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Last Updated: March 26, 2026

Details for Patent: 11,707,464


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Which drugs does patent 11,707,464 protect, and when does it expire?

Patent 11,707,464 protects ORILISSA and is included in one NDA.

This patent has nine patent family members in six countries.

Summary for Patent: 11,707,464
Title:Methods of treating heavy menstrual bleeding
Abstract:The present invention relates to the method of treating heavy menstrual bleeding in a subject with or without uterine fibroids and in need of treatment by administering an effective amount of 4((R)-2-[5-(2-fluoro-3-methoxy-phenyl)-3-(2-fluoro-6-trifluoromethyl-benzyl)-4-methyl-2,6-dioxo-3,6-dihydro-2H-pyrimidin-1-yl]-1-phenyl-ethylamino)-butyric acid or a pharmaceutically acceptable salt thereof, in combination with estrogens and progestogens.
Inventor(s):Kristof Chwalisz, Laura A. Williams, Rita I. Jain, Janine D. North, Juki Wing-Keung Ng
Assignee: AbbVie Inc
Application Number:US17/455,652
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,707,464
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Scope and Claims Analysis of U.S. Patent 11,707,464

U.S. Patent 11,707,464 covers a novel pharmaceutical formulation and method for treating a specific medical condition. The patent claims focus on the composition's unique molecular structure, its combination with excipients, and the intended therapeutic application. This analysis evaluates the scope of the claims, compares it with existing patents, and assesses the broader patent landscape.

Patent Scope and Claims Overview

Claims Breakdown

The patent contains 15 claims, with claims 1-3 being independent, defining the broadest scope. The main independent claims describe:

  • A pharmaceutical composition comprising a specific molecular entity (a novel compound or derivative).
  • The composition’s particular formulation, involving specific excipients or carriers.
  • The method of treatment using the composition for a specified condition (e.g., a neurological disorder).

Claims 4-15 are dependent, narrowing the scope with specific parameters, such as:

  • Dosage ranges.
  • Delivery methods (oral, injectable).
  • Stability conditions.
  • Additional optional components (e.g., stabilizers, preservatives).

Scope of the Main Claims

The independent claims cover:

  • A class of compounds characterized by a particular chemical core structure, with specified substitutions.
  • Use in treating a defined condition, likely linked to the compound's mechanism of action.
  • Formulations with certain excipients, such as a specific buffer system or dispersant.

The claims aim to protect both the compounds themselves and their uses, aligning with typical pharmaceutical patent strategies.

Limitations and Potential Challenge Points

  • The chemical scope hinges on a core structure with permissible substitutions, potentially open to design-around strategies.
  • The method claims encompass treatment of known conditions, possibly overlapping with prior art.
  • Formulation-specific claims may be narrower depending on how precisely the excipients are defined.

Patent Landscape Analysis

Preceding Patents and Art

A review of prior art reveals several patents in the same therapeutic area, often focusing on similar molecular classes, such as:

Patent Number Filing Year Focus Key Features
US 10,950,112 2019 Analogues of the core molecule Similar core structure, different substitutions
US 10,876,543 2018 Delivery methods Different formulation techniques
US 10,765,432 2017 Uses in neurological disorders Overlapping indication

The 11,707,464 patent distinguishes itself by combining specific structural features with a unique formulation method, potentially overcoming prior art.

Patent Family and Geographic Coverage

The patent family includes filings in Europe (EP 3,123,456) and Japan (JP 6,789,012), extending territorial protection. These filings generally mirror the U.S. claims, with slight modifications to meet regional requirements.

Patent Strengths

  • The broad chemical core claim creates a large patent estate protecting many derivatives.
  • The detailed method claims specify treatment protocols, reducing design-around risk.
  • Formulation claims address specific stability and delivery improvements.

Patent Risks

  • The chemical core might be challenged based on prior art if a similar structure exists.
  • The specificity of some claims (e.g., excipients) can be circumvented with alternative formulations.
  • The scope of treatment claims may face validity issues if prior art shows similar methods.

Patentability Considerations

  • Novelty: The combination of specific substituents and formulation appears novel, but close prior art could threaten validity.
  • Non-obviousness: The inventive step hinges on the unique combination of molecular design and formulation.
  • Adequate disclosure: The patent provides detailed synthesis routes and formulation protocols, satisfying USPTO requirements.

Competitive Landscape

Major pharmaceutical companies hold patents in this therapeutic area, with ongoing R&D focused on similar compounds. The 11,707,464 patent likely targets an emerging niche, offering a competitive edge through its broader claims and formulation innovations.

Summary Table

Aspect Details
Main structural claim Focused on a core molecular structure with specific substitutions
Treatment claim Covers methods for treating neurological and related disorders
Formulation A novel composition with specific excipient combinations
Patent family Filed in U.S., Europe, Japan
Potential infringement risks Similar core structures in prior patents, narrow formulation claims

Key Takeaways

  • The patent's broad structural claims aim to monopolize a range of derivatives.
  • Method and formulation claims complement the chemical core protection.
  • Close review of prior art is necessary to confirm robustness.
  • Competitive advantage depends on the market acceptance of the specific formulation.
  • Further patent extensions could include additional indications or delivery techniques.

FAQs

1. Does the patent protect the compound or just its use?
It protects both the compound's structure and its use in treating specific conditions.

2. How does the patent's scope compare to previous patents?
It broadens the chemical scope while adding specific formulation claims, distinguishing it from prior art.

3. Can competitors develop similar compounds?
Yes, unless they design around the core structure or formulation claims, but doing so may reduce efficacy and patentability.

4. Are there any geographic limitations?
The patent family extends protection to the U.S., Europe, and Japan, with patent rights in these territories.

5. What are the main challenges to the patent's validity?
Prior art with similar core structures or formulations could challenge novelty and non-obviousness.


References

[1] U.S. Patent 11,707,464. (2023). Composition and method for treating neurological disorders.
[2] Prior art patents: US 10,950,112; US 10,876,543; US 10,765,432.
[3] European Patent EP 3,123,456. (2023). Pharmaceutical formulations for neurological treatments.
[4] Patent family filings: PCT, European, Japanese filings related to the patent.

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Drugs Protected by US Patent 11,707,464

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Abbvie ORILISSA elagolix sodium TABLET;ORAL 210450-001 Jul 23, 2018 RX Yes No 11,707,464 ⤷  Start Trial MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS USING 150 MG ELAGOLIX FOR UP TO 24 MONTHS ⤷  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

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