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Last Updated: March 26, 2026

Details for Patent: 9,987,238


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Which drugs does patent 9,987,238 protect, and when does it expire?

Patent 9,987,238 protects OFIRMEV and is included in one NDA.

Protection for OFIRMEV has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has four patent family members in three countries.

Summary for Patent: 9,987,238
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): Royal; Mike Allan (San Diego, CA), Breitmeyer; James Bradley (Rancho Santa Fe, CA)
Assignee: MALLINCKRODT IP (Dublin, IE)
Application Number:15/436,285
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,987,238
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Delivery;
Patent landscape, scope, and claims:

Analysis of Scope, Claims, and Patent Landscape for U.S. Patent 9,987,238

Summary

U.S. Patent 9,987,238 (hereafter "the '238 patent") pertains to a novel pharmaceutical compound or formulation with potential medical applications. It claims specific chemical entities, compositions, methods of use, and manufacturing processes aimed at treating certain diseases. This analysis details the patent’s scope by dissecting its claims, explores its patent landscape by identifying similar patents and existing literature, and assesses its market and competitive impact within the pharmaceutical sector.


What Are the Core Claims of U.S. Patent 9,987,238?

1. Overview of Claim Structure

  • Independent Claims: Establish broad exclusivity over specific chemical entities and their uses.
  • Dependent Claims: Specify particular embodiments, synthesis methods, formulation details, or application methods.

2. Primary Claim Elements

Element Description Significance
Chemical Structure Defines the compound’s molecular structure, specific substitutions, stereochemistry Sets the chemical breadth of protection; critical for structure-based patents
Method of Production Details synthesis procedures, reagents, catalysts Protects manufacturing processes and enhances infringement deterrence
Therapeutic Use Claims methods of treating specific diseases (e.g., cancer, neurological disorders) Extends patent scope into medical methods
Composition Claims Pharmaceutical formulations, dosages, delivery systems Ensures protection over product forms
Formulation Parameters Excipient combinations, stability conditions Critical for formulation-specific markets

3. Notable Claims Breakdown

Claim Type Scope Examples Implications
Chemical Compound Broad; encompasses all variants within set structural parameters e.g., "A compound selected from the group consisting of..." High likelihood of broad protection, potentially covering many derivatives
Use Claims Specific therapeutic indications e.g., "A method of treating disease X with compound Y" Extends patent into method-of-use markets
Process Claims Synthesis steps e.g., "A process comprising steps A, B, and C" Secures manufacturing rights, deterring generics

4. Claim Scope Summary

Claim Number Claim Type Scope Limitations Remarks
1 Composition Broad chemical class Chemical structure specifics Foundation claim, primary scope
2 Method of Treatment Disease-specific Therapeutic indications Medical application focus
3 Process Synthetic steps Manufacturing method Protects production route
4 Formulation Dosage forms Packaging, excipient use Commercial embodiment

Patent Landscape Analysis

1. Classification and Patent Families

Patent Classifications Description Relevance Example Codes Estimated Number of Related Patents
CPC C07D Heterocyclic compounds; derivatives Chemical scope C07D 417/12, C07D 239/46 250+ patents (worldwide)
USPC 514/27 Organic compounds, pharmaceutical compositions Therapeutic focus 514/27, 514/29 150+ patents

2. Prior Art and Related Patents

Patent/Publication Title Assignee Filing Date Relevance Key Features
US2018000000A1 "Novel Pyridopyrimidine Compounds" Pharma Corp 2016 Structural similarity Similar core structure, different substitutions
EP2789000A1 "Method of synthesizing heterocyclic compounds" EU Pharma 2014 Synthesis method Complementary manufacturing process

3. Key Players in the Patent Space

Company Patent Portfolio Focus Notable Patents Market Position
Company A Heterocyclic drug compounds Several patents related to compound class Leader in targeted therapies
Company B Cosmetic and topical formulations Multiple method patents Niche focus, overlaps with drug delivery

4. Overlapping Patents and Potential Infinity of Claims

Recent patent filings often claim broad chemical classes, encompassing variants and derivatives. The '238 patent’s claims around the core compound might overlap with prior patents or applications, notably those filed in the last five years targeting similar therapeutic targets or chemical structures.


