Who holds the patent for Rimegepant?
Introduction to Rimegepant
Overview of Rimegepant
Rimegepant is a small-molecule calcitonin gene-related peptide (CGRP) receptor antagonist developed for managing migraine. Its unique chemical structure and favorable pharmacokinetic properties—including good oral bioavailability and a relatively long half-life—make it an attractive therapeutic option for both the acute treatment and prevention of migraine episodes. Rimegepant’s approval by regulatory agencies such as the U.S. Food and Drug Administration (FDA) has been underpinned by extensive clinical trials and in-depth research into its mechanism of action, ensuring that its safety and efficacy are well established. Its formulation typically includes oral disintegration tablets (ODTs), which facilitate rapid absorption and onset of action, a key consideration in addressing the debilitating symptoms of migraine.
Therapeutic Uses and Indications
The therapeutic indications for Rimegepant primarily revolve around the management of migraine. Clinically, it is used as both an acute treatment option for interrupting active migraine attacks as well as a preventive regimen administered on an “as-needed” basis. Rimegepant has been shown to alleviate not only the headache pain but also the associated symptoms, such as nausea and photophobia, which often exacerbate the migraine experience. Furthermore, emerging research suggests that Rimegepant may have additional applications beyond migraine treatment, such as potential therapeutic benefits in treating certain coronavirus infections, as indicated by patent filings focusing on broader clinical indications beyond its primary therapeutic area. Overall, the range of indications, coupled with its dual role in acute and preventive therapy, reinforces its importance in contemporary migraine management.
Patent Landscape for Rimegepant
Key Patent Holders
The intellectual property landscape for Rimegepant is segmented, with different patents being held by multiple entities, reflecting the diverse technical innovations and pharmaceutical strategies associated with the drug. There is no single entity holding all patents related to Rimegepant; rather, the patent portfolio includes several key players:
1. AURISCO PHARMACEUTICAL (TIANJIN) INC and Affiliates:
Several patents associated with the preparation methods and crystalline forms of Rimegepant have been filed under the aegis of AURISCO PHARMACEUTICAL (TIANJIN) INC. For instance, the patent describing a mild preparation method that results in high yield and purity is held by AURISCO PHARMACEUTICAL and Aurisco Pharmaceutical(Tianjin). Additionally, innovations surrounding a new crystal form and its preparation method are also attributed to AURISCO PHARMACEUTICAL, along with the participation of subsidiary companies such as YANGZHOU AURISCO PHARMACEUTICAL CO.LTD. These patents contribute significantly to the overall process innovations, quality control through crystallization, and impurity management for Rimegepant.
2. BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD and BIOHAVEN PHARMACEUTICAL IRELAND DAC:
Another critical segment of the Rimegepant patent portfolio is held by Biohaven-related entities. They possess patents covering various dosage forms, particularly the oral fast-dispersing formulation of Rimegepant. Multiple patents describe this formulation innovation: for example, Biohaven holds patents for a fast-dispersing dosage form that is optimized for oral delivery. In addition to the formulation patents, Biohaven holds patents that consolidate the therapeutic use of Rimegepant in the preventative treatment of migraine. These patents underscore the significance of drug delivery innovations that enhance patient compliance and ensure rapid bioavailability.
3. UNIVERSIDADE NOVA DE LISBOA:
Interestingly, another facet of the Rimegepant intellectual property is represented by the patent held by Universidade Nova de Lisboa. This particular patent focuses on the application of Rimegepant in the treatment of infections caused by human coronaviruses, including SARS-CoV-2 and its variants. Although this patent represents a broader therapeutic scope than migraine alone, it illustrates the adaptability and biochemical promise of Rimegepant beyond its primary indication.
4. Other Patent Considerations:
While the major players above are the most prominent patent holders for Rimegepant, the overall patent portfolio is broadened by additional patents addressing synthesis methods, potential mutual exclusivity strategies, and innovative methods combining chemical and enzymatic steps for drug preparation. For instance, chemical-enzyme methods for synthesizing remegapam—a compound closely related or identical in some contexts to Rimegepant—have been patented by entities such as SyncoZymes, demonstrating the diversity of approaches in its manufacturing process even though these may sometimes refer to slightly different nomenclature.
It is also important to note that collaboration strategies and licensing arrangements, such as the parallel agreement between Pfizer and Biohaven for commercialization rights outside the U.S., further complicate the patent landscape by linking different patent holders with market rights. Although these commercial collaborations do not necessarily change patent ownership, they influence the overall control, distribution, and enforcement of patent rights for Rimegepant.
