When does rexulti go generic?

Timeline for Generic Rexulti Availability

Rexulti, also known as brexpiprazole, is a medication used for the treatment of schizophrenia and depression. The generic drug equivalent is expected to enter the market in the coming years, but the exact dates are subject to various factors.

Patent Expiry and Exclusivity

According to DrugPatentWatch.com, the patent for Rexulti was set to expire on October 4, 2027 [1]. However, the patent holder, Otsuka Pharmaceutical, has applied for extensions and certifications, which may impact the actual patent expiry date.

Generic Rexulti Entry

Although the patent expiry date has been set, the generic entry date may differ depending on various factors, such as FDA approval, manufacturing, and marketing considerations. As of now, there are several generic versions of Rexulti currently undergoing clinical trials or awaiting FDA approval.

Potential Generic Launch Date

Based on the available information, the first generic version of Rexulti is expected to launch around 2028, approximately 6-9 months after the patent expiry date. However, this information is subject to change and may be influenced by factors such as patent disputes, FDA regulations, and market dynamics.

Regulatory and Commercial Factors

The availability of generic Rexulti will be influenced by regulatory factors, including FDA approval and patent challenges. Commercial considerations, such as licensing agreements and marketing strategies, will also play a role in determining the generic entry date.

References

[1] DrugPatentWatch.com. (n.d.). Brexpiprazole. Retrieved from https://www.drugpatentwatch.com/drug/brexpiprazole

Sources

1. DrugPatentWatch.com (n.d.). Brexpiprazole.