Who holds the patent for Ticagrelor?

Introduction to Ticagrelor 
Overview of Ticagrelor 
Ticagrelor is a potent, orally administered antiplatelet agent designed to inhibit platelet aggregation by reversibly binding to the P2Y12 receptor. As a non-thienopyridine drug, it is distinguished by its rapid onset and offset, its reversible mode of action, and its potential pleiotropic effects that extend beyond the direct antiplatelet mechanism. Originally introduced under the brand name Brilinta, ticagrelor represents a significant advancement in the pharmacotherapy of atherothrombotic diseases. Its physicochemical properties and pharmacokinetics have been the subject of extensive research and innovative methodologies, as evidenced by a multitude of patents focusing on its preparation, formulation, and delivery systems.

Therapeutic Uses 
Clinically, ticagrelor is primarily used to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndromes (ACS) and myocardial infarction (MI). Its rapid and consistent inhibition of platelet aggregation translates into improved outcomes in high-risk cardiovascular populations. Beyond its established role in coronary heart disease, emerging studies have also explored its potential in treating other conditions where platelet activation is a critical component, such as ischemic stroke and even some immune-mediated diseases. This broad therapeutic application has driven a diverse range of research on ticagrelor, including an emphasis on optimizing its formulation and delivery to enhance patient compliance and overall effectiveness.

Patent Basics 
Definition and Importance of Patents 
Patents are legal instruments designed to protect intellectual property in the field of innovation. In the pharmaceutical industry, they serve to safeguard novel compounds, methods of synthesis, formulations, and various drug delivery technologies for a specific period—typically 20 years from the filing date—thus providing inventors and companies exclusive rights to invest in, manufacture, and market a drug without immediate generic competition. Patents are crucial because they incentivize innovation by ensuring that companies can reap the benefits of their substantial investments in research and development. In rapidly evolving fields like biopharmaceuticals, where development costs are exorbitant, maintaining a robust patent portfolio is essential for retaining market exclusivity and stimulating further innovation.

General Process of Patent Filing in Pharmaceuticals 
The patenting process in the pharmaceutical realm generally involves multiple stages. Initially, any novel discovery or improvement must be thoroughly documented, followed by a patent application that includes claims describing the invention in precise terms. Successful applications undergo examination for criteria such as novelty, non-obviousness, and industrial applicability. In many cases, different aspects of a drug—from its chemical entity to its methods of production and final formulations—are each protected under separate patents. This strategy not only fortifies the overall intellectual property but also provides a layered protection scheme, enabling companies to extend the market lifespan of their products even after the primary composition-of-matter patent expires.

Ticagrelor Patent Details 
Original Patent Holder 
In the global market, ticagrelor was originally developed and introduced by AstraZeneca. As such, the fundamental active ingredient patent as well as the primary composition-of-matter patents for ticagrelor were historically held by AstraZeneca. These patents cover the molecular structure and intrinsic pharmacological properties of ticagrelor, forming the backbone of its intellectual property protection. However, the innovative momentum for ticagrelor did not end with its initial discovery. Over time, numerous secondary patents have been filed that focus on improved synthesis methods, novel formulations, modified release systems, and even combination therapies that include ticagrelor as a key active component. These subsequent patents are frequently filed by pharmaceutical companies, particularly in markets such as China, where local manufacturers have developed alternative production processes or enhanced formulations. For example, some patents on the preparation method of ticagrelor are held by Nanjing Yixinhe Pharmaceutical Technology, while others pertaining to improved dosage forms have been assigned to Chengdu Hengrui Pharmaceutical and Zhejiang East Asia Pharmaceutical.

Patent Timeline and Expiry 
A review of the patent landscape reveals significant diversity in filing dates and patent expiry timelines. Many recently filed patents focus on innovative production or formulation techniques that optimize the bioavailability, stability, and therapeutic efficacy of ticagrelor. For instance, one patent that describes a streamlined preparation method for ticagrelor was filed with an application date of December 22, 2022, and is expected to maintain protection until the publication of its patent term, benefitting from a route that emphasizes green production and cost reduction. 
Other patents, such as those for sustained-release formulations (e.g., sustained-release solid composition and sustained-release pellet formulations) have filing dates in mid-2022, with expected market protections extending into the 2030s depending on regional patent laws. Additionally, patents covering methods to obtain high-purity forms of ticagrelor and those detailing novel approaches such as nano-liposome injections have emerged with diverse filing dates, indicating a robust and evolving patent portfolio that spans the lifecycle of ticagrelor’s market presence. 
This timeline diversity illustrates that while the original compound patents originated with AstraZeneca, the landscape now includes a series of subsequent patents granted or filed by various companies, each contributing to the overall protection strategy by focusing on unique aspects of production and formulation.

Geographical Patent Coverage 
Patent coverage for ticagrelor is not uniform worldwide. While AstraZeneca’s foundational patents likely enjoy broad international protection in major jurisdictions such as the United States, Europe, and Japan, many of the secondary patents have been filed strategically in specific regions to meet local market demands and further extend market exclusivity. A number of the recent patents, as revealed in our references, are predominantly from China. For instance, the patent held by Nanjing Yixinhe Pharmaceutical Technology focuses on an efficient preparation method of ticagrelor, and additional patents from companies such as Zhejiang East Asia Pharmaceutical and Tianjin Lisheng Pharmaceutical showcase innovations in solid dosage forms and orally disintegrating tablets, respectively. 
These targeted filings serve dual purposes: they accommodate regional regulatory and industrial standards while also complementing the global market presence originally established by AstraZeneca. Moreover, firms like Wisdom Pharmaceutical and WISDOM PHARMACEUTICAL CO., LTD. have filed patents that span international jurisdictions, particularly in cases involving novel sustained-release formulations and advanced solid dispersion technologies. 
The multiplicity of filings thus contributes to a layered, geographical mosaic of patent rights, ensuring that while the original molecule is globally recognized, subsequent improvements capture value in localized markets, often leading to a diversified patent ownership landscape.

Implications of Patent Ownership 
Market Impact 
The ownership of patents related to ticagrelor has profound implications for market dynamics. When AstraZeneca held the original patents, it enjoyed near-complete exclusivity, which allowed the company to invest heavily in clinical trials, secure regulatory approvals, and market ticagrelor as a breakthrough therapy. This exclusivity was pivotal in enabling the successful commercial launch of Brilinta, and it helped differentiate ticagrelor from other antiplatelet agents through its unique pharmacological profile. 
As secondary patents have been developed by other companies—particularly those focusing on new formulations, manufacturing methods, or combination therapies—the market landscape has diversified. The presence of multiple patents and corresponding patent holders means that while the active pharmaceutical ingredient remains under the original protection umbrella in many jurisdictions, certain aspects of ticagrelor’s development (such as its preparation process or sustained-release versions) are now subject to competitive patents. This may result in complex licensing agreements or even patent litigations that could impact market share and pricing strategies. 
For instance, improved formulations such as orally disintegrating tablets can offer advantages in patient compliance and rapid onset of action, thereby potentially capturing niche markets that favor these qualities over conventional tablets. However, such advantages come with the added complexity of navigating multiple patent estates, each influencing pricing, distribution, and accessibility. These factors ultimately shape the competitive landscape and determine the long-term revenue streams from ticagrelor products.

Licensing and Generic Production 
The scenario of multiple patents has also given rise to various licensing models. Licensing agreements between the original patent holder and other companies can allow access to advanced formulations or process innovations while preserving overall market control. Such agreements can be particularly common in regions where local pharmaceutical firms have developed alternative production techniques that meet stringent regulatory standards or that are more cost-effective. 
For example, companies like Nanjing Yixinhe Pharmaceutical Technology, Zhejiang East Asia Pharmaceutical, and others have secured patents that complement the original composition-of-matter patents. These patents often cover specific manufacturing processes or drug delivery systems and may be licensed or cross-licensed to ensure market penetration without infringing on one another’s rights. 
Licensing becomes especially crucial when the original patents near expiry. In anticipation of generic competition, many stakeholders develop data packages and enhanced formulations that satisfy regulatory requirements for bioequivalence while fostering a competitive advantage. In this manner, the fragmented patent portfolio also helps delay the introduction of generics by creating barriers related to manufacturing complexity and formulation novelty, even as the primary patents on the active substance expire.

Future Considerations 
Upcoming Patent Expirations 
Though the original patent(s) for the core ticagrelor molecule likely still enjoy protection in major markets, many of the secondary patents have shorter lifespans and are subject to standard expiry rules, meaning that their protection will diminish over time. As patents covering various innovative aspects of ticagrelor’s formulation or manufacturing eventually expire, the overall exclusivity chain can be disrupted, paving the way for increased competition. 
For example, patents related to methods of high-yield synthesis, stable sustained-release forms, or advanced solid dispersion formulations—filed in recent years by companies like Jiangsu Purun Bio-Medical or Tianjin Lisheng Pharmaceutical—will ultimately reach their expiration dates as per regional patent laws. These expirations are critical milestones that could affect the pricing and market strategy of ticagrelor. The documented application and publication dates in our references—for instance, some with publication dates in 2024, 2025, or even 2030 as possible expiry dates—illustrate a timeline that market players must carefully monitor in order to strategize around potential losses in exclusivity.

Potential for Generic Competition 
The expiry of patents, particularly those that cover solely the production or formulation improvements, has a direct impact on the possibility of generic drug market entry. Once the main patents on ticagrelor expire, generic manufacturers may pursue bioequivalence studies and streamlined regulatory approvals to capture a portion of the market. However, the presence of secondary patents, which cover innovative dosing forms such as nano-liposome injections or orally disintegrating tablets, may temporarily hinder the entry of generic versions, as these additional layers of intellectual property protection create technical and legal challenges that generics must navigate. 
In many markets, especially those where regulatory measures favor local manufacturing or where patent linkage mechanisms are robust, the surge of generic ticagrelor formulations may be delayed but is ultimately inevitable. Moreover, as generic competitors study the patent landscape, they can develop alternative manufacturing routes or reformulations which do not infringe on existing patents. This competitive dynamic is one of the reasons why the patent landscape for ticagrelor reflects a complex interplay of original and secondary patents, each influencing the duration and depth of market exclusivity. 
The evolution of generic competition also has broader implications for treatment costs. As seen in other therapeutic classes, the expiration of patents can lead to rapid decreases in drug prices—sometimes dropping to 20% to 98% of the original brand price—thereby impacting the overall market revenue for the originator and licensed entities.

Conclusion 
In summary, while ticagrelor’s original active ingredient patent was held by AstraZeneca, the global patent landscape for ticagrelor is now multifaceted. Numerous patents that address different aspects of ticagrelor—from synthesis methods and innovative production processes to advanced formulations and specialized delivery systems—are held by a variety of companies, particularly within regional markets such as China. For instance, Nanjing Yixinhe Pharmaceutical Technology holds patents related to efficient preparation methods, Zhejiang East Asia Pharmaceutical and Chengdu Hengrui Pharmaceutical have patents on various tablet formulations, and companies like Wisdom Pharmaceutical as well as WISDOM PHARMACEUTICAL CO., LTD. hold patents on sustained-release and solid dispersion technologies. 

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