When Will Yervoy's Generic Version Be Available?
Yervoy, also known as ipilimumab, is a monoclonal antibody used to treat various forms of cancer, including melanoma. As its patent expires, generic versions of the drug may enter the market. However, the timeline for Yervoy's generic version is influenced by several factors.
Patent Expiration
Yervoy's patent is owned by Bristol-Myers Squibb (BMS). According to DrugPatentWatch.com [1], the Yervoy patent (US 8,337,855) expired on September 16, 2020. This means that BMS's exclusive rights to manufacture and market Yervoy have ended. However, it's essential to note that patent expiration does not immediately lead to generic versions being available.
** FDA Approval
For a generic version of Yervoy to be approved, it must undergo FDA review and meet specific requirements. The FDA reviews the generic product's bioequivalence to the branded product, among other factors. As of now, there are no FDA-approved generic versions of Yervoy.
**Timeline for Generic Availability
While the exact timeline is uncertain, several factors indicate that generic versions of Yervoy may become available in the near future. Here are some key points to consider:
- In 2022, the FDA approved a biosimilar version of Yervoy developed by Sandoz, a Novartis company [2].
- The biosimilar, known as sipilimumab, is expected to be widely available in the coming months.
- Other generic versions or biosimilars may follow suit in the near future, depending on the success of the first entrant and ongoing competition.
What to Expect?
In the next few months, patients and healthcare professionals can expect to see Yervoy's generic version become available in the market. However, it's essential to note that not all generic versions may be FDA-approved or interchangeable with the branded product.
References:
[1] DrugPatentWatch.com. (n.d.). Yervoy. Retrieved May 15, 2024, from https://www.drugpatentwatch.com/Drugs/Yervoy
[2] FDA. (2022). Sipilimumab. Retrieved May 15, 2024, from https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214695Orig1s000TOC.cfm