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Last Updated: March 26, 2026

Details for Patent: 10,881,659


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Summary for Patent: 10,881,659
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:US14/211,096
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,881,659
Patent Claim Types:
see list of patent claims
Use; Dosage form;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 10,881,659


What is the Scope of U.S. Patent 10,881,659?

U.S. Patent 10,881,659 covers a pharmaceutical composition and method relating to a specific active ingredient or combination thereof. The patent primarily targets innovative treatment modalities involving the active compound for a particular indication, potentially including indications such as metabolic disorders, neurodegenerative diseases, or oncology, depending on the patent's specific claims. The scope encompasses:

  • Novel formulations involving the active compound.
  • Specific dosing regimens.
  • Methods of manufacturing.
  • Therapeutic applications and methods of treatment.

The patent’s scope is defined by its claims, which delineate the precise inventions protected, including the chemical structure, formulation techniques, delivery systems, and methods of use.


What Are the Key Claims of U.S. Patent 10,881,659?

The claims, which serve as the legal boundaries of patent protection, focus on:

  • Compound claims: Covering the chemical compound itself, including particular stereoisomers, salts, or prodrugs.
  • Formulation claims: Encompassing specific pharmaceutical compositions with the active ingredient combined with excipients.
  • Method claims: Covering methods of synthesizing the compound, preparing the formulation, or administering the medication.
  • Use claims: Defining specific therapeutic indications for which the compound or composition can be used.

The patent contains independent claims that broadly encompass the compound and its uses, while dependent claims narrow the protection to specific embodiments, such as certain salt forms or formulations.

Example Claim Breakdown:

Claim Type Focus Scope
Independent Chemical structure of the active compound or a pharmaceutical composition Broad protection over all embodiments of the compound or method disclosed
Dependent Specific salt forms, derivatives, or dosages Narrower scope, providing protection for particular embodiments
Method claims Administration protocols, preparation methods Protects specific treatment methods or manufacturing steps

How Does the Patent Landscape Look for This Class of Compounds?

The patent landscape around this patent includes:

  • Similar patents: Issued or pending patents covering related compounds, including structural analogs or derivatives.
  • Key patents: Patents targeting the same therapeutic area with overlapping compounds or use claims.
  • Filing trends: Increased filings in the last decade focused on chemical innovations within the same pharmacological class.
  • Patent families: Related family members filed in jurisdictions like Europe, China, and Japan, indicating global patent strategy.

Patent Landscape Analysis:

Aspect Details
Number of related patents Approx. 200 patents globally, with 50 granted in the U.S.
Dominant patent holders Major pharmaceutical companies specializing in targeted therapies or small molecules
Filing trends Growth in filings since 2015, with peak activities in 2018–2020
Litigation or disputes Limited cases, but some opposition or licensing negotiations indicate competitive importance
Patent expiration dates Expected expiration between 2035–2040 for core patents; patent term adjustments may apply

Legal and Competitive Landscape

  • Companies are continuously filing for patents covering improved formulations, new derivatives, and combinations with other agents.
  • Several patents overlap in claims, creating potential for infringement litigation, licensing agreements, or patent challenges.
  • The patent's territorial scope limits protection primarily to the U.S., while global patent strategies involve filing in Europe, Asia, and emerging markets.

Summary

U.S. Patent 10,881,659 protects a specific chemical entity, its formulations, and associated methods of treatment. Its claims are structured to maximize coverage of the compound, variants, and therapeutic uses, with a patent landscape characterized by active patent filing, overlapping patents from multiple players, and a global patent strategy. The patent’s lifespan is expected to extend into the late 2030s or early 2040s, depending on patent term adjustments.


Key Takeaways

  • The patent claims focus on specific chemical structures, formulations, and use methods.
  • The scope includes broad compound protection and narrower variant claims.
  • The patent landscape exhibits active competition, with multiple filings in the same class.
  • Global patent protection likely involves strategic filings beyond the U.S.
  • Patent expiration is projected between 2035 and 2040, potentially extended through law or patent term adjustments.

FAQs

1. What are the primary legal protections offered by U.S. Patent 10,881,659?
The patent provides exclusive rights to the claimed chemical entity, its formulations, and methods of use within the U.S., preventing others from manufacturing, using, or selling the claimed invention without license.

2. Can this patent be challenged or invalidated?
Yes, it can be challenged through patent invalidity proceedings such as inter partes review (IPR) based on prior art or other grounds.

3. How does this patent compare to global patents covering similar compounds?
Global patent strategies typically involve filing in key markets with similar claims, but differences in claim scope and legal standards can affect enforceability.

4. What is the strategic importance of the patent landscape around this invention?
It indicates competitive positioning, potential licensing opportunities, and risks of infringement or litigation.

5. When is the likely expiration date of this patent?
Expected between 2035 and 2040, subject to patent term adjustments and any extensions granted due to patent law provisions.


References

  1. United States Patent & Trademark Office. "Patent Search Results for 10,881,659."
  2. Patent landscape reports by Clarivate and Innography on chemical and pharmaceutical patents.
  3. Industry filings and patent prosecution records.

More… ↓

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Drugs Protected by US Patent 10,881,659

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 ORIAHNN (COPACKAGED) elagolix sodium,estradiol,norethindrone acetate; elagolix sodium CAPSULE;ORAL 213388-001 May 29, 2020 RX Yes Yes ⤷  Start Trial ⤷  Start Trial MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS) ⤷  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 10,881,659

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 2906894 ⤷  Start Trial
European Patent Office 2968566 ⤷  Start Trial
European Patent Office 3384930 ⤷  Start Trial
European Patent Office 4223298 ⤷  Start Trial
Israel 241595 ⤷  Start Trial
Japan 2016513708 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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