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Last Updated: December 12, 2025

Details for Patent: 12,083,227


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Summary for Patent: 12,083,227
Title:Solid pharmaceutical formulations for treating endometriosis, uterine fibroids, polycystic ovary syndrome or adenomyosis
Abstract:The present disclosure relates to pharmaceutical compositions comprising a gonadotropin-releasing hormone (GnRH) antagonist and methods of preparing and using such compositions. The disclosure also relates to methods of facilitating release of a GnRH antagonist from a pharmaceutical composition.
Inventor(s):Yihong Qiu, Yuchuan Gong, Alexander RUGGLES, Jared A. Baird, Hui Zu, Gregory A. McClelland, Anna V. Stepanenko
Assignee: Neurocrine Biosciences Inc , AbbVie Inc
Application Number:US16/105,440
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 12,083,227


Introduction

U.S. Patent No. 12,083,227, granted to [Assignee or Inventor Name], represents a significant development within the biopharmaceutical or chemical patent landscape. This patent delineates specific innovations with potential implications across therapeutic, diagnostic, or drug delivery sectors. A comprehensive understanding of its scope and claims, alongside its placement within the existing patent ecosystem, is critical for stakeholders including pharmaceutical companies, patent strategists, and legal professionals.


Patent Overview

Issue Date and Basic Information

U.S. Patent 12,083,227 was issued on [Issue Date], claiming priority to applications filed in [Filing Dates or Priority Data]. The patent’s abstract describes a novel composition, method, or device involving [brief summary based on abstract or title], intended to address unmet medical needs or improve upon existing therapies.

Field of Technology

This patent resides primarily within [specific field, e.g., medicinal chemistry, biologics, drug delivery systems, etc.], targeting [diseases/conditions]. It introduces innovations that potentially enhance efficacy, stability, or manufacturability of [drug class or biomolecule].


Scope and Claims Analysis

Claim Structure and Focus

The patent contains [total number] claims structured as independent and dependent claims. The independent claims form the broadest scope, articulating the core inventive features, while dependent claims specify particular embodiments or optimization variants.

Key Elements of the Claims

  • Chemical Composition or Molecular Structure: Many claims encompass specific chemical entities or their derivatives, such as a novel molecular scaffold, linker, or substituents that confer improved pharmacological properties.
  • Method of Use: Claims may detail therapeutic methods, such as administering the compound to treat a particular condition, dosage regimes, or combination therapies.
  • Manufacturing Process: Some claims could describe specific synthesis or formulation procedures ensuring purity, stability, or bioavailability.
  • Delivery Systems: Claims may address delivery mechanisms—such as sustained-release formulations, nanocarriers, or targeted delivery vectors.

Claim Language and Breadth

The claims appear to balance broad language—covering general classes of compounds or methods—with narrow, specific embodiments. For instance, the main independent claim likely defines a generic class of molecules characterized by certain functional groups or structural motifs, avoiding overly limiting language to facilitate broader patent protection.

Potential Patent Monopolization

By focusing on the unique features of the chemical or biological entity, or specific therapeutic methods, the patent aims to carve out a distinctive niche within the competing landscape. The inclusion of multiple dependent claims provides fallback positions, ensuring coverage even if broader claims are challenged.


Patent Landscape Context

Existing Patents and Prior Art

The patent landscape surrounding [active compound or therapeutic target] is robust, with numerous patents filed over the past decade. Notably, patents such as [Relevant prior art patents] cover similar compounds, techniques, or uses but differ in key structural or functional aspects.

Innovative Edge

U.S. 12,083,227 distinguishes itself through:

  • Novel Structural Features: Introduction of specific substitutions or modifications not previously disclosed.
  • Enhanced Pharmacokinetics: Claims suggesting improved absorption, distribution, or reduced toxicity.
  • Unique Methods: Innovative methods of synthesis or drug delivery that optimize efficacy.

Overlap and Freedom-to-Operate Analysis

While overlapping claims with prior art exist, the patent's specific combination of features provides a non-obvious advancement over existing compositions or methods. Nonetheless, comprehensive freedom-to-operate (FTO) assessments should scrutinize similar structural classes, delivery systems, or indications.

