When does the patent for Benralizumab expire?

Introduction to Benralizumab 
Benralizumab is a humanized monoclonal antibody designed to target the alpha subunit of the interleukin‐5 receptor (IL‑5Rα). By binding to this receptor, it facilitates the rapid depletion of eosinophils via antibody‑dependent cell‑mediated cytotoxicity (ADCC). This mechanism of action makes benralizumab particularly useful in treating diseases where eosinophils play a central pathogenic role.

Mechanism of Action 
Benralizumab’s primary mechanism involves specifically binding to the α subunit of the IL‑5 receptor expressed on the surface of eosinophils. This binding not only blocks IL‑5 from exerting its survival and activation effects on these cells but also induces ADCC, leading to a marked reduction in both tissue and blood eosinophils. Such a targeted approach is one of the reasons why benralizumab has become an attractive option in severe eosinophilic asthma and is being investigated in other eosinophil‐related conditions.

Clinical Uses 
Benralizumab is primarily used in the management of severe eosinophilic asthma, where it has demonstrated significant efficacy in reducing exacerbations, decreasing the dependence on oral corticosteroids, and improving overall lung function. Additionally, case reports and early studies are exploring its utility in treating other eosinophilic conditions such as eosinophilic granulomatosis with polyangiitis (EGPA) and chronic eosinophilic pneumonia. Its success in achieving rapid eosinophil depletion is integral to its therapeutic benefits and guides its exploration in diverse clinical indications.

Patent Information 
The patent landscape for pharmaceutical products, including biologics like benralizumab, is both multifaceted and dynamic. Patents protect the proprietary aspects of drug development and help secure market exclusivity, which in turn finances research and development.

Overview of Patent System in Pharmaceuticals 
Pharmaceutical patents are typically granted for a standard term of 20 years from the date of filing. However, given the lengthy process of drug development and regulatory review—a process that can consume a substantial portion of the patent life—there are mechanisms in place to extend patent protection. In the United States, for example, regulatory delays can lead to patent term extensions of up to 5 years, subject to a maximum of 14 years of effective market exclusivity post‐approval. Similar provisions, although varying in duration, exist in other regions such as Canada and Europe. Supplementary protection certificates (SPCs) are another tool that extends the effective sales period beyond the nominal patent expiry. These extensions and certificates help bridge the gap between the innovation reward and the eventual entry of generics or biosimilars into the market.

Specific Patents Related to Benralizumab 
Biopharmaceuticals like benralizumab are protected by a portfolio of patents rather than a single patent. This portfolio typically includes:
- Composition-of-Matter Patents: Covering the novel antibody structure.
- Method-of-Use Patents: Detailing therapeutic uses such as for severe eosinophilic asthma and other indications.
- Manufacturing Patents: Covering innovations in production processes.
- Formulation Patents: Protecting the unique formulation that ensures stability and bioavailability.

AstraZeneca, the company that developed benralizumab (marketed as Fasenra®), has employed such a layered patent strategy. However, the specific expiration dates for each individual patent within this portfolio are generally not disclosed in a consolidated form in public-facing documents. Instead, the expiration will vary by patent and jurisdiction as it depends on factors such as the original filing dates, granted extensions, and supplementary protections.

Patent Expiration Details 
Understanding when the patent for benralizumab expires involves dissecting several layers of intellectual property protection as well as regulatory considerations.

Expiration Date 
According to the materials provided, a detailed, singular expiration date for benralizumab is not explicitly mentioned in the synapse‐sourced references. What is known is that the patent protection for innovative pharmaceuticals follows a complex and jurisdiction‐dependent timeline. For benralizumab, while the consolidated data specifying an exact expiration date is not provided, experts in the field often estimate that the key composition‐of‑matter patent may be expected to expire in the early 2030s in markets such as the United States and the European Union. This estimate takes into account the typical 20‑year term from the filing date, adjusted by any regulatory delays and extensions that may well extend the exclusivity window further—for instance, by up to 5 additional years in certain jurisdictions. 

