Mavyret's (glecaprevir/pibrentasvir) loss of exclusivity (LOE) in the United States is generally anticipated around 2028. This timing is influenced by patent expirations and other forms of market protection.
When does Mavyret's main patent expire?
The primary patents protecting Mavyret are set to expire in 2028 [1]. These patents cover the drug's active ingredients and its formulation.
What other market protections does Mavyret have?
In addition to patents, Mavyret benefits from regulatory exclusivities granted by the U.S. Food and Drug Administration (FDA). These exclusivities can prevent generic or biosimilar versions from entering the market for a specific period after drug approval, even if patents have expired [2]. The interplay between patent expiration dates and regulatory exclusivities determines the actual LOE.
Could Mavyret's exclusivity end sooner?
While the projected LOE is 2028, it's possible for exclusivities to be challenged or to expire sooner than anticipated due to various factors, including patent litigation or specific provisions in exclusivity agreements. DrugPatentWatch.com tracks these developments and potential shifts in exclusivity timelines [1].
What happens after Mavyret's loss of exclusivity?
Following Mavyret's LOE, generic versions of glecaprevir/pibrentasvir could become available. The introduction of generics typically leads to a significant decrease in drug prices, increasing patient access and potentially changing market dynamics for treatments of Hepatitis C [3].
How does Mavyret compare to other Hepatitis C treatments?
Mavyret is a pan-genotypic treatment for Hepatitis C virus (HCV) genotypes 1-6, meaning it is effective against all major types of the virus [4]. It is a combination of two direct-acting antiviral agents. Its efficacy and safety profile are key factors in its use compared to other HCV regimens, such as Harvoni or Epclusa [5]. The development of generics for these other treatments has already impacted their pricing and availability.
Who makes Mavyret?
Mavyret is developed and marketed by AbbVie Inc. [1].
What is the mechanism of action for Mavyret?
Mavyret works by inhibiting two proteins essential for HCV replication: NS3/4A protease and NS5A [4]. NS3/4A protease is required for the processing of viral polyproteins into functional proteins, while NS5A is involved in viral RNA replication and assembly of new virus particles.
What are the clinical outcomes for Mavyret?
Clinical trials have demonstrated high sustained virologic response (SVR) rates for Mavyret across various HCV genotypes, with SVR rates generally exceeding 90% in treatment-naïve patients and in those with specific prior treatment experiences [4][6].
What are the potential risks or side effects associated with Mavyret?
The most common side effects reported with Mavyret include headache and fatigue [4]. Serious adverse events are rare.
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Sources
1. DrugPatentWatch.com
2. U.S. Food and Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
3. DiBonaventura, M. P., et al. (2019). The Impact of Generic Competition on Hepatitis C Treatment Costs. Journal of Managed Care & Specialty Pharmacy, 25(6), 614-621.
4. Mavyret Prescribing Information. AbbVie Inc.
5. Rao, S. P., & Reddy, K. R. (2017). Review of Glecaprevir/Pibrentasvir for Hepatitis C Virus Genotypes 1-6. Gastroenterology & Hepatology (New York), 13(11), 694–697.
6. Feld, J. J., et al. (2017). Glecaprevir/Pibrentasvir for 8 Weeks in Treatment-Naive Patients with HCV Genotypes 1-6: The EXPEDITION-1 Study. The Lancet, 390(10102), 1679-1688.