Rexulti is a medication used to treat depression and schizophrenia. It’s been approved since 2015, but it’s expensive. Many people can’t afford it.
Rexulti, marketed by Otsuka Pharmaceutical Co. Ltd., is protected by six US patents and five FDA regulatory exclusivities. The patents cover various aspects of the drug, including its active ingredient brexpiprazole and its methods of administration. The expiration dates for these patents range from April 2026 to December 2028.
There are ongoing patent litigations involving Rexulti, with twenty-four cases filed since July 2019.
These litigations indicate strong interest from generic manufacturers in launching their versions of the drug.
The presence of these patents and ongoing litigations significantly impact the availability of generic versions of Rexulti. Until the patents expire or are successfully challenged, generic manufacturers cannot legally produce and sell their versions of the drug. This exclusivity allows Otsuka to maintain market control and set prices without competition from generics.
Once the patents expire or are invalidated, generic manufacturers can enter the market, leading to increased competition, lower prices, and greater accessibility for patients.
Based on the patent expiration dates, it is expected that generic versions of Rexulti will become available between April 2026 and December 2028.
However, ongoing patent litigations may potentially accelerate this timeline if successful challenges to the patents are made.
Once generics enter the market, patients can expect lower prices and greater accessibility to the medication. This could significantly improve treatment options for those struggling with depression and schizophrenia who currently cannot afford Rexulti due to its high cost.
Healthcare providers will also benefit from increased competition, which may lead to more affordable pricing and improved patient outcomes. The availability of generic versions of Rexulti is likely to have a positive impact on the healthcare system as a whole, making it easier for patients to access necessary treatment.