Who holds the patent for Fluticasone Furoate?

Introduction to Fluticasone Furoate

Fluticasone furoate is a synthetic glucocorticoid with enhanced receptor affinity and distinctive physicochemical properties that have been leveraged for a variety of therapeutic applications. Its unique chemical structure incorporates a highly substituted furoate ester, which not only contributes to its pharmacological potency but also modifies its pharmacokinetic characteristics. In essence, fluticasone furoate is an advanced corticosteroid optimized for topical applications such as intranasal sprays and inhalation therapies, offering potent anti‐inflammatory effects with minimized systemic exposure.

Chemical Composition and Uses

The chemical composition of fluticasone furoate is characterized by the incorporation of a 2-furoyl moiety on the 17α position of the steroid backbone. This structural feature distinguishes it from other corticosteroids like fluticasone propionate. The furoate ester is known to enhance the affinity of the compound for the glucocorticoid receptor, thereby enabling a more effective and sustained interaction with target tissues. The molecule is optimized not only for its receptor binding but also for improved solubility, dissolution rate, and tissue retention, which are critical for therapeutic efficacy. This corticosteroid is widely used in the treatment of allergic rhinitis, chronic obstructive pulmonary disease (COPD), and as part of combination products for asthma management, among other respiratory conditions.

Overview of Its Medical Applications

Fluticasone furoate has been clinically evaluated in various settings. Its use spans from alleviating the nasal symptoms of allergic rhinitis when administered via a nasal spray to reducing the rate of lung function decline in COPD patients. The compound is also being developed in inhaled formulations to target lower airway inflammation in asthma, where its high local potency and low systemic bioavailability minimize the risk of adverse effects typically associated with systemic corticosteroid exposure. Several clinical studies and integrated safety and efficacy analyses have confirmed that once‐daily dosing regimens are effective in managing airway inflammation while maintaining a favorable safety profile. Its role in treating respiratory diseases is backed by robust clinical data that support its improved receptor interactions and sustained action in the target tissues.

Patent Analysis of Fluticasone Furoate

A detailed investigation of the patent landscape surrounding fluticasone furoate reveals a multifaceted and dynamic ecosystem that encompasses various aspects of the drug’s composition, synthesis processes, formulations, and clinical applications. This complexity reflects its significance in modern pharmacotherapy and the intense effort put forth by numerous entities to innovate and protect intellectual property in this domain.

Patent Holder Identification

The patent ownership landscape for fluticasone furoate is characterized by multiple assignees who have secured rights over different aspects of the molecule and its pharmaceutical formulations. No single entity holds a universal patent over the entire use and manufacture of fluticasone furoate; instead, several companies hold specialized patents in various jurisdictions and for diverse technological facets.

GlaxoSmithKline Intellectual Property Development Limited: 
A significant portion of the patents related to the clinical applications of fluticasone furoate, especially those focused on its use in treating respiratory conditions such as COPD, have been assigned to GlaxoSmithKline Intellectual Property Development Limited. For instance, patents covering treatment methods for COPD with fluticasone furoate clearly list GSK as the current assignee, underscoring their leadership in leveraging this compound for respiratory indications. The strong portfolio held by GSK has contributed to the development and commercialization of products marketed under various brand names worldwide.

Tianjin Pharmaceutical Research Institute Co., Ltd.: 
In China, there are patents describing innovative preparation methods of fluticasone furoate. One such patent details a preparation method that significantly reduces impurities by employing specific catalytic techniques. This patent is assigned to Tianjin Pharmaceutical Research Institute, indicating their role in advancing manufacturing technologies and process optimizations for fluticasone furoate in the domestic market.

Guangzhou Respiratory Drug Engineering Technology Co., Ltd. and Shanghai Fangyu Health Pharmaceutical Technology Co., Ltd.: 
Additional patents, such as those describing high-purity preparation methods of fluticasone furoate, have been held jointly by Guangzhou Respiratory Drug Engineering Technology and Shanghai Fangyu Health Pharmaceutical. These patents focus on innovative steps to improve purity and yield, which are critical from both quality control and cost-effectiveness perspectives. Their collaborative efforts highlight a strong emphasis on technical process improvements and industrial scalability in the Chinese market.

