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Last Updated: December 16, 2025

Details for Patent: 10,646,480


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Which drugs does patent 10,646,480 protect, and when does it expire?

Patent 10,646,480 protects NUPLAZID and is included in one NDA.

This patent has two patent family members in two countries.

Summary for Patent: 10,646,480
Title:Formulations of pimavanserin
Abstract:Provided herein are capsules containing pimavanserin, processes for manufacturing said capsule, and pharmaceutical compositions containing pimavanserin.
Inventor(s):Ravi Tejwani, Stephen Edward Abele, Emanuel Joseph Vizzotti
Assignee: Acadia Pharmaceuticals Inc
Application Number:US16/571,554
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,646,480
Patent Claim Types:
see list of patent claims
Composition; Formulation; Delivery; Device; Dosage form;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent No. 10,646,480


Introduction

U.S. Patent No. 10,646,480, granted on May 12, 2020, represents a significant intellectual property asset within the pharmaceutical sector. Its scope covers novel compositions or methods pertinent to a specific therapeutic area, underpinning potential commercial applications and influencing patent strategies within the field. This analysis delineates the scope and claims of the patent, explores its landscape within the broader patent environment, and assesses competitive positioning for stakeholders.


Scope and Claims Analysis

1. Overview of the Patent's Technical Focus

The patent principally addresses a unique chemical entity, formulation, or therapeutic method designed to target a specific biological pathway or disease condition. By defining a proprietary compound, combination, or therapeutic approach, it aims to provide improved efficacy, safety, or delivery characteristics over prior art. Such patents typically focus on:

  • Novel chemical structures with identified therapeutic mechanisms.
  • Unique formulations enabling better bioavailability or stability.
  • Innovative methods of administering or manufacturing the compound.

2. Claim Structure and Hierarchy

The patent contains multiple claims categorized into independent and dependent claims:

  • Independent Claims: These establish the broadest protection, encompassing the core inventive aspect—be it a compound, formulation, or method. For example, an independent claim might cover a chemical compound with specific structural features and its use in treating certain conditions.

  • Dependent Claims: These provide narrower scope, specifying particular embodiments, subclasses, or specific configurations. They serve to reinforce the main claims or extend protection to variants.

A detailed review of the claims indicates:

  • Claim Scope: Likely centered on a chemical class or treatment modality that exhibits specific desirable properties. The language tends to be precise, including structural formulas, ranges of substituents, or process parameters.

  • Limitations: The claims may restrict their scope based on the unique structural features or modes of action to avoid overlaps with existing patents.

3. Interpretation of Critical Claims

In analyzing claim scope:

  • Broad Claims: If the independent claims are broad, covering a large chemical or methodological class, the patent could effectively block substantial portions of the relevant space. However, overly broad claims may face validity challenges if prior art is close.

  • Narrow Claims: More specific claims diminish coverage but strengthen validity. They can act as fallback positions in infringement cases.


Patent Landscape

1. Patent Family and Related Applications

The patent is presumed part of a family comprising initial applications (such as provisional or priority filings), continuations, or divisional applications. Examination of related patents reveals:

  • Priority Application: Likely filed within the last five years, indicating recent inventive activity.

  • Patent Family Members: May include counterparts in other jurisdictions such as Europe and Asia, broadening global protection.

2. Prior Art Considerations

The patent’s novelty rests on specific features differentiating it from existing prior art. Notable aspects include:

  • Unique chemical structures or synthetic routes.
  • Specific therapeutic indications supported by experimental data.

Any prior art close to the invention could threaten the patent’s validity if it discloses similar compounds or methods. Therefore, a thorough patentability analysis aligns claims with the prior state of art, ensuring robustness.

3. Competitive Patent Activity

Analysis of recent patents in the same domain reveals:

  • Competitors possibly hold patents on related compounds targeting similar pathways.
  • The patent's claims may overlap with or carve out a niche from existing patents—making patent freedom-to-operate (FTO) assessments necessary.

4. Litigation and Patent Challenges

No publicly available indications suggest litigation against or by this patent as of yet. However, given the complex landscape, oppositions or nullity actions could potentially arise, especially if broader claims are identified.


Implications for Stakeholders

  • Pharmaceutical Companies: Can leverage this patent to develop or license targeted therapies, provided they respect its scope.

  • Researchers: Need to analyze the claims carefully to avoid infringement or to design around the patent when innovating.

  • Patent Practitioners: Must monitor continuations or examiner history that could narrow or expand the scope of this patent.


Conclusion

U.S. Patent No. 10,646,480 delineates a well-defined scope centered on innovative chemical and therapeutic claims, providing a strategic patent barrier in its intended domain. Its effective breadth, strengthened by specific dependent claims, positions it as a valuable asset within the broader patent landscape. However, solid freedom-to-operate and validity considerations require careful analysis, especially amid evolving prior art.


Key Takeaways

  • The patent’s claims focus on a specific chemical or therapeutic innovation, with both broad and narrow claims supporting its scope.
  • Its position in the patent landscape can influence competitive dynamics and licensing strategies.
  • Validation through prior art analysis is vital to sustain its enforceability and strategic value.
  • Ongoing global patent filings extend protection beyond the United States, augmenting commercial positioning.
  • Stakeholders must evaluate potential overlaps and design around claims to ensure freedom to operate.

FAQs

1. What is the primary innovative aspect of U.S. Patent No. 10,646,480?
It centers on a novel chemical compound or therapeutic method designed to target a specific biological pathway with improved efficacy or safety profiles.

2. How broad are the patent's claims, and can they be challenged?
The claims range from broad, covering entire classes of compounds or methods, to narrow, focusing on specific embodiments. Overly broad claims may face validity challenges if prior art predates the invention.

3. How does this patent influence the competitive landscape?
It potentially blocks competitors from developing similar compounds or methods within its scope, serving as a strategic asset in licensing negotiations and patent portfolios.

4. Are there international equivalents or related patents?
Likely, yes. The applicant may have filed corresponding applications in other jurisdictions, broadening global patent protection.

5. What should companies consider when developing products related to this patent?
They should conduct comprehensive freedom-to-operate analyses, evaluate the scope of the claims, and consider designing around claimed features or pursuing licensing opportunities.


References

  1. United States Patent and Trademark Office. Patent No. 10,646,480.
  2. Patent landscape reports and prior art searches relevant to the patent's technical domain.

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Drugs Protected by US Patent 10,646,480

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Acadia Pharms Inc NUPLAZID pimavanserin tartrate CAPSULE;ORAL 210793-001 Jun 28, 2018 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 10,646,480

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Sweden1730232Sep 1, 2017

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