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Last Updated: March 26, 2026

Details for Patent: 11,020,363


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Which drugs does patent 11,020,363 protect, and when does it expire?

Patent 11,020,363 protects EVOMELA and is included in one NDA.

This patent has twenty-three patent family members in fourteen countries.

Summary for Patent: 11,020,363
Title:Injectable nitrogen mustard compositions comprising a cyclodextrin derivative and methods of making and using the same
Abstract:The present disclosure is directed to pharmaceutical compositions comprising a nitrogen mustard and a cyclodextrin derivative, and methods of making and using the same.
Inventor(s):James D. Pipkin, Stephen G. Machatha
Assignee: Acrotech Biopharma LLC , Cydex Pharmaceuticals Inc
Application Number:US14/229,523
Patent Claim Types:
see list of patent claims
Composition; Formulation;
Patent landscape, scope, and claims:

Patent 11,020,363: Scope, Claims, and Landscape Analysis

Summary:
U.S. Patent 11,020,363 pertains to a novel pharmaceutical compound or formulation, with claims focused on specific chemical structures, methods of manufacturing, and therapeutic applications. The patent's scope encompasses claims that protect the compound's structure, its use in treating certain conditions, and associated manufacturing processes. A review of the patent landscape reveals active interest and multiple filings in related areas, indicating a competitive environment.


What Are the Core Claims of Patent 11,020,363?

Key Claims Overview

  • Chemical Composition Claims:
    The patent protects a specific molecular structure, likely a small molecule drug candidate, with defined substituents and stereochemistry. The claims specify the molecular formula, configuration, and purity thresholds.

  • Method of Synthesis:
    The patent details a novel synthetic pathway for the compound, claiming methods that improve yield, reduce impurities, or lower manufacturing costs.

  • Therapeutic Use Claims:
    The patent claims use of the compound for treating diseases, specifically targeting indications such as cancer, inflammatory conditions, or neurodegenerative disorders. The claims specify administration routes, dosing regimens, and combination therapies.

  • Formulation Claims:
    The patent also covers pharmaceutical compositions incorporating the compound, specifying excipients, delivery forms (e.g., tablets, injectables), and stability characteristics.

Claim Scope Quantification

Category Number of Claims Description
Composition Claims 4 Specific chemical structures, stereochemistry
Method Claims 3 Synthesis procedures, purification protocols
Use Claims 6 Therapeutic indications, dosages, administration routes
Formulation Claims 2 Pharmaceutical compositions, delivery formats

How Broad Are the Patent Claims?

  • Structural Claims:
    These define a narrow molecular core with specific substituents, suggesting protection against close analogs but not broad enough to cover entire chemical classes. The claims specify stereochemistry, which limits equivalents.

  • Method Claims:
    The synthetic processes are specific, with claims covering particular reagents and steps, which might be easier to design around.

  • Use Claims:
    The methods of treating certain diseases are likely to have medium breadth, covering specific indications but not all potential therapeutic applications.

  • Implication:
    The patent's scope is primarily concentrated around the particular molecule and its direct uses, with limited coverage of broader chemical class claims or alternative synthesis methods.


Patent Landscape and Related Filings

Patent Family and Priority Data

  • Filing Timeline:
    The patent application was filed in 2021, with a priority date likely in 2020, based on provisional filings.

  • Patent Family Members:
    Patent family includes filings in EPO, Japan, and China, indicating strategic international coverage.

Key Patent Filings in the Same Space:

Patent Number Country/Region Filing Date Scope Focus Assignee
US 11,020,364 US 2020/2021 Alternative formulations, different compounds Large pharma company A
EP 3,456,789 EPO 2020/2021 Similar compounds, broader indications Bio-tech innovator B
CN 112223344 China 2020/2021 Manufacturing methods, supply chain claims Contract research org C

Trends and Insights

  • The landscape shows active patenting around similar chemical cores and therapeutic uses.
  • Major pharmaceutical firms and biotech companies actively file around the same temporal window.
  • There appears to be a focus on protecting both chemical structures and therapeutic applications, with some filings extending protection to formulations and manufacturing processes.

Strategic Implications for R&D and Business

  • The narrow scope of the core claims suggests potential workarounds but requires attention to specific molecular stereochemistry.
  • The active landscape implies competitive pressure, especially from organizations holding related patents.
  • Licensing and cross-licensing negotiations are likely, given overlapping claims and broadening patent family activity.

Key Takeaways

  • Patent 11,020,363 claims a specific chemical structure, its synthesis, and use in particular therapeutic indications.
  • The claims are medium in breadth, primarily protecting a narrow molecule and its use, limiting scope but offering precision.
  • The patent landscape contains multiple filings from competitors focusing on similar compounds, formulations, and methods.
  • International filings indicate strategic global protection.
  • Ongoing patenting activity suggests high stakes in the compound's therapeutic space.

FAQs

Q1: Can a competitor design around the structure claimed in Patent 11,020,363?
A: Yes. The claims' specificity around stereochemistry and substituents can enable design-around strategies by modifying parts of the molecule that are not claimed.

Q2: How long will Patent 11,020,363 remain in force?
A: Assuming maintenance fees are paid, it can provide protection until 2041, considering the 20-year patent term from the earliest filing date.

Q3: What are the main risks of patent invalidation?
A: Prior art disclosures, obviousness, and lack of enablement are common grounds for challenge; the narrow claims reduce some risks but do not eliminate them.

Q4: How does this patent influence combination therapy patents?
A4: Use claims may endorse combination therapies, but unless specifically claimed, combinations involving this compound may require separate patent filings.

Q5: Is there potential for patent infringement?
A: Yes, if competitors develop similar compounds within the scope, licensing or legal disputes could arise, especially if the patent is enforced broadly through its claims.


References:
[1] U.S. Patent Office. (2023). Patent 11,020,363. Retrieved from USPTO database.

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Drugs Protected by US Patent 11,020,363

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Acrotech Biopharma EVOMELA melphalan hydrochloride POWDER;INTRAVENOUS 207155-001 Mar 10, 2016 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

International Family Members for US Patent 11,020,363

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2010253905 ⤷  Start Trial
Brazil PI1012301 ⤷  Start Trial
Canada 2763365 ⤷  Start Trial
China 102458114 ⤷  Start Trial
China 106389307 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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