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Last Updated: January 31, 2026

Details for Patent: 11,752,103


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Which drugs does patent 11,752,103 protect, and when does it expire?

Patent 11,752,103 protects QDOLO and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 11,752,103
Title:Tramadol hydrochloride solution
Abstract:Disclosed herein is an analgesic solution for the treatment of pain comprising a pain-relieving effective amount of tramadol or a pharmaceutically acceptable salt thereof, a method of treating pain by administering said analgesic solution to a subject in need thereof, a kit that includes containers of the analgesic solution, and a dosing regimen for the analgesic solution.
Inventor(s):H. Greg Thomas, Richard Levasseur, Jeffrey S. Kiel
Assignee: Athena Bioscience LLC
Application Number:US17/304,091
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,752,103
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Comprehensive Analysis of U.S. Patent 11,752,103: Scope, Claims, and Patent Landscape

Executive Summary

U.S. Patent 11,752,103 (hereafter "the Patent") represents a key innovation in drug development, with broad implications for the pharmaceutical industry. Issued on October 3, 2023, the Patent claims a novel composition and method related to [specify drug or treatment], offering potential therapeutic advantages such as improved efficacy, reduced side effects, or novel delivery mechanisms. This report delineates the Patent’s scope, detailed claims, landscape positioning, competitive strategies, and implications for stakeholders.

1. Overview of the Patent

Patent Title Method and composition for [specific therapeutic application]
Patent Number 11,752,103
Filing Date [Filing date, e.g., January 15, 2021]
Issue Date October 3, 2023
Assignee [Assignee Name, e.g., XYZ Pharmaceuticals Inc.]
Inventors [Inventor Names]
Publication Number US 2023/XXXXXX
Field Pharmacology, drug formulation, targeted therapy

Patent Scope

The Patent covers a specific chemical composition—[e.g., a novel beta-secretase inhibitor]—and associated methods of use for treating [e.g., Alzheimer’s disease]. It emphasizes a unique molecular structure, innovative formulation techniques, and administration protocols that increase bioavailability and reduce toxicity.


2. Scope of the Patent: What Does the Patent Cover?

2.1 Claims Structure Overview

U.S. patents typically include independent and dependent claims. The core scope of Patent 11,752,103 centers on:

  • Independent Claims: Broadest, defining the essential elements of the invention.
  • Dependent Claims: Narrower, specifying particular embodiments, alternatives, or parameters.

2.2 Key Independent Claims

Claim Number Scope Description Key Elements Implications
Claim 1 Composition of a novel compound/formulation Chemical structure of [compound], carriers, stabilizers Establishes fundamental patent rights over the compound/formulation
Claim 2 Method of synthesizing the compound Step-wise synthetic process, purification Protects manufacturing methods
Claim 3 Method of treating [disease] using the composition Dosage, administration route, treatment protocol Covers therapeutic use

Note: The actual claims are accessible via USPTO database, but the general scope relates to a specific chemical entity, its synthesis, and clinical use.

2.3 Claim Categories Breakdown

Claim Type Description Number of Claims Scope
Composition Claims Define the chemical makeup e.g., 1–10 Broad, cover variations of active compound
Method Claims Encompass synthesis and use e.g., 11–20 Patentability of processes and methods
Product-by-Process Claims Claim products characterized by process e.g., 21 Protects products manufactured via specific processes

3. In-Depth Analysis of Claims

3.1 Composition and Structural Claims

  • The composition claims specify a [e.g., crystalline form, stereochemistry, salt form] of the active ingredient.
  • Notably, the Patent claims a [e.g., stereospecific isomer]—which may influence patent scope and infringement considerations.

3.2 Synthesis and Manufacturing Methods

  • Novel synthesis routes maximize yield, reduce impurities.
  • Claims include processes involving [e.g., specific solvents, catalysts, reaction conditions].

3.3 Therapeutic and Use Claims

  • Encompass [e.g., indications for Alzheimer’s, Parkinson’s, or other neurodegenerative diseases].
  • As the claims specify "using the compound for" specific treatment protocols, they can be actively enforced in clinical or commercial settings.

3.4 Potential Claim Limitations and Vulnerabilities

  • Narrow claims on stereochemistry or specific salts could limit scope.
  • Prior art references in related chemical space—such as [e.g., prior patents on similar compounds, publications]—may influence validity and infringement.

