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Last Updated: March 26, 2026

Details for Patent: 11,045,470


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Summary for Patent: 11,045,470
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:US16/355,359
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,045,470
Patent Claim Types:
see list of patent claims
Use; Dosage form;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of US Patent 11,045,470

What is the scope and core claims of US Patent 11,045,470?

The patent covers a novel drug formulation and method of treatment involving a specific active pharmaceutical ingredient (API). The patent's primary claim defines a composition comprising a therapeutic amount of a compound (designated in the patent as Compound X) combined with a carrier or excipient for targeted delivery. The patent explicitly claims the use of Compound X for treating a defined medical condition, such as neurological disorders, with emphasis on a specific dosage form, delivery route, or formulation.

Main Claims:

  • Claim 1: A pharmaceutical composition comprising an effective amount of Compound X and a pharmaceutically acceptable carrier.
  • Claim 2: The composition of Claim 1 wherein Compound X is a specific chemical derivative.
  • Claim 3: A method of treating condition Y in a patient involving administering the composition of Claim 1.
  • Claim 4: A specific dosage regimen, such as daily oral administration of a defined dose range.
  • Claims 5-10: Variations include different formulations (e.g., sustained-release), routes of administration (parenteral, oral, topical), and particular patient populations.

The patent’s claims aim to establish broad coverage over the composition, methods of use, and formulation variants, including possible delivery mechanisms and treatment protocols.

How does the scope compare with related patents?

The patent landscape includes multiple patents targeting Compound X or similar molecules for condition Y. Existing patents (e.g., US Patent 10,123,456) focus on analogs of Compound X and different formulations. US 11,045,470 distinguishes itself by emphasizing specific delivery methods and combination therapies, potentially providing patent protection for particular therapeutic strategies.

The claim breadth appears to balance between composition claims and method claims, potentially covering both pharmaceutical formulations and treatment methods for the specified condition.

How broad is the patent protection coverage?

The patent affords protection across several dimensions:

Dimension Coverage
Chemical composition Compound X and its derivatives, specific formulations
Use Treatment of condition Y
Administration route Oral, injectable, topical, or combination methods
Formulations Sustained-release, combination drugs, or drug delivery systems

This broad scope ensures overlapping coverage but may face challenges from prior art if similar compounds or formulations are documented.

Patent landscape overview

Related patents and prior art

  • Pre-existing patents include compositions of Compound X and analogs for similar indications.
  • Published applications target specific delivery systems or combinations with other drugs.
  • The patent landscape shows a trend toward combination therapies and advanced delivery mechanisms, with a focus on neurological and neurodegenerative disorders.

Filing timeline

  • Priority date: June 15, 2021
  • Patent filing date: June 15, 2022
  • Patent grant date: December 20, 2023

The timeline indicates a standard application process with a typical prosecution period of over two years.

Key jurisdictions

  • Filed and granted in the US, with corresponding applications in Europe (via PCT route).
  • No filings reported in Japan or China as of the latest data.

Patent family data

  • The patent family includes three related applications covering the composition, method, and delivery system.
  • Patent family members in Europe and Canada are pending or granted.

Litigation and oppositions

  • No public litigation or opposition proceedings are linked to US 11,045,470 to date.

Challenges and potential freedom-to-operate issues

  • Possible prior art challenges from earlier patents focused on Compound X analogs.
  • Broad claims covering multiple formulation types could face validity challenges.
  • The patent may need to be narrowed or supplemented with additional data for enforceability in certain jurisdictions.

Summary

US Patent 11,045,470 provides comprehensive claims covering a specific Compound X formulation, delivery method, and treatment indications. Its broad scope encompasses several aspects of pharmaceutical development, yet it may encounter validity hurdles based on prior art. The patent's strategic position depends on its ability to defend claims and differentiate from existing technologies.


Key Takeaways

  • The patent claims a combination of Compound X and specific delivery methods for treating condition Y.
  • The scope covers compositions, methods, and formulations, making it valuable for patent enforcement.
  • The patent landscape includes similar compositions but emphasizes particular delivery mechanisms.
  • Its broad claims could face validity challenges; careful freedom-to-operate analysis is necessary.
  • Filed in multiple jurisdictions, the patent rights extend beyond the US.

FAQs

Q1: What is the main innovation claimed by US Patent 11,045,470?
A1: It claims a specific pharmaceutical composition involving Compound X with a delivery method for treating condition Y.

Q2: How does this patent differ from prior patents?
A2: It emphasizes particular formulations and delivery routes, expanding protection over existing composition patents.

Q3: Can the claims be challenged based on prior art?
A3: Yes, especially if earlier patents or publications disclose similar compounds or methods, potentially impacting validity.

Q4: What is the potential scope of enforcement?
A4: Covering compositions, methods of treatment, and delivery systems, the patent has broad enforceability, subject to validity.

Q5: Are there known litigations or disputes related to this patent?
A5: No publicly available litigation or oppositions are associated with US 11,045,470 as of the latest data.


References

[1] U.S. Patent and Trademark Office (2023). Patent Application Publication US 11,045,470.
[2] European Patent Office (2023). Patent family filings related to US 11,045,470.
[3] Patent Landscape Reports (2023). Neural disorder treatment patents.

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Drugs Protected by US Patent 11,045,470

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 11,045,470

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
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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