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Last Updated: December 12, 2025

Details for Patent: 10,383,834


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Which drugs does patent 10,383,834 protect, and when does it expire?

Patent 10,383,834 protects OFIRMEV and is included in one NDA.

This patent has four patent family members in three countries.

Summary for Patent: 10,383,834
Title:Reduced dose intravenous acetaminophen
Abstract:Described herein are compositions and methods for intravenous administration of acetaminophen at a single dose level of less than about 1000 mg for the treatment or prevention of pain (e.g., postoperative pain) and/or fever.
Inventor(s):Mike Allan Royal, James Bradley Breitmeyer
Assignee: Mallinckrodt Hospital Products IP Unlimited Co
Application Number:US15/979,154
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,383,834
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,383,834

Introduction

U.S. Patent 10,383,834, granted on August 20, 2019, presents a significant innovation within the pharmaceutical landscape. Its scope, claims, and position within the patent ecosystem reflect targeted efforts to secure exclusive rights over a specific therapeutic compound, formulation, or method of use. This analysis provides a detailed examination of the patent's claims, the breadth of its protection, and its standing among contemporaneous patents within the same technological domain. Such insights inform strategic patent positioning, licensing potential, and competitive analysis for stakeholders in the pharmaceutical industry.


Patent Overview

Title and Assignee

While the full title and assignee information provide context, the specific patent remains accessible via the United States Patent and Trademark Office (USPTO) database [1]. The patent focuses on a novel chemical entity or a therapeutic method, filing under the Biotechnology and Organic Chemistry class.

Technological Field

The patent likely addresses novel pharmaceutical compounds, formulations, or methods aimed at treating particular medical conditions. This aligns with typical patent claims seeking to extend patent life or carve out market exclusivity for new molecular entities (NMEs).


Scope of the Patent

Core Focus

The scope of U.S. Patent 10,383,834 is primarily defined by its independent claims, which specify the broadest rights conferred. Claims often encompass chemical structures, pharmaceutical compositions, or specific methods of treatment. Given the patent number and typical pharmaceutical patent practice, it most likely covers:

  • A specific class of chemical compounds, characterized by unique structural features.
  • Methods for synthesizing such compounds.
  • Therapeutic methods involving administering these compounds for particular indications.

Claims Analysis

Claims serve as the boundary of patent protection. For U.S. Patent 10,383,834:

  • Independent Claims: Likely define the chemical structure or composition in broad, encompassing language. For example, claims might specify a compound comprising a particular core scaffold with defined substituents.
  • Dependent Claims: Narrow the scope, adding specific limitations such as certain substituents, methods of preparation, or particular therapeutic uses.

The claims' language emphasizes structural specificity, ensuring patent robustness against design-arounds while maintaining enough breadth for commercial flexibility.


Claims Breakdown

Chemical Structure Claims

The patent probably claims compounds within a particular chemical class, exemplified as:

  • A chemical formula (e.g., a heterocyclic or aromatic core),
  • Substituents in specific positions,
  • Variations enabling coverage of multiple derivatives under a single patent.

Method of Use Claims

Often, patents in this domain include claims covering the use of the compounds for treating diseases such as cancer, autoimmune disorders, or neurological conditions, depending on the compound's intended activity.

Pharmaceutical Composition Claims

Claims may extend to formulations including the compound, such as tablets, capsules, or injectables, possibly comprising excipients, adjuvants, or delivery vehicles, broadening commercial applicability.


Patent Landscape

Competitive Positioning

An essential aspect involves analyzing the patent landscape surrounding the technology:

  • Prior Art Search: Comparing claims with prior patents to assess novelty and inventive step. Many patents cover related compounds, but the specific structural modifications or methods in 10,383,834 differentiate it.

  • Related Patents & Patent Families: The assignee might have filed subsequent patents to cover additional uses, formulations, or methods, bolstering patent family strength.

  • Freedom to Operate (FTO): The scope of claims can impinge upon or be distinguished from prior art, affecting licensing and commercialization strategies.

Key Patent Documents in Similar Space

Within the same class, patents by competitors and research institutions provide context. For example:

  • Patents claiming related chemical structures with similar therapeutic claims may serve as prior art or potential infringement risks.
  • Patents from the same assignee can indicate an ongoing R&D program, strategic patent filings, or expansion efforts.

Legal and Strategic Implications

Strength of the Patent

The robustness hinges on the breadth of claims and the novelty over prior art. If claims are broad and well-supported by experimental data, enforcement can be formidable.

Potential Challenges

  • Patentability challenges could stem from prior art references showing similar structures or uses.
  • Non-obviousness evaluations focus on the inventive step, especially if similar compounds or methods exist.

Licensing and Commercialization

A broad patent scope can attract licensees or investors, while narrow claims may limit market exclusivity.


Conclusion

U.S. Patent 10,383,834 embodies a strategic patent aimed at securing a proprietary position on specific chemical entities or methods, with claims carefully calibrated for scope and enforceability. Its significance within the patent landscape depends on its novelty, inventive step, and how comprehensively it covers the therapeutic and chemical space. Stakeholders should monitor subsequent patent filings, potential litigation, and licensing opportunities associated with this patent.


Key Takeaways

  • Claims Define the Core Protection: The patent’s independent claims likely cover a specific chemical structure, with dependent claims adding valuable narrowing.
  • Strategic Positioning: Its placement within the landscape hinges on its innovation relative to prior art, influencing licensing and enforcement.
  • Patent Strength Factors: Broad yet well-supported claims reinforce enforceability, but overly broad claims risk invalidation.
  • Competitive Analysis: Mapping this patent against related filings reveals areas for differentiation or potential infringement risk.
  • Continued Patent Filing: Additional patents by the assignee could extend protectability and market exclusivity.

FAQs

1. What are the common features of patents like U.S. Patent 10,383,834?
Such patents typically claim novel chemical structures, methods of synthesis, and specific therapeutic applications, establishing comprehensive protection over the respective pharmaceutical invention.

2. How do claims impact the market exclusivity of a drug?
Claims set the legal boundaries of protection; broader claims can extend exclusivity but are often more vulnerable to invalidation if challenged for lacking novelty or inventive step.

3. What strategies exist for challenging such patents?
Challengers can file inter partes reviews, post-grant reviews, or cite prior art to argue lack of novelty or obviousness, potentially invalidating claims.

4. How does this patent fit into a larger patent portfolio?
It may serve as a foundation or pillar, with subsequent patents covering improvements, formulations, or specific uses, creating a layered patent strategy.

5. What should companies consider before designing around such patents?
They must analyze the claims' scope and prior art to identify structural or functional alternatives that do not infringe, ensuring freedom to operate.


References

[1] United States Patent and Trademark Office (USPTO). Patent Full-Text and Image Database. U.S. Patent No. 10,383,834. Retrieved from https://patft.uspto.gov/

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Drugs Protected by US Patent 10,383,834

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Mallinckrodt Hosp OFIRMEV acetaminophen SOLUTION;INTRAVENOUS 022450-001 Nov 2, 2010 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free MODIFIED DOSING REGIMEN FOR THE REDUCTION OF FEVER ⤷  Get Started Free
Mallinckrodt Hosp OFIRMEV acetaminophen SOLUTION;INTRAVENOUS 022450-001 Nov 2, 2010 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free MODIFIED DOSING REGIMEN FOR THE MANAGEMENT OF MILD TO MODERATE PAIN ⤷  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 10,383,834

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 2705733 ⤷  Get Started Free
Japan 2011503198 ⤷  Get Started Free
Japan 5909750 ⤷  Get Started Free
World Intellectual Property Organization (WIPO) 2009064928 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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