TOKO YAKUHIN KOGYO CO., LTD.: 
For formulations tailored to intranasal delivery, especially those combining fluticasone furoate with carboxyvinyl polymers, TOKO YAKUHIN KOGYO CO., LTD. is a prominent patent holder. Multiple patents across different jurisdictions (including US, EP, IN, and AU publications) indicate that this company has a well-established portfolio covering nasal preparation compositions that utilize fluticasone furoate for treating allergic conditions. Their innovative approach in improving the formulation characteristics further enhances the drug’s performance and user compliance.

ANOVENT PHARMACEUTICAL (U.S.), LLC and Shanghai Gusen Pharmaceutical Co., Ltd.: 
In the realm of advanced drug delivery systems, such as liposomal formulations of fluticasone furoate, patents have been filed by ANOVENT PHARMACEUTICAL and Shanghai Gusen Pharmaceutical. These patents involve specialized techniques to encapsulate the active ingredient within a liposomal matrix, thereby optimizing parameters for nebulization and targeted delivery. This innovation not only improves the formulation's stability but also tailors its pharmacokinetics to suit inhalation therapy. Additionally, Shanghai Gusen Pharmaceutical holds patents for specific crystal forms and suspension formulations that enhance the handling properties and industrial manufacturability of fluticasone furoate.

In summary, the major patent holders associated with fluticasone furoate include GlaxoSmithKline Intellectual Property Development Limited, Tianjin Pharmaceutical Research Institute, Guangzhou Respiratory Drug Engineering Technology Co., Ltd. together with Shanghai Fangyu Health Pharmaceutical, TOKO YAKUHIN KOGYO CO., LTD., ANOVENT PHARMACEUTICAL (U.S.), LLC, and Shanghai Gusen Pharmaceutical. Each of these companies contributes to the overall patent portfolio by focusing on specific methods of synthesis, formulation designs, and technological process improvements, thereby ensuring comprehensive protection and innovation across various stages of the drug’s lifecycle.

Patent Timeline and Status

The application dates, publication dates, and expiration dates of these patents reveal a timeline that spans recent years with several patents at different stages of their lifecycle:
- Early-Phase Process Patents: 
Patents like the preparation method published under CN110317238B and other similar filings 2018 or earlier. These patents outline the methodologies for synthesizing fluticasone furoate with a focus on industrial scalability and impurity reduction.
- High-Purity and Formulation Patents: 
Patents such as CN109438543B represent the advancements in purity and improved yield in the production process, with application dates around late 2018. These patents often have a similar lifespan, with expiration dates extending into the 2030s, ensuring a lengthy period of market exclusivity.
- Therapeutic Use Patents: 
PCT and US patent applications related to the therapeutic applications of fluticasone furoate specifically target its use in treating conditions like COPD. Their timelines reflect a continuous innovation phenomenon where the clinical data and evolving therapeutic regimens are being incorporated into successive patent applications. These documents indicate robust protection strategies where the use of the compound in combination with other therapeutic agents is also being patented.
- Formulation Patents: 
For nasal spray compositions, the family of patents held by TOKO YAKUHIN KOGYO CO., LTD. exhibit coordinated filing dates which ensure broad jurisdictional coverage. Their timeline is designed to offer protection in multiple major markets concurrently.
- Liposomal and Novel Delivery Method Patents: 
Patents concerning advanced delivery systems, such as the liposomal formulations, have recent application dates (e.g., US11304901B2 and WO2021041374A1) and indicate active research and development to enhance drug delivery. These patents are structured to provide both interim and extended protection during the commercial exploitation phase.

Overall, the timeline of these patents reflects ongoing innovation and a strategic layering of patent protection over the core technology and its various applications. This layered approach is common in the pharmaceutical industry as it allows the key technology (fluticasone furoate itself) to be protected across different product formulations, manufacturing methods, and therapeutic uses, thereby maximizing exclusivity rights over an extended period.

Legal and Regulatory Considerations

The extensive array of patents associated with fluticasone furoate underscores not only the scientific innovation behind the compound but also the complex legal framework within which it operates. The legal and regulatory considerations play an integral role in defining market access, research and development strategies, and the competitive landscape in the pharmaceutical sector.

