ADASUVE

LOE Approaching

loxapine

Teva

NDAINHALATIONPOWDER

Approved

Dec 2012

Lifecycle

LOE Approaching

Competitive Pressure

25/100

Clinical Trials

Data completeness

5/8 — Partial

ADASUVE (loxapine) by Teva is clinical pharmacology pharmacodynamics: pharmacologically, loxapine is an antipsychotic for which the exact mode of action has not been established. Approved for schizophrenia, agitation. First approved in 2012.

Drug data last refreshed 18h ago · AI intelligence enriched 1w ago

AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data

ADASUVE is an inhaled powder formulation of loxapine, a classic antipsychotic that works through dopamine antagonism in subcortical brain regions. It is approved for acute agitation in patients with schizophrenia or bipolar disorder, with onset of action within 20–30 minutes and peak effects at 1.5–3 hours. The inhalation route enables rapid systemic absorption and faster clinical response compared to oral antipsychotics.

LOE Approaching6mo to LOE

Product faces imminent loss of exclusivity (October 2026), signaling a transitioning team focused on defending market share against generics and repositioning for post-LOE profitability.

Mechanism of Action