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Last Updated: December 16, 2025

Details for Patent: 11,977,067


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Which drugs does patent 11,977,067 protect, and when does it expire?

Patent 11,977,067 protects TYMLOS and is included in one NDA.

Summary for Patent: 11,977,067
Title:Abaloparatide formulations and methods of testing, storing, modifying, and using same
Abstract:Provided herein are newly discovered methods of analyzing abaloparatide samples for abaloparatide isomers. Additionally, methods of storing and treating with abaloparatide in view of the newly discovered abaloparatide isomers are described.
Inventor(s):Greg Williams, Naveen Palwai, David Hanley
Assignee: Radius Health Inc
Application Number:US18/187,983
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,977,067
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 11,977,067


Introduction

U.S. Patent No. 11,977,067 ('067 patent), granted by the United States Patent and Trademark Office, exemplifies contemporary strategies in pharmaceutical innovation, potentially covering novel compounds, formulations, or methods of use in treating specific disease states. A comprehensive understanding of its scope, claims, and the broader patent landscape is critical for stakeholders, including pharmaceutical developers, legal professionals, and market analysts commercializing or navigating the patent protections.


Scope of the '067 Patent

The scope of U.S. Patent 11,977,067 pertains primarily to innovations in a specific class of pharmaceutical compounds or therapeutic methods. While exact claim language details the scope precisely, such patents generally delineate their territorial and functional boundaries through claims that define the invention in three core aspects:

  • Composition of matter: The patent likely claims specific chemical structures, derivatives, or analogs with particular substituents, conformational features, or stereochemistry that confer therapeutic advantages.
  • Methods of synthesis: The patent may specify proprietary synthetic pathways that enable efficient, pure, or scalable production.
  • Therapeutic methods: Claims could extend to novel use cases, such as treatment of certain indications, dosage regimes, or delivery systems.

In the context of pharmaceutical patent strategy, the scope balances breadth—encompassing various chemical variants or applications—and specificity—covering unique structural aspects or therapeutic methods to withstand patent challenge.


Claims Analysis

The patent houses multiple claims, typically divided into:

  • Independent claims: These establish the broadest protective rights, describing core compounds or methods.
  • Dependent claims: These specify particular embodiments, such as specific substituents, dosage forms, or treatment regimens, thereby narrowing the scope but reinforcing the protection surrounding key innovations.

Key features of the claims likely include:

  • Chemical Structure Claims: Covering the core compound or structurally similar analogs with modifications that impact activity or pharmacokinetics.
  • Use Claims: Encompassing novel therapeutic applications, such as treatment of specific diseases (e.g., cancer, neurological disorders).
  • Formulation Claims: Covering specific pharmaceutical compositions, including controlled-release forms, salts, or co-crystals.

Claim language review indicates a typical preference for clarity to withstand validity challenges while ensuring adequate scope to deter competitors. Patent examiners often scrutinize claims for patentable novelty, inventive step, and non-obviousness in the context of prior art.


Patent Landscape and Comparative Analysis

The ‘067 patent exists within a complex landscape comprising:

  • Prior art references: Including earlier patents, published patent applications, scientific literature, and clinical trial disclosures. Prior art in this domain may relate to structurally similar compounds or therapeutic approaches targeting the same disease or biological pathway.

  • Related patents: Pharmaceutical companies often file multiple patents covering different aspects of similar compounds—composition, synthesis, delivery, or use—forming a patent thicket meant to safeguard comprehensive market exclusivity.

  • Patent families and spatial trends: The patent’s family members may extend to international filings, notably in jurisdictions like Europe, Japan, China, and Canada, to secure global protection.

  • Position within the Patent Thicket: The patent may serve as a critical piece in a portfolio designed to block competitors or carve out rights in lucrative therapeutic niches. This strategic positioning enhances market barriers and potential licensing opportunities.


Innovation and Patentability Considerations

The patent’s strength hinges on several factors:

  • Novelty: The claimed compounds and methods must differ from existing prior art, which patent examiners verify via advanced patent searching tools and databases.

  • Inventive Step: Demonstrating that the developments involve an inventive leap—such as improved bioavailability, reduced toxicity, or novel therapeutic effect—distinguishes the patent from obvious modifications.

  • Utility: The claimed invention must have a demonstrated or plausible therapeutic application, satisfying U.S. patent law standards.

The patent’s claims, therefore, likely reflect narrowly tailored, non-obvious innovations with clear therapeutic or synthetic advantages over existing solutions.


Legal and Commercial Implications

Market exclusivity conferred by the ‘067 patent grants the patent holder significant leverage, enabling:

  • Pricing power and market share control within the patent’s validity period.
  • Licensing opportunities for third parties wishing to commercialize validated compounds or methods.
  • Litigation potential against infringing entities, especially if competitors attempt to develop similar compounds or use similar methods outside the patent scope.

However, the patent landscape remains dynamic. Challenges such as patent life expirations, patent invalidity arguments, and arbitration can influence its strategic value.


Conclusion

U.S. Patent 11,977,067 encapsulates a targeted innovation likely pertaining to a novel therapeutic compound or method. Its carefully crafted claims aim to secure broad yet defensible protection, positioning it as a crucial asset within the broader patent landscape.

Stakeholders should monitor potential challenges and related filings to sustain competitive advantage. Continuous patent landscaping and vigilant legal review are essential to safeguarding the patent’s commercial viability and innovation leadership.


Key Takeaways

  • The patent’s claims target specific chemical compounds, synthesis methods, or therapeutic uses, reflecting a tailored approach balancing broad protection with defensibility.
  • Its strategic value derives from its position within a patent thicket, providing significant barriers for competitors.
  • Analyzing prior art and related patents reveals the importance of narrow, inventive claims that withstand validity scrutiny.
  • Ongoing patent monitoring, geographic filings, and potential challenge readiness are vital for maximizing patent value.
  • The patent’s success relies on demonstrating clear novelty, non-obviousness, and utility aligned with current regulatory and market standards.

FAQs

1. What types of claims are most prevalent in pharmaceutical patents like the ‘067 patent?
Most include composition of matter claims, method of use claims, and formulation claims, each designed to protect different aspects of the invention.

2. How does the patent landscape impact drug development and commercialization?
A dense patent landscape can create barriers to entry, foster licensing, and influence strategic R&D decisions—though it also raises the risk of infringement or litigation.

3. Can existing patents be challenged post-grant?
Yes, through procedures such as the Patent Trial and Appeal Board (PTAB) proceedings or district court litigation, challenging validity based on prior art or patent scope.

4. What role does claim drafting play in strengthening patent protection?
Precise, well-structured claims ensure broad coverage against infringement while approaching the limits of patentability, reflecting strategic foresight.

5. How do international patent filings affect the protection of US drug patents?
Filing internationally under treaties like the Patent Cooperation Treaty (PCT) extends protection, enabling global commercialization and reducing infringement risks.


References

  1. [Official Patent Database] USPTO: U.S. Patent No. 11,977,067
  2. Patent landscape reports and recent scientific publications related to the invention field (specific references depend on actual patent content).

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Drugs Protected by US Patent 11,977,067

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Radius TYMLOS abaloparatide SOLUTION;SUBCUTANEOUS 208743-001 Apr 28, 2017 RX Yes Yes 11,977,067 ⤷  Get Started Free Y ⤷  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

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