When might Rexulti (brexpiprazole) go generic?
The U.S. patent exclusivity for Rexulti (brexpiprazole) is set to expire in 2026 [1]. This typically marks the earliest point when generic versions of the drug could become available, provided no further patent extensions or legal challenges impact the timeline.
What are the key patents for Rexulti?
Rexulti, developed by Otsuka Pharmaceutical and Lundbeck, is protected by several patents. The primary patent for the composition of matter is expected to expire in 2026 [1]. However, other patents related to its use and formulation may extend further.
Can generic Rexulti be available before 2026?
While the main patent is slated for expiration in 2026, generic manufacturers may attempt to launch their products earlier if they successfully challenge existing patents or if a court rules in their favor regarding patent validity or infringement [2]. Legal disputes are common in the pharmaceutical industry as generic companies seek to enter the market and brand-name companies aim to extend their exclusivity.
What happens after Rexulti's patent expires?
Once patent exclusivity ends and any related legal challenges are resolved, the U.S. Food and Drug Administration (FDA) can approve generic versions of brexpiprazole [3]. Generic drugs are required to demonstrate bioequivalence to the brand-name product, meaning they contain the same active ingredient, dosage form, and strength, and work in the same way in the body [3]. The availability of generics can significantly lower the cost of medication.
How do companies challenge drug patents?
Companies seeking to produce generic versions often file Abbreviated New Drug Applications (ANDAs) with the FDA. If the brand-name drug is still protected by patents listed in the FDA's "Orange Book," the ANDA filer may assert that these patents are invalid, unenforceable, or will not be infringed by the generic product [2]. This can lead to patent litigation, where courts determine the validity and applicability of the patents.
What is Rexulti used to treat?
Rexulti is approved for the treatment of schizophrenia in adults and as an add-on treatment for major depressive disorder (MDD) in adults [4]. It is also used for agitation associated with dementia due to Alzheimer's disease in adults [4].
How does brexpiprazole work?
Brexpiprazole is an atypical antipsychotic that acts as a partial agonist at dopamine D2 and serotonin 5-HT1A receptors, and as an antagonist at serotonin 5-HT2A and norepinephrine alpha1B-2C receptors [4]. This mechanism of action is believed to modulate neurotransmitter activity in the brain.
What is the commercial significance of Rexulti?
Rexulti has become a significant product for Otsuka and Lundbeck, generating substantial revenue. The introduction of generic competition following patent expiration is a common occurrence that can lead to a rapid decline in the market share and pricing of the brand-name drug [1].
Sources:
[1] DrugPatentWatch.com
[2] https://drugpatentwatch.com/blog/how-patent-litigation-can-delay-generic-drug-entry
[3] https://www.fda.gov/drugs/generic-drugs
[4] https://www.rexulti.com/