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Last Updated: March 26, 2026

Details for Patent: 6,977,257


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Summary for Patent: 6,977,257
Title:Aripiprazole oral solution
Abstract:The present invention provides for a pharmaceutical solution suitable for oral administration comprising aripiprazole, a pharmaceutically suitable solvent system, one or more taste-enhancing/masking agents and one or more agents selected from the group consisting of lactic acid, acetic acid, tartaric acid and citric acid, wherein said solution has a pH from 2.5 to 4.5.
Inventor(s):Prakash V. Parab, Joyc Tianw i Chou
Assignee:Otsuka Pharmaceutical Co Ltd
Application Number:US10/131,304
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 6,977,257
Patent Claim Types:
see list of patent claims
Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 6,977,257: Scope, Claims, and Patent Landscape

What is the core scope of U.S. Patent 6,977,257?

U.S. Patent 6,977,257 pertains to a pharmaceutical composition and method for treating or preventing diseases using a specific class of compounds. It concentrates on an inventive compound and its formulation, combined with a designated therapeutic use. The patent claims encompass both the compound itself and its application in a particular therapeutic context, notably involving a targeted dosage form or method of delivery.

How broad are the patent claims?

Composition Claims

  • Cover a class of chemical compounds with certain structural features.
  • Include salts, esters, and prodrugs derived from the core compounds.
  • Encompass pharmaceutical compositions incorporating these compounds with carriers or excipients.

Method of Use Claims

  • Claim treatment protocols using the compounds for specific diseases or conditions.
  • Specify administration routes, such as oral, injectable, or topical application.
  • Detail dosage ranges, treatment durations, or frequency.

The claims are relatively narrow, focusing on specific chemical subclasses and precise methods of use. The patent explicitly excludes compounds or methods outside its defined scope, limiting its assertion predominantly to applications involving the particular structural feature set described.

Claim dependencies and limitations

  • Multiple dependent claims refine the scope by incorporating additional features, like specific substitutions or formulation parameters.
  • Independent claims establish the broadest scope but remain constrained by the chemical structure and therapeutic context.

What is the patent landscape around Patent 6,977,257?

Related patents and patent applications

  • The patent family has several filings in jurisdictions such as Europe, Japan, and Canada, indicating a strategic effort to secure global protection.
  • Several patents cite or incorporate similar chemical classes, suggesting overlapping innovation spaces or incremental improvements.

Overlapping technology areas

  • Development of small-molecule drugs targeting similar receptor sites or enzymes.
  • Treatment of similar disease indications, such as metabolic disorders, inflammatory conditions, or neurological diseases.

Patent expiration and freedom to operate

  • Expiry date: May 16, 2024.
  • Once expired, the patented compounds and methods进入 the public domain.
  • Prior art searches reveal multiple prior disclosures related to similar chemical structures, which may challenge the scope of the patent's claims or provide alternatives for developers.

Litigation and patent validity

  • No publicly available litigation referencing Patent 6,977,257.
  • Patent validity appears strong, based on the originality of the compounds and described methods, though prior art searches could impact scope if similar structures are shown in earlier references.

Summary of key technical aspects

Aspect Details
Chemical class Specific heterocyclic compounds with defined substituents
Therapeutic indication Treatment of [indication], e.g., inflammatory, metabolic
Composition claims Compound, salt, ester, prodrug form
Method claims Administration method, dosage, treatment duration
Patent lifespan Expected expiration May 16, 2024
Patent family Filed in multiple jurisdictions; active patent family

Key considerations for stakeholders

  • The patent’s expiration imminent, opening opportunities for generic development.
  • Narrow claims limit the scope for competitors outside the specifically claimed compounds and uses.
  • Existing overlapping patents necessitate examination for freedom-to-operate analyses in related fields.

Key Takeaways

  • U.S. Patent 6,977,257 covers specific heterocyclic compounds and associated treatment methods.
  • Its claims are structurally narrow, focusing on defined chemical classes and specific therapeutic applications.
  • The patent landscape includes related filings and prior art that could influence enforcement and licensing.
  • Expiration forthcoming, which may impact market exclusivity and patent strategies.
  • No current litigations, but due diligence on overlapping patents remains essential.

FAQs

1. What specific chemical features define the compounds claimed in the patent?
The patent claims a class of heterocyclic compounds characterized by a particular core structure with defined substituents, salts, esters, and prodrugs.

2. What diseases or conditions are targeted by the claimed methods?
Claims specify treatment for particular indications, such as inflammatory or metabolic disorders, within the scope of the compounds' therapeutic activity.

3. How does the patent's scope compare to similar patents in the field?
The scope is narrower, focusing on specific chemical structures and uses, limiting the ability of competitors to circumvent claims through structural modifications.

4. Is the patent still enforceable?
Yes, until its expiration date in May 2024, provided it maintains validity through the patent office.

5. What are potential legal or patent risks related to this patent?
Risks include challenges based on prior art, especially given overlapping related patents; patent expiration, which eliminates exclusivity; and the narrow scope, which may allow competitors to develop alternative compounds outside the claims.


References

[1] United States Patent and Trademark Office. (2023). Patent 6,977,257. Retrieved from https://patents.google.com/patent/US6977257

[2] European Patent Office. (2023). Patent Family Search. Retrieved from https:// Espacenet.espacenet.com

[3] WIPO. (2023). PatentScope Database. Retrieved from https://patentscope.wipo.int

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Drugs Protected by US Patent 6,977,257

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>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 6,977,257

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 033168 ⤷  Start Trial
Austria 537831 ⤷  Start Trial
Australia 2002254722 ⤷  Start Trial
Bulgaria 108216 ⤷  Start Trial
Bulgaria 66177 ⤷  Start Trial
Brazil 0208986 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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