Who holds the patent for Glecaprevir/Pibrentasvir?

Introduction to Glecaprevir/Pibrentasvir

Glecaprevir/Pibrentasvir is an innovative, fixed-dose combination regimen used in the treatment of chronic hepatitis C virus (HCV) infection. Glecaprevir acts as a potent NS3/4A protease inhibitor, while Pibrentasvir functions as an efficient NS5A inhibitor. This combination demonstrates pan-genotypic activity, which means it is effective across all major HCV genotypes, including genotypes 1 to 6. The regimen is formulated in an oral dosage form, typically as a bilayer tablet or coated oral pellets, and is designed to provide a high cure rate coupled with a favorable safety profile, especially in patient populations with comorbidities such as renal impairment or compensated cirrhosis.

Therapeutic Use and Importance 
The clinical relevance of Glecaprevir/Pibrentasvir stems from its ability to achieve sustained virological response (SVR) rates that frequently exceed 95% in both clinical trial settings and real-world studies. Its importance is further highlighted by the fact that interferon-free regimens, such as Glecaprevir/Pibrentasvir, have revolutionized HCV treatment, significantly reducing treatment durations (often to as short as 8 weeks) while minimizing adverse events. Moreover, this regimen has broadened therapeutic options for historically difficult-to-treat patient groups, including those with prior treatment failures and those with concurrent renal dysfunction. As treatment paradigms in HCV continue to evolve, the availability of effective, short-duration therapies has substantial implications for global public health initiatives aimed at the elimination of HCV infection.

Patent Details for Glecaprevir/Pibrentasvir

Identification of Patent Holder(s) 
A careful examination of the structured patent references from Synapse reveals that the majority of patents associated with the composition and formulation of Glecaprevir/Pibrentasvir have been assigned to AbbVie Inc. For instance, multiple patent documents such as the "Solid pharmaceutical composition for treating HCV" (patent numbers CN108024964B, MY192606A, US11246866B2 list the current assignee as AbbVie Inc. These assignments indicate that AbbVie Inc. holds the intellectual property rights for these key aspects of the Glecaprevir/Pibrentasvir formulation, covering both the composition of matter and the methods used in manufacturing the amorphous solid dispersions in the drug’s formulation. In addition to these patents, other patent documents concerning crystalline forms of the compounds and treatment methods also attribute ownership—directly or indirectly—to AbbVie Inc. These findings collectively underscore that AbbVie Inc. is the primary patent holder for the Glecaprevir/Pibrentasvir regimen.

Patent Numbers and Filing Information 
The identified patent documents provide specific details regarding the filing information, patent numbers, and dates of publication and expiration. For example: 
- One patent, CN108024964B, with an application date of July 18, 2016, and a publication date of May 03, 2022, lists AbbVie as the current assignee with an expiration date of July 18, 2036. 
- Another patent document, MY192606A, filed on June 24, 2016, and published on August 29, 2022, is also assigned to ABBVIE INC. and falls within the same family of intellectual property covering the dual antiretroviral formulation. 
- Further, US11246866B2, published on February 15, 2022, clearly identifies ABBVIE INC. as the sole assignee, reiterating the control the company maintains over the solid pharmaceutical composition that comprises 100 mg of Compound 1 and 40 mg of Compound 2 in its two-layer formulation. 

These patents, among others cited in the Synapse database, collectively assemble a robust intellectual property portfolio that not only protects the pharmaceutical composition but also the specific manufacturing processes and method claims associated with the formulation of this pangenotypic HCV treatment regimen. The detailed filing and expiration dates ensure that market exclusivity is maintained well into the future, upholding the commercial interests of AbbVie Inc.

Implications of Patent Ownership

Market Exclusivity and Competitors 
The patent portfolio held by AbbVie Inc. provides substantial market exclusivity for the Glecaprevir/Pibrentasvir regimen. This exclusivity is a critical competitive advantage in the highly competitive pharmaceutical markets. By securing strong and far-reaching patents, AbbVie is able to shield their innovative antiviral combination from generic manufacturers for a significant period, thus preventing the early entry of lower-cost generic alternatives. The exclusive rights to both the composition and the formulation methods ensure that competitors find it challenging to replicate the exact optimized formulation used in Glecaprevir/Pibrentasvir. 