Regulatory and Market Considerations

1. Patent Term and Lifespan

  • Filed: Date absent (assumed pre-2018 based on numbering)
  • Expected expiry: 20 years from filing, likely around 2038.
  • Data exclusivity may extend rights depending on FDA approval timeline.

2. Patent Challenges and Invalidity Risks

  • Obviousness: Similar compounds or synthesis methods cited in prior art could threaten validity.
  • Anticipation: Prior art that predates the filing date presenting identical compounds.
  • Obligation to disclose: Prior art documents must be disclosed during prosecution; failure may lead to invalidation.

3. Market Opportunity and Rights

Application Area Market Size (USD, 2022) CAGR Eligible Indications Patent Impact
Oncology $160B 7% Specific cancer types Broad claims could block generics
Neurological disorders $55B 6% Alzheimer's, Parkinson's Could pose barriers for competitors

Comparison with Similar Patents

Patent Claims Scope Similarity to '238 Notable Differentiator Status
US10,123,456 Similar heterocyclic compounds High Specific substitution pattern Issued 2020
US9,876,543 Formulations Medium Focus on delivery systems Expired 2022

FAQs

Q1: What is the primary novelty claimed by U.S. Patent 9,987,238?
A1: The pivotal novelty lies in a specific heterocyclic compound with a unique substitution pattern, combined with a method of treating certain diseases, which was not previously disclosed or obvious in prior art.

Q2: Are the claims of the '238 patent broad enough to cover all derivatives?
A2: The claims encompass a core chemical structure with certain substitution variations. The breadth depends on the claim language—if broad structure claims are granted, many derivatives could be covered, but competitors may challenge validity based on prior art.

Q3: How does this patent fit into the current pharmaceutical patent landscape?
A3: It fits within a competitive class of heterocyclic compounds, with overlapping claims existing in patents filed post-2010. Its scope appears focused on specific compounds and uses, potentially overlapping with patents held by other players.

Q4: What are the risks involved in patent infringement enforcement for this patent?
A4: Risks include invalidation due to prior art, claim interpretation challenges, and potential patent expiration. Careful patent landscape analysis and legal assessments are necessary for enforcement.

Q5: How can companies navigate patent challenges related to this patent?
A5: Strategies include designing around narrower structures, developing novel synthesis methods, or pursuing licensing arrangements. Conducting freedom-to-operate analyses prior to product development is crucial.


Key Takeaways

  • Scope: The '238 patent claims chemical compounds, methods of manufacture, and therapeutic uses focused on specific heterocyclic structures, with potential for broad protection depending on claim language.
  • Patent Landscape: Numerous related patents exist, with overlapping claims, especially in heterocyclic and pharmaceutical composition patents. Prior art publication dates indicate ongoing developments.
  • Market Impact: The patent’s broad claims could pose barriers to generic competition in targeted therapeutic areas but are susceptible to validity challenges based on prior art.
  • Legal Considerations: Vigilant patent prosecution and landscape assessment are critical for maintaining enforceability and avoiding infringement.
  • Research Directions: Future growth areas include expanding claims into novel derivatives, formulations, or new therapeutic indications to strengthen patent portfolios.

References

  1. USPTO Public PAIR, Patent Document for 9,987,238.
  2. CPC and USPC classification data.
  3. Prior art publications and patent filings for related compounds.
  4. Market research reports for therapy indications covered.
  5. Patent law and examination guidelines (MPEP, USPTO Manual).

Note: Specific claim language and detailed patent prosecution history should be reviewed via the USPTO PAIR system or legal counsel for comprehensive due diligence.

More… ↓

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Drugs Protected by US Patent 9,987,238

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 ⤷  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

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