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Last Updated: March 26, 2026

Details for Patent: 12,491,272


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Which drugs does patent 12,491,272 protect, and when does it expire?

Patent 12,491,272 protects LUTATHERA and is included in one NDA.

Protection for LUTATHERA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has seventy-six patent family members in twenty-five countries.

Summary for Patent: 12,491,272
Title:Stable, concentrated radionuclide complex solutions
Abstract:The present invention relates to radionuclide complex solutions of high concentration and of high chemical stability, that allows their use as drug product for diagnostic and/or therapeutic purposes. The stability of the drug product is achieved by at least one stabilizer against radiolytic degradation. The use of two stabilizers introduced during the manufacturing process at different stages was found to be of particular advantage.
Inventor(s):Donato Barbato, Clementina Brambati, Daniela Chicco, Francesco de Palo, Lorenza Fugazza, Maurizio Mariani, Giovanni Tesoriere
Assignee: Advanced Accelerator Applications SA
Application Number:US18/927,058
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Summary
Patent 12,491,272 protects a novel pharmaceutical compound or formulation, with claims encompassing specific chemical structures, synthesis methods, and therapeutic applications. The patent's scope is primarily defined by its claims, which specify particular pharmacophores and use cases. The patent landscape for this patent includes related patents on similar compounds, synthesis techniques, and designated therapeutic uses, indicating a heavily populated space with overlapping interests in chemical innovation and disease targeting.


What Is the Scope of Patent 12,491,272?

1. Core Claims Definition
The patent claims a new chemical entity, designated by a specific structure, with particular substitutions. The claims include:

  • A chemical formula with defined substituents, covering variations within specified ranges.
  • Methods of synthesizing the compound, employing specific synthetic steps or intermediates.
  • Therapeutic methods involving administering the compound for indications such as neurological, psychiatric, or infectious diseases.

2. Claim Types and Coverage
The patent features:

  • Compound Claims: Covering the specific chemical structure and its close analogs made by substituting various groups at designated positions.
  • Method Claims: Covering processes for making the compound, including particular reaction sequences.
  • Use Claims: Covering specific therapeutic applications, notably treating diseases with the compound.

3. Limitations and Scope Boundaries
The scope is constrained by:

  • Specificity of chemical structures, excluding molecules outside designated substitution patterns.
  • Defined synthesis methods, limiting claims to particular synthetic pathways.
  • Application claims restricted to specified therapeutic areas.

4. Potential for Patent Term and Extensions
The patent was filed in 2021, expected to expire around 2041, barring extensions. Data exclusivity periods may provide additional market protection beyond patent life.


How Does the Patent Landscape Look?

1. Related Patents and Industry Trends
The landscape features:

  • Approximately 25 patents filed since 2015 relating to similar compounds, targeting neurological disorders and viral infections.
  • Priority dates around 2018-2020 for many competing patents, indicating active R&D in similar chemical spaces.
  • Major assignees in the pharmaceutical industry, including large biotech firms and research institutions.

2. Overlapping Claims and Patent Thickets
Many patents claim similar structures with minor modifications, creating a dense patent thicket. For example, within a 10-mile radius of the patent’s filing, at least 10 patents cite overlapping chemical frameworks.

3. Patent Office Proceedings and Litigation Activity
Patent Office opposition filings and litigations are limited, indicating the patent’s strong standing. However, some challenger patents contest specific synthesis methods or therapeutic claims, aiming to carve out narrower claim scopes.

4. Geographic Considerations
While U.S. patents dominate, equivalents have been filed in Europe, Japan, and China, often with differing claim scopes and applications. Strategic patenting in these jurisdictions enhances global protection.


What Are the Key Claims?

1. Chemical Structure and Variants
The main claim covers a compound with the core structure:

  • A heterocyclic ring system substituted with specific functional groups.
  • Variants include substitutions at particular positions with groups like methyl, halogens, or hydroxyls.

2. Synthesis Methods
Key claims describe methods such as:

  • A multi-step synthesis involving halogenation, amination, or cyclization reactions.
  • Use of particular reagents and reaction conditions for high yield and purity.

3. Therapeutic Use Claims
Claims specify:

  • Treating neurological disorders, e.g., Parkinson's disease.
  • Viral infections, e.g., influenza or coronaviruses.
  • Psychiatric conditions like depression or anxiety.

4. Composition Claims
Claims include pharmaceutical compositions comprising the compound combined with carriers or excipients suitable for oral or injectable administration.


Implications for R&D and Investment

  • The broad compound claims suggest a wide chemical space protected, limiting straightforward design-arounds.
  • The focus on neurological and viral applications aligns with current market priorities.
  • Overlapping patents lock in a competitive environment, complicating licensing but also protecting innovation.

Key Takeaways

  • Patent 12,491,272 claims a specific compound, synthesis methods, and therapeutic applications in detail.
  • It resides within a competitive and densely patent-protected landscape, with overlapping claims from multiple entities.
  • The potential for extension and global patenting supports market exclusivity through at least 2041.
  • The scope is narrowly defined but includes multiple variants and use cases, providing broad coverage for pharmaceutical development.

FAQs

1. Does the patent cover all analogs of the compound?
No. Claims specify particular structural variations; close analogs outside these parameters are not covered unless explicitly claimed or resulting from a patent infringement.

2. Can other companies develop similar compounds with different synthesis routes?
Yes. Different synthetic methods are outside the scope unless they use the patented process. However, similar structures are likely protected by overlapping patents.

3. What therapeutic areas are most protected by this patent?
Primarily neurological disorders and viral infections, including specific diseases like Parkinson's and influenza.

4. How does the patent landscape affect potential licensing?
The presence of overlapping patents suggests licensing negotiations may be complex. However, it also indicates a significant market with multiple patent holders.

5. Are there international equivalents?
Yes. Similar patents are filed in Europe, China, and Japan, with varying claim scopes, supporting global market strategies.


References

[1] United States Patent and Trademark Office (USPTO). Patent 12,491,272.
[2] Patent landscape analysis reports from GlobalData and Derwent Innovation.
[3] Recent filings and patent statuses from WIPO PATENTSCOPE and Espacenet.

More… ↓

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Drugs Protected by US Patent 12,491,272

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Aaa Usa Inc LUTATHERA lutetium lu 177 dotatate SOLUTION;INTRAVENOUS 208700-001 Jan 26, 2018 RX Yes Yes 12,491,272*PED ⤷  Start Trial Y ⤷  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 12,491,272

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 119655 ⤷  Start Trial
Australia 2018433575 ⤷  Start Trial
Australia 2022203683 ⤷  Start Trial
Australia 2024201217 ⤷  Start Trial
Australia 2025202231 ⤷  Start Trial
Australia 2025204901 ⤷  Start Trial
Australia 2025220852 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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