Who holds the patent for Burosumab-twza?

Introduction to Burosumab-twza

Overview of Burosumab-twza 
Burosumab-twza is a human immunoglobulin G subclass 1 (IgG1) monoclonal antibody developed using recombinant DNA technology in Chinese hamster ovary cells. It functions by binding to and inhibiting the biological activity of fibroblast growth factor 23 (FGF23), a key regulator of phosphate metabolism. By neutralizing FGF23, Burosumab-twza restores renal phosphate reabsorption and increases the serum concentration of 1,25-dihydroxy vitamin D. This mechanism forms the scientific basis for Burosumab-twza’s application as a therapeutic agent, ensuring effective management of disorders characterized by phosphate dysregulation.

Clinical Uses and Indications 
Burosumab-twza is indicated for the treatment of rare phosphate-wasting disorders, most notably X-linked hypophosphatemia (XLH). XLH is a genetic disorder that leads to impaired phosphate reabsorption in the kidneys, resulting in bone demineralization, skeletal deformities, and, in some cases, growth deficiencies. The clinical benefits of Burosumab-twza include improved bone mineralization and normalization of serum phosphate levels, which in turn relieve the debilitating symptoms and improve the quality of life of affected patients. Clinical trials have corroborated these effects by demonstrating a dose-dependent increase in serum phosphate levels and favorable pharmacokinetic profiles, with a steady-state trough concentration and elimination half-life that support its use as a long-acting intervention.

Patent Details of Burosumab-twza

Identification of Patent Holder 
Based on the synapse-sourced references and structured patent documents, the patent rights related to Burosumab-twza – particularly those that focus on its anti-FGF23 activity – are jointly held by ULTRAGENYX PHARMACEUTICAL INC. and KYOWA HAKKO KIRIN CO., LTD. For example, one of the key patent documents, titled "Effective and efficient control of serum phosphate for optimal bone formation," explicitly states that the pharmaceutical composition containing the anti-FGF23 ligand, which is engineered into Burosumab-twza, is assigned to these two companies. Similarly, another patent document reaffirms this arrangement by listing the same entities as current assignees under a comparable filing that details the dosing regimen and the control of FGF23 activity. This joint patent arrangement signifies a collaborative effort between ULTRAGENYX PHARMACEUTICAL INC. and KYOWA HAKKO KIRIN CO., LTD., ensuring that both companies maintain exclusive rights to the intellectual property underpinning the innovative anti-FGF23 approach embodied by Burosumab-twza.

Patent Filing and Approval Dates 
The patent documents associated with the anti-FGF23 technology used in Burosumab-twza have undergone various filings and approvals over the past several years. For instance, one of the patent documents pertaining to the therapeutic strategy was filed on May 29, 2015, and later published on December 17, 2015, under the publication number WO2015191312A1. This document reflects the early strategic move by the patent holder consortium of ULTRAGENYX and KYOWA HAKKO KIRIN to secure intellectual property covering their novel approach to managing hypophosphatemic disorders. Additionally, another document – which again outlines the required dosing and the anti-FGF23 composition – was filed on November 12, 2021, and published on May 05, 2022, under the publication number US20220133871A1. These patent-related dates not only indicate an expanding and reinforcing IP portfolio for the Burosumab-twza technology but also highlight the progression of ongoing innovation and improvements in its clinical application strategy over time.

Legal and Commercial Aspects

Licensing Agreements 
The joint patent ownership by ULTRAGENYX PHARMACEUTICAL INC. and KYOWA HAKKO KIRIN CO., LTD. is a fundamental element of the legal and commercial strategy underpinning Burosumab-twza. The licensing agreements in place between these entities and their affiliated partners ensure wide-ranging protection and regulatory compliance across multiple jurisdictions. Although the detailed terms of any third-party licensing or strategic alliance agreements are not fully disclosed in the available synapse references, these partnerships typically include provisions for the shared commercialization rights, revenue distribution, and technology transfer. Such licensing arrangements are designed to prevent infringement by competitors while facilitating market entry and expansion strategies in key markets around the United States, Europe, and other significant economic zones. This legal framework also provides a robust defense mechanism in the event of patent litigation and addresses potential challenges from third parties seeking to utilize similar technology or methods in their pharmaceutical innovations.

Market Impact and Competition 
From a commercial perspective, Burosumab-twza represents a breakthrough in the management of rare phosphate-wasting disorders, and its patent protection by two major pharmaceutical companies directly affects its market positioning. The joint patent held by ULTRAGENYX and KYOWA HAKKO KIRIN creates substantial barriers to entry for potential competitors looking to develop similar treatments targeting FGF23. In addition to the exclusivity provided by these patents, the extensive research and development efforts—reflected in the detailed pharmacokinetic evaluations—underscore the significant investment in securing a competitive advantage in this niche therapeutic area. Market dynamics for Burosumab-twza are influenced not only by its clinical efficacy and safety profile but also by the strategic negotiation of patent licensing deals, capitalizing on both companies’ established reputations and global distribution networks. This integrated approach ensures that Burosumab-twza occupies a strong market share, while its patent portfolio continues to serve as a critical asset in negotiations, potential partnerships, or further commercialization endeavors.

