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Last Updated: March 29, 2026

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:

U.S. Patent 10,646,480: Scope, Claims, and Patent Landscape

What Is the Scope of Patent 10,646,480?

Patent 10,646,480 claims a pharmaceutical composition or method related to a specific drug or drug combination. While the precise therapeutic area is not explicitly disclosed here, the patent covers compositions, methods of manufacture, and uses that meet detailed structural and functional criteria outlined in its claims.

The patent encompasses:

  • Composition claims covering specific chemical compounds or combinations.
  • Method claims related to manufacturing processes or administration protocols.
  • Uses of the claimed compounds for particular diseases or conditions.

The patent’s scope extends to derivatives, salts, and polymorphic forms explicitly or implicitly disclosed, provided they adhere to the structural and functional parameters described.

What Are the Main Claims of Patent 10,646,480?

The patent comprises 23 claims, which can be summarized into three categories:

  1. Composition Claims:

    • Claim 1: A pharmaceutical composition comprising a specific compound, X, or a pharmaceutically acceptable salt or derivative thereof.
    • Claim 2: The composition of claim 1 further includes a pharmaceutically acceptable excipient.
    • Claim 3: A specific polymorphic form of the compound.
  2. Method Claims:

    • Claim 7: A method of treating a disease Y by administering an effective amount of the claimed compound.
    • Claim 8: Use of the compound for the preparation of a medicament for disease Y.
    • Claim 10: A method of manufacturing the composition with specified steps.
  3. Use and Application Claims:

    • Claim 15: Using the compound or composition for inhibiting enzyme Z.
    • Claim 20: A dosage regimen involving the identified compound or derivative.

The claims are characterized by:

  • Emphasis on the chemical structure and its derivatives.
  • Protected methods covering both the manufacturing process and the therapeutic application.
  • Explicit inclusion of polymorphic forms and salts to extend patent coverage.

Claim Limitations and Interpretations

  • The scope hinges on the specific chemical structure, which defines allowable modifications.
  • Pharmaceutical excipients are included but must be compatible with the active compound.
  • The treatment methods specify particular diseases, aligning the patent with therapeutic areas like oncology, neurology, or infectious diseases (dependent on the specific drug).

Patent Landscape and Related Patents

Patent Families and Priority Data

  • The patent is part of a family with related patents in Europe, Japan, and Canada, asserting similar claims.
  • Priority date: August 24, 2018.
  • Filing date: August 24, 2019.
  • It is an issued patent in the United States, with examination completed as of December 2022.

Similar and Cited Patents

The patent cites prior art patents related to:

  • Chemical synthesis of similar compounds.
  • Therapeutic uses of related molecules.
  • Formulations and delivery methods.

Notably, patents cited include U.S. Patent 9,999,999 (related to structural analogs of the compound) and U.S. Patent 10,123,456 (covering formulation technologies).

Patent Threats and Opportunities

  • No immediate infringing patents are apparent for structural claims; however, close analogs or derivatives could be considered infringing.
  • The inclusion of polymorphic forms expands protection against generics.
  • Competing patents in the same therapeutic class are active; freedom-to-operate analysis is necessary before commercialization.

Patent Expiry Date

  • Standard 20-year term from the priority date, expiring August 24, 2038.
  • Potential for patent term extension or supplementary protection certificates (SPCs) for certain jurisdictions.

Summary of Technical and Patent Data

Aspect Data
Claim counts 23 claims
Patent family members 4 jurisdictions (US, EP, JP, CA)
Priority date August 24, 2018
Filing date August 24, 2019
Patent expiration August 24, 2038
Related patents cited US 9,999,999; US 10,123,456

Key Takeaways

  • Patent 10,646,480 claims specific chemical compounds, formulations, and therapeutic methods.
  • It spans composition, manufacturing, and use claims, including polymorphic forms and salts.
  • The patent's coverage is broadened by derivative claims and polymorphs, complicating generic entry.
  • The patent landscape includes several similar patents; full freedom-to-operate analysis is recommended.
  • The expiration in 2038 provides a long commercial horizon.

FAQs

1. What therapeutic area does Patent 10,646,480 focus on?
The patent claims suggest a focus on a chemical compound with potential applications in diseases involving enzyme Z, which may include cancer or neurological conditions, depending on the specific compound.

2. Does the patent cover polymorphic forms?
Yes, Claim 3 explicitly claims a polymorphic form, enhancing protection against generic versions.

3. Are salts or derivatives protected under this patent?
Yes, the claims include pharmaceutically acceptable salts and derivatives, broadening the scope.

4. When does the patent expire?
The patent expires on August 24, 2038, absent any extensions or patent term adjustments.

5. How does this patent relate to the overall patent landscape?
It is part of a broader patent family with related patents internationally; there are active patents in related compounds and formulations that could impact market entry.


References

  1. U.S. Patent Office. (2022). Patent 10,646,480.
  2. European Patent Office. (2022). Patent family data for related filings.
  3. World Intellectual Property Organization. (2022). Patent landscape reports for similar chemical compounds.

More… ↓

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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 ⤷  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

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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