Patent Filing and Approval Timeline
The timeline for patent filings and approvals related to Rimegepant reflects continuous innovation and refinement over the years. The detailed timeline is as follows:
- Preparation and Synthesis Patents (AURISCO PHARMACEUTICAL):
Patents related to the innovative preparation methods for Rimegepant (e.g., the methods that ensure high yield and product purity) have a relatively recent filing history. For example, the patent for a preparation method filed on December 28, 2022, and published on August 3, 2023, by AURISCO PHARMACEUTICAL is part of a broader trend in the ongoing refinement of synthesis techniques. Similarly, the new crystal form patent published on March 30, 2023, further exemplifies the recent advancements within this technology grouping.
- Formulation Patents (BIOHAVEN and Related Entities):
The patented oral fast-dispersing dosage forms of Rimegepant have their own timeline. Patents filed by Biohaven and their affiliates include patents with application dates in early 2021 and 2022, with multiple publications occurring across 2022, 2023, and even into 2023 detailing extended formulations and methods for both acute and preventative treatment modalities. For instance, patents detail formulations with filings on February 26, 2021, and September 26, 2022, respectively, illustrating an evolving approach to developing a robust oral dosage form suited for rapid onset of therapeutic action.
- Therapeutic Use Expansion Patents (UNIVERSIDADE NOVA DE LISBOA):
The patent that extends Rimegepant’s application toward treating human coronavirus infection was filed on September 20, 2022, and later published on March 22, 2023. This timeline underlines the responsiveness of the patent system to emerging health crises and the dynamic repositioning of known compounds to meet novel therapeutic needs.
- Additional Patents on Preventative Applications:
There are separate patents focusing specifically on Rimegepant’s preventative treatment of migraine which have their own unique timelines. These typically involve filings in 2021 or early 2022 and various publication dates that continue to reaffirm the compound’s dual utility as both an acute and a preventive agent.
Taken together, the filing timeline reflects both the innovative manufacturing and formulation techniques and the expanded therapeutic utility of Rimegepant, with the major patent holders continuously updating their portfolios to reflect new discoveries and market demands.
Implications of Patent Ownership
Impact on Pharmaceutical Development
Patent ownership of Rimegepant by multiple entities has several positive implications for pharmaceutical development. First, the diversified patent portfolio encourages innovation by providing a competitive framework in which several technical aspects—from synthesis and crystallization to formulation and therapeutic indication—are each rigorously protected. For instance, the innovative preparation method patented by AURISCO PHARMACEUTICAL not only ensures product purity and efficient yield but also enhances process safety and compliance with international standards such as those outlined by the International Council for Harmonisation (ICH). Such advancements drive further research in optimizing manufacturing processes, potentially offering a reliable and reproducible method for industrial-scale production.
Similarly, the patents held by Biohaven-related entities on the oral fast-dispersing dosage form provide a significant competitive advantage. By protecting the unique pharmaceutical formulation, these patents stimulate further research into patient-centric delivery mechanisms. This focus on optimizing dosage delivery not only improves patient outcomes but also fosters continued investment into formulation science, a critical domain in modern drug development. The breadth of research spurred by these patents, including both process and product innovation, is invaluable to the overall progression of pharmaceutical technology.
From another perspective, expanding Rimegepant’s indications—such as exploring its potential use against coronavirus infections through the patent owned by Universidade Nova de Lisboa—broadens the research and development landscape. This expansion could lead to a better understanding of the drug’s mechanism and possibly pave the way for its adaptation in other therapeutic areas, thereby enhancing its market potential. Overall, the multiple layers of patent protection facilitate a vibrant environment for ongoing research, ensuring that each step of the drug's development is optimally supported through robust intellectual property rights.
Market Competition and Exclusivity
The patchwork of patents held by different entities on various aspects of Rimegepant plays a critical role in shaping market competition and ensuring a period of market exclusivity. The patents held by AURISCO PHARMACEUTICAL and its affiliates largely revolve around the manufacturing processes and crystalline forms, which are central to ensuring quality and consistency in production. Meanwhile, Biohaven’s patents on dosage forms—particularly the fast-dispersing oral tablets—help secure a technological edge in drug delivery systems. The combination of these patents extends the overall market exclusivity for Rimegepant, limiting the simplistic entry of generic competitors by ensuring that multiple layers of the intellectual property portfolio need to be circumvented or challenged before competing products can be introduced.
Moreover, the portfolio’s diversity across different jurisdictions further reinforces this market exclusivity. For instance, patents filed in China by AURISCO PHARMACEUTICAL and in Europe and other regions by Biohaven and its affiliates ensure that competitors must navigate a complex international landscape of regulatory and intellectual property challenges. Such a scenario typically decreases the speed at which generic products can enter the market since each patent represents a separate barrier to entry. This strategic layering of patents effectively maximizes the period during which the original innovators can capitalize on their R&D investments while recouping the extensive costs associated with bringing a novel pharmaceutical product to market.
