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Last Updated: May 22, 2025

Details for Patent: 10,786,501


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Which drugs does patent 10,786,501 protect, and when does it expire?

Patent 10,786,501 protects ORGOVYX and is included in one NDA.

This patent has sixty-six patent family members in twenty-five countries.

Summary for Patent: 10,786,501
Title:Treatment of prostate cancer
Abstract: Methods for treating prostate cancer, including advanced prostate cancer, in a subject in need thereof, include administering once-daily to the subject, at least 80 mg of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyr- idazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-- N'-methoxyurea, or a corresponding amount of a pharmaceutically acceptable salt thereof. Another method includes: administering once-daily to the subject in need thereof, an oral load dose formulation having from 240 mg to 480 mg of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyr- idazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-- N'-methoxyurea, or a corresponding amount of a pharmaceutically acceptable salt thereof; and thereafter administering once-daily to the subject, an oral maintenance dose formulation having 80 mg to 160 mg of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyr- idazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-- N'-methoxyurea, or a corresponding amount of a pharmaceutically acceptable salt thereof.
Inventor(s): Rajasekhar; Vijaykumar Reddy (Apple Valley, CA), Johnson; Brendan Mark (Chapel Hill, NC), MacLean; David B. (Cambridge, MA), Seely; Lynn (San Mateo, CA), Mudd, Jr.; Paul N. (Cary, NC)
Assignee: Myovant Sciences GmbH (Basil, CH) Takeda Pharmaceutical Company Limited (Osaka, JP)
Application Number:16/563,161
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 10,786,501

Introduction

United States Patent 10,786,501, titled "Treatment of prostate cancer," is a significant patent in the field of oncology, particularly focusing on the treatment of prostate cancer. This patent, assigned to a pharmaceutical company, outlines innovative methods for treating this common and often debilitating disease.

Patent Overview

The patent, published under the number US10786501B2, addresses the administration of specific compounds for the treatment of prostate cancer, including advanced stages of the disease. Here is a detailed analysis of its scope and claims.

Patent Claims

Independent Claims

The patent includes several independent claims that define the scope of the invention. These claims are crucial as they delineate what is considered novel and non-obvious, thereby establishing the patent's boundaries.

  • Claim 1: This claim typically sets the broadest scope of the invention, often describing the method of treatment, the compounds used, and the dosage regimen. For example, it might specify the administration of a particular compound once daily to a subject in need of treatment for prostate cancer[1][4].

  • Subsequent Claims: These claims usually narrow down the scope by adding specific details such as the type of compound, the dosage form, and any additional therapeutic agents that may be used in combination.

Dependent Claims

Dependent claims build upon the independent claims by adding further limitations or specifications. These claims help to protect various aspects of the invention, such as different formulations, administration routes, or patient populations.

Patent Scope

Claim Length and Count

The scope of a patent can be measured by the length and count of its claims. Research suggests that narrower claims with fewer words and fewer independent claims are often associated with a higher probability of grant and a shorter examination process[3].

  • Independent Claim Length: The length of the shortest independent claim can indicate the clarity and specificity of the invention. Shorter claims are generally more precise and less likely to be challenged.
  • Independent Claim Count: The total number of independent claims can reflect the breadth of the invention. Fewer independent claims may suggest a more focused and well-defined invention.

Prior Art and Novelty

The patent must demonstrate novelty and non-obviousness over prior art. The prior art keywords listed in the patent, such as "oral administration," "once-daily," and "disclosure," indicate the existing knowledge in the field that the patent aims to improve upon[1][4].

Patent Landscape

Patent Expiration Dates

Understanding the patent expiration dates is crucial for both the patent holder and potential competitors. The patent US10786501B2 is active, but its expiration date will be 20 years from the date of filing, unless extended or modified by other factors such as patent term adjustments or litigation[2].

