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Last Updated: December 12, 2025

Details for Patent: 10,420,841


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Which drugs does patent 10,420,841 protect, and when does it expire?

Patent 10,420,841 protects ZERBAXA and is included in one NDA.

This patent has forty-four patent family members in twenty-seven countries.

Summary for Patent: 10,420,841
Title:Ceftolozane antibiotic compositions
Abstract:This disclosure provides pharmaceutical compositions comprising ceftolozane, pharmaceutical compositions comprising ceftolozane and tazobactam, methods of preparing those compositions, and related methods and uses of these compositions.
Inventor(s):Joseph Terracciano, Nicole Miller Damour, Chun Jiang, Giovanni Fogliato, Giuseppe Alessandron DONADELLI, Dario Resemini
Assignee: Merck Sharp and Dohme LLC
Application Number:US15/844,961
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,420,841


Introduction

U.S. Patent No. 10,420,841, granted on September 24, 2019, represents a significant patent in the pharmaceutical sector, specifically addressing innovative compounds, formulations, or methods relevant to treatment modalities. This patent's scope and claims delineate the boundaries of intellectual property rights applicable to its inventors, impacting subsequent innovation, licensing opportunities, and competitive landscape within its therapeutic domain. A comprehensive understanding of its claims and the broader patent landscape informs stakeholders of the patent's strength, potential challenges, and strategic implications.


Scope of U.S. Patent 10,420,841

The patent's scope primarily hinges upon the broadness of its claims, which define the legal protections conferred. At its core, this patent appears to cover novel chemical entities, their pharmaceutical formulations, or methods of use. The scope can be segmented into:

  • Chemical Structure and Composition Claims: Covering specific molecules with defined structural features, possibly including salts, esters, or prodrugs derived thereof.
  • Method of Use Claims: Encompassing therapeutic protocols, dosages, or methods of administering the compounds for particular indications.
  • Formulation and Delivery Claims: Addressing pharmaceutical compositions, delivery systems, or combinations with other agents.

Pending the detailed claim language, the patent likely aims to establish a broad barrier protecting the underlying innovation, shielding against competitors designing around narrower claims. The patent's scope aims to balance specificity in chemical structure with broader utility claims, enhancing enforceability and market exclusivity.


Claims Analysis

Independent Claims:

The core independent claims of the '841 patent typically define the broadest scope. These likely specify the chemical structure with particular substituents and their pharmaceutically acceptable salts or derivatives. For example, an independent claim might state:

"A compound selected from the group consisting of [core structure], substituted with [specific groups], or pharmaceutically acceptable salts and stereoisomers thereof."

Key features of these claims include:

  • Structural Breadth: Covering variations of a core scaffold, such as heterocycles or aromatic systems.
  • Functional Group Limitations: Defining allowable substituents to delimit scope without being overly narrow.
  • Method of Synthesis or Use: Possibly included as method claims directed toward preparing or utilizing the compounds.

Dependent Claims:

Dependent claims narrow the scope by specifying particular embodiments, such as:

  • Specific substitutions or stereochemistry.
  • Particular salts or formulations.
  • Specific dosing regimens or administration routes.

This layered claim structure ensures comprehensive protection, with the independent claims covering broad innovation and dependent claims providing fallback positions against validity challenges.


Patent Landscape and Competitive Analysis

Existing Patent Landscape:

The patent landscape surrounding this patent likely involves several key players engaged in the development of similar chemical entities or therapeutic methods. A landscape analysis reveals:

  • Prior Art Foundations: Pre-existing patents may pertain to earlier compounds with similar core structures or mechanisms of action, which this patent either builds upon or differentiates from.
  • Related Patents and Applications: Several patents filed prior to or following the '841 patent may involve similar chemical scaffolds, indicating a crowded patent space.
  • Amended or Cited Patents: During prosecution, prior art references cited by the patent examiner or those cited by the applicant influence scope shaping and patentability assessments.

Strategic Position:

Given the often incremental nature of pharmaceutical patents, the '841 patent's strength depends on its novelty and non-obviousness over prior art. A broad claim set effectively blocks competitors but may face validity challenges if prior art anticipates or renders obvious claims. Conversely, overly narrow claims risk easy workarounds.

Geographical Patent Considerations:

While this analysis centers on the U.S., similar patent families often exist internationally, such as in Europe, China, and Japan, affecting global patent strategies. The patent's positioning within an international patent portfolio influences licensing and litigation prospects.


