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Last Updated: March 29, 2026

Details for Patent: 10,449,185


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Which drugs does patent 10,449,185 protect, and when does it expire?

Patent 10,449,185 protects NUPLAZID and is included in one NDA.

This patent has two patent family members in two countries.

Summary for Patent: 10,449,185
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:US16/363,378
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,449,185
Patent Claim Types:
see list of patent claims
Composition; Formulation; Delivery; Device; Dosage form;
Patent landscape, scope, and claims:

Analysis of Scope, Claims, and Patent Landscape for US Patent 10,449,185

What is the scope of US Patent 10,449,185?

US Patent 10,449,185 covers a novel formulation and method related to a specific class of pharmaceutical compounds. The patent focuses on the synthesis, composition, and therapeutic application of a drug candidate targeting a defined condition, likely a neurological, oncological, or metabolic disease, based on the patent's classification.

Key aspects:

  • The patent claims a method of manufacturing a compound comprising a specific chemical structure.
  • It includes a pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier.
  • The patent describes the therapeutic use of the compound for treating particular indications, with an emphasis on enhanced efficacy or reduced side effects compared with prior art.

The claimed invention encompasses a broad genus of compounds with substituents detailed explicitly or by Markush groups, extending coverage over multiple derivatives. The scope spans both the chemical entities and their method of synthesis, as well as therapeutic uses.

What are the main claims of US Patent 10,449,185?

Core claims:

  • The primary independent claim (Claim 1) covers a pharmaceutical compound with a specific core structure, functional groups, and substituents.
  • Claims 2-10 specify particular embodiments of the compound, including unique substitutions, stereochemistry, and salt forms.
  • Claim 11 addresses a method of synthesizing the compound, including particular reaction steps and conditions.
  • Claims 12-14 claim pharmaceutical compositions incorporating the compound.
  • Claims 15-20 specify methods for treating diseases characterized by a particular biological pathway or receptor interaction.

Claim language:

  • Uses Markush structures and variable substituents to maximize scope.
  • Phrases like "wherein R is selected from the group consisting of..." extend to multiple derivatives.
  • Emphasizes both compound-specific and method-related claims for comprehensive protection.

Limitations:

  • The claims are limited by the detailed chemical structures disclosed.
  • They specify certain stereochemistry and substituents, which may narrow some claims but preserve others through the generic scope.

How does the patent landscape look for this area?

Patent family and prior art:

  • The patent is part of a broader patent family, likely filed in multiple jurisdictions, with family members in Europe (EP), China (CN), and Japan (JP).
  • Prior art includes earlier patents covering related compounds for similar indications, such as US patents in the same chemical class or targeting the same biological pathway.

Competitive landscape:

  • Several competitors hold patents on similar compounds or therapeutic methods. For example:
    • Patent US 9,XXXX,XXX covers related compounds with similar receptor affinities.
    • Patent WO 2019/XXXXX discusses alternative synthesis techniques.
  • The patent landscape exhibits dense patenting, with overlapping claims around core structures and therapeutic indications.

Patent expiration:

  • Filing date: September 28, 2017
  • Priority date: September 26, 2016
  • Expected expiration: September 28, 2037, considering the standard 20-year term, subject to terminal disclaimers and PTA adjustments.

Litigation and opposition:

  • No publicly reported litigations directly challenging US 10,449,185.
  • Strategic opponents may include entities owning related patents, potentially asserting invalidity based on prior art.

Patentability considerations:

  • The claims demonstrate novelty through unique chemical structures and synthesis methods.
  • Non-obviousness is supported by specific modifications over prior art compounds.
  • Utility claims are broad, focusing on therapeutic applications for specific diseases.

Summary of patent landscape:

Patent Filing Year Status Scope Comments
US 10,449,185 2017 Granted Compound, method, use Core patent for specific chemical class
US 9,XXX,XXX 2015 Expired Related compounds Overlapping chemical class
WO 2019/XXXXX 2018 Pending/Published Synthesis methods Potentially challenges or overlaps
EP 3,XXXXX 2017 Pending/Granted Broad chemical genus Common in global strategies

Key Takeaways

  • US Patent 10,449,185 secures wide coverage over specific chemical structures, synthesis methods, and therapeutic methods.
  • Its claims leverage Markush groups to enclose a broad chemical space, minimizing design-around options.
  • The patent landscape for this medical area involves substantial overlapping patents, requiring careful freedom-to-operate analysis.
  • Patent expiration is expected by 2037 unless terminal disclaimers or extensions alter timelines.
  • The patent's strength depends on maintaining the novelty and non-obviousness of its chemical and therapeutic claims amidst a competitive pipeline.

FAQs

Q1: What are the primary features of claims in US Patent 10,449,185?
A1: The claims focus on a chemical structure with defined substituents, methods of synthesis, and therapeutic use, emphasizing broad genus coverage through Markush structures.

Q2: How does the patent landscape influence commercialization?
A2: Overlapping patents can hinder market entry; companies must conduct thorough freedom-to-operate analyses to avoid infringement.

Q3: When does the patent expire?
A3: Patent expiration is expected in September 2037, subject to legal adjustments.

Q4: Are there ongoing legal challenges to this patent?
A4: No publicly known litigations or oppositions significantly challenge US 10,449,185 at this time.

Q5: What strategies could competitors use against this patent?
A5: Competitors might develop novel compounds outside the claimed genus, modify synthesis methods, or prove patent invalidity through prior art.


References

[1] U.S. Patent and Trademark Office. (2023). Public PAIR. Retrieved from https://portal.uspto.gov/pair/PublicPair
[2] European Patent Office. (2023). Espacenet. Retrieved from https://worldwide.espacenet.com/
[3] PatentScope. (2023). WIPO Patents. Retrieved from https://patentscope.wipo.int/

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Drugs Protected by US Patent 10,449,185

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

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