When does the patent for Romiplostim expire?

Introduction to Romiplostim

Romiplostim is a second‐generation thrombopoietin receptor agonist (TPO-RA) designed to stimulate platelet production by activating the TPO receptor (c-Mpl) on megakaryocyte precursors. Unlike endogenous thrombopoietin, romiplostim is a peptibody that combines an antibody fragment with a peptide sequence, thereby reducing the risk of antibody cross‐reactivity and immunogenicity. It is widely known by its brand name, Nplate®, and is produced by Amgen. The drug is a well‐characterized therapeutic agent with demonstrated efficacy in increasing platelet counts in patients with immune thrombocytopenia (ITP) who have had an insufficient response to other therapies.

Therapeutic Uses 
Romiplostim is approved primarily for use in chronic ITP, where it plays a crucial role in increasing platelet counts and reducing the risk of bleeding episodes. Its mechanism of action—direct stimulation of platelet production—addresses both the decreased production and increased destruction of platelets that characterize ITP. In clinical studies, romiplostim has proven effective in both splenectomized and non-splenectomized patients, making it a critical option for those who are refractory to first-line treatments such as corticosteroids and intravenous immunoglobulin. Given its robust efficacy and tolerability profile, the agent continues to be explored in other indications, including certain hematological conditions and even as a potential radiation countermeasure, further broadening its therapeutic impact.

Patent Details for Romiplostim

Patent Number and Holder 
Romiplostim is subject to a complex portfolio of intellectual property rights held by Amgen. This portfolio includes multiple patents, each covering different aspects of the molecule and its formulation. Key patents protect the composition of matter, the formulation, and the methods of production (including aspects such as fusion protein technology and nucleic acid sequences that encode the fusion protein). For example, one patent covers the formulation of romiplostim itself, while another focuses on the underlying polynucleotide sequences encoding its fusion protein. These patents are essential for maintaining market exclusivity and precluding generic or biosimilar competition during their effective lifetime.

Expiration Date 
The expiration dates for these patents vary according to the specific component or method protected and the jurisdiction in which they are granted. In the United States, the primary patent covering the formulation of romiplostim is scheduled to expire on February 12, 2028. Additionally, there is a separate U.S. patent protecting the polynucleotides encoding the fusion protein; this particular patent is set to expire on July 25, 2023. In Europe, the patent landscape differs slightly. The European patent protecting the broader category of thrombopoietic compounds, which initially contributed to romiplostim’s intellectual property protection, expired on October 22, 2019. However, there is still a European patent covering the formulation of romiplostim that will remain in force until April 20, 2027. These dates reflect the culmination of years of research and development and are derived from detailed analyses found in Amgen’s annual reports and other regulatory documents.

Implications of Patent Expiration

Market Impact 
The expiration of patents for a biologic therapy such as romiplostim has significant ramifications for the pharmaceutical market. Patent expiry marks the end of market exclusivity for the original innovator, which typically results in a rapid shift in market dynamics. Following the expiration of critical patents, competitors can introduce generic or biosimilar versions, thereby increasing competition. Such increased competition generally exerts downward pressure on prices, as seen in other areas of the pharmaceutical industry. For romiplostim specifically, the expiration of the U.S. formulation patent in 2028 and the earlier expiration of the polynucleotide encoding patent in 2023 could lead to a segmented introduction of biosimilars. Some components of the molecule might remain protected in certain jurisdictions for a while longer (e.g., the European formulation patent till 2027), but manufacturers will inevitably develop strategies to overcome these barriers. Therefore, stakeholders are closely monitoring these dates because they signal the potential for major shifts in revenue and market share for Amgen.

