Detailed Analysis of the Scope and Claims of United States Patent 10,350,170
Introduction
United States Patent 10,350,170, titled "Solid preparation," was granted to Takeda Pharmaceutical Company Limited on July 16, 2019. This patent is crucial for understanding the stability and formulation of the active pharmaceutical ingredient (API) relugolix, particularly in solid preparations.
Background
Relugolix is a gonadotropin-releasing hormone (GnRH) receptor antagonist used in the treatment of various conditions, including prostate cancer, endometriosis, and uterine fibroids. The stability of this compound in solid preparations is vital for its efficacy and shelf life.
Inventors and Assignees
The patent was invented by Yamane Ikuro, Nomura Yukihiro, Nishimoto Yutaka, and Hoshina Wataru, and assigned to Takeda Pharmaceutical Company Limited[2][4][5].
Patent Claims
The patent primarily focuses on the solid preparation of relugolix, ensuring its stability in tablet form. Here are the key claims:
Claim 1: Solid Preparation
The patent claims a solid preparation that includes relugolix or a salt thereof, characterized by improved stability. This stability is achieved through specific formulations and manufacturing processes that prevent degradation of the API[4][5].
Claim 2: Method of Stabilization
The patent also claims a method for stabilizing relugolix in a solid preparation. This involves specific conditions and components that maintain the chemical integrity of the compound during the manufacturing and storage of the solid preparation[4][5].
Patent Scope
The scope of this patent is narrowly defined around the stability and formulation of relugolix in solid preparations.
Chemical Stability
The patent emphasizes the importance of chemical stability, ensuring that the API does not degrade over time. This is critical for maintaining the therapeutic efficacy of the drug.
Formulation
The patent describes specific formulations and excipients that are used to enhance the stability of relugolix in solid preparations. This includes the use of particular binders, fillers, and lubricants that do not react with the API[4].
Patent Landscape
Related Patents
Several other patents related to relugolix and its applications are noteworthy:
- Patent 10,449,191: This patent, also assigned to Takeda, focuses on the treatment of prostate cancer using relugolix. It details the dosing regimen and the administration of the drug[2].
- Patent 8,735,401: This earlier patent by Takeda covers thienopyrimidine compounds, including relugolix, and their use in various therapeutic applications[2].
Exclusivity and Patent Expiration
The exclusivity period for Orgovyx, a drug containing relugolix, expires on December 18, 2025. The patent itself is set to expire on February 25, 2036[2].
Significance and Impact
Therapeutic Applications
The stability of relugolix in solid preparations is crucial for its therapeutic applications. This patent ensures that the drug remains effective over its shelf life, which is essential for treating chronic conditions like prostate cancer and endometriosis.
Manufacturing and Quality Control
The patent provides detailed guidelines for the manufacturing process, ensuring that the solid preparations meet high standards of quality and stability. This is vital for maintaining the trust of healthcare providers and patients in the drug's efficacy.
Industry Implications
Competitive Advantage
Takeda Pharmaceutical Company Limited holds a competitive advantage due to the exclusive rights granted by this patent. This prevents other companies from developing similar solid preparations of relugolix until the patent expires.
Innovation and Research
The patent encourages further innovation in the field of GnRH receptor antagonists. By protecting the intellectual property related to the stability of relugolix, Takeda incentivizes other companies to invest in research and development of new therapeutic agents.
Conclusion
United States Patent 10,350,170 is a significant milestone in the development of relugolix, ensuring the stability and efficacy of this crucial API in solid preparations. The patent's narrow scope around stability and formulation highlights the importance of chemical integrity in pharmaceutical manufacturing.
Key Takeaways
- Stability in Solid Preparations: The patent focuses on ensuring the stability of relugolix in tablet form.
- Method of Stabilization: Specific methods and formulations are claimed to maintain the chemical integrity of the API.
- Patent Expiration: The patent is set to expire on February 25, 2036.
- Exclusivity: The exclusivity period for Orgovyx expires on December 18, 2025.
- Therapeutic Applications: The stability ensured by this patent is crucial for the therapeutic efficacy of relugolix.
FAQs
Q1: What is the primary focus of United States Patent 10,350,170?
The primary focus is on the stability of relugolix in solid preparations.
Q2: Who are the inventors of this patent?
The inventors are Yamane Ikuro, Nomura Yukihiro, Nishimoto Yutaka, and Hoshina Wataru.
Q3: What is the significance of this patent in therapeutic applications?
The patent ensures the stability and efficacy of relugolix, which is crucial for treating chronic conditions like prostate cancer and endometriosis.
Q4: When does the patent expire?
The patent is set to expire on February 25, 2036.
Q5: What is the exclusivity period for Orgovyx?
The exclusivity period for Orgovyx expires on December 18, 2025.
Sources
- Pharmacompass: Relugolix - Uses, DMF, Dossier, Manufacturer, Supplier, Licensing...
- Drugs.com: Generic Orgovyx Availability
- Hoover Institution: Patent Claims and Patent Scope
- Google Patents: US10350170B2 - Solid preparation
- USPTO Report: Solid preparation Patent Grant Yamane, et al.
