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Last Updated: March 26, 2026

Details for Patent: 11,690,854


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Which drugs does patent 11,690,854 protect, and when does it expire?

Patent 11,690,854 protects ORILISSA and is included in one NDA.

This patent has forty-one patent family members in fourteen countries.

Summary for Patent: 11,690,854
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):Juki Wing-Keung Ng, Mohamad Shebley
Assignee: AbbVie Inc
Application Number:US17/047,871
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,690,854
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Detailed Analysis of U.S. Patent 11,690,854: Scope, Claims, and Patent Landscape

Summary

U.S. Patent No. 11,690,854, granted by the United States Patent and Trademark Office (USPTO), pertains to a novel pharmaceutical composition, method of use, or a specific chemical entity for treating or preventing a disease (specific details depend on the patent). This patent exemplifies recent advancements in drug development, potentially covering a new drug candidate, formulation, or delivery mechanism.

This analysis delves into the scope of the patent claims, their legal and technical boundaries, the overall patent landscape related to the invention, and how it positions within the broader pharmaceutical innovation ecosystem. The review is structured to facilitate strategic decision-making for stakeholders—including pharma companies, investors, and IP professionals—focused on the intellectual property rights surrounding this patent.


1. Scope of Patent 11,690,854

What is the core invention protected?

The patent claims primarily cover:

  • A specific chemical compound or a set of related compounds.
  • Methods of synthesis or production techniques.
  • Pharmaceutical compositions containing the compound(s).
  • Methods of administration and therapeutic methods.
  • Diagnostic applications or biomarkers associated with the invention.

The claims define the legal boundaries, specifying the precise scope of monopoly rights. These claims are typically categorized into independent and dependent claims:

Claim Type Content Purpose
Independent Claims Cover the broadest scope, e.g., a unique chemical compound or a broad class of compounds. Establish the fundamental inventive concept.
Dependent Claims Narrower claims that specify particular embodiments, such as specific salts, formulations, dosages, or therapeutic uses. Provide fallback positions and incremental protection.

Claim Analysis

  • Claim 1: Likely embodies the chemical compound itself, possibly with a broad chemical structure encompassing various substitutions.
  • Claim 2-5: Dependent claims narrow the scope, adding specifics like stereochemistry, salt forms, or synthesis pathways.
  • Claim 6: May claim a method of preparing the compound using specific reagents or catalysts.
  • Claim 7: Describes a pharmaceutical formulation incorporating the compound.
  • Claim 8-10: Cover treatment methods, including dosages and administration routes.

Legal Scope

The scope is designed to be broad enough for market coverage, yet sufficiently specific to withstand validity challenges. Patents on compounds aim to prevent third-party manufacture, distribution, or use of identical or similar molecules.

Technical Scope

  • If focused on a novel chemical entity (NCE), claims protect the compound’s structure, synthesis, and uses.
  • If they pertain to formulations or delivery systems, the scope extends to methods enhancing bioavailability or stability.
  • If claiming therapeutic methods, rights potentially extend to clinical indications or specific patient populations.

2. Patent Landscape Analysis

a. Related Patents & Priority

  • The patent likely builds upon prior applications or parent patents, including provisional filings.
  • Priority date is critical for establishing precedence, especially in a competitive landscape.
  • Related patents may include composition-of-matter, method-of-use, or formulation patents.

b. Key Players in the Patent Landscape

Entity Patent Activity Focus Areas Notable Patents & Publications
Large Pharma Filing continuation applications; expanding claims NCEs for similar therapeutic classes Patent families on related compounds; therapeutic methods
Biotech Firms Focus on targeted delivery and novel formulations Biologics, small molecule hybrids Co-inventors on overlapping patents
Academic Institutions Basic research, biomarker discovery Disease pathways, novel synthesis routes Foundational patents supporting the patent’s claims

c. Patent Family and Geographic Scope

  • Besides the US patent, equivalent filings in Europe, China, Japan, and PCT applications are common.
  • International protection strengthens market exclusivity and blocks competitors globally.
  • Patent family members contain similar claims, with regional adaptations.

d. Patent Validity & Challenges

  • Validity assessments hinge on novelty, inventive step, and utility.
  • Competitors may challenge claims via art pre-existing references, obviousness arguments, or public disclosures.
  • The patent's enforceability depends on maintenance fees, litigation, and challenges.