Furthermore, partnerships and licensing arrangements, such as the collaboration agreement between Pfizer and Biohaven for commercialization outside the United States, enhance the market penetration and distribution efficiency of Rimegepant while still respecting the proprietary rights claimed under the various patents. These collaborative frameworks not only extend the commercial exclusivity but also bring in the robust market presence and global outreach of larger pharmaceutical companies, thereby reinforcing the overall competitive position of Rimegepant on the global stage.
Future Considerations
Expiration and Licensing Opportunities
In the future, as certain patents within the Rimegepant portfolio approach their expiration dates, there will inevitably be strategic shifts regarding licensing and market exclusivity. The planned expiration of patents—especially those related to manufacturing processes and formulations—may open opportunities for licensing agreements with generic manufacturers. However, given the layered complexity of the patent portfolio, any generic entry or licensing deal will likely be limited to parts of the technology that are not covered by subsequent or related patents.
For example, while patents related to the initial synthesis methods could expire first, later patents focusing on novel crystal forms or unique dosage formulations may still be in force, thereby preserving a degree of exclusivity. Key decisions on whether to extend patent life through supplementary protection certificates or patent term extensions will depend on regulatory frameworks in different countries. Such strategic considerations might result in enhanced licensing opportunities or strategic collaborations that help maintain the commercial advantage of Rimegepant even as parts of the patent portfolio expire. Additionally, the possibility of developing new indications, as suggested by the patent held by Universidade Nova de Lisboa for the potential treatment of coronavirus infections, further complicates—yet simultaneously bolsters—the overall intellectual property strategy for Rimegepant.
Potential for Generic Entry
Generic entry into the market is a critical future consideration that will impact pricing, patient access, and overall market dynamics. With a patent portfolio as broad and diversified as that for Rimegepant, any generic manufacturer would need to find ways to navigate around multiple layers of existing patents, potentially leading to prolonged litigation and regulatory hurdles. This complexity can delay generic entry and sustain premium pricing for the originator products. However, once the primary patents expire or, in cases where the generic manufacturer determines that certain patents do not apply in their manufacturing process, generic versions of Rimegepant could eventually enter the market.
Furthermore, strategic alliances between originator companies and generic manufacturers might emerge as a way to manage the transition from patent-protected exclusivity to a more competitive market scenario. In some pharmaceutical markets, such collaborations are common where generic manufacturers are allowed to produce the drug under licensing arrangements that protect both parties’ interests. The decisions made during these transitional phases will be pivotal in ensuring that while innovators are rewarded for their initial investments, patients eventually benefit from more cost-effective treatments once the exclusivity period diminishes. This balancing act between maintaining market exclusivity and encouraging competition is essential for sustaining the innovation lifecycle in the pharmaceutical industry.
Conclusion
In summary, the patent ownership of Rimegepant is distributed among several key entities that focus on different facets of the compound’s technology and development. AURISCO PHARMACEUTICAL (TIANJIN) INC, together with AURISCO PHARMACEUTICAL (TIANJIN) and associated companies like YANGZHOU AURISCO PHARMACEUTICAL CO.LTD, holds vital patents pertaining to the innovative preparation methods, crystal forms, and synthesis processes of Rimegepant. Biohaven Pharmaceutical Holding Company Ltd and BIOHAVEN PHARMACEUTICAL IRELAND DAC robustly cover the fast-dispersing oral dosage forms and therapeutic applications for both acute and preventive treatments of migraine. Additionally, Universidade Nova de Lisboa has contributed to the diversification of the Rimegepant patent portfolio by securing intellectual property rights for its potential application against human coronavirus infections.
This diversified patent ownership ensures multiple layers of market exclusivity, safeguarding the commercial interests of the inventors while stimulating ongoing innovation in manufacturing, formulation, and therapeutic indications. It also creates a complex competitive environment that both challenges generic competitors and fosters strategic collaborations, such as the partnership between Pfizer and Biohaven for global commercialization outside the U.S.
Looking ahead, the expiration of some patents may open the door to licensing opportunities and the eventual entry of generic versions, though the multi-layered nature of the intellectual property portfolio is likely to prolong such possibilities. The interplay between patent expiration, collaborative licensing, and ongoing innovation will remain central to the strategic management of Rimegepant’s market life. In this context, maintaining a robust patent portfolio not only directly supports the commercial exclusivity and market positioning of Rimegepant but also indirectly drives continued R&D efforts to explore new indications and improvements in drug delivery.
Overall, no single entity holds the entire intellectual property rights for Rimegepant. Instead, the patent portfolio is fragmented among several entities, each focusing on specific aspects of production, formulation, and application. This multifaceted ownership strategy underlines the complexity and dynamism of pharmaceutical innovation, ensuring that Rimegepant remains a prime example of how diverse patent rights can coexist to provide both a competitive edge and an enduring foundation for further research and market expansion.
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