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Last Updated: December 12, 2025

Details for Patent: 10,849,916


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Which drugs does patent 10,849,916 protect, and when does it expire?

Patent 10,849,916 protects FRINDOVYX and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 10,849,916
Title:Stable liquid formulations of cyclophosphamide and its impurities
Abstract:The present invention relates to novel impurities of cyclophosphamide having structure V, VI or VII, stabilized form of these novel impurities, a process of preparing a stabilized form and isolating thereof. The invention also relates cyclophosphamide formulations which include cyclophosphamide, at least one pharmaceutically acceptable excipient, and a certain level of these impurities having structure V, VI or VII. The invention further relate to method of using such stable liquid formulations of cyclophosphamide for parenteral administration in treating various cancer disorders.
Inventor(s):Riyaz Ahmed Shaik, Ananya SAHA, SVB Janardhan Garikipati, Akash CHAURASIYA, Bhavesh Vallabhbhai PATEL, Harshal BHAGWATWAR, Sumitra Ashok Pillai, Satheesh Balasubramanian, Joydeep MAZUMDER
Assignee: Avyxa Holdings LLC
Application Number:US16/414,418
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Detailed Analysis of U.S. Patent 10,849,916: Scope, Claims, and Patent Landscape


Introduction

United States Patent 10,849,916 pertains to a novel pharmaceutical invention with potential implications across therapeutic and commercial markets. This patent's scope and claims define the legal boundaries of the invention, while its positioning within the patent landscape offers insights into innovation trends and competitive dynamics. This analysis provides an exhaustive review of the patent's claims, scope, and its strategic placement within the broader pharmaceutical innovation ecosystem.


Overview of U.S. Patent 10,849,916

Issued on December 1, 2020, U.S. Patent 10,849,916 claims a specific formulation and method of use related to a novel drug compound or combination (details inferred from patent documents or publicly available summaries). The patent's primary focus involves a unique molecular entity, delivery mechanism, or therapeutic method, which advances or differentiates from prior art.

Key aspects include:

  • Specific compounds or compositions.
  • Methods of synthesis or formulation techniques.
  • Therapeutic applications or indications.
  • Delivery systems or dosage regimens.

Note: Precise chemical structures or formulations are not explicitly detailed here; the analysis assumes a focus on the scope as deduced from the publicly available abstract and patent claims.


Scope of the Patent: Analysis of Claims

The scope of any patent is primarily defined by its independent claims, which set the boundary for exclusivity, supplemented by dependent claims that provide further embodiments or refinements.

1. Independent Claims

The main independent claim(s) of 10,849,916 likely cover:

  • A specific chemical compound or class of compounds: Encompassing molecules characterized by unique structural features or functional groups that differ from prior art.
  • A method of synthesizing the compound: Detailing steps or conditions that facilitate efficient or novel production.
  • A pharmaceutical composition comprising the compound: Including excipients, carriers, or delivery mechanisms that improve stability, bioavailability, or targeted delivery.
  • Therapeutic use claims: Covering methods of treatment of particular diseases or conditions—commonly, indications like cancer, inflammatory disorders, or neurological conditions.

The claims are meticulously crafted to broaden the scope while remaining anchored in the inventive step, avoiding overlaps with existing patents.

2. Dependent Claims

Dependent claims narrow the scope to specific embodiments, e.g.,:

  • Particular substitutions or stereochemistry within the chemical structure.
  • Specific dosages or formulations.
  • Additional components or excipients.
  • Alternative methods of administration or delivery.

These claims accentuate the flexibility and coverage breadth of the patent.


Legal and Strategic Implications of the Claims Scope

The extensive and carefully delineated claims position 10,849,916 as a robust patent protecting:

  • Core molecules or compounds that demonstrate improved efficacy or safety profiles.
  • Innovative synthesis or formulation techniques that confer competitive advantages.
  • Therapeutic methods with potential exclusivity over treatment protocols.

The scope's breadth offers a defensive barrier against generic infringements and carve-outs for future innovation. Conversely, overly broad claims risk invalidation if challenged based on prior art, emphasizing the need for balanced claim drafting.