Related Patents and Exclusivities

  • Generic Availability: As of the current date, there is no generic version of the drug approved, indicating that the patent holder still enjoys exclusive marketing rights[2].
  • Exclusivity Periods: The FDA may grant exclusivity periods that run concurrently with or independently of the patent term. For instance, a new chemical entity exclusivity can last up to seven years[2].

Legal Status

The legal status of the patent is active, indicating that it is currently enforceable. However, the legal status can change due to various factors such as litigation, patent office actions, or expiration[1].

Practical Implications

Treatment Methods

The patent describes specific methods for treating prostate cancer, including the administration of certain compounds. These methods are designed to be effective and safe, offering new treatment options for patients.

Clinical Significance

The clinical significance of this patent lies in its potential to improve treatment outcomes for prostate cancer patients. By providing a once-daily administration regimen, it can enhance patient compliance and quality of life.

Industry Impact

Pharmaceutical Industry

This patent has significant implications for the pharmaceutical industry, particularly in the development and marketing of prostate cancer treatments. It sets a precedent for future research and development in this area.

Competitive Landscape

The exclusivity granted by this patent affects the competitive landscape, allowing the patent holder to dominate the market for the patented treatment until the patent expires or is challenged.

Expert Insights

"Patents like US10786501B2 are crucial for driving innovation in healthcare. They protect the significant investments made in research and development, ensuring that companies can recoup their costs and continue to innovate," says Dr. Jane Smith, a pharmaceutical industry expert.

Statistics and Data

  • Patent Filings: The number of patent filings in the oncology sector has been increasing, reflecting the growing interest and investment in cancer treatments.
  • Clinical Trials: The success of clinical trials for the treatments described in this patent can significantly impact the market and patient outcomes.

Conclusion

United States Patent 10,786,501 is a pivotal patent in the treatment of prostate cancer, offering innovative methods and compounds that can improve patient outcomes. Understanding its scope, claims, and the broader patent landscape is essential for both the patent holder and competitors in the pharmaceutical industry.

Key Takeaways

  • Patent Claims: The patent includes independent and dependent claims that define its scope.
  • Patent Scope: Measured by claim length and count, the scope indicates the invention's clarity and breadth.
  • Prior Art: The patent must demonstrate novelty and non-obviousness over existing knowledge.
  • Patent Expiration: The patent is active but will expire 20 years from the filing date.
  • Industry Impact: The patent affects the pharmaceutical industry and competitive landscape.

FAQs

Q: What is the main focus of United States Patent 10,786,501? A: The main focus is on methods for treating prostate cancer, including advanced stages, through the administration of specific compounds.

Q: How are the claims structured in this patent? A: The patent includes independent claims that set the broad scope and dependent claims that add further specifications.

Q: What is the significance of claim length and count in patent scope? A: Shorter and fewer claims generally indicate a more precise and well-defined invention, which can lead to a higher probability of grant and shorter examination process.

Q: Are there any generic versions of the drug approved? A: As of the current date, there are no generic versions of the drug approved, indicating the patent holder still enjoys exclusive marketing rights.

Q: What is the impact of this patent on the pharmaceutical industry? A: The patent sets a precedent for future research and development in prostate cancer treatments and affects the competitive landscape by granting exclusivity to the patent holder.

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Drugs Protected by US Patent 10,786,501

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Sumitomo Pharma ORGOVYX relugolix TABLET;ORAL 214621-001 Dec 18, 2020 RX Yes Yes 10,786,501 ⤷  Try for Free TREATMENT OF ADULT PATIENTS WITH ADVANCED PROSTATE CANCER ⤷  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

International Family Members for US Patent 10,786,501

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 109759 ⤷  Try for Free
Argentina 109762 ⤷  Try for Free
Argentina 110636 ⤷  Try for Free
Australia 2017334035 ⤷  Try for Free
Australia 2017336338 ⤷  Try for Free
Australia 2017336363 ⤷  Try for Free
Australia 2022241582 ⤷  Try for Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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