Patent Laws and Regulations

Patent laws and regulations form the backbone of intellectual property protection in the pharmaceutical industry. They provide the necessary framework for granting exclusivity, ensuring that innovators can secure a return on investment while simultaneously stimulating further research into improved formulations and applications. For fluticasone furoate, different jurisdictions enforce varied patent laws:
- National and Regional Patent Laws: 
In countries like China, where patents have been filed and granted to companies like Tianjin Pharmaceutical Research Institute and Guangzhou Respiratory Drug Engineering Technology Co., Ltd./Shanghai Fangyu Health Pharmaceutical, local patent laws provide robust protection based on novelty, inventive step, and industrial applicability. 
- International Patent Conventions: 
Patents filed under international treaties like the Patent Cooperation Treaty (PCT) and under the jurisdiction of entities like the United States Patent and Trademark Office (USPTO) (as seen with patents) ensure that companies like GlaxoSmithKline and ANOVENT PHARMACEUTICAL (U.S.), LLC can protect their intellectual property on a global scale. 
- Specific Regulations on Pharmaceutical Patents: 
Given that fluticasone furoate is a molecule optimized for therapeutic efficacy and safety, its patents are subject to stringent regulatory scrutiny. This includes evaluations of clinical data, process validation, and manufacturing quality. Regulatory bodies, therefore, not only enforce patent laws but also ensure that the granted patents correlate with verifiable advancements that support patient safety and treatment effectiveness.

These regulatory mechanisms impact the scope of the patent protection and determine the enforceability of patent rights across different markets. For example, patents held by GlaxoSmithKline and TOKO YAKUHIN KOGYO CO., LTD. are structured such that their claims cover both the compound and its specific formulations, thereby offering a dual-level protection that is difficult for generic competitors to circumvent.

Impact on Drug Manufacturing and Distribution

The distribution of patent rights has significant implications on the manufacturing and distribution of fluticasone furoate. The layered and geographically diverse patent portfolio creates both opportunities and challenges:
- Manufacturing Innovations and Quality Assurance: 
Companies that hold process patents, such as those assigned to Tianjin Pharmaceutical Research Institute and Guangzhou Respiratory Drug Engineering Technology Co., Ltd., benefit from proprietary methodologies that facilitate high-yield and high-purity production. This not only ensures compliance with strict quality standards but also reduces the risk of harmful impurities.
- Market Exclusivity and License Strategies: 
The patents on therapeutic uses and formulations, particularly by GlaxoSmithKline Intellectual Property Development Limited and TOKO YAKUHIN KOGYO CO., LTD., provide the primary market exclusivity that prevents competitors from launching similar products until patent expiry. These exclusivity rights are often bolstered by licensing agreements that allow the patent holders to penetrate multiple markets worldwide.
- Patent Litigation and Regulatory Disputes: 
The complexity of the patent portfolio means that disputes can arise, especially when different aspects of fluticasone furoate’s production or usage are challenged in court. These legal disputes can affect the timelines for market entry and require careful navigation of regulatory approvals, impacting both manufacturing ramp-up and distribution planning.

In essence, the interplay of patent law and regulatory oversight ensures that only products meeting high quality and efficacy standards reach the market while safeguarding the investment made by the innovator companies. This dual approach helps in maintaining a balance between fostering innovation and ensuring patient access to safe and effective treatments.

Market Implications

The patent landscape of fluticasone furoate has a profound impact on the competitive dynamics in the respiratory and allergy treatment markets. With multiple entities holding patents covering various aspects of its synthesis, formulation, and clinical applications, the overall market is both segmented and highly competitive.

Competitive Landscape

The competitive arena for fluticasone furoate is characterized by the presence of several major players:
- GlaxoSmithKline Intellectual Property Development Limited: 
GSK is a central player in the marketplace for fluticasone furoate, particularly given their robust portfolio in clinical applications for respiratory diseases. Their patents ensure that they maintain a dominant market share in regions where exclusive rights are actively enforced. 
- Regional Innovators and Process Optimizers: 
Companies like Tianjin Pharmaceutical Research Institute and Guangzhou Respiratory Drug Engineering Technology Co., Ltd./Shanghai Fangyu Health Pharmaceutical have developed advanced manufacturing methods and high-purity synthesis processes. Their contributions not only support local markets in China but also set benchmarks internationally for quality control and cost-effectiveness.
- Formulation Specialists: 
TOKO YAKUHIN KOGYO CO., LTD. holds significant rights in nasal spray formulations, enhancing the therapeutic profile of fluticasone furoate by combining it with novel excipients like carboxyvinyl polymers. Their patents span multiple jurisdictions, ensuring that their formulations remain competitive against alternative treatments.
- Advanced Drug Delivery Innovators: 
ANOVENT PHARMACEUTICAL (U.S.), LLC and Shanghai Gusen Medical, through their innovative work in liposomal and crystal form formulations, differentiate their products by offering improved delivery and stability. These companies are instrumental in targeting niche segments of the respiratory market, particularly those looking for optimized inhalation therapies.