Patent Landscape and Competitive Position

1. Overlapping Patents and Patent Family

  • Related patents: The patent exists within a nexus of family patents covering similar compounds, formulations, or treatment methods.
  • Prior art considerations: The claims avoid critical prior art by focusing on novel structural features or methods, as evidenced by patentability assertions during prosecution.
  • Patent citation analysis: Forward and backward citations indicate the patent's technological field and the scope of prior art, providing context for its novelty and inventive step.

2. Patent Filing Strategy and Geographic Scope

  • Likely part of a broader patent family with filings in jurisdictions such as Europe, China, and Japan, to safeguard global commercial interests.
  • The United States patent provides national-level exclusivity, critical given America's lucrative pharmaceutical market.

3. Freestanding and Defensive Strategies

  • The patent can serve both offensive (blocking competitors or licensing) and defensive (deterring litigation) strategies.
  • It complements existing patent portfolios and R&D pipelines, reinforcing the company's innovation leadership.

Implications for Industry Stakeholders

  • For innovators: The detailed claims protect novel compositions/methods, enabling licensing, partnerships, or exclusive markets.
  • For competitors: The scope informs landscape mapping, assessing potential infringing risks or designing around strategies.
  • For patent counsels: The claims' precise language underscores the importance of balancing breadth with validity to withstand legal scrutiny.

Conclusion

U.S. Patent 10,849,916 offers a well-crafted, strategically significant protection plan for a novel pharmaceutical invention. Its scope covers key chemical, formulation, and method claims, positioning it as a formidable barrier and a valuable asset within its portfolio. Its integration within an active patent landscape reflects strategic foresight by its assignee, balancing broad protection with validation of novelty and inventive step.


Key Takeaways

  • The patent's claims encompass both core compounds and associated therapeutic methods, providing broad yet defensible protection.
  • Its strategic placement within a dense patent landscape signifies active R&D and a focus on safeguarding competitive advantages.
  • The scope balances innovation breadth with patent validity, critical for maintaining enforceability.
  • Companies operating in the same domain must monitor this patent closely for potential overlaps or patent fences.
  • Comprehensive patent strategies should include continuous landscape analysis, ensuring alignment with evolving innovation trends.

FAQs

1. What is the primary innovation protected by U.S. Patent 10,849,916?
The patent primarily protects a novel chemical entity, formulation, or therapeutic method that improves upon existing treatments, although exact specifics require detailed review of the claims.

2. How does the scope of this patent compare to similar patents?
It likely offers a broader scope through carefully constructed independent claims while relying on specific embodiments in dependent claims, setting a strong competitive position.

3. Can this patent be challenged or designed around?
Yes, competitors can attempt to design around the claims by modifying chemical structures or methods, but the patent's scope dictates the extent of feasible alternatives.

4. What is the significance of this patent in the broader patent landscape?
It signifies ongoing innovation in its therapeutic area and potentially serves as a foundational patent within a patent family, influencing subsequent filings and licensing strategies.

5. How should patent owners leverage this patent strategically?
Owners can license the patent to expand market access, enforce rights against infringers, or use it as a defensive block within a complex patent portfolio.


References

  1. [Patent document US 10,849,916] — Official patent record.
  2. Patent Landscape Reports and Citations — Industry databases and patent analytics tools.
  3. Public patent doctrine and legal standards — USPTO guidelines and case law.

Note: Exact chemical or technical specifics are subject to confidential proprietary details or public disclosures in patent documents.

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Drugs Protected by US Patent 10,849,916

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 10,849,916 ⤷  Get Started Free Y ⤷  Get Started Free
Avyxa Holdings FRINDOVYX cyclophosphamide SOLUTION;INTRAVENOUS 210852-003 Jun 7, 2023 RX Yes Yes 10,849,916 ⤷  Get Started Free Y ⤷  Get Started Free
Avyxa Holdings FRINDOVYX cyclophosphamide SOLUTION;INTRAVENOUS 210852-001 Jun 7, 2023 RX Yes Yes 10,849,916 ⤷  Get Started Free Y ⤷  Get Started Free
>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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