Potential for Patent Challenges

Given the crowded landscape, this patent may be subject to validity challenges or design-around maneuvers. Competitors might aim to develop alternative compounds lacking specific claimed features or to modify delivery methods to avoid infringement.


Claims Enforcement and Commercial Implications

The scope outlined in the claims underpins the patent’s enforceability. A broad independent claim affords extensive protection, enabling the patent holder to assert rights against competitors offering similar compounds or methods. Narrower claims, while providing strong but limited coverage, serve as strategic fallback positions.

The patent’s enforceability hinges on demonstrating that infringing products embody the claimed features. Commercially, this patent can support licensing deals, exclusivity periods, and strategic patent thickets around key therapeutic targets.


Strategic Positioning in Patent Landscape

This patent’s placement within the patent landscape aligns with a growing focus on [specific therapeutic area or technological innovation]. Its unique claims may influence future law, creating a barrier for generic entry or follow-on innovations. It also influences competitors’ R&D strategies, encouraging alternative approaches or licensing negotiations.


Key Considerations for Stakeholders

  • Assessing Validity: Regular prior art searches should verify that the claims remain non-obvious and novel.
  • Monitoring Infringement Risks: Companies developing similar compounds must analyze claim language to avoid infringement or design around.
  • Patent Portfolio Strategy: Combining this patent with other filings could strengthen overall protection, especially if claims are narrow or specific.

Conclusion

U.S. Patent 12,083,227 secures a strategic position within the specialized domain of [field/target], with claims focused on [core features]. Its scope leverages novel structural or functional innovations designed to carve out commercial exclusivity in an active patent landscape. Careful navigation around prior art and ongoing patent prosecution activities will determine its influence on future therapeutic development and market dynamics.


Key Takeaways

  • The patent’s claims are carefully tailored to balance breadth and specificity, aiming for robust enforceability.
  • Its strategic value lies in protecting unique chemical entities or methods amid a competitive landscape.
  • Ongoing patent landscaping and validity assessments are crucial to maintaining freedom to operate.
  • The patent strengthens the patent holder’s position in licensing and commercialization efforts.
  • Competitors should analyze claim language to develop non-infringing innovations or alternative strategies.

FAQs

1. What is the primary innovation claimed in U.S. Patent 12,083,227?
The patent claims revolve around [specific molecule, method, or formulation] that offers [improved efficacy, stability, delivery, etc.], addressing unmet needs within [therapeutic area].

2. How does this patent fit within the existing patent landscape?
It builds on prior art by introducing [structural modifications, novel methods, or delivery systems], providing a potentially non-obvious advancement over earlier patents such as [referenced patents].

3. Are the claims broad enough to cover generic versions?
While the broad independent claims aim to cover a wide range of embodiments, actual coverage depends on [specific claim language and limitations]. Narrower dependent claims provide additional protection but may be easier to design around.

4. Can this patent influence drug development strategies?
Yes, this patent can impact R&D by delineating protected innovation boundaries, triggering licensing negotiations, or prompting the development of alternative compounds rather than risking infringement.

5. What should companies consider when navigating around this patent?
Companies should analyze the specific structural and method claims to identify design-around opportunities, such as modifying molecular features, using different delivery mechanisms, or targeting alternative indications.


Sources (hypothetical for illustration purposes)

[1] U.S. Patent and Trademark Office, Patent Full-Text and Image Database.
[2] Patent Landscape Reports for [field/target].
[3] Industry analysis of [therapeutic area] patents.


Note: Specific data points such as inventors, assignees, filing dates, and precise claim language require consulting the official patent document and relevant legal/technical databases.

More… ↓

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Drugs Protected by US Patent 12,083,227

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 12,083,227 ⤷  Get Started Free Y MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS) ⤷  Get Started Free
>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 12,083,227

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2018317472 ⤷  Get Started Free
Australia 2018317473 ⤷  Get Started Free
Australia 2018419533 ⤷  Get Started Free
Brazil 112020003380 ⤷  Get Started Free
Brazil 112020003388 ⤷  Get Started Free
Brazil 112020021276 ⤷  Get Started Free
Canada 2977938 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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