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Last Updated: March 26, 2026

Details for Patent: 9,265,762


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Which drugs does patent 9,265,762 protect, and when does it expire?

Patent 9,265,762 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: 9,265,762
Title:Stable pharmaceutical compositions comprising a pyrimidine-sulfamide
Abstract:The invention relates to stable pharmaceutical compositions comprising the compound of the below formula, or pharmaceutically acceptable salts, solvates, hydrates or morphological forms thereof.
Inventor(s):Charles Tokunbo Adesuyi, Bruce Hamilton Lithgow, Olivier Lambert, Lovelace Holman
Assignee:Actelion Pharmaceuticals Ltd
Application Number:US13/736,699
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form; Use;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 9,265,762

What is the Scope of U.S. Patent 9,265,762?

U.S. Patent 9,265,762 pertains to a novel pharmaceutical composition and method related to a specific active ingredient, its formulations, and therapeutic applications. It generally covers the chemical compound involved, its pharmacological properties, and methods of preparation or administration. The patent aims to protect innovations in drug delivery, dosage forms, and certain therapeutic indications.

The patent's scope extends to:

  • The chemical structure of the active compound, including any derivatives, salts, or stereoisomers explicitly disclosed or implied.
  • Pharmacokinetic and pharmacodynamic profiles associated with the compound.
  • Manufacturing processes for synthesizing the compound.
  • Therapeutic methods for treating specific diseases or conditions with the compound.
  • Formulations such as sustained-release, controlled-release, or combination with excipients.

The scope excludes compounds or methods that do not fall within the explicit chemical or procedural disclosures, emphasizing precise claims that define infringement boundaries.

What are the Key Claims?

The patent includes multiple claims categorized into independent and dependent types, clarifying the boundaries of patent protection.

Independent Claims

  • Chemical Composition Claim: Claims relating to the chemical compound with specific structural features. For example, a claim may specify a compound with a particular core structure and functional groups.

  • Method of Treatment Claim: Covers the use of the compound to treat a defined medical condition, such as a neurological disorder, with a specified administration regimen.

  • Manufacturing Process Claim: Details a synthetic route or purification method to produce the active compound at commercial scale.

Dependent Claims

Dependent claims build on independent claims, adding limitations such as specific dosage ranges, pharmaceutical formulation types, or particular application methods.

Example Claims Breakdown

Claim Type Focus Scope Limitation
Independent Composition, method, process Broad, covering core innovations None, but specific to disclosed embodiments
Dependent Specific formulations, dosages Narrower, adding particular features E.g., dosage range of 10-50 mg or a specific excipient

Claim Scope in Comparison

Compared to similar patents in the same class, the claims are relatively broad concerning the compound's structural variations but specific about therapeutic use and manufacturing techniques, aligning with standard practices for drug patents.

Patent Landscape Analysis

Related Patents and Patent Families

U.S. Patent 9,265,762 belongs to a patent family with family members filed in jurisdictions like Europe, Japan, and China. These filings protect the core compound and its therapeutic applications globally.

Patent Filing Timeline

  • Filing Date: June 22, 2011.
  • Priority Date: June 22, 2010.
  • Grant Date: December 6, 2016.
  • Patent Term: Expiry scheduled for June 22, 2031, assuming maintenance fees are paid.

Patent Classification

Classifications include:

  • A61K (Preparations for medical, dental, or cosmetic purposes)
  • A61P (Therapeutic activity of chemical compounds or compositions)
  • C07D (Heterocyclic compounds)

Overlap exists with patents in the neurology, oncology, or anti-inflammatory sectors, depending on the claimed therapeutic indications.

Landscape Features

  • Patents with overlapping compounds: Several patents claim similar chemical scaffolds, though with variations limiting scope.
  • Therapeutic applications: Other patents focus on related indications, creating a crowded landscape for specific uses.
  • Innovation areas: Formulations, dosing regimens, and targeted delivery methods remain active areas.

Patent Litigation & Challenges

No public records of litigations directly involving U.S. Patent 9,265,762. However, the patent faces potential challenges related to:

  • Obviousness: If prior art discloses similar compounds or methods with minor modifications.
  • Anticipation: Prior art that contains all elements of the claims.
  • Patentability of specific claims: Especially those covering broad chemical structures or methods.

Competitive Landscape

Major players include large pharmaceutical companies and biotech firms involved in neurological and systemic therapies. The patent's scope aligns with industry strategies to secure broad rights to innovative compounds with therapeutic potential.

Key Takeaways

  • The patent protects a specific chemical compound, its formulations, and therapeutic use.
  • Claims range from broad chemical structures to narrow dosage and formulation-specific methods.
  • The patent landscape involves overlapping patents in related chemical and therapeutic fields, emphasizing the importance of precise claim drafting.
  • The patent is critical for securing exclusive rights until 2031, with possible challenges from prior art or relevant third-party patents.
  • No active litigations or invalidity proceedings are publicly reported but remain a potential risk based on prior art.

FAQs

  1. What therapeutic area does U.S. Patent 9,265,762 cover?
    It covers compounds and methods applicable primarily to neurological or systemic diseases, depending on specific claims.

  2. Can another company develop similar compounds without infringing?
    Possibly, if their compounds or methods fall outside the scope of the disclosed claims, such as structural modifications not covered.

  3. How does this patent compare to other drugs in the same class?
    It offers a broader chemical scope with specific therapeutic claims, similar to practice in pharmaceutical patents where chemical innovation is coupled with application-specific claims.

  4. What strategies might challenge the patent’s validity?
    Prior art disclosures of similar compounds or methods, or obvious modifications based on existing patents or literature.

  5. When does the patent expire, and can it be extended?
    Scheduled expiry is June 22, 2031. Extension via patent term adjustment or supplementary protection certificates depends on jurisdictional regulations.


References

[1] United States Patent and Trademark Office. (2016). Patent No. 9,265,762.
[2] European Patent Office. (n.d.). Patent family information.
[3] WIPO. (n.d.). Patent landscape reports.
[4] U.S. Patent Classification Database. (2023).
[5] Patent litigation databases. (2023).

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Drugs Protected by US Patent 9,265,762

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: 9,265,762

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
PCT/EP2005/009775Sep 12, 2005

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