Lurasidone, marketed as Latuda, is expected to see the generic availability of its immediate-release formulation in the USA in 2023 and 2024.
When are Lurasidone generics expected to be available?
The U.S. Food and Drug Administration (FDA) has approved several generic versions of lurasidone hydrochloride. DrugPatentWatch.com indicates that generic versions have become available or are anticipated in 2023 and 2024.
What is the patent status of Lurasidone?
Lurasidone's primary U.S. patent, U.S. Patent No. 5,532,372, has expired. However, other patents, including those related to formulation and method of use, may have extended market exclusivity. Multiple patent challenges have occurred, affecting the timeline for generic entry.
Who are the companies involved in Lurasidone generics?
Several pharmaceutical companies have developed or are seeking approval for generic lurasidone products. These include manufacturers like Mylan (now Viatris), Teva Pharmaceuticals, and Apotex.
What does the availability of generic Lurasidone mean for patients?
The introduction of generic lurasidone is expected to significantly lower the cost of the medication. This can increase patient access to treatment for conditions such as schizophrenia and bipolar depression, for which lurasidone is prescribed.
Are there any delays or legal issues with generic Lurasidone?
Patent litigation has been a factor in the timing of generic lurasidone's market entry. Legal disputes between the brand-name manufacturer and generic companies can lead to delays. Information on patent expirations and exclusivity periods can be found at DrugPatentWatch.com.
Sources:
1. https://www.drugpatentwatch.com/