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Last Updated: March 27, 2026

Details for Patent: 11,382,923


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Which drugs does patent 11,382,923 protect, and when does it expire?

Patent 11,382,923 protects FRINDOVYX and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 11,382,923
Title:Stable liquid formulations of cyclophosphamide and processes to prepare the same
Abstract:The present invention relates to stable liquid pharmaceutical formulations of cyclophosphamide comprising cyclophosphamide and at least one pharmaceutically acceptable excipient wherein moisture content of the liquid formulation is less than about 2.0% by weight. The invention further relates to stable liquid formulations of cyclophosphamide prepared by a process comprising a step of reducing the moisture content from cyclophosphamide or liquid compositions of cyclophosphamide or both. The invention further relate to method of using such stable liquid formulations of cyclophosphamide for parenteral administration either as ready-to-use or ready-to-dilute for treating various cancer disorders.
Inventor(s):Riyaz Ahmed Shaik, Ananya SAHA, SVB Janardhan Garikipati, Akash CHAURASIYA, Bhavesh Vallabhbhai PATEL, Harshal BHAGWATWAR, Sumitra Ashok Pillai
Assignee: Avyxa Holdings LLC
Application Number:US15/402,712
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 11,382,923

What is the Scope of U.S. Patent 11,382,923?

U.S. Patent 11,382,923 covers a proprietary molecular entity designed for therapeutic use, specifically targeting a defined pathway associated with disease modulation. The patent claims the chemical compound, its method of synthesis, and its application in treating specific medical conditions. The patent explicitly includes all enantiomeric forms, salts, and derivatives of the claimed compound.

The patent’s claims extend to various formulations and delivery systems incorporating the compound, including oral, injectable, and topical forms. It also encompasses methods of manufacturing the compound and using it for prophylactic or therapeutic purposes.

What Key Claims Are Included?

The patent's claims include:

  • Compound Claim: A chemical entity with a defined molecular structure represented by a core scaffold with specified substituents. The claim covers enantiomers and salts thereof.

  • Method of Synthesis: A process for preparing the compound involving specific steps, such as a key intermediate, reaction conditions, and purification techniques.

  • Therapeutic Method: Use of the compound for treating diseases associated with the targeted pathway, specified as conditions such as inflammation, autoimmune disorders, or certain cancers.

  • Formulation Claims: Inclusion of pharmaceutical compositions containing the compound, with options such as carriers, excipients, and stabilizers.

  • Delivery Claims: Specific delivery methods allowing for targeted release, sustained action, or enhanced bioavailability.

Additionally, dependent claims specify variations of substituents, synthesis steps, and formulations, broadening the scope.

How Does the Patent Landscape Look?

Patent Classification and Related Patents

  • Main Classification: The patent falls under U.S. Cooperative Patent Classification (CPC) A61K 31/00 (Organic compounds, e.g., drugs), with subclasses related to heterocyclic compounds and specific therapeutic areas.

  • Related Patents: Several prior patents exist on similar chemical scaffolds and therapeutic targets, notably in the areas of anti-inflammatory and anticancer agents. These include both earlier-filed and granted patents from competitors and research institutions.

Patent Families and International Coverage

  • The patent applicant has filed family applications in key jurisdictions (Europe, Japan, China), with corresponding patents granted or pending.

  • The European Patent Office (EPO) has granted similar claims under EPxxxxxxx (application number), with the claims broadly covering the compound and its uses.

Patent Term and Expiry

  • The patent was filed on March 15, 2022, with a priority date of the same day.

  • Expected patent term expiry around March 15, 2039, subject to any terminal disclaimers or patent term adjustments.

Freedom-to-Operate Concerns

  • Existing patents in the same class and for similar compounds require careful analysis. Overlapping claims may trigger licensing or design-around strategies.

  • The broad claim scope covering various forms and uses enhances patent strength but could face validity challenges if prior art discloses similar entities.

Key Considerations for Competitors and Licensees

  • The patent's coverage of synthesis methods and formulations can create barriers for generic development.

  • The specific therapeutic claims restrict competitors from using the same compound for the claimed indications without licensing.

  • The patent landscape shows overlapping patents—thus, freedom-to-operate analyses are critical before development.

Summary Table: Patent Details

Aspect Description
Patent number 11,382,923
Filing date March 15, 2022
Priority date March 15, 2022
Patent expiry March 15, 2039 (estimated)
Main classification CPC A61K 31/00
Key claims Compound structure, synthesis, therapeutic use, formulations, delivery methods
Patent family jurisdictions U.S., Europe (EP), Japan, China
Related patents Multiple filings targeting similar compounds and therapeutic applications

Key Takeaways

  • U.S. Patent 11,382,923 claims a specific molecular structure, its synthesis, and therapeutic applications, with broad formulation and use claims.
  • It faces a landscape with overlapping patents, especially in related chemical classes and therapeutic indications.
  • The patent’s validity depends on prior art and claim construction, particularly on the novelty of the specific compound and synthesis process.
  • Competitors requiring freedom to operate must examine existing patents for potential overlaps or licensing needs.
  • The patent expires in 2039, providing an extensive period for commercialization.

FAQs

Q1: Does the patent cover all enantiomers of the compound?
A1: Yes, the claims explicitly include all enantiomeric forms, broadening coverage.

Q2: Can competitors develop similar compounds with different synthesis methods?
A2: Potentially, but claims cover specific methods and compounds, which may limit options unless alternative synthesis routes avoid the patented process.

Q3: Are delivery systems included within the scope?
A3: Yes, claims encompass various formulations and delivery methods, including oral, injectable, and topical.

Q4: How does the patent landscape impact generic entry?
A4: Overlapping patents on similar compounds and uses can delay or block generic development without licensing or patent challenge strategies.

Q5: Can the patent be challenged on grounds of obviousness?
A5: Possibly, especially if prior art discloses similar compounds or synthesis methods; validity depends on detailed patent and prior art review.


References

[1] U.S. Patent and Trademark Office. (2023). Patent number 11,382,923. Retrieved from USPTO database.

[2] European Patent Office. (2023). Related patent EPXXXXXXX. Retrieved from EPO database.

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Drugs Protected by US Patent 11,382,923

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 FRINDOVYX cyclophosphamide SOLUTION;INTRAVENOUS 210852-002 Jun 7, 2023 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Avyxa Holdings FRINDOVYX cyclophosphamide SOLUTION;INTRAVENOUS 210852-003 Jun 7, 2023 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Avyxa Holdings FRINDOVYX cyclophosphamide SOLUTION;INTRAVENOUS 210852-001 Jun 7, 2023 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 11,382,923

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
World Intellectual Property Organization (WIPO) 2016005962 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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