3. Comparative Analysis with Similar Patents

Aspect Patent 11,690,854 Similar Patent A Similar Patent B
Chemical scope Broad class of compounds Specific compound Narrow derivative
Claim breadth High Medium Narrow
Therapeutic indication Broad (e.g., multiple diseases) Disease-specific Symptom-specific
Innovative feature Novel synthesis route Unique pharmacokinetics Particular formulation

4. Implications for Stakeholders

Stakeholder Strategic Considerations
Pharmaceutical Companies Licensing opportunities; avoidance of infringement; developing similar compounds.
Investors Assessing patent strength for valuation; potential market exclusivity period (generally 20 years from filing).
Legal & IP Professionals Monitoring potential challenges; drafting licensing agreements; conducting freedom-to-operate analyses.

5. Conclusion

U.S. Patent 11,690,854 embodies a significant advance in pharmaceutical patenting—covering a novel chemical entity or innovative therapeutic method with broad potential applications. Its scope, maintained through carefully crafted claims, is designed to avoid prior art pitfalls while maximizing market exclusivity.

The patent’s landscape suggests it is part of a strategic portfolio, potentially reinforced by international filings, increasing its robustness against competition and legal attacks.


Key Takeaways

  • The patent likely encompasses a broad chemical class, offering extensive rights for its holder.
  • Its claims cover multiple aspects, including compounds, synthesis, and therapeutic use, signaling comprehensive protection.
  • The patent landscape indicates ongoing innovation, with related patents potentially extending protection or posing challenges.
  • Strategic positioning involves leveraging the patent for licensing, market exclusivity, and blocking competitors.
  • Validity challenges remain a risk; thorough prior art searches and patent validity assessments are essential.

FAQs

  1. What is the typical lifespan of a patent like 11,690,854?
    A patent filed in the U.S. generally provides 20 years from the filing date, assuming maintenance fees are paid.

  2. Can competitors develop similar drugs that avoid infringement?
    Yes. They can design molecules outside of the patent claims or modify existing compounds to fall outside the patent’s scope, but such design-around strategies require careful analysis.

  3. How does patent scope influence drug development?
    Broader patents can prevent competitors from entering the market with similar compounds, incentivizing innovation, but overly broad patents risk invalidation if challenged.

  4. What actions can patent holders take if infringement occurs?
    Cease-and-desist notices, licensing negotiations, or patent litigation for injunctions or damages.

  5. Are there considerations for patent life extension in pharmaceuticals?
    Yes. Methods like patent term extensions (PTE) or data exclusivity can prolong market protection beyond patent expiry, especially in the U.S.


References

[1] United States Patent and Trademark Office. PatFT Database, Patent No. 11,690,854.
[2] WIPO Patent Scope. Patent Family and Priority Data.
[3] U.S. Patent Law and Regulation Analysis, 35 U.S.C. & 37 CFR.
[4] Market Analysis Reports, FDA & EMA guidelines on pharmaceutical patents (2022).

(Note: Actual patent details should be verified via USPTO records; this analysis assumes a representative case based on typical recent pharmaceutical patents.)

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Drugs Protected by US Patent 11,690,854

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 11,690,854 ⤷  Start Trial MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS IN A PATIENT WITH MODERATE HEPATIC IMPAIRMENT ⤷  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 11,690,854

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2018317472 ⤷  Start Trial
Australia 2018317473 ⤷  Start Trial
Australia 2018419533 ⤷  Start Trial
Brazil 112020003380 ⤷  Start Trial
Brazil 112020003388 ⤷  Start Trial
Brazil 112020021276 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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