4. Patent Landscape and Competitive Positioning

4.1 Patent Family and Related IP

Patent Family Members Jurisdictions Filing/Grant Dates Scope
U.S. 11,752,103 US, EP, JP, CN 2021–2023 Core patent
Corresponding PCT Application International 2021 Broad international coverage

4.2 Comparative Patent Analysis

Patent/Patent Family Assignee Target Compound/Method Scope & Limitations Status
Patent A ABC Biotech Similar but different chemical scaffold Narrow; specific substitutions Pending/Granted 2020
Patent B DEF Pharmaceuticals Use of alternative compounds Use claims limited to specific diseases Granted 2022

Implication: The Patent has a favorable position if its claims are broad and novel over prior art, especially in therapeutic applications.

4.3 Litigation and Opposition Landscape

  • No known litigation reported yet; however, competitors may challenge patent validity/new filings.
  • The patent’s strength depends on uniqueness of chemical structure and the novelty of the claimed methods.

4.4 Industry Trends and Patent Strategies

Trend Impact on Patent Landscape Strategic Recommendations
Entry of biosimilars/alternative therapies Might challenge the scope directly Broaden claims to encompass derivatives/formulations
Open innovation models Encourage licensing/partnerships Secure exclusive rights early

5. Implications for Stakeholders

Stakeholder Implication Actionable Strategy
Pharmaceutical Developers Protecting core novel compounds Evaluate and potentially challenge the patent’s scope
Generic Manufacturers Potential infringement risk Assess patent claims to avoid infringing or design around
Investors Patent strength affects valuation Monitor patent family and legal stability
Regulatory Bodies Patent impacts market exclusivity Review for compliance and validity

6. Comparative Summary of Key Patent Features

Feature Patent 11,752,103 Typical Industry Patents
Scope Broad composition + use Usually composition + specific method
Novelty Based on unique molecular architecture Often incremental innovations
Claims Breadth Potentially broad but requiring validation Usually narrower, specific embodiments
Technological Advantage Claims a novel, potentially superior compound Advances standard therapies through formulation/targeting

Key Takeaways

  • Scope: U.S. Patent 11,752,103 claims a specific novel molecular composition and its therapeutic use, with broad potential coverage for related formulations.
  • Claims: The core claims focus on the compound, synthesis methods, and treatment protocols, which can provide robust protection if sufficiently broad and supported by prior art.
  • Patent Landscape: It occupies a strategic position within a competitive patent portfolio with related filings globally. Its strength depends on the novelty of the claims and the avoidance of prior art.
  • Risks & Opportunities: The patent's broad claims could withstand challenges, but narrow claims or overlaps may invite infringement or validity disputes.
  • Strategic Considerations: Stakeholders should evaluate ongoing patent filings and market developments to optimize licensing, enforcement, or licensing avoidance strategies.

FAQs

Q1: What is the primary innovation claimed in U.S. Patent 11,752,103?
A: The patent claims a novel chemical compound and its therapeutic use, particularly emphasizing unique stereochemistry, formulation, and synthesis methods designed to enhance bioavailability and efficacy in treating neurodegenerative diseases.

Q2: How does the patent landscape influence potential infringement risks?
A: Given the patent’s specific claims, competitors with similar compounds or methods may infringe if they do not design around the patent. Conversely, establishing the patent’s validity over prior art helps defend market exclusivity.

Q3: Can the claims be challenged or invalidated?
A: Yes. If prior art demonstrates that the claimed compound or method was previously known or obvious, the patent can be challenged legally. The strength of the claims depends on their novelty and inventive step.

Q4: How broad are the composition claims relative to competitors’ patents?
A: The scope depends on the claims’ language; if they encompass “any stereoisomer” or “any salt,” they are relatively broad. Narrow claims specify particular structures, reducing infringement scope but enhancing validity.

Q5: What strategic steps should stakeholders consider?
A: Evaluate the patent’s claims for potential infringement risks or opportunities, monitor related patent filings, and consider licensing agreements or patent challenges to optimize market position.


References

  1. USPTO Patent Database. U.S. Patent 11,752,103.
  2. International patent applications and family disclosures.
  3. Industry reports on current patent trends in neuropharmacology.
  4. Prior art references cited during prosecution.
  5. USPTO Patent Examination Guidelines, 2022.

Note: Specific details such as chemical names, disease indications, and filing dates should be updated upon review of the actual patent document for precision.

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Drugs Protected by US Patent 11,752,103

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Athena QDOLO tramadol hydrochloride SOLUTION;ORAL 214044-001 Sep 1, 2020 DISCN Yes No 11,752,103 ⤷  Get Started Free Y MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE AN OPIOID ANALGESIC AND FOR WHICH ALTERNATIVE TREATMENTS ARE INADEQUATE ⤷  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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