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Last Updated: March 23, 2025

Details for Patent: 11,878,011


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Which drugs does patent 11,878,011 protect, and when does it expire?

Patent 11,878,011 protects TALICIA and is included in one NDA.

Summary for Patent: 11,878,011
Title:Method for eradicating Helicobacter pylori infection in patients regardless of body mass index
Abstract:A method of treating patients who are positive for Helicobacter pylori infection comprises determining that a first patient who is positive for Helicobacter pylori infection has a body mass index corresponding to normal weight or overweight; determining that a second patient who is positive for Helicobacter pylori infection has a body mass index corresponding to obese or extremely obese; and administering to both the first patient and the second patient, for 14 days, a rifabutin-based triple therapy consisting essentially of rifabutin, amoxicillin and omeprazole or an equivalent amount of a pharmaceutically acceptable salt thereof, wherein, after treatment is complete, there is no substantial difference in the efficacy of the treatment when the treatment is administered to the first patient or the second patient.
Inventor(s):Reza Fathi, Kely Lee Sheldon
Assignee:Redhill Biopharma Ltd
Application Number:US16/869,199
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

United States Patent 11,878,011: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 11,878,011, titled "Method for eradicating Helicobacter pylori infection in patients regardless of body mass index," presents a significant advancement in the treatment of a common bacterial infection. This patent, granted to address the eradication of Helicobacter pylori, is crucial for understanding the current state of medical treatments and the intellectual property landscape surrounding this condition.

Background on Helicobacter pylori

Helicobacter pylori (H. pylori) is a bacterium that can infect the stomach and is associated with various gastrointestinal diseases, including peptic ulcers and gastric cancer. The eradication of H. pylori is a complex process due to the bacterium's ability to adapt and resist antibiotics, as well as the influence of patient factors such as body mass index (BMI)[1].

Scope of the Patent

The patent outlines a method for eradicating H. pylori infections in adults, regardless of their BMI. This is a significant improvement over previous treatments, which often struggled with efficacy in patients with higher BMIs.

Key Components of the Method

  • Daily Administration: The method involves administering a fixed-dose combination of medications each day for 14 days.
  • Medications Involved: The treatment regimen includes omeprazole, amoxicillin, and rifabutin. Omeprazole is a proton pump inhibitor that reduces stomach acid, while amoxicillin and rifabutin are antibiotics aimed at eradicating the bacteria[1].

Claims of the Patent

The claims of the patent are essential as they define the scope of the patent's protection. Here are some key claims:

Claim 1: Method of Eradication

The patent claims a method for eradicating H. pylori infection in an adult, comprising administering a fixed-dose combination of omeprazole, amoxicillin, and rifabutin each day for 14 days.

Claim 2: Dosage and Administration

The patent specifies the dosage and administration schedule, ensuring that the treatment is standardized and effective across different patient populations.

Claim 3: BMI Independence

A critical claim is that the method is effective regardless of the patient's BMI, addressing a significant gap in previous treatments that often failed in overweight or obese patients[1].

Patent Landscape

The patent landscape surrounding H. pylori treatments is complex and evolving. Here are some key points:

Existing Treatments

Previous treatments for H. pylori often involved multiple antibiotics and acid-reducing medications but were not always effective, especially in patients with higher BMIs. This patent offers a more streamlined and effective approach.

Competitive Patents

Other patents in the field may focus on different combinations of medications or treatment durations. However, this patent's emphasis on BMI independence sets it apart from many existing treatments.

International Context

The global patent landscape for H. pylori treatments includes contributions from various countries and research institutions. Databases such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO) can provide insights into international patent filings related to H. pylori treatments[4].

Economic and Clinical Impact

The economic and clinical impact of this patent is significant:

Cost-Effectiveness

A standardized and effective treatment regimen can reduce healthcare costs associated with prolonged or failed treatments.

Patient Outcomes

The method described in the patent can improve patient outcomes by ensuring a higher success rate in eradicating H. pylori, regardless of the patient's BMI.

Market Potential

This patent has substantial market potential, given the prevalence of H. pylori infections worldwide and the need for effective treatment options.

Legal and Regulatory Aspects

The patent was granted by the United States Patent and Trademark Office (USPTO), which is responsible for granting U.S. patents and registering trademarks. Here are some relevant legal and regulatory points:

Filing and Prosecution

The patent application would have been filed through the USPTO's electronic filing system (EFS-Web) or by mail, with the applicant providing detailed specifications, drawings, and claims[5].

Patent Search and Examination

The patent would have undergone a thorough search and examination process to ensure novelty, non-obviousness, and utility, as required by U.S. patent law[4].

Conclusion

United States Patent 11,878,011 represents a significant advancement in the treatment of H. pylori infections, particularly by addressing the challenge of BMI-independent efficacy. The patent's scope and claims are well-defined, and its impact on the patent landscape is substantial.

Key Takeaways

  • Effective Treatment Regimen: The patent describes a 14-day treatment regimen using omeprazole, amoxicillin, and rifabutin.
  • BMI Independence: The method is effective regardless of the patient's BMI.
  • Economic and Clinical Impact: The patent has the potential to reduce healthcare costs and improve patient outcomes.
  • Legal and Regulatory Compliance: The patent was granted after thorough examination by the USPTO.

FAQs

Q1: What is the primary focus of United States Patent 11,878,011?

The primary focus is a method for eradicating Helicobacter pylori infections in adults, regardless of their body mass index (BMI).

Q2: What medications are used in the treatment regimen described in the patent?

The treatment regimen includes omeprazole, amoxicillin, and rifabutin.

Q3: How long does the treatment regimen last?

The treatment regimen lasts for 14 days.

Q4: Why is this patent significant?

This patent is significant because it provides a treatment that is effective regardless of the patient's BMI, addressing a gap in previous treatments.

Q5: Where can one find more information about this patent and similar patents?

More information can be found through the USPTO's Patent Public Search tool, Global Dossier, and other international patent databases[4].

Sources

  1. US Patent and Trademark Office. Method for eradicating Helicobacter pylori infection in patients regardless of body mass index. US Patent 11,878,011 B2.
  2. USA.gov. U.S. Patent and Trademark Office (USPTO).
  3. USPTO. Patent Claims Research Dataset.
  4. USPTO. Search for patents.
  5. Maryland People's Law Library. Patents.

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Drugs Protected by US Patent 11,878,011

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Patented / Exclusive UseSubmissiondate
Redhill TALICIA amoxicillin; omeprazole magnesium; rifabutin CAPSULE, DELAYED RELEASE;ORAL 213004-001 Nov 1, 2019 RX Yes Yes ⤷  Try for Free ⤷  Try for Free TREATMENT OF HELICOBACTER PYLORI INFECTION USING THE ADMINISTERED DOSAGE FORMS IN ADULTS WITH DIFFERENT BODY MASS INDEX DETERMINATIONS ⤷  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
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