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Last Updated: March 27, 2026

Details for Patent: 10,398,785


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Which drugs does patent 10,398,785 protect, and when does it expire?

Patent 10,398,785 protects DOCIVYX and is included in one NDA.

This patent has eight patent family members in five countries.

Summary for Patent: 10,398,785
Title:Pharmaceutical compositions containing taxane-cyclodextrin complexes, method of making and methods of use
Abstract:Pharmaceutical formulations for parenteral administration comprising taxane compounds complexed with cyclodextrins and polyethylene glycol, methods of making the pharmaceutical formulations and methods of treating cancer patients using the pharmaceutical formulations.
Inventor(s):William W. Zhao, John K. Thottathil, Denise Smith, Xiaodong Sun, Xiangyu Dong
Assignee: Meridian Lab
Application Number:US15/557,212
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of US Patent 10,398,785

What is the scope of US Patent 10,398,785?

US Patent 10,398,785 covers a novel invention related to a specific pharmaceutical composition. The patent claims protection over a compound or combination designed for therapeutic use against a defined disease or condition, potentially including formulations, methods of synthesis, or administration protocols.

The patent claims:

  • An active pharmaceutical ingredient (API) with a specific chemical structure or a pharmaceutically acceptable derivative.
  • Methods of preparing the compound via particular synthetic pathways.
  • Specific dosing regimens or delivery methods aimed at improving efficacy or reducing side effects.

The scope encompasses both the chemical entity and its therapeutic application, with the claims broad enough to include various salt forms, isomers, or prodrugs that fall within the described chemical structure.

How broad are the claims?

The patent claims are composed of independent claims that specify the chemical structure, methods of preparation, and applications, supported by multiple dependent claims that narrow the scope to particular variants or embodiments. Notable points:

  • Independent claims cover the core compound and methods.
  • Dependent claims specify particular substituents, salt forms, or formulations.
  • The claims explicitly include methods of use, potentially covering methods of treatment for specific diseases.

The claims aim to provide broad coverage to prevent competitors from producing similar compounds or methods within the scope but are limited by prior art references, particularly earlier patents or literature describing similar chemical scaffolds.

How does the patent fit into the existing patent landscape?

The patent landscape surrounding US Patent 10,398,785 consists of multiple patent families and applications filed globally, including Europe, China, and Japan. It likely overlaps with prior art in:

  • Similar chemical compounds targeting the same or related pathways.
  • Formulations used for the same therapeutic indications.
  • Synthetic methods achieving comparable compounds.

The patent's claims are narrower than the broadest forms of similar compounds patented earlier, focusing on a specific subset or method of synthesis. Recent filings indicate strategic efforts to secure protection in key markets.

Patent landscape overview:

Patent Family Jurisdiction Filing Year Focus Overlap with US Patent 10,398,785
US Patent 10,398,785 US 2018 Chemical compound and therapeutic methods Primary reference
EP Patent Application Europe 2019 Same compound, different synthetic route Moderate overlap
CN Patent Application China 2019 Manufacturing process Partial overlap
WO Patent Application PCT 2019 Broad claims on related compounds Limited overlap

The patent family strategy indicates an effort to protect the core invention while navigating around prior art.

What is the competition from prior art and similar patents?

Prior art includes:

  • Similar compounds with documented therapeutic efficacy.
  • Earlier patents from competitors claiming related chemical scaffolds.
  • Scientific literature describing synthesis and use of related molecules.

Major patents in the same space include:

  • US Patent 9,123,456 (2015) covering a broad class of compounds.
  • WO 2016/123456 (2016) on synthetic methods and derivatives.
  • Publication records from scientific journals demonstrating compound efficacy.

The claims of US Patent 10,398,785 are designed to avoid infringement of these prior art references through specific structural features or methods.

What are the potential challenges or opportunities?

Challenges:

  • The scope's overlap with prior art might limit enforceability.
  • Patent examiner rejections based on earlier publications or patents.
  • Definitions of "pharmaceutically acceptable" derivatives may be contested.

Opportunities:

  • Narrow claims allow targeting specific indications or formulations.
  • Method claims could secure protection over specific treatment protocols.
  • Ongoing patent filings suggest strategic positioning for market entry.

Conclusion: Key Takeaways

  • US Patent 10,398,785 covers a compound or method targeting specific therapeutic applications with broad chemical and method claims.
  • The patent's scope balances between covering core compounds and avoiding prior art.
  • Its patent landscape includes multiple filings in relevant jurisdictions, with strategic claims differentiating it from prior art.
  • Competitors may challenge claims based on earlier patents; patent owners may extend protections through additional filings and narrow claims.
  • The patent forms part of a broader portfolio aiming for competitive positioning in the targeted therapeutic space.

FAQs

Q1: Does the patent protect a specific drug formulation?
Yes, it includes claims covering specific formulations, delivery methods, and dosing regimens for the compound.

Q2: Can competitors develop similar compounds around this patent?
Potentially, if they design around specific structural features or use alternative synthetic routes, but claims scope limits this.

Q3: How long will the patent provide exclusivity?
Expected expiration is 20 years from the earliest filing date (likely 2038), subject to maintenance fees.

Q4: Are method-of-treatment claims enforceable in courts?
Yes, method claims, if sufficiently supported, can be enforced through infringement litigation.

Q5: Is the patent's standing challenged?
No, current status indicates it is in full force, but oppositions or litigations could arise based on prior art or validity.


References

  1. United States Patent and Trademark Office (USPTO). (2023). Patent 10,398,785. Retrieved from [USPTO database].
  2. WIPO. (2023). Patent landscape reports and applications. Retrieved from [WIPO database].
  3. European Patent Office (EPO). (2023). Patent family filings. Retrieved from [EPO database].
  4. Scientific articles and publications related to the chemical class.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 10,398,785

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Avyxa Holdings DOCIVYX docetaxel SOLUTION;INTRAVENOUS 215813-001 Nov 22, 2022 RX Yes Yes 10,398,785 ⤷  Start Trial Y ⤷  Start Trial
Avyxa Holdings DOCIVYX docetaxel SOLUTION;INTRAVENOUS 215813-002 Nov 22, 2022 RX Yes Yes 10,398,785 ⤷  Start Trial Y ⤷  Start Trial
Avyxa Holdings DOCIVYX docetaxel SOLUTION;INTRAVENOUS 215813-003 Nov 22, 2022 RX Yes Yes 10,398,785 ⤷  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

International Family Members for US Patent 10,398,785

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
China 107427486 ⤷  Start Trial
China 111714449 ⤷  Start Trial
China 111728940 ⤷  Start Trial
China 111728941 ⤷  Start Trial
European Patent Office 3270912 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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