Future Developments

Ongoing Research and Trials 
The trajectory of Burosumab-twza development is closely intertwined with an active pipeline of ongoing research and clinical trials. The existing patents for Burosumab-twza, while ensuring exclusive rights in the current market, also provide a platform from which further enhancements and modifications can be developed. Clinical trials currently in progress explore various dosing regimens, potential combinations with other therapeutic agents, and extended indications beyond XLH. These trials are designed to assess additional safety profiles, optimize pharmacokinetic parameters, and address other metabolic and skeletal disorders where FGF23 dysregulation plays a role. The data from these studies, which continue to be published in reputable sources, will likely lead to supplementary patents or expansion of the current patent claims, thereby extending the period of market exclusivity and opening new therapeutic avenues.

Potential Expansions and New Indications 
Looking forward, the robust patent portfolio held by ULTRAGENYX PHARMACEUTICAL INC. and KYOWA HAKKO KIRIN CO., LTD. may be further expanded through additional filings that broaden the scope of Burosumab-twza’s clinical applications. There is active exploration into the efficacy of Burosumab-twza for other phosphate-wasting conditions and potential off-label uses that could include metabolic bone diseases and possibly other rare disorders where FGF23 plays a critical role. In the competitive landscape of biologic therapies, the strategic expansion of patent claims—supported by emerging clinical data and technological enhancements—is a key focus. Moreover, the companies involved are continuously monitoring advances in immunotherapy and biosimilar development, which may prompt additional innovation in the formulation or administration methods of Burosumab-twza. The adaptive nature of its patent strategy, supported by ongoing clinical research and a proactive legal framework, ensures that the treatment remains at the forefront of precision medicine while also safeguarding its commercial interests in a globally competitive market.

Conclusion

In summary, the detailed examination of the patent documents and literature available from synapse sources reveals that the patent for Burosumab-twza is held jointly by ULTRAGENYX PHARMACEUTICAL INC. and KYOWA HAKKO KIRIN CO., LTD. This conclusion is supported by key patent documentation and further reinforced by additional filings, which outline the patent protection strategy used to secure the anti-FGF23 technology that underpins Burosumab-twza. 

The analysis began with an overview of Burosumab-twza as a therapeutic monoclonal antibody designed specifically to target FGF23, thereby correcting phosphate metabolism disorders such as XLH. We then detailed the clinical uses and significant advantages of the drug in managing phosphate homeostasis, ultimately leading to improved bone formation and patient outcomes. 

Subsequently, the patent details section illuminated the timeline and critical filing dates pertinent to the intellectual property rights of Burosumab-twza. Notably, the patents were filed in both 2015 and 2021, with publications confirming the assignment to both ULTRAGENYX and KYOWA HAKKO KIRIN. These patents form a robust shield against potential competitive challenges and secure exclusivity for the use and commercialization of the anti-FGF23 approach. 

In the legal and commercial aspects section, we reviewed the significance of the licensing agreements that facilitate the seamless marketing and distribution of Burosumab-twza across multiple jurisdictions. The joint patent ownership has established a formidable barrier to entry, ensuring a competitive edge in the global pharmaceutical market. This strategy not only mitigates risks of infringement but also reinforces the market impact by directly influencing competitive dynamics in the biologics segment.

Looking ahead, the ongoing research and trials section highlighted that Burosumab-twza is not a static product; rather, it is the subject of continuous clinical research aimed at broadening its therapeutic indications and optimizing dosing regimens. The potential expansions into new indications promise to drive further innovation and could lead to additional IP filings that enhance and extend the patent portfolio, ensuring long-term market sustainability. 

From a general perspective, the collaboration between ULTRAGENYX PHARMACEUTICAL INC. and KYOWA HAKKO KIRIN CO., LTD. not only exemplifies a successful joint venture in biopharmaceutical innovation but also underscores the importance of strategic patent management in driving scientific and commercial success. The patent ownership arrangement has provided a stable foundation for the development and ongoing evolution of Burosumab-twza, thereby securing its role as a transformative therapy in the treatment of phosphate-wasting disorders.

In conclusion, a comprehensive review of the available synapse references and related patent documents confirms that the primary patent for Burosumab-twza is held by ULTRAGENYX PHARMACEUTICAL INC. and KYOWA HAKKO KIRIN CO., LTD. This joint patent ownership is strategically significant as it addresses multiple facets—ranging from clinical efficacy and safety to market impact and competitive legal protection—thus ensuring that Burosumab-twza remains a leading biologic therapeutic in its field. The future prospects, driven by continuous clinical trials and evolving research avenues, are anticipated to further cement its patent portfolio and underpin its long-term success, ultimately benefiting patients worldwide.

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