United States Patent 9,186,411: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,186,411, titled "Pharmaceutical composition," is a significant patent in the pharmaceutical industry, particularly for the stabilization of pharmaceutically active ingredients. This patent, assigned to Takeda Pharmaceutical Company Limited, provides insights into the formulation and stabilization of certain drugs, which is crucial for their efficacy and shelf life.
Patent Overview
Inventors and Assignee
The patent was invented by Hiraishi Yasuhiro and Nonomura Muneo and is assigned to Takeda Pharmaceutical Company Limited[5].
Issue Date and Expiration
The patent was issued on November 17, 2015, and is set to expire on August 11, 2030[5].
Scope of the Patent
Pharmaceutically Active Ingredient
The patent focuses on a stabilized pharmaceutical composition containing a nonpeptidic pharmaceutically active ingredient. This active ingredient has a primary or secondary amino group, which is common in various drugs used for treating conditions such as peptic ulcer, gastritis, and erosive esophagitis[1].
Stabilizing Components
The composition includes an excipient and an acidic compound to enhance the stability of the active ingredient. Additionally, the patent describes the use of titanium oxide and a chain organic acid in solid preparations to improve photostability during light irradiation[1].
Claims of the Patent
Main Claims
The patent claims cover a stabilized pharmaceutical composition comprising:
- A nonpeptidic pharmaceutically active ingredient with a primary or secondary amino group.
- An excipient.
- An acidic compound.
- Optionally, titanium oxide and a chain organic acid for improved photostability in solid preparations[1].
Specific Chemical Structures
The patent details specific chemical structures of the active ingredients, including compounds represented by various formulas. For example, it describes compounds with monocyclic nitrogen-containing heterocyclic groups, optionally substituted aryl groups, and other specific substituents[1].
Patent Landscape
Related Patents
The patent is part of a broader family of patents related to the stabilization and formulation of pharmaceuticals. For instance, another related patent, US7977488, also protects aspects of the drug, including dosage and mode of administration[2].
Exclusivity and Market Protection
The patent provides exclusive rights to the patent holder, Takeda Pharmaceutical Company Limited, until its expiration in 2030. This exclusivity is crucial for maintaining market dominance and preventing generic versions of the drug from entering the market during this period[5].
Impact on Pharmaceutical Industry
Stability and Efficacy
The stabilization methods described in the patent are critical for maintaining the efficacy of the pharmaceutically active ingredients. This is particularly important for drugs that are sensitive to light and other environmental factors, ensuring that the drug remains effective throughout its shelf life[1].
Regulatory and Legal Considerations
The patent's scope and claims are subject to regulatory and legal scrutiny. Changes in patent laws, such as those related to genus claims and enablement requirements, can impact the validity and breadth of patent protection. This is a significant consideration in the pharmaceutical industry, where broad patent claims can be challenging to maintain due to stringent legal standards[3].
Generic Launch and Exclusivity
Estimated Generic Launch Date
The generic launch date for drugs protected by this patent is estimated to be August 11, 2030, assuming no extensions or changes in the patent term. This date is critical for both the patent holder and potential generic manufacturers[2].
Exclusivity Periods
In addition to patent protection, the drug may also enjoy exclusivity periods granted by the FDA, such as New Product, New Chemical Entity, and New Indication exclusivities. These exclusivities can run concurrently with patent protection and further delay the entry of generic versions into the market[2].
Key Takeaways
- Patent Scope: The patent covers stabilized pharmaceutical compositions with specific active ingredients and stabilizing components.
- Claims: The claims include detailed chemical structures and stabilization methods.
- Exclusivity: The patent provides exclusive rights until August 11, 2030, with additional FDA-granted exclusivities.
- Impact: The patent is crucial for maintaining drug efficacy and market protection in the pharmaceutical industry.
- Regulatory Considerations: The patent is subject to regulatory and legal scrutiny, particularly regarding genus claims and enablement requirements.
FAQs
What is the main focus of United States Patent 9,186,411?
The main focus of this patent is on the stabilization of pharmaceutical compositions containing nonpeptidic pharmaceutically active ingredients with primary or secondary amino groups.
Who are the inventors and assignee of this patent?
The inventors are Hiraishi Yasuhiro and Nonomura Muneo, and the assignee is Takeda Pharmaceutical Company Limited.
When does the patent expire?
The patent is set to expire on August 11, 2030.
What are the key components of the stabilized pharmaceutical composition?
The composition includes a nonpeptidic pharmaceutically active ingredient, an excipient, an acidic compound, and optionally, titanium oxide and a chain organic acid for photostability.
How does this patent impact the pharmaceutical industry?
This patent ensures the stability and efficacy of certain drugs, providing market protection to the patent holder until its expiration and influencing the timing of generic drug launches.
Cited Sources:
- US9186411B2 - Pharmaceutical composition - Google Patents
- Voquezna patent expiration - Pharsight - GreyB
- Eviscerating Patent Scope - DigitalCommons@NYLS
- Vonoprazan - Phathom Pharmaceuticals, Inc.
- Generic Voquezna Availability - Drugs.com
