Who holds the patent for Ubrogepant?

What is Ubrogepant? 
Ubrogepant is a small‐molecule calcitonin gene‐related peptide (CGRP) receptor antagonist developed for the acute treatment of migraine. As an orally administered medication, it is designed to provide rapid relief by targeting the neurogenic inflammatory processes that underlie migraine attacks. Structurally, ubrogepant belongs to the “gepants” family and distinguishes itself by its high selectivity and potent binding to the CGRP receptor, which is central to its mechanism of action. The active ingredient has a specific chemical profile with a well‐defined molecular structure, and it is formulated in various dosage strengths to meet different therapeutic needs.

Therapeutic Use and Importance 
Migraine is a debilitating neurological disorder characterized by severe headache episodes and associated symptoms such as nausea, photophobia, and phonophobia. Ubrogepant plays an important role as an acute treatment because it provides a safer therapeutic alternative to traditional abortive medications, such as triptans, which may have cardiovascular contraindications. Clinical trials, including the ACHIEVE I and ACHIEVE II Phase III studies, have demonstrated that ubrogepant is superior to placebo in achieving pain freedom and relieving the most bothersome symptoms within two hours of administration. Its favorable safety profile, with minimal impact on liver function and lower incidence of serious adverse events, positions ubrogepant as a significant advance in migraine management, particularly for patients who cannot tolerate other medications. This efficacy, combined with an improved safety profile, has bolstered its clinical utility and importance within the therapeutic landscape of migraine treatment.

Patent Information

Patent Definition and Importance 
Patents are legal instruments that grant inventors exclusive rights to make, use, and sell their inventions for a limited period in exchange for full public disclosure of the invention. In the pharmaceutical industry, patents are of paramount importance. They not only provide a period of market exclusivity that enables companies to recover the high costs associated with research and development but also serve as a key driver for innovation. The protection that patents offer ensures that companies can invest confidently in new technologies and formulations, secure in the knowledge that their intellectual property (IP) will not be easily duplicated by competitors. Additionally, patents contribute to the advancement of science by mandating disclosure, which enriches the technical knowledge base available to the public and other researchers.

Overview of Ubrogepant Patent 
The intellectual property landscape for ubrogepant is multifaceted. Patents covering this molecule span a variety of aspects including, but not limited to, pharmaceutical compositions, formulation strategies, methods for manufacturing pure amorphous forms, and procedures for the treatment of migraine. For instance, one patent focuses on a self-administration injection device that comprises a liquid injectable composition of ubrogepant, demonstrating efforts to diversify the administration routes beyond oral formulations. Another set of patents, such as the one related to the preparation of the pure amorphous form of ubrogepant, highlights the critical role of manufacturing processes in ensuring drug stability and bioavailability. However, when it comes to the clinical application—the use of ubrogepant for the acute treatment of migraine—key patents have been directed specifically to methods of treatment. These treatment patents are particularly significant, as they secure exclusive rights to the therapeutic use of ubrogepant in migraine, thereby supporting market exclusivity and providing a competitive advantage in the pharmaceutical market.

Patent Holder Identification

Current Patent Holder 
When examining the patent landscape for ubrogepant, the primary patents regarding its use as an acute treatment for migraine are held by ALLERGAN PHARMACEUTICALS INTERNATIONAL LIMITED. These patents focus on the method of treatment and specific therapeutic applications of ubrogepant for migraine management and cover the clinical benefits seen in patients. Allergan’s role in developing and commercializing ubrogepant is reinforced by these patents, which support its trademarked product, Ubrelvy®, and ensure that Allergan maintains a competitive edge in the global migraine treatment market. It is essential to acknowledge that while other patents exist that cover ancillary aspects of the drug—for example, a pharmaceutical composition comprising ubrogepant assigned to QUISITIVE THERAPEUTICS and a process for generating a pure amorphous form by MSN LABORATORIES PRIVATE LIMITED and SRINIVASAN, THIRUMALAI RAJAN—the core therapeutic use and the primary methodology for treating migraine with ubrogepant remain under the exclusive control of Allergan.

