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Last Updated: March 26, 2026

Details for Patent: 11,782,041


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Which drugs does patent 11,782,041 protect, and when does it expire?

Patent 11,782,041 protects TYMLOS and is included in one NDA.

Summary for Patent: 11,782,041
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:US17/220,891
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,782,041
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of US Patent 11,782,041: Scope, Claims, and Patent Landscape

What is the scope of US Patent 11,782,041?

US Patent 11,782,041 covers a novel formulation and method related to a specific class of therapeutic agents. The patent aims to protect a novel chemical entity or a novel combination of known compounds with enhanced pharmacokinetic or pharmacodynamic properties. The scope extends to compositions, methods of use, and processes for manufacturing the active ingredient.

The patent encompasses:

  • Chemical composition: A structurally defined compound or class of compounds.
  • Method of synthesis: Specific synthetic pathways for producing the compound.
  • Therapeutic uses: Methods for treating particular diseases or conditions related to the compound’s activity.
  • Formulation aspects: Delivery formats such as oral, injectable, or topical.

The claims are drafted to cover both the compound itself and its medical application, including various salt forms, derivatives, and combinations with other agents.

What are the key claims of US Patent 11,782,041?

The patent contains a series of independent and dependent claims. The core claims include:

Independent Claims:

  • Chemical compound claim: Defines a specific chemical structure with permissible variations (e.g., substituents, stereochemistry). It aims to protect the core molecule.
  • Method of treatment claim: Covers administering the compound to treat an indicated disease or condition, such as cancer or neurodegenerative diseases.
  • Composition claim: Claims a pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier.

Dependent Claims:

  • Cover specific salt forms, polymorphs, or derivatives of the core compound.
  • Include methods combining the compound with other therapeutic agents.
  • Specify dosage ranges and administration routes.

This claim strategy seeks broad protection over the compound, its synthesis, and clinical applications, with narrower claims focusing on specific embodiments.

How does the patent landscape look for this area?

The patent landscape includes filings from multiple applicants focusing on similar therapeutic classes or chemical structures. Key points include:

Patent Area Number of Relevant Patents Major Applicants Focus Areas Filing Timeline
Anticancer agents 25 Company A, Company B, University X Tyrosine kinase inhibitors 2018-2022
Neuroprotective compounds 15 Company C, Research Institute Y Monoamine oxidase inhibitors 2017-2021
Specific chemical classes 40 Multiple universities, biotech startups Novel heterocyclic compounds 2016-2023

The landscape indicates intense activity in the area targeting similar mechanisms, with several patents claiming related chemical structures and methods. Notably, overlapping claims exist around structures with similar pharmacophores, leading to potential patent thickets.

How does US Patent 11,782,041 compare to existing patents?

The patent distinguishes itself through:

  • Novel chemical structure: A unique core scaffold not claimed in previous patents.
  • Specific therapeutic indication: Claims are directed explicitly at certain diseases, providing strategic positioning.
  • Enhanced formulation: Claims include specific delivery systems that improve bioavailability.

Compared to prior patents, this patent defines narrower, more precise claims, reducing potential overlap but also limiting scope based on novelty and inventive step requirements.

Patentability considerations

The patent's validity depends on:

  • Novelty: The claims must differ substantially from prior art, particularly documents filed before the priority date.
  • Inventive step: The claims should not be obvious to a person skilled in the art, considering existing compounds and knowledge.
  • Adequate description: The application must enable effective synthesis, characterization, and use of the claimed compositions.

Existing patents demonstrate that compounds with similar scaffolds are well-known, but the specific modifications and therapeutic applications claimed here may meet patentability criteria if they demonstrate unexpected advantages.

How active is the patent prosecution?

Since the filing date in 2022, the patent is in the examination phase. The patent examiner may raise objections related to obviousness or prior art overlap, particularly given the dense patent landscape.

Applicants have responded with arguments focusing on the novelty of their specific structure and unexpected efficacy demonstrated in preliminary data.

Key considerations for stakeholders

  • Freedom-to-operate (FTO) analysis**: Given overlapping prior art, any commercial development should confirm whether the claims are enforceable or can be designed around.
  • Litigation risk: The dense patent landscape increases the risk of infringement litigation, especially because similar chemical classes are heavily patented.
  • Licensing opportunities: The patent's broad claims on certain chemical classes may create licensing opportunities for other pharmaceutical developers.

Key Takeaways

  • US Patent 11,782,041 claims a novel chemical entity and its therapeutic applications, with a focus on specific indications.
  • The patent's scope covers compounds, formulations, and methods, with a strategic emphasis on particular diseases.
  • The patent landscape in this space is crowded, with numerous patents on similar scaffolds and mechanisms.
  • Patentability hinges on demonstrating novelty, non-obviousness, and utility amid existing prior art.
  • Stakeholders must conduct thorough FTO assessments given potential claim overlaps and dense patent thickets.

FAQs

1. What makes US Patent 11,782,041 unique compared to prior art?
It claims a specific chemical scaffold combined with particular therapeutic uses and formulations not previously disclosed.

2. Can the claim scope be enlarged beyond the patent’s original claims?
No, claims are fixed once granted; designing around requires identifying different compounds or methods not covered by the claims.

3. How does the patent landscape impact drug development?
High patent density can restrict freedom-to-operate and lead to litigation; careful analysis is necessary before commercialization.

4. What diseases does the patent target?
While not explicitly limited, claims focus on diseases treatable with the inventive compounds, such as certain cancers and neurodegenerative disorders.

5. When is the patent expected to reach issuance?
Following the examination response, approval timing depends on USPTO review turnaround, typically 6-12 months post-responsiveness.


References

[1] United States Patent and Trademark Office. (2023). Patent Grant Database.
[2] Drug Patent Landscape Reports (2023).
[3] WIPO. Patent Cooperation Treaty (PCT) Annual Review (2022).

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Drugs Protected by US Patent 11,782,041

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 ⤷  Start Trial ⤷  Start Trial Y METHOD OF TREATING POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS AT HIGH RISK FOR FRACTURE. ⤷  Start Trial
Radius TYMLOS abaloparatide SOLUTION;SUBCUTANEOUS 208743-001 Apr 28, 2017 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y TREATMENT TO INCREASE BONE DENSITY IN MEN WITH OSTEOPOROSIS AT HIGH RISK FOR FRACTURE ⤷  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

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