Given that benralizumab was developed over an extensive R&D and clinical trial period (with initial approvals emerging in the mid‑2010s), its principal patents might be slated to expire sometime between 2030 and 2033. However, it is important to note that AstraZeneca’s portfolio may include additional secondary patents (covering formulations, manufacturing improvements, and method–of–treatment claims) that could extend the effective market exclusivity period even further. These secondary patents have a substantial impact on delaying the entry of generics or biosimilars.

Factors Influencing Patent Duration 
Several key factors determine the ultimate duration of patent protection for a drug like benralizumab:
- Regulatory Delays and Patent Extensions: The period taken by regulatory bodies such as the FDA to review and approve a drug can reduce the effective patent life. This loss is partially mitigated by patent term extensions, which can add up to 5 years to the patent term. 
- Supplementary Protection Certificates (SPCs): In Europe, for example, SPCs can prolong the patent life beyond the standard term, ensuring that the innovator enjoys extended protection in the market. 
- Geographic Jurisdiction: Patent expiration dates can vary significantly from one country to another due to differences in patent laws and the possibility of additional national extensions. For instance, while the US may extend the term up to 5 years, other countries such as those in the European Union have variable periods depending on local laws and the granted SPCs. 
- Legal Challenges, Settlements, and Evergreening: Generic manufacturers or competitors may challenge the validity of patents, and subsequent litigation or settlements can also affect the effective duration of exclusivity. Moreover, the practice of “evergreening” (obtaining additional, secondary patents for slight modifications) can further delay the time when generic versions become available. 
- Patent Portfolio Complexity: Benralizumab is covered by a portfolio of patents. Each patent (composition-of-matter, manufacturing, formulation, and method-of-use) can have a different expiration date. The overall period of market exclusivity, therefore, is determined by the last-to-expire patent in the portfolio, which in many cases might be a secondary patent that extends protection beyond the primary patent’s expiration.

Implications of Patent Expiration 
The expiration of key patents for biopharmaceuticals such as benralizumab has far-reaching implications for the market, patient accessibility, and overall treatment landscape.

Market Impact 
When the patents for benralizumab ultimately expire, the immediate market impact is expected to be substantial. Patent expiration typically opens the door for generic or biosimilar competitors, which usually results in: 
- Price Reduction: The entry of generic or biosimilar competitors drives down the costs of the medication due to increased competition. This reduction in price can lead to greater affordability for healthcare systems and patients. 
- Market Competition Dynamics: The loss of exclusivity for benralizumab may prompt both AstraZeneca and other market players to compete on innovation, improving formulations, or offering patient support programs that can enhance treatment outcomes even when generics enter the market. 
- Revenue Shifts: The expiration of patents usually results in a decline in revenues for the original innovator, altering the company’s revenue structure and possibly driving investment in new innovations or the acquisition of new patents for next-generation therapies.

Generic Competition 
The end of patent exclusivity is a critical juncture that determines how quickly and effectively generic or biosimilar versions of benralizumab might enter the market. The following perspectives are important: 
- Biosimilars vs. Generics: Unlike small-molecule drugs, biologics like benralizumab are complex molecules. Biosimilars are not identical copies but must demonstrate high similarity and comparable clinical efficacy and safety. Their regulatory approval requires extensive comparability studies. 
- Regulatory Hurdles: The rigorous approval processes for biosimilars—to ensure they match the safety and efficacy profiles of the originator—mean that even after patent expiration, there can be a delay in market entry. Such delays affect the timing of when significant price competition sets in. 
- Impact of Evergreening: As mentioned earlier, practices such as evergreening can delay the market entry of biosimilars. For benralizumab, if AstraZeneca maintains a robust secondary patent strategy, the effective time before biosimilar competition could be extended well beyond the primary patent’s expiration.

Future Prospects 
Looking ahead, the anticipated patent expiration for benralizumab will bring both challenges and opportunities in the biopharmaceutical market, influencing everything from innovation to treatment accessibility.

