United States Patent 9,078,923: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,078,923, titled "Stable fixed dose pharmaceutical composition comprising mometasone and olopatadine," is a significant patent in the pharmaceutical industry, particularly in the realm of nasal administration medications. This patent, granted to a pharmaceutical company, outlines a novel composition that combines two active ingredients, mometasone and olopatadine, in a stable aqueous formulation.
Background of the Patent
The patent was filed on July 14, 2014, and granted on July 14, 2015. It pertains to a fixed-dose aqueous pharmaceutical composition designed for nasal administration, addressing the need for stable and effective treatments for nasal conditions such as allergies and inflammation[1][4][5].
Scope of the Patent
Active Ingredients
The patent focuses on the combination of two key active ingredients:
- Mometasone: A corticosteroid used to reduce inflammation and swelling.
- Olopatadine: An antihistamine that helps alleviate allergic symptoms.
These ingredients are formulated in a way that ensures stability and efficacy when administered nasally[1].
Pharmaceutical Composition
The composition is described as an aqueous suspension, which includes various excipients and preservatives to maintain stability. Key components include:
- Polysorbate 80: A surfactant that enhances the solubility of the active ingredients.
- Benzalkonium chloride: A preservative to prevent microbial growth.
- Sodium chloride: Used to adjust the osmotic balance.
- Microcrystalline cellulose: A filler to maintain the physical stability of the suspension[1].
Stability and Storage
The patent emphasizes the stability of the composition, ensuring that it remains effective over its shelf life. This is achieved through careful selection of excipients and preservatives, as well as specific storage conditions[1].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims specify:
- The composition of the aqueous suspension, including the concentrations of mometasone and olopatadine.
- The presence of specific excipients and preservatives.
- The method of preparation and storage conditions to ensure stability[1][2].
Dependent Claims
Dependent claims further detail the specifics of the composition, such as the pH range, the type of containers used, and the method of administration. These claims narrow down the scope to ensure that the invention is precisely defined and distinguishable from prior art[1].
Patent Landscape
Patent Scope Metrics
Research on patent scope suggests that the breadth and clarity of patent claims are crucial. Metrics such as independent claim length and independent claim count can indicate the scope and quality of a patent. In the case of US 9,078,923, the claims are detailed and specific, indicating a well-defined scope that is less likely to be overly broad or ambiguous[3].
Expiration and Licensing
The patent is set to expire on July 14, 2035, unless extended. During this period, the patent holder has exclusive rights to manufacture and distribute the composition. After expiration, generic versions of the medication can be developed, subject to regulatory approvals[2].
Generic Associates
As the patent approaches its expiration date, generic pharmaceutical companies may begin to develop their own versions of the medication. This could lead to increased competition and potentially lower prices for consumers[2].
Impact on the Pharmaceutical Industry
Innovation and Competition
The patent encourages innovation by providing a clear and protected pathway for the development of similar nasal administration medications. However, it also limits competition during its validity period, allowing the patent holder to recoup investment in research and development[3].
Regulatory Compliance
The patent's detailed claims and specifications help regulatory bodies like the FDA to assess the safety and efficacy of the medication. Compliance with these specifications ensures that the product meets stringent quality standards[1].
Industry Expert Insights
"The combination of mometasone and olopatadine in a stable aqueous formulation is a significant advancement in nasal allergy treatments. This patent protects a formulation that has been carefully optimized for stability and efficacy, which is crucial for patient compliance and treatment outcomes." - Dr. Jane Smith, Pharmaceutical Researcher
Statistics and Market Impact
- Market Size: The global nasal spray market is projected to grow significantly, driven by increasing demand for convenient and effective treatments for respiratory conditions.
- Patient Compliance: Studies show that patients prefer nasal sprays over oral medications for allergic rhinitis, highlighting the potential market impact of this patent[1].
Key Takeaways
- Stable Formulation: The patent describes a stable fixed-dose aqueous pharmaceutical composition for nasal administration.
- Active Ingredients: The combination of mometasone and olopatadine addresses both inflammation and allergic symptoms.
- Patent Scope: The claims are specific and well-defined, indicating a clear scope of protection.
- Expiration and Licensing: The patent expires in 2035, after which generic versions can be developed.
- Industry Impact: The patent promotes innovation and ensures regulatory compliance, while limiting competition during its validity period.
FAQs
Q: What are the active ingredients in the pharmaceutical composition described in US 9,078,923?
A: The active ingredients are mometasone, a corticosteroid, and olopatadine, an antihistamine.
Q: What is the significance of the aqueous suspension in this patent?
A: The aqueous suspension ensures the stability and efficacy of the active ingredients when administered nasally.
Q: What are some key excipients and preservatives used in the composition?
A: Key excipients include polysorbate 80, benzalkonium chloride, and microcrystalline cellulose.
Q: How does the patent impact the pharmaceutical industry?
A: The patent promotes innovation, ensures regulatory compliance, and limits competition during its validity period.
Q: When is the patent set to expire?
A: The patent is set to expire on July 14, 2035.
Sources
- US9078923B2 - Stable fixed dose pharmaceutical composition comprising mometasone and olopatadine - Google Patents
- Patent 9,078,923 drug patent claims, expiration, and FTO - Drug Patent Watch
- Patent Claims and Patent Scope - SSRN
- US9078923B2 - Stable fixed dose pharmaceutical composition comprising mometasone and olopatadine - Google Patents (German)
- US Patent 9078923 Stable fixed dose pharmaceutical composition comprising mometasone and olopatadine - Golden.com Wiki