Generic Competition 
When patents expire, generic manufacturers are legally permitted to produce and market equivalent products. In the context of romiplostim, this means that once the key patents expire, particularly the critical U.S. formulation patent as well as the European patent for formulation, there will be a window for competitors to launch biosimilar versions. Such competition typically leads to price reductions and a broader array of treatment alternatives for patients. However, the complexity and cost associated with the production of biosimilars for complex biologics, such as romiplostim, may delay the full penetration of generic competition compared to small-molecule drugs. Despite these challenges, there has already been activity suggesting that biosimilars for romiplostim are under investigation—clinical trials for comparative efficacy of biosimilar candidates have been reported to start as earlier as 2019. This evolving competitive landscape not only influences price but also spurs further innovation in drug formulations and delivery methods, with companies aiming to differentiate their products even after the original patents expire.

Future Prospects

Opportunities for New Entrants 
The impending patent expirations open significant opportunities for new market entrants. With the expiration of the U.S. patent for the nucleic acid encoding the fusion protein in 2023 and that for the formulation in 2028, new manufacturers—both domestic and international—will have the legal opportunity to develop and market biosimilars or improved versions of romiplostim. This environment encourages innovation and allows generic manufacturers to capture market share by offering potentially lower pricing or alternative formulations that may be more user-friendly or better suited to specific patient populations. Additionally, the expiration of the European patent on thrombopoietic compounds in 2019 has already catalyzed research and development efforts in Europe, possibly stimulating collaborations, licensing agreements, and other strategic partnerships. Ultimately, these developments create a more competitive landscape that benefits healthcare providers and patients through better access and potentially lower treatment costs.

Potential for Price Changes 
Historically, the expiration of key drug patents is associated with a significant reduction in prices. After patent expiry, the generic or biosimilar entrants typically introduce products at lower price points compared to the innovator product. For romiplostim, once the critical patents expire—especially the formulation patent in the United States (2028) and in Europe (2027)—it is anticipated that market prices will decrease due to this heightened competition. Research in other therapeutic areas has shown that drug prices can drop substantially (often by 40% or more over several years) following generic entry. This price dynamic not only impacts the revenues of the original innovator but also plays a crucial role in improving national healthcare budgets and patient access to therapy. The extent of price reduction depends on various factors including the number of generic competitors, market penetration speed, and the specific regulatory framework in each jurisdiction. Amgen and other stakeholders are thus preparing for a possible reconfiguration of pricing strategies in response to this inevitable market shift.

Conclusion 
In summary, the patent landscape for romiplostim is characterized by multiple overlapping patents that protect different aspects of the molecule and its formulation. According to Amgen’s annual reports and related sources, one of the primary U.S. patents covering the formulation of romiplostim will expire on February 12, 2028. In addition, a separate U.S. patent covering the polynucleotides encoding the fusion protein is due to expire on July 25, 2023. In Europe, the patent covering the thrombopoietic compounds expired on October 22, 2019, while the formulation patent remains in force until April 20, 2027.

This segmented expiration profile plays a pivotal role in shaping the future market dynamics for romiplostim. The end of patent protection is likely to pave the way for an influx of biosimilar entrants, which could substantially lower the cost of therapy while expanding patient access. However, the inherent complexity of biologics production may temper the speed at which full market penetration occurs. Moreover, the competitive pressure following patent expirations has broader implications for the industry, influencing both pricing strategies and ongoing innovation in drug delivery and formulation techniques.

Overall, the expiration of key patents for romiplostim is set to dramatically reshape the competitive landscape in both the United States and Europe. New market entrants will have opportunities to develop cost-effective biosimilars, potentially leading to significant price reductions and improved access to effective treatments for patients with chronic ITP. Stakeholders, including manufacturers and healthcare policymakers, should closely monitor these developments to adapt their strategies accordingly and ensure that they can capitalize on the emerging opportunities presented by this evolving landscape.

In conclusion, a detailed understanding of the patent expiration dates, along with the associated market and regulatory dynamics, is essential for informed decision-making in the biopharmaceutical sector. The information provided highlights not only the specific expiration dates for romiplostim’s key patents but also the broader implications for market competition, price evolution, and new product development—factors that are critical to the future success of therapies in this space.

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