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Last Updated: March 16, 2025

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 Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

United States Patent 11,752,103: A Detailed Analysis of Scope, Claims, and Patent Landscape

Overview of the Patent

United States Patent 11,752,103, titled "Tramadol hydrochloride solution," is a patent that discloses an analgesic solution for the treatment of pain. This patent is crucial in the pharmaceutical industry, particularly in the development and marketing of tramadol-based pain relief solutions.

Patent Details

  • Publication Number: US11752103B2
  • Authority: United States
  • Prior Art Date: The patent's prior art date is significant for understanding the novelty and non-obviousness of the invention. However, the exact prior art date is not specified in the provided sources, but it is tied to the filing date of the patent application[4].

Claims of the Patent

The patent includes several claims that define the scope of the invention. Here are some key claims:

  • Claim 1: The patent claims an analgesic solution comprising a pain-relieving effective amount of tramadol or a pharmaceutically acceptable salt thereof, such as tramadol hydrochloride. The solution is designed for oral administration and contains specific concentrations of various ingredients like propylene glycol, glycerin, citrate buffer, sucralose, and grape flavoring[4].

  • Claim Details: The solution is formulated to provide 50 to 100 mg of tramadol per day, administered as needed for pain relief every four to six hours, not exceeding 400 mg per day. The composition includes a non-aqueous solvent, taste enhancer, buffer, sweetener, and flavoring agent in specified amounts[4].

Patent Scope

The scope of the patent is defined by the claims and the detailed description of the invention.

  • Compositional Ingredients: The patent specifies the exact amounts and types of ingredients used in the tramadol hydrochloride solution. For example, it includes propylene glycol, glycerin, citrate buffer, sucralose, and grape flavoring in precise concentrations[4].

  • Administration: The solution is designed for oral administration, with specific dosing instructions to ensure effective pain relief while minimizing the risk of overdose.

Patent Landscape

The patent landscape for tramadol hydrochloride solutions involves several key aspects:

  • Competing Patents: Other patents related to tramadol formulations may exist, potentially limiting the scope of this patent. However, the specific composition and dosing regimen described in US11752103B2 differentiate it from other similar patents[5].

  • International Patents: The patent may have international counterparts, which would be listed in the international patent section. This is crucial for understanding global protection and potential generic entry in different markets[5].

  • Expiration and Generic Entry: The expiration date of the patent is critical for determining when generic versions of the tramadol hydrochloride solution can enter the market. As of the current date, this information is not provided in the sources, but it can be found through patent databases or legal analyses[5].

Economic and Market Impact

The economic and market impact of this patent can be significant:

  • Market Exclusivity: The patent grants the holder exclusive rights to manufacture and market the specified tramadol hydrochloride solution, providing a competitive advantage in the pain relief market.

  • Research and Development: The detailed claims and composition of the patent can guide further research and development in the pharmaceutical industry, potentially leading to new formulations or improvements in existing ones.

Legal Considerations

  • Litigation and Enforcement: The patent holder must be prepared to defend the patent against potential infringement. The legal status and any ongoing litigation related to this patent would be crucial for understanding its current standing[4].

  • Small Claims Patent Court: In the context of patent disputes, the concept of a small claims patent court, as studied by the Administrative Conference of the United States (ACUS), could potentially impact how future disputes related to this patent are handled. Such a court could provide a more streamlined and cost-effective way to resolve patent infringement cases[2].

Access to Patent Information

For those interested in conducting a thorough search related to this patent or similar patents, several resources are available:

  • USPTO Patent Public Search: This tool provides enhanced access to prior art and allows users to search for patents and published patent applications using modern interfaces[1].

  • Global Dossier: This service offers access to the file histories of related applications from participating IP Offices, which can be useful for understanding the global patent family and related citations[1].

  • Patent and Trademark Resource Centers (PTRCs): These centers provide local search resources and training in patent search techniques, which can be invaluable for researchers and inventors[1].

Key Takeaways

  • Specific Composition: The patent specifies a unique composition of tramadol hydrochloride solution with precise amounts of various ingredients.
  • Oral Administration: The solution is designed for oral administration with specific dosing instructions.
  • Market Exclusivity: The patent grants exclusive rights to the holder, impacting market competition.
  • Legal and Economic Impact: The patent's legal status and potential for litigation, as well as its impact on research and development, are significant.

FAQs

What is the main subject of United States Patent 11,752,103?

The main subject of United States Patent 11,752,103 is an analgesic solution for the treatment of pain, specifically a tramadol hydrochloride solution.

What are the key ingredients in the tramadol hydrochloride solution described in the patent?

The solution includes tramadol hydrochloride, propylene glycol, glycerin, citrate buffer, sucralose, and grape flavoring in specified concentrations.

How is the tramadol hydrochloride solution administered?

The solution is administered orally, with dosing instructions to provide 50 to 100 mg of tramadol per day, every four to six hours, not exceeding 400 mg per day.

What resources can be used to search for patents related to this one?

Resources such as the USPTO Patent Public Search, Global Dossier, and Patent and Trademark Resource Centers (PTRCs) can be used to search for related patents.

How does the patent impact the market for pain relief solutions?

The patent grants the holder exclusive rights to manufacture and market the specified tramadol hydrochloride solution, providing a competitive advantage in the pain relief market.

Sources

  1. USPTO, "Search for patents - USPTO", October 18, 2018.
  2. ACUS, "U.S. Patent Small Claims Court", April 28, 2022.
  3. USPTO, "Patent Claims Research Dataset", August 28, 2017.
  4. Google Patents, "US11752103B2 - Tramadol hydrochloride solution".
  5. DrugPatentWatch, "Patent 11,752,103".

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Drugs Protected by US Patent 11,752,103

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Patented / Exclusive UseSubmissiondate
Athena QDOLO tramadol hydrochloride SOLUTION;ORAL 214044-001 Sep 1, 2020 DISCN Yes No ⤷  Try for Free ⤷  Try for Free Y MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE AN OPIOID ANALGESIC AND FOR WHICH ALTERNATIVE TREATMENTS ARE INADEQUATE ⤷  Try for 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
Showing 1 to 1 of 1 entries

International Family Members for US Patent 11,752,103

CountryPatent NumberEstimated ExpirationSupplementary Protection CertificateSPC CountrySPC Expiration
World Intellectual Property Organization (WIPO) 2021092406 ⤷  Try for Free
>Country>Patent Number>Estimated Expiration>Supplementary Protection Certificate>SPC Country>SPC Expiration
Showing 1 to 1 of 1 entries

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