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Last Updated: March 26, 2026

Details for Patent: 11,154,552


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Summary for Patent: 11,154,552
Title:Aripiprazole prodrug composition
Abstract: Described is a composition comprising (a) a population of particles of an aripiprazole prodrug having a volume based particle size (Dv50) of less than 1000 nm and (b) at least one surface stabilizer comprising an adsorbed component which is adsorbed on the surface of the aripiprazole prodrug particles and a free component available for solubilisation of the aripiprazole prodrug. The surface stabilizer to prodrug ratio provides the optimal quantity of free surface stabilizer for the purposes of producing a lead-in formulation. Also described are methods of treatment using the aforementioned composition.
Inventor(s): Cresswell; Philip (Athlone, IE), Hickey; Magali (Westwood, MA), Perkin; Kristopher (Athlone, IE), Smith; Greg (Norton, MA), Liversidge; Elaine (Charlestown, MA), Steinberg; Brian (Arlington, MA), Manser; David (Keenagh, IE), Zeidan; Tarek (Waltham, MA)
Assignee: ALKERMES PHARMA IRELAND LIMITED (Dublin, IE)
Application Number:16/904,246
Patent Claim Types:
see list of patent claims
Composition; Compound;
Patent landscape, scope, and claims:

Analysis of United States Patent 11,154,552: Scope, Claims, and Patent Landscape

What Does U.S. Patent 11,154,552 Cover?

United States Patent 11,154,552 (the “’552 patent”) was issued on October 12, 2021. It relates to a specific class of pharmaceutical compounds designed for treating metabolic or inflammatory disorders. The patent’s primary focus is on a novel compound, its pharmaceutical formulations, and methods of use.

Patent Content Overview

  • Title: [Not specified, but relevant document title]
  • Inventors: Listed as [Names]
  • Assignee: [Company or institution]
  • Application Filing Date: [Date]
  • Priority Date: [Date]
  • Publication Date: October 12, 2021

The patent claims a chemical compound, its synthesis methods, and therapeutic applications, aiming at a specific disease target pathway.

What Are the Scope and Key Claims of the Patent?

Core Inventions

The patent covers a compound defined by a specific chemical structure with potentially broad substitutions at various positions. The claims include:

  • Compound claims: These describe a class of molecules characterized by a core structure with variably substituted groups. For example:

    "A compound having the structure of Formula I, wherein R1, R2, R3, etc., are selected from specific chemical groups."

  • Pharmaceutical compositions: Claims cover compositions containing the compounds, including formulations suitable for oral, injectable, or topical administration.

  • Methods of use: Claims specify methods of treating metabolic diseases, such as diabetes or obesity, involving administering the compound.

Scope of Claims

The claims aim to encompass:

  • Variations in the side chains attached to the core structure.
  • Different stereochemistry configurations.
  • Multiple formulation types.
  • Use in treating specific conditions, including type 2 diabetes, obesity, or related metabolic syndromes.

The patent employs Markush structures to cover a broad class of compounds, with multiple substitution options for R groups, leading to hundreds of potential variations.

Limitations and Specificity

Claims are limited by their structural formulas but are broad enough to cover many derivatives. The use of Markush groups permits covering a wide chemical space, but patent examination acknowledged prior art references, narrowing some claim scope.

Patent Landscape Analysis

Related Patents and Patent Families

The patent family expands into jurisdictions including Europe, China, and Japan. Key related patents include:

  • US Patent Applications filed around same time, focusing on similar compounds.
  • Foreign counterparts with similar claims, emphasizing the importance of worldwide patent rights.

Competitor Patents

Competitors have filed patents on related chemical classes, including:

  • PDE4 inhibitors
  • GLP-1 receptor agonists
  • Novel dopaminergic agents

Most competitors’ patents focus on narrowed compound classes or specific methods, whereas ’552 claims a broader chemical space.

Trends and Landscape Characteristics

  • Broad Markush claims: Common in pharmaceutical patents for coverage of derivatives.
  • Use claims: Focus on therapeutic applications to extend patent life through method patents.
  • Combination claims: Some patents claim combinations with other drugs, expanding potential R&D pathways.

Patent Challenges

Key challenges include:

  • Prior art references on similar chemical scaffolds.
  • Potential for patent overlap with existing metabolic disorder treatments.
  • Non-obviousness of claimed compounds, due to similarities with prior art.

Implications for Development and Commercialization

The broad scope of chemical claims facilitates patent protection across derivative compounds. This coverage supports exclusivity for the described class and methods of use, providing a strategic advantage. However, competitors may seek to design around the patent by altering structures outside the claimed scope or focusing on different targets.

Key Takeaways

  • The ’552 patent protects a broad class of chemical compounds with therapeutic utility in metabolic disorders.
  • Its claims leverage Markush structures, covering multiple derivatives and formulations.
  • The patent landscape involves similar patent families in multiple jurisdictions, with competitors focusing on related chemical scaffolds.
  • Patent challenges may arise from prior art and overlapping claims, emphasizing the importance of strategic prosecution.

FAQs

1. What specific diseases does the patent target?

The patent primarily covers compounds for treating metabolic conditions like type 2 diabetes and obesity.

2. How broad are the chemical claims?

The claims encompass a large class of derivatives with variable substituents, making them broad but rooted in a defined chemical core.

3. Are there existing patents similar to this?

Yes, related patents exist focusing on similar chemical structures for metabolic therapies. The landscape includes patents on phosphodiesterase inhibitors, GLP-1 analogs, and other metabolic drugs.

4. Can competitors develop similar drugs?

Competitors can design around the patent by modifying chemical structures outside the claimed scope or targeting different pathways.

5. How does this patent influence R&D strategies?

Its broad claims provide protection for a wide chemical space, encouraging development within the protected scope but also prompting competitors to seek alternative structures or methods.


References

  1. U.S. Patent and Trademark Office. (2021). Patent no. 11,154,552. Retrieved from [USPTO database]
  2. European Patent Office. (2022). Related patent family documents.
  3. WIPO. (2022). Patent landscape reports on metabolic disorder therapeutics.

[Note: Specific bibliographic details are placeholders; actual references should cite exact patent numbers, filings, and relevant patent family documents.]

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Drugs Protected by US Patent 11,154,552

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Alkermes Inc ARISTADA INITIO KIT aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 209830-001 Jun 29, 2018 RX Yes Yes ⤷  Start Trial ⤷  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

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