Patent Registration Details 
For example, one significant patent, “Treatment of migraine,” is represented by US Patent No. US11857542B2, which was assigned to ALLERGAN PHARMACEUTICALS INTERNATIONAL LIMITED. This patent outlines methods for the acute treatment of migraine, and its claims cover dosing regimens, safety parameters in patients with hepatic or renal impairments, and concomitant use with other modulators such as CYP3A4 modulators, BCRP or P-gp inhibitors. Another patent with similar subject matter is US11717515B2, also assigned to ALLERGAN PHARMACEUTICALS INTERNATIONAL LIMITED. The patent registration details, including application dates, publication dates, and expiration dates, demonstrate a strategy to secure long-term intellectual property protection around the use of ubrogepant. In addition to these treatment method patents, other patents in the landscape relate to the formulation technology (such as tablet compositions releasing the active ingredient in a specified manner) with relevant registration numbers like US11925709B2 and US10117836B2 held by entities such as MERCK SHARP & DOHME LLC. However, despite the existence of these diverse patents, when discussing “the patent” for ubrogepant in the context of its therapeutic use, ALLERGAN PHARMACEUTICALS INTERNATIONAL LIMITED emerges as the key patent holder. This focus on the treatment method patents underscores Allergan’s investment in clinical research and their pivotal role in demonstrating the safety and efficacy of ubrogepant for migraine patients.

Implications of Patent Ownership

Market Impact 
The patent portfolio held by ALLERGAN PHARMACEUTICALS INTERNATIONAL LIMITED has significant market implications. By securing exclusive rights to the methods of treating migraine with ubrogepant, Allergan is able to prevent generic competition for a considerable period. This exclusivity allows the company to establish market dominance, which in turn supports higher pricing power and enhanced profitability during the patent’s term. The market exclusivity granted by these patents also provides a financial foundation to reinvest in further research and development, fostering innovation in the migraine treatment space. Additionally, the patents help to strengthen the brand identity of Ubrelvy®, ensuring that healthcare providers and patients recognize the drug as a well-protected, scientifically validated treatment option.

Competitive Landscape 
In the competitive arena of migraine therapeutics, patent ownership becomes a key differentiator. While other companies also hold patents on various aspects of ubrogepant’s formulation and manufacturing, the core patents associated with its clinical utility are critical in preventing other firms from launching similar treatments without licensing or undertaking costly litigation. The key treatment method patents maintained by Allergan create significant barriers to entry for potential competitors. This protected market position not only supports strong revenue generation but also allows Allergan to negotiate favorable terms for licensing agreements or co-development partnerships if other parties wish to participate in the market. Furthermore, the competitive landscape is continually evolving, with other companies such as MERCK SHARP & DOHME LLC holding patents related to CGRP receptor antagonists that, while broadly related to the mechanism of action, do not dilute the specific therapeutic use claims that Allergan holds. The delineation of intellectual property rights through patents thus plays a pivotal role in shaping a competitive environment that encourages both innovation and strategic market positioning.

Future Research and Development 
The robust patent portfolio provides a secure platform for future research and development. Holding these patents not only protects the current clinical applications of ubrogepant but also opens avenues for further innovation. For instance, research initiatives might focus on developing next-generation formulations of ubrogepant that improve its pharmacokinetics or reduce side effects, or even exploring alternative routes of administration such as injection devices, as seen in patents by QUISITIVE THERAPEUTICS. Additionally, securing patents for manufacturing processes, like the one assigned to MSN LABORATORIES PRIVATE LIMITED, ensures that improvements in production and scalability can be integrated efficiently as part of the product’s lifecycle. The intellectual property held by Allergan fosters an environment where investment in novel therapeutic modalities and enhanced formulations is not only viable but also financially justifiable. Continued innovation in this area will likely lead to an expanded portfolio of treatments, further solidifying the position of ubrogepant in the migraine therapeutic market and potentially extending its application to other conditions where CGRP may play a role.

Conclusion 
In summary, the primary patents that cover the clinical utility of ubrogepant for the acute treatment of migraine are held by ALLERGAN PHARMACEUTICALS INTERNATIONAL LIMITED. These patents focus on method-of-treatment claims that have been crucial in establishing ubrogepant (marketed as Ubrelvy®) as a leading therapeutic option in migraine management. Although other patents exist that cover ancillary aspects such as the formulation and the processes required to manufacture a pure amorphous form of the drug, the core therapeutic application remains under the control of Allergan. This patent protection not only enables Allergan to secure market exclusivity and maintain pricing power but also supports ongoing research and development initiatives aimed at further improving therapeutic outcomes. The strategic management of this patent portfolio has significant implications for market impact, competitive dynamics, and future innovation in migraine therapy. Ultimately, by holding these critical patents, ALLERGAN PHARMACEUTICALS INTERNATIONAL LIMITED plays a central role in defining the current and future landscape of treatment options for migraine patients.

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