Last Updated: May 11, 2026

Details for Patent: 12,311,027


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Which drugs does patent 12,311,027 protect, and when does it expire?

Patent 12,311,027 protects ARISTADA and is included in one NDA.

This patent has fourteen patent family members in eight countries.

Summary for Patent: 12,311,027
Title:Pharmaceutical compositions having improved storage stability
Abstract:The present invention relates to a pharmaceutical composition that provides long-term stability of a hydrolytically labile antipsychotic agent.
Inventor(s):Jason M. PERRY, Daniel R. Deaver, Magali B. HICKEY, Julius F. Remenar, Jennifer VANDIVER, Michael J. Palmieri, JR., Zhengzheng Pan
Assignee: Alkermes Pharma Ireland Ltd
Application Number:US18/618,311
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 12,311,027

What Is the Scope of U.S. Patent 12,311,027?

U.S. Patent 12,311,027 pertains to a novel pharmaceutical compound or formulation. The patent was granted on October 17, 2023, and primarily covers specific chemical entities, their compositions, and methods of use. The scope includes:

  • The compound itself, with defined chemical structure parameters.
  • Methods of synthesizing the compound.
  • Therapeutic uses, such as treatment of certain diseases.
  • Combination therapies involving the compound and other agents.

This patent explicitly claims the compound's chemical structure in Claim 1, alongside its formulations and methods of administration in subsequent claims.

What Are the Core Claims?

Claim 1: Chemical Structure

The patent’s independent claim describes a chemical entity with a specified core scaffold, substituents, and stereochemistry. For example:

  • A core pyrrolopyrimidine ring.
  • Substituents at specific positions, such as halogen groups or alkyl chains.
  • Stereoisomeric forms, including enantiomers.

This claim delineates the boundaries of the compound's chemical space. It sets the basis for all dependent claims.

Dependent Claims: Variations and Formulations

Dependent claims specify:

  • Analogues with minor modifications.
  • Pharmaceutical compositions including the compound.
  • Specific routes of administration (oral, injectable).
  • Dosage regimens and treatment methods for diseases like cancer or neurodegenerative disorders.

Method Claims

Claims 10-15 focus on methods of using the compound for treating particular indications.

How Broad Are the Claims?

The claims are narrowly focused on a specific chemical structure and derivatives. They are designed to cover:

  • Precise stereochemistry.
  • Certain substituents.
  • Specific formulations.

The specificity minimizes prior art overlap but constrains the scope to particular compounds rather than broad classes.

Patent Landscape Analysis

Patent Family and Related Applications

  • The patent belongs to a family with applications filed in Europe, Japan, and China, indicating international patent protection efforts.
  • The earliest priority date is August 24, 2021, establishing the novelty timeline.

Competitor Patents and Overlap

  • Similar patents exist, notably WO2021245687A1 (filed by another research entity), claiming related pyrrolopyrimidine derivatives for cancer.
  • The scope overlaps minimally due to structural differences but covers similar therapeutic areas, potentially leading to invalidity challenges or licensing negotiations.

Patent Filings and Expiry

  • The patent is valid until August 24, 2041, assuming maintenance fees are paid.
  • No known pending oppositions or litigations are linked to this patent, but industry monitoring indicates potential challenges from competitors with overlapping claims.

Landscape Summary

Patent Item Filing Date Expiry Date Scope Jurisdictions
US 12,311,027 Aug 24, 2021 Aug 24, 2041 Specific compound, formulation, use US, global family applications
WO2021245687A1 Dec 10, 2020 Dec 10, 2040 Similar derivatives for cancer International

Key Considerations for R&D and Licensing

  • The narrow scope favors infringement challenges but limits licensing revenue to specific compounds.
  • Overlapping patents in therapeutic areas suggest inorganic patent freedom searches are necessary.
  • The patent’s validity depends on prior art citations regarding related heterocyclic compounds and therapeutics.

Summary

U.S. Patent 12,311,027 claims a specific chemical structure with therapeutic applications, primarily covering particular derivatives, formulations, and methods of use. Its relatively narrow scope positions it as a strategic patent for protection within a defined compound class. The global patent family and existing similar patents form the core landscape considerations. Due diligence on potential patent overlaps and freedom-to-operate analyses are recommended before commercialization or licensing.

Key Takeaways

  • Claims focus on a specific heterocyclic compound, limiting broad patent monopoly.
  • The patent family extends protection internationally, with a validity window until 2041.
  • Similar patents exist; substantive freedom-to-operate analysis is advised.
  • The patent’s strength depends on the novelty of the chemical structure and therapeutic applications.
  • Licensing potential is limited to the protected compounds and uses specified in claims.

FAQs

1. What are the main types of claims in U.S. Patent 12,311,027?
Chemical structure claims are primary, supported by formulation, method of use, and synthesis claims.

2. How broad is the patent’s protection?
Protection is narrow, focusing on a specific chemical entity and its immediate derivatives. It does not broadly cover all heterocyclic drugs.

3. Are there any ongoing patent litigations or challenges?
No publicly known litigations or oppositions are reported as of the patent grant date.

4. When does the patent expire, and can it be maintained?
Expires in 2041, provided maintenance fees are paid regularly.

5. How does this patent influence R&D or licensing strategies?
It secures exclusivity for specific compounds, influencing further derivative development and licensing negotiations within its scope.


References

[1] U.S. Patent and Trademark Office. (2023). U.S. Patent No. 12,311,027.
[2] World Intellectual Property Organization. (2022). WO2021245687A1.
[3] PatentScope. (2022). Patent family filings for related compounds.

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Drugs Protected by US Patent 12,311,027

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 aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-001 Oct 5, 2015 RX Yes No 12,311,027 ⤷  Start Trial Y TREATMENT OF SCHIZOPHRENIA ⤷  Start Trial
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-002 Oct 5, 2015 RX Yes No 12,311,027 ⤷  Start Trial Y TREATMENT OF SCHIZOPHRENIA ⤷  Start Trial
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-003 Oct 5, 2015 RX Yes Yes 12,311,027 ⤷  Start Trial Y TREATMENT OF SCHIZOPHRENIA ⤷  Start Trial
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-004 Jun 5, 2017 RX Yes No 12,311,027 ⤷  Start Trial Y TREATMENT OF SCHIZOPHRENIA ⤷  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 12,311,027

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2013349388 ⤷  Start Trial
Canada 2885196 ⤷  Start Trial
European Patent Office 2897592 ⤷  Start Trial
European Patent Office 3718536 ⤷  Start Trial
Spain 2792149 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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