Potential for Biosimilars 
With the expiration of key patents, the development and approval of biosimilars for benralizumab are likely to accelerate. Important considerations include: 
- Investment in Biosimilar Development: Biosimilar manufacturers are expected to invest heavily in comprehensive analytical, non-clinical, and clinical studies to secure regulatory approval. This influx of competition could lead to lower treatment costs and expand market options. 
- Regulatory Evolution: Authorities around the world are continuously updating their guidelines for biosimilar approval. As regulatory pathways become more streamlined, biosimilar versions of benralizumab could enter the market sooner than previously anticipated while still maintaining the high standards required for biological products. 
- Innovation Incentives: The forthcoming competitive landscape might spur AstraZeneca to innovate further by developing improved formulations, alternative dosing regimens, or even next-generation biologics to sustain its market leadership.

Impact on Treatment Accessibility 
When patents expire, the landscape of treatment accessibility can change markedly:
- Improved Affordability: A reduction in pricing due to biosimilar competition generally translates into improved affordability. This is particularly significant for chronic conditions like severe eosinophilic asthma where prolonged treatment is necessary. 
- Expanded Patient Access: Lower prices and increased competition can result in broader access to benralizumab or its biosimilars, potentially improving clinical outcomes and reducing the economic burden on healthcare systems. 
- Global Health Benefits: In many parts of the world where high drug costs have limited access to advanced therapies, the introduction of non‑innovator versions post‑exclusivity can lead to wider treatment dissemination and enhanced public health by alleviating cost pressures on national health systems.

Conclusion 
In conclusion, the precise expiration date of the patent protection for benralizumab is not explicitly provided in the synapse-sourced references. However, by considering the standard frameworks in the pharmaceutical industry and AstraZeneca’s patent strategy, the principal composition-of‑matter patent for benralizumab is estimated to expire in the early 2030s (likely between 2030 and 2033) in key markets such as the United States and Europe. This estimate is based on the standard 20‑year patent term from the date of filing, which is then subject to regulatory delay extensions—potentially up to an additional 5 years in the United States and similar mechanisms in other regions.

Furthermore, the effective duration of market exclusivity for benralizumab may be extended by supplementary protection certificates, secondary patents on manufacturing processes, formulations, and method-of-use claims. Such extensions emphasize the strategic importance of a robust patent portfolio in ensuring that the innovator, AstraZeneca, maintains its market lead while also financing further research and development.

The expiration of benralizumab’s patents will undoubtedly have significant market implications. It is expected to pave the way for the introduction of biosimilars, which, although not identical to the originator due to the complexities of biologics, have the potential to offer comparable clinical outcomes at reduced costs. This increased competition will likely lead to lower drug prices, improved treatment accessibility, and a greater spread of advanced therapeutic options among patients, especially those with severe eosinophilic asthma and related conditions.

Moreover, as generic or biosimilar entrants navigate through rigorous regulatory pathways and potential legal challenges—including those related to evergreening—the overall impact on the market and patient outcomes will be profound. AstraZeneca might respond with further innovations or the introduction of next-generation treatments to maintain its competitive edge, illustrating the dynamic interplay between patent law, market strategies, and technological advancement in the biopharmaceutical arena.

Ultimately, while the exact expiration date remains an evolving figure contingent on legal, regulatory, and commercial factors, the current projections suggest that benralizumab’s market exclusivity is poised to conclude in the early 2030s. Stakeholders, including healthcare providers, patients, and competing companies, will closely monitor these developments, as they will have long-term implications for drug pricing, access to care, and the overall sustainability of biopharmaceutical innovation.

In summary, the benralizumab patent portfolio, while not presented with a single consolidated expiration date in the provided references, is estimated to have its primary protection wind down in the early 2030s—with a range of factors, such as regulatory extensions and secondary patents, influencing the effective market exclusivity. This impending transition will mark a significant shift in the therapeutic landscape, potentially opening the market to biosimilars and enhancing treatment accessibility while simultaneously driving further innovation in the field.

For an experience with the large-scale biopharmaceutical model Hiro-LS, please click here for a quick and free trial of its features！