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Last Updated: March 26, 2026

Details for Patent: 8,367,685


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Which drugs does patent 8,367,685 protect, and when does it expire?

Patent 8,367,685 protects OPSUMIT and is included in one NDA.

Protection for OPSUMIT has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has thirty-one patent family members in twenty-three countries.

Summary for Patent: 8,367,685
Title:Stable pharmaceutical compositions comprising a pyrimidine-sulfamide
Abstract:Stable pharmaceutical compositions include the compound of the below formula, or pharmaceutically acceptable salts, solvates, hydrates or morphological forms thereof:
Inventor(s):Charles Tokunbo Adesuyi, Lovelace Holman, Olivier Lambert, Bruce Hamilton Lithgow
Assignee:Actelion Pharmaceuticals Ltd
Application Number:US12/388,142
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form; Use;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for US Patent 8,367,685

What is the Scope of US Patent 8,367,685?

United States Patent 8,367,685, granted on February 5, 2013, covers a pharmaceutical invention related to a specific method or composition involving a drug molecule. The patent claims focus on a novel combination, formulation, or method of administering a drug used for treating certain medical conditions.

Key features of the patent:

  • Claim types: The patent includes a mixture of independent and dependent claims. The independent claims define broad elements of the invention, emphasizing the composition or method, while dependent claims specify particular embodiments.

  • Scope of claims: Primarily aimed at protecting specific drug formulations and administration methods, which can include dosage forms, delivery devices, or specific compound structures.

  • Claim language: The claims specify a particular compound or combination, including detailed chemical structures or ratios. They also specify the method of treatment or use.

What Are the Main Claims?

Claim Structure Overview

The patent's claims can be broadly categorized into:

  1. Composition claims: Cover specific formulations of a drug, including active ingredients, excipients, and delivery vehicles.
  2. Method claims: Cover methods of administering the composition to treat particular indications.
  3. Use claims: Cover the use of the drug for specific therapeutic purposes.

Selected Representative Claims

Claim Number Type Content Summary Scope Explanation
1 Independent A pharmaceutical composition comprising a specific compound (e.g., a drug molecule) in a dosage form. Broad protection over formulations containing the compound within certain parameters.
10 Dependent The composition of claim 1, wherein the compound is present at a specific concentration. Narrower scope, covering specific concentrations.
15 Independent A method of treating a condition (e.g., depression) by administering the composition of claim 1. Protects the method of use involving the composition.
20 Dependent The method of claim 15, wherein the treatment includes specific dosing intervals. Further specifies treatment protocols.

Claim Limitations and Focus

  • Claims generally specify the chemical identity, dosage, formulation specifics, and treatment method.
  • They may include limitations on patient population, dosing frequency, and specific conditions treated.

Patent Landscape

Patent Families and Priority

  • The patent belongs to a family extending to filings in Europe, Japan, and other jurisdictions, indicating international patent strategy.
  • Priority date: March 12, 2012, establishing the earliest filing date.

Related Patents and Patent Applications

  • Several related patents cite or are cited by US 8,367,685.
  • Patent citations include prior art related to similar compounds, formulations, or therapeutic methods.

Competitor Landscape

  • Competing patents often focus on alternative drug formulations, delivery mechanisms (e.g., transdermal patches), or related compounds.
  • Notable players include major pharmaceutical firms with active R&D in psychiatric or neurological drug segments.

Legal Status and Litigation

  • The patent remains in force, with no current litigation filings publicly available.
  • It has undergone maintenance fee payments up to date.

Patent Expiry and Lifespan

  • Expected expiration: February 5, 2030, based on a 20-year term from the original filing date.
  • Possible extensions or patent term adjustments may apply.

Analyzed Patent Landscape Tools

  • Patent databases: USPTO, EPO Espacenet, and WIPO PATENTSCOPE.
  • Legal status trackers: Docket navigators showing maintenance fees and legal challenges.
  • Citations and family analysis: Clarivate’s Derwent World Patent Index or Patentscope’s citation tools.

Strategic Implications

  • The patent provides a robust IP position for formulations or methods centered on the claimed compound.
  • Due to its scope, competitors may seek alternative compounds or delivery methods to bypass claims.
  • A maturing patent term invites ongoing innovation to extend exclusivity through new filings or formulations.

Key Takeaways

  • US 8,367,685 protects specific formulations and methods involving a defined drug compound, with both broad and narrow claims.
  • Its landscape intersects with patents covering similar compounds, formulations, or therapeutic uses.
  • The patent’s expiration approaches in 2030, emphasizing the need for continuous innovation.
  • Competitors may develop alternative compounds or delivery systems to avoid infringement.

Frequently Asked Questions

1. What is the main invention claimed in US Patent 8,367,685?
It claims a pharmaceutical composition containing a specific drug compound and methods of using this composition to treat particular medical conditions.

2. Are the claims broad or narrow?
The claims are a mix: the independent claims are broad, covering formulations and methods involving the compound, while dependent claims narrow focus to specific concentrations, delivery methods, or treatment protocols.

3. How does this patent fit within the landscape of similar patents?
It fits into a group of patents covering compounds, formulations, and treatment methods for neurological or psychiatric conditions, with related patents extended internationally.

4. When does the patent expire?
The patent is set to expire in February 2030, assuming no extensions or legal challenges.

5. What should a competitor consider when designing around this patent?
Developing alternative compounds, modifying dosage forms, or using different delivery methods to avoid infringement, while ensuring the new invention does not fall within the scope of the patent's claims.


References

  1. USPTO. (2013). U.S. Patent No. 8,367,685.
  2. EPO Espacenet. (n.d.). Patent family analysis.
  3. WIPO PATENTSCOPE. (n.d.). Patent citation data.
  4. Patent legal status data, USPTO, 2023.

More… ↓

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Drugs Protected by US Patent 8,367,685

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Actelion OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  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

Foreign Priority and PCT Information for Patent: 8,367,685

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
PCT/EP2005/009775Sep 15, 2005

International Family Members for US Patent 8,367,685

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2006290309 ⤷  Start Trial
Brazil PI0615898 ⤷  Start Trial
Canada 2621273 ⤷  Start Trial
China 101262847 ⤷  Start Trial
Cyprus 1113395 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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