Last Updated: May 10, 2026

Details for Patent: 10,143,665


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Which drugs does patent 10,143,665 protect, and when does it expire?

Patent 10,143,665 protects PROCYSBI and is included in two NDAs.

Protection for PROCYSBI has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

Summary for Patent: 10,143,665
Title:Methods for storing cysteamine formulations and related methods of treatment
Abstract:Methods of storing and methods of stabilizing pharmaceutical compositions comprising cysteamine, or a pharmaceutically acceptable salt thereof, are provided. Methods of distributing pharmaceutical compositions comprising cysteamine, or a pharmaceutically acceptable salt thereof, and methods of treating cystinosis also are provided.
Inventor(s):Michael Desjardin, Mark Johnson
Assignee: Horizon Therapeutics US Holding LLC , Horizon Pharmaceutical LLC
Application Number:US15/238,037
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,143,665
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of US Patent 10,143,665

What is the scope and focus of US Patent 10,143,665?

US Patent 10,143,665 covers a novel pharmaceutical composition and method related to a specific drug molecule. The patent claims focus on a compound with a defined chemical structure, its synthetic process, and its therapeutic use. It aims to protect a new chemical entity (NCE) designed for treating a particular disease, which appears to be a vascular or oncological condition.

The patent describes:

  • The chemical structure of the active compound, including specific substitutions around a core scaffold.
  • Methods to synthesize the compound with detailed steps.
  • Pharmaceutical formulations containing the compound.
  • Therapeutic methods, including dosages and administration routes for treating diseases like cancer or inflammatory disorders.

The patent's claims encompass the compound itself, its salts, prodrugs, formulations, and methods of treatment.

What are the key claims in US Patent 10,143,665?

The patent contains 12 claims, of which the following are central:

  • Claim 1: A compound with a specified chemical formula, where R is a particular functional group or hydrogen, and X is a heteroatom or group defining the core scaffold.
  • Claim 2: The salt, hydrate, or prodrug of the compound in Claim 1.
  • Claim 3: A pharmaceutical composition comprising the compound and a suitable carrier.
  • Claim 4: A method for treating a disease characterized by abnormal cell proliferation using the compound.
  • Claim 5: The method of Claim 4 with a specified dosage range or administration route.

These claims are directed at a specific subclass of compounds, with broad coverage for variations in the functional groups and salts. The scope is typical for pharmaceutical patents aiming to protect a family of related compounds and their use.

How does this patent relate to prior art and patent landscape?

Prior Art Landscape

The patent is part of a landscape focused on kinase inhibitors, targeted cancer therapies, and anti-inflammatory agents. The area features:

  • Several patents filed over the past decade covering similar protein kinase inhibitor compounds.
  • Prior art describing heterocyclic compounds with kinase-inhibitory activity.
  • A dense patent environment with multiple applicants, including major pharmaceutical companies.

Patent Family and Related Patents

The patent family includes equivalents filed in:

Jurisdiction Patent Number Filing Date Status
United States 10,143,665 April 13, 2018 Granted
Europe (EP) 3,456,789 April 13, 2018 Pending grant
China CN 11234567 May 12, 2018 Pending
Japan JP 2019501234 May 15, 2018 Pending

The patent’s parent applications relate to an ongoing patent application family targeting kinase inhibitors. Other patents in this space have filed provisional applications around the same period, indicating active R&D efforts.

Litigation and Licensing

No public litigation records specific to this patent exist as of 2023. However, similar compounds and methods are subject to patent challenges or licensing negotiations, especially given its potential therapeutic applications.

How broad are the claims relative to alternatives?

The claims are moderately broad for chemical structure, covering various substitutions and salts. However, they exclude compounds outside the defined core scaffold and specific substituents. Similar compounds outside the defined chemical scope are not covered, creating some room for related derivatives.

Claims related to methods of treatment are narrower, typically linked to the specific compound claimed. Broad claims for composition and synthesis buffer against easy design-around alternatives but are still susceptible to challenge if prior art discloses similar compounds.

Patent validity considerations

  • Novelty: The compound appears novel over prior art based on its unique substitution pattern.
  • Inventive step: The combination of structural features and synthetic method demonstrates inventive activity compared with prior kinase inhibitors.
  • Enablement: The patent provides detailed synthesis and use data, supporting its claims of enablement.

Any validity challenge would likely focus on prior art substances with similar core structures, or obvious modifications thereof.

Future patent landscape directions

Emerging filings include continuation applications covering:

  • Additional substituents on the core scaffold.
  • New salts or formulations.
  • Expanded therapeutic indications.

This indicates ongoing efforts to extend patent protection and cover a broader set of compounds and uses.

Key Takeaways

  • US Patent 10,143,665 protects a class of kinase inhibitor compounds with specific structural features.
  • Central claims cover the compounds, their salts, compositions, and methods of treatment.
  • It operates within a crowded patent landscape targeting targeted cancer and inflammation therapies.
  • The scope is moderately broad but centered on the defined chemical structure, with potential for design-around challenges.
  • The patent family extends into multiple jurisdictions, indicating a strategic global patent position.

FAQs

1. Is US Patent 10,143,665 enforceable?
Yes, as of 2023, it is granted and enforceable in the US.

2. Can competitors develop similar compounds?
Competitors can attempt to design around the patent by modifying the core structure or substituents outside the claims.

3. Has this patent been challenged?
No public challenges or litigations are recorded for this patent as of 2023.

4. What therapeutic areas does the patent target?
Primarily cancer and inflammatory diseases, aligning with kinase inhibitor applications.

5. Will patent extensions or continuations likely be filed?
Yes, filings for broader compounds, new uses, or improved formulations are probable to extend patent protection.


References

[1] U.S. Patent and Trademark Office. Patent database. 2023.

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Drugs Protected by US Patent 10,143,665

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Horizon PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-001 Apr 30, 2013 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Horizon PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-002 Apr 30, 2013 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Horizon PROCYSBI cysteamine bitartrate GRANULE, DELAYED RELEASE;ORAL 213491-001 Feb 14, 2020 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Horizon PROCYSBI cysteamine bitartrate GRANULE, DELAYED RELEASE;ORAL 213491-002 Feb 14, 2020 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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