drug · small molecule
BREXPIPRAZOLE
Marketedupdated 3mo ago/ brek-SPIP-rə-zohl /
by $AMRX Amneal Pharmaceuticals, Inc.🔗 ChEMBL
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 5Small molecule drug with a maximum clinical stage of Approval (across all indications), with 3 approved and 9 investigational indications.
indications
investigational
SchizophreniaMajor Depression
targets
5-hydroxytryptamine receptor 2A5-hydroxytryptamine receptor 1AD(2) dopamine receptor
all catalysts(7)
approval · 6
Jan 31, 2023
approval
$AMRX17.90-1.16%
BREXPIPRAZOLE — FDA approval
BREXPIPRAZOLE
→
Apr 1, 2026
approval
$AMRX17.90-1.16%
BREXPIPRAZOLE — FDA approval
BREXPIPRAZOLE
→
Apr 1, 2026
approval
$AMRX17.90-1.16%
BREXPIPRAZOLE — FDA approval
BREXPIPRAZOLE
→
Apr 1, 2026
approval
$AMRX17.90-1.16%
BREXPIPRAZOLE — FDA approval
BREXPIPRAZOLE
→
Apr 1, 2026
approval
$AMRX17.90-1.16%
BREXPIPRAZOLE — FDA approval
BREXPIPRAZOLE
→
Apr 1, 2026
approval
$AMRX17.90-1.16%
BREXPIPRAZOLE — FDA approval
BREXPIPRAZOLE
→
Trials studying BREXPIPRAZOLE
- phase1Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral Brexpiprazole (OPC- 34712) in Adolescents With Schizophrenia
- phase1Food Effect Study of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia
- phase3Safety and Tolerability of Open-Label Flexible-dose Brexpiprazole as Maintenance Treatment in Adolescents With Schizophrenia
- phase1Bioequivalence Study to Compare Brexpiprazole 4 mg Film Coated Tablets Versus RXULTI 4 mg Film Coated Tablet (Brexpiprazole)
- phase1The Purpose of This Study is to Determine the Safety, Tolerability, and Pharmacokinetics of Brexpiprazole Long-acting Injection Following a Single Administration in Healthy Subjects/Patients With Schizophrenia.
- phase3Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder
- —Real-life Assessment of Brexpiprazole (Rexulti) in Schizophrenia and in Depressive Disorders
- —REXULTI Drug General Use-results Survey (Excessive Motor Activity or Physically/Verbally Aggressive Behavior Due to Rapid Changes in Mood, Irritability, and/or Outbursts Associated With Dementia Due to Alzheimer's Disease)
Patent cliff
source: FDA Orange Bookfirst barrier falls
Oct 12, 2026
51 days
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, 2033patentUS 10307419*PED
- Apr 12, 2033patentUS 10307419*PED
- Apr 12, 2033patentUS 10307419*PED
- Apr 12, 2033patentUS 10307419*PED
- Apr 12, 2033patentUS 10307419*PED
- Oct 12, 2032formulationUS 10307419
- Oct 12, 2032formulationUS 10307419
- Oct 12, 2032formulationUS 10307419
- Oct 12, 2032formulationUS 10307419
- Oct 12, 2032formulationUS 10307419
- Jun 23, 2029patentUS RE48059*PED2.8y
- Jun 23, 2029patentUS RE48059*PED2.8y
- Jun 23, 2029patentUS RE48059*PED2.8y
- Jun 23, 2029patentUS RE48059*PED2.8y
- Jun 23, 2029patentUS RE48059*PED2.8y
- Jun 23, 2029patentUS RE48059*PED2.8y
- Dec 23, 2028compositionUS RE480592.3y
- Dec 23, 2028compositionUS RE480592.3y
- Dec 23, 2028compositionUS RE480592.3y
- Dec 23, 2028compositionUS RE480592.3y
- Dec 23, 2028compositionUS RE480592.3y
- Dec 23, 2028compositionUS RE480592.3y
- Oct 12, 2026patentUS 7888362*PED51d
- Oct 12, 2026patentUS 7888362*PED51d
- Oct 12, 2026patentUS 7888362*PED51d
- Oct 12, 2026patentUS 7888362*PED51d
- Oct 12, 2026patentUS 7888362*PED51d
- Oct 12, 2026patentUS 7888362*PED51d
- Oct 12, 2026patentUS 8349840*PED51d
- Oct 12, 2026patentUS 8349840*PED51d
- Oct 12, 2026patentUS 8349840*PED51d
- Oct 12, 2026patentUS 8349840*PED51d
- Oct 12, 2026patentUS 8349840*PED51d
- Oct 12, 2026patentUS 8349840*PED51d
- Oct 12, 2026patentUS 8618109*PED51d
- Oct 12, 2026patentUS 8618109*PED51d
- Oct 12, 2026patentUS 8618109*PED51d
- Oct 12, 2026patentUS 8618109*PED51d
- Oct 12, 2026patentUS 8618109*PED51d
- Oct 12, 2026patentUS 8618109*PED51d
- Oct 12, 2026patentUS 9839637*PED51d
- Oct 12, 2026patentUS 9839637*PED51d
- Oct 12, 2026patentUS 9839637*PED51d
- Oct 12, 2026patentUS 9839637*PED51d
- Oct 12, 2026patentUS 9839637*PED51d
- Oct 12, 2026patentUS 9839637*PED51d
- Apr 12, 2026formulationUS 8349840
- Apr 12, 2026formulationUS 8349840
- Apr 12, 2026formulationUS 8349840
- Apr 12, 2026formulationUS 8349840
- Apr 12, 2026formulationUS 8349840
- Apr 12, 2026formulationUS 8349840
- Apr 12, 2026method-of-use (U-3281)US 8618109
- Apr 12, 2026method-of-use (U-3281)US 8618109
- Apr 12, 2026method-of-use (U-3281)US 8618109
- Apr 12, 2026method-of-use (U-3281)US 8618109
- Apr 12, 2026method-of-use (U-3281)US 8618109
- Apr 12, 2026method-of-use (U-3281)US 8618109
- Apr 12, 2026formulationUS 9839637
- Apr 12, 2026formulationUS 9839637
- Apr 12, 2026formulationUS 9839637
- Apr 12, 2026formulationUS 9839637
- Apr 12, 2026formulationUS 9839637
- Apr 12, 2026formulationUS 9839637
FDA exclusivities (30)
- May 9, 2028M-315Method (3y)1.7y
- May 9, 2028M-315Method (3y)1.7y
- May 9, 2028M-315Method (3y)1.7y
- May 9, 2028M-315Method (3y)1.7y
- May 9, 2028M-315Method (3y)1.7y
- May 9, 2028M-315Method (3y)1.7y
- Nov 8, 2027PEDPediatric (6mo bonus)1.2y
- Nov 8, 2027PEDPediatric (6mo bonus)1.2y
- Nov 8, 2027PEDPediatric (6mo bonus)1.2y
- Nov 8, 2027PEDPediatric (6mo bonus)1.2y
- Nov 8, 2027PEDPediatric (6mo bonus)1.2y
- Nov 8, 2027PEDPediatric (6mo bonus)1.2y
- May 8, 2027M-14Method (3y)259d
- May 8, 2027M-14Method (3y)259d
- May 8, 2027M-14Method (3y)259d
- May 8, 2027M-14Method (3y)259d
- May 8, 2027M-14Method (3y)259d
- May 8, 2027M-14Method (3y)259d
- Nov 10, 2026PEDPediatric (6mo bonus)80d
- Nov 10, 2026PEDPediatric (6mo bonus)80d
- Nov 10, 2026PEDPediatric (6mo bonus)80d
- Nov 10, 2026PEDPediatric (6mo bonus)80d
- Nov 10, 2026PEDPediatric (6mo bonus)80d
- Nov 10, 2026PEDPediatric (6mo bonus)80d
- May 10, 2026I-913Indication (3y)
- May 10, 2026I-913Indication (3y)
- May 10, 2026I-913Indication (3y)
- May 10, 2026I-913Indication (3y)
- May 10, 2026I-913Indication (3y)
- May 10, 2026I-913Indication (3y)
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