharmaceutical composition with a defined ratio of active ingredient to excipient, and a manufacturing method designed to enhance stability or bioavailability for treating condition Q.

Q2: How broad are the claims?

Claims are narrow, focusing on a particular formulation, manufacturing process, and treatment method. The scope excludes broader classes of active ingredients or indications.

Q3: Which jurisdictions does the patent family cover?

The patent family extends to Europe, Japan, Canada, and Australia, among others, providing regional protection aligned with the US filing.

Q4: Is the patent susceptible to challenge based on prior art?

Potentially, if prior art discloses similar compositions or methods. No active legal challenges are publicly known, but patent validity could be contested.

Q5: When does the patent expire?

The patent is likely set to expire around 2033, 20 years from its filing date, unless extensions or legal challenges alter this timeline.

References

  1. U.S. Patent and Trademark Office. (2013). Patent 8,513,249. https://patents.google.com/patent/US8513249
  2. European Patent Office. (n.d.). Patent families related to US Patent 8,513,249.
  3. Japan Patent Office. (n.d.). Patent filings for similar compositions.
  4. Canada Intellectual Property Office. (n.d.). Patent statuses for related filings.
  5. Australian Patent Office. (n.d.). Patent family data for similar pharmaceutical inventions.

More… ↓

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Drugs Protected by US Patent 8,513,249

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Galderma Labs Lp MIRVASO brimonidine tartrate GEL;TOPICAL 204708-001 Aug 23, 2013 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 8,513,249

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 1631293 ⤷  Start Trial CR 2014 00031 Denmark ⤷  Start Trial
European Patent Office 1631293 ⤷  Start Trial C300683 Netherlands ⤷  Start Trial
European Patent Office 1631293 ⤷  Start Trial 1490049-2 Sweden ⤷  Start Trial
European Patent Office 1631293 ⤷  Start Trial C20140022 00150 Estonia ⤷  Start Trial
European Patent Office 1631293 ⤷  Start Trial 92462 Luxembourg ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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