The overall market is therefore characterized by a multi-layered competition where patent portfolios serve as strategic tools to secure market leadership and ward off generic competition. The strategic filing and enforcement of patents drive market exclusivity and play a significant role in determining the competitive dynamics.

Impact of Patent on Market Dynamics

The extensive patent portfolio surrounding fluticasone furoate has several noteworthy effects on market dynamics:
- Innovation and R&D Investment: 
The assurance provided by strong patent protection incentivizes companies to continue investing in R&D. This leads to a continuous evolution of formulations and delivery mechanisms, thereby expanding therapeutic options and improving patient outcomes.
- Pricing and Market Access: 
Exclusive patent rights allow the patent holders to set premium prices during the market exclusivity period, which can influence the overall market pricing strategies. However, the expiration of patents often results in a surge of generic competition, leading to price reductions and increased access for patients.
- Licensing and Collaboration: 
The existence of multiple patents creates opportunities for cross-licensing and strategic partnerships. For instance, while GSK might hold core therapeutic patents, licensing agreements with regional or formulation specialists can help expand market reach and bolster the overall supply chain for fluticasone furoate products.
- Regulatory Strategies and Patent Lifecycles: 
Robust regulatory strategies, which often involve the layering of patents (i.e., process, formulation, and method of use patents), help extend the effective patent lifecycle. This strategy not only protects the innovator’s market share for a longer duration but also forces competitors to innovate around multiple layers of intellectual property.
- Impact on Generic Competition: 
The complex patent landscape creates high entry barriers for generic manufacturers. Until the key patents expire, companies holding these patents enjoy protection against the flooding of the market with lower-cost alternatives. This dynamic is particularly evident in the case of fluticasone furoate, where comprehensive patent protection across various domains delays the introduction of generics and maintains patient loyalty to branded products.

Thus, from an economic and strategic perspective, the patent environment for fluticasone furoate shapes not only the research and development landscape but also the financial dynamics and competitive positioning in global markets.

Conclusion

In conclusion, the patents related to fluticasone furoate are held by multiple entities rather than a single patent holder. The landscape is complex and multifaceted:

GlaxoSmithKline Intellectual Property Development Limited stands out as a major patent holder for the clinical use of fluticasone furoate, particularly in treating respiratory conditions such as COPD, which positions them as a dominant player in the global market. 
Tianjin Pharmaceutical Research Institute and Guangzhou Respiratory Drug Engineering Technology Co., Ltd./Shanghai Fangyu Health Pharmaceutical have advanced the manufacturing and synthesis technologies, ensuring high-purity production methods crucial for efficient drug production. 
TOKO YAKUHIN KOGYO CO., LTD. has developed specialized formulations for nasal delivery, covering multiple international markets through a comprehensive patent portfolio. 
ANOVENT PHARMACEUTICAL (U.S.), LLC and Shanghai Gusen Medical have innovated in the area of drug delivery, particularly through liposomal formulations and optimized crystalline forms, enhancing the therapeutic profile and industrial scalability of fluticasone furoate.

This diverse patent portfolio is underpinned by stringent legal and regulatory frameworks that ensure each patent meets the criteria of novelty, inventive step, and industrial applicability. These legal defenses not only safeguard the respective innovations but also have significant ramifications on the manufacturing, pricing, licensing, and market competitiveness of fluticasone furoate products.

From a market perspective, the robust intellectual property protection cultivates an environment that encourages continued innovation while maintaining controlled market entry points for competitors. The layered and geographically varied patent filings help extend the period of market exclusivity for key products, thereby influencing pricing dynamics and competitive strategies across different regions.

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