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BREXPIPRAZOLE · pharmadog
pharmadog › drugs › BREXPIPRAZOLE patient view
This page is a research summary built from public sources (FDA, NIH, clinical trial registries). It is not medical advice. Always talk to your doctor about treatment decisions. Drug information here may be incomplete or out of date — verify with your prescriber and the manufacturer's package insert.
BREXPIPRAZOLE Marketed updated 2mo ago / brek-SPIP-rə-zohl /
by $AMRX Amneal Pharmaceuticals, Inc. 🔗 ChEMBL Approved
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Small molecule drug with a maximum clinical stage of Approval (across all indications), with 3 approved and 9 investigational indications.
indications investigational
Schizophrenia Major Depression
targets 5-hydroxytryptamine receptor 2A 5-hydroxytryptamine receptor 1A D(2) dopamine receptor
News(0) no news has mentioned this drug yet
trade names
Rexulti, Rxulti
MOA
12.1 Mechanism of Action The mechanism of action of brexpiprazole in the treatment of major depressive disorder or schizophrenia is unknown. However, the efficacy of brexpiprazole may be mediated through a combination of partial agonist activity at serotonin 5-HT 1A and dopamine D 2 receptors, and antagonist activity at serotonin 5-HT 2A receptors.
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Patent cliff source: FDA Orange Book first barrier falls
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (64) Apr 12, 2033 patent US 10307419*PED Apr 12, 2033 patent US 10307419*PED Apr 12, 2033 patent US 10307419*PED Apr 12, 2033 patent US 10307419*PED Apr 12, 2033 patent US 10307419*PED Oct 12, 2032 formulation US 10307419 Oct 12, 2032 formulation US 10307419 Oct 12, 2032 formulation US 10307419 Oct 12, 2032 formulation US 10307419 Oct 12, 2032 formulation US 10307419 Jun 23, 2029 patent US RE48059*PED 3.0y Jun 23, 2029 patent US RE48059*PED 3.0y Jun 23, 2029 patent US RE48059*PED 3.0y Jun 23, 2029 patent US RE48059*PED 3.0y Jun 23, 2029 patent US RE48059*PED 3.0y Jun 23, 2029 patent US RE48059*PED 3.0y Dec 23, 2028 composition US RE48059 2.5y Dec 23, 2028 composition US RE48059 2.5y Dec 23, 2028 composition US RE48059 2.5y Dec 23, 2028 composition US RE48059 2.5y Dec 23, 2028 composition US RE48059 2.5y Dec 23, 2028 composition US RE48059 2.5y Oct 12, 2026 patent US 7888362*PED 97d Oct 12, 2026 patent US 7888362*PED 97d Oct 12, 2026 patent US 7888362*PED 97d Oct 12, 2026 patent US 7888362*PED 97d Oct 12, 2026 patent US 7888362*PED 97d Oct 12, 2026 patent US 7888362*PED 97d Oct 12, 2026 patent US 8349840*PED 97d Oct 12, 2026 patent US 8349840*PED 97d Oct 12, 2026 patent US 8349840*PED 97d Oct 12, 2026 patent US 8349840*PED 97d Oct 12, 2026 patent US 8349840*PED 97d Oct 12, 2026 patent US 8349840*PED 97d Oct 12, 2026 patent US 8618109*PED 97d Oct 12, 2026 patent US 8618109*PED 97d Oct 12, 2026 patent US 8618109*PED 97d Oct 12, 2026 patent US 8618109*PED 97d Oct 12, 2026 patent US 8618109*PED 97d Oct 12, 2026 patent US 8618109*PED 97d Oct 12, 2026 patent US 9839637*PED 97d Oct 12, 2026 patent US 9839637*PED 97d Oct 12, 2026 patent US 9839637*PED 97d Oct 12, 2026 patent US 9839637*PED 97d Oct 12, 2026 patent US 9839637*PED 97d Oct 12, 2026 patent US 9839637*PED 97d Apr 12, 2026 formulation US 8349840 Apr 12, 2026 formulation US 8349840 Apr 12, 2026 formulation US 8349840 Apr 12, 2026 formulation US 8349840 Apr 12, 2026 formulation US 8349840 Apr 12, 2026 formulation US 8349840 Apr 12, 2026 method-of-use (U-3281) US 8618109 Apr 12, 2026 method-of-use (U-3281) US 8618109 Apr 12, 2026 method-of-use (U-3281) US 8618109 Apr 12, 2026 method-of-use (U-3281) US 8618109 Apr 12, 2026 method-of-use (U-3281) US 8618109 Apr 12, 2026 method-of-use (U-3281) US 8618109 Apr 12, 2026 formulation US 9839637 Apr 12, 2026 formulation US 9839637 Apr 12, 2026 formulation US 9839637 Apr 12, 2026 formulation US 9839637 Apr 12, 2026 formulation US 9839637 Apr 12, 2026 formulation US 9839637 FDA exclusivities (30) May 9, 2028 M-315 Method (3y) 1.8y May 9, 2028 M-315 Method (3y) 1.8y May 9, 2028 M-315 Method (3y) 1.8y May 9, 2028 M-315 Method (3y) 1.8y May 9, 2028 M-315 Method (3y) 1.8y May 9, 2028 M-315 Method (3y) 1.8y $AMRX 17.25 +0.58%
$AMRX 17.25 +0.58%
$AMRX 17.25 +0.58%
$AMRX 17.25 +0.58%
$AMRX 17.25 +0.58%
$AMRX 17.25 +0.58%
Nov 8, 2027
PED
Pediatric (6mo bonus)
1.3y
Nov 8, 2027 PED Pediatric (6mo bonus) 1.3y
Nov 8, 2027 PED Pediatric (6mo bonus) 1.3y
Nov 8, 2027 PED Pediatric (6mo bonus) 1.3y
Nov 8, 2027 PED Pediatric (6mo bonus) 1.3y
Nov 8, 2027 PED Pediatric (6mo bonus) 1.3y
May 8, 2027 M-14 Method (3y) 305d
May 8, 2027 M-14 Method (3y) 305d
May 8, 2027 M-14 Method (3y) 305d
May 8, 2027 M-14 Method (3y) 305d
May 8, 2027 M-14 Method (3y) 305d
May 8, 2027 M-14 Method (3y) 305d
Nov 10, 2026 PED Pediatric (6mo bonus) 126d
Nov 10, 2026 PED Pediatric (6mo bonus) 126d
Nov 10, 2026 PED Pediatric (6mo bonus) 126d
Nov 10, 2026 PED Pediatric (6mo bonus) 126d
Nov 10, 2026 PED Pediatric (6mo bonus) 126d
Nov 10, 2026 PED Pediatric (6mo bonus) 126d
May 10, 2026 I-913 Indication (3y)
May 10, 2026 I-913 Indication (3y)
May 10, 2026 I-913 Indication (3y)
May 10, 2026 I-913 Indication (3y)
May 10, 2026 I-913 Indication (3y)
May 10, 2026 I-913 Indication (3y)
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