Legal and Commercial Implications

The scope and claims of the '841 patent underpin its enforceability and commercial value:

  • Market Exclusivity: Broad claims can extend patent life and market dominance but heighten scrutiny during validity assessments.
  • Licensing and Partnerships: Clear, enforceable claims facilitate licensing negotiations for commercialization rights.
  • Potential Challenges: Competitors may attempt to design around narrow claims or challenge validity based on prior art, emphasizing the importance of robust patent prosecution strategies.

Conclusion

U.S. Patent 10,420,841 expands the IP boundaries within its therapeutic domain through strategic claim breadth covering compounds, methods, and formulations. Its scope aims to provide robust protection against competitors while aligning with existing patent landscapes. Vigilant monitoring of cited prior art and potential challenges ensures optimal leveraging of its patent rights. The strategic positioning within a global patent portfolio and the strength of its claims determine its influence on the competitive pharmaceutical landscape.


Key Takeaways

  • Claim Breadth Matters: Effective patent claims balance broad coverage with defensibility; overly broad claims risk invalidation, while narrow claims limit exclusivity.
  • Understand the Patent Landscape: Analyzing prior art and related patents ensures innovative differentiation and strengthens patent validity.
  • Global Strategy is Crucial: International patent filings expand market protection but require tailored claim strategies.
  • Monitoring and Enforcement: Vigilant enforcement protects market share; comprehensive claims facilitate legal action against infringers.
  • Continuous Innovation: Incremental improvements and strategic patenting sustain competitive advantage in a rapidly evolving pharmaceutical sector.

FAQs

1. What is the core chemical structure covered by U.S. Patent 10,420,841?
The patent claims a specific chemical scaffold with defined substituents, aiming to protect novel derivatives with therapeutic utility. The detailed structure is described in the claims section, encompassing variations such as salts and stereoisomers.

2. How broad are the claims in this patent?
The claims are designed to be broad enough to cover multiple derivatives and methods of use but are tailored to maintain novelty and non-obviousness. Overall, they likely protect a core chemical group with applicable modifications.

3. Can this patent be challenged based on prior art?
Yes, if prior art demonstrates identical or obvious modifications of the claimed compounds or methods, validity challenges may ensue. A thorough prior art search is essential for strategic planning.

4. How does this patent influence competitors in its therapeutic region?
It creates a legal barrier, preventing competitors from making or selling similar compounds or methods without license. Its scope determines how easily competitors can design around it.

5. What strategies can stakeholders adopt post-grant to maximize patent value?
Stakeholders should consider filing continuation or divisional applications, expanding claims, and pursuing international patents. Active enforcement and monitoring patent validity are also essential.


References

  1. U.S. Patent No. 10,420,841. (2019). Title: [Patent Title]. U.S. Patent & Trademark Office.
  2. Additional references would include related patent literature and scientific publications cited during prosecution or relevant to the underlying invention.

Note: Full analysis of the patent claims requires detailed review of the exact claim language, which should be conducted in conjunction with the patent’s specification and prosecution history.

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Drugs Protected by US Patent 10,420,841

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Cubist Pharms Llc ZERBAXA ceftolozane sulfate; tazobactam sodium POWDER;INTRAVENOUS 206829-001 Dec 19, 2014 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free TREATMENT OF COMPLICATED URINARY TRACT INFECTION ⤷  Get Started Free
Cubist Pharms Llc ZERBAXA ceftolozane sulfate; tazobactam sodium POWDER;INTRAVENOUS 206829-001 Dec 19, 2014 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTION ⤷  Get Started Free
Cubist Pharms Llc ZERBAXA ceftolozane sulfate; tazobactam sodium POWDER;INTRAVENOUS 206829-001 Dec 19, 2014 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free COMPLICATED URINARY TRACT INFECTIONS (CUTI), INCLUDING PYELONEPHRITIS, IN ADULT AND PEDIATRIC PATIENTS (BIRTH TO LESS THAN 18 YEARS OLD) ⤷  Get Started Free
Cubist Pharms Llc ZERBAXA ceftolozane sulfate; tazobactam sodium POWDER;INTRAVENOUS 206829-001 Dec 19, 2014 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free COMPLICATED INTRA-ABDOMINAL INFECTIONS (CIAI), USED IN COMBINATION WITH METRONIDAZOLE, IN ADULT AND PEDIATRIC PATIENTS (BIRTH TO LESS THAN 18 YEARS OF AGE) ⤷  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

International Family Members for US Patent 10,420,841

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2014227660 ⤷  Get Started Free
Australia 2015200599 ⤷  Get Started Free
Brazil 112015023523 ⤷  Get Started Free
Canada 2906151 ⤷  Get Started Free
Chile 2015002755 ⤷  Get Started Free
China 105392485 ⤷  Get Started Free
China 110279698 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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