Moreover, this exclusivity contributes to sustaining higher sales margins during the patent-protected period, which in turn supports continued research and development investments. Maintaining robust patent protection is essential given that HCV is a target for various competitors, and the inability to duplicate the treatment without infringing on these patents limits market competition and fosters a stronger position in international markets.

Licensing and Partnership Opportunities 
The strategic ownership of patents by AbbVie Inc. not only secures market exclusivity but also positions the company as an attractive partner for licensing and collaborative ventures. The robust milestone and royalty licensing arrangements evident in corporate reports and press releases, such as those detailed in Enanta Pharmaceuticals’ communications, demonstrate how AbbVie effectively leverages its intellectual property. These partnerships offer a dual benefit: they generate significant royalty revenue from net sales while providing complementary expertise in drug development. For instance, while the discovery of glecaprevir originated partly through collaborative efforts with research partners, AbbVie’s ability to consolidate patent rights and engage in licensing deals has ensured that subsequent commercialization benefits remain largely with them. This arrangement reinforces the commercial strength of the product, securing predictable revenue streams and fostering long-term investments.

Future Considerations

Patent Expiry and Generic Competition 
Looking into the future, the patent expiration dates are critical in determining when generic competition might emerge. For example, one of the key patents (CN108024964B) for the solid pharmaceutical composition of Glecaprevir/Pibrentasvir is set to expire on July 18, 2036. Other related patents also have similar expiration dates, which implies that AbbVie’s market exclusivity for this regimen is well-protected for the next decade or more. 
This long period of exclusivity not only allows AbbVie Inc. to benefit from premium pricing and limited competition but also provides an ample window for recouping the substantial investments in research and development. However, as the expiration dates draw nearer, there will be an inevitable shift with the possibility of generic competitors developing alternative formulations or bioequivalent products, provided they can navigate the regulatory and legal pathways. The anticipated future expiration of patents will therefore create opportunities for the market shift towards generics, which will lead to pricing pressures and increased competition in the HCV treatment landscape.

Research and Development Opportunities 
Despite the looming expiration of certain patents, the period before these expiries is also rich in research and development opportunities. AbbVie Inc. may pursue improvements and next-generation compositions that build upon the currently approved formulation of Glecaprevir/Pibrentasvir. By investing in follow-on innovation strategies, such as modifications that improve solubility, patient compliance, and safety profiles, AbbVie can file additional patents, thereby extending the overall life cycle of their HCV therapy. Moreover, ongoing clinical studies and real-world evidence (as reported in multiple phase 3 and post-marketing observational studies) continue to validate the efficacy and safety of this regimen, which further supports its continued clinical use and enables potential incremental innovation.

Furthermore, the company’s collaborative arrangements with other research institutions and biopharmaceutical companies offer continued opportunities to expand the therapeutic indications of Glecaprevir/Pibrentasvir. By extending the model of combination therapy to address resistance patterns, emerging HCV genotypes, or even co-infections with other viruses, AbbVie can maintain a forward trajectory in combating viral threats. These R&D opportunities are both a strategic buffer against future generic competition and an engine for further market expansion through innovative therapeutic applications.

Conclusion

To summarize, the available structured patent documents and associated references from Synapse provide comprehensive evidence that AbbVie Inc. holds the patents for Glecaprevir/Pibrentasvir. The patents, such as CN108024964B, MY192606A, and US11246866B2, explicitly list AbbVie Inc. as the current assignee, indicating that the company controls the intellectual property covering both the composition and formulation of this innovative HCV treatment regimen. 

From the perspective of market exclusivity, this robust patent portfolio ensures that AbbVie maintains a dominant market position, safeguarding it against competition and enabling lucrative licensing and royalty revenue streams. Additionally, the patents provide a strategic barrier against generic competition until their expiration dates, which, based on current filings, extend well into the 2030s. Looking forward, while eventual patent expirations will open the door to generic alternatives, AbbVie’s proactive investment in research and development may allow for the extension of market exclusivity through next-generation formulations and further innovation. 

In conclusion, through a multi-faceted analysis involving patent filing details, market exclusivity considerations, and licensing opportunities, it is evident that AbbVie Inc. is the primary patent holder for Glecaprevir/Pibrentasvir. This consolidated control not only underscores the company’s leadership in HCV treatment innovation but also provides critical strategic advantages in maintaining market dominance amidst evolving competition and upcoming opportunities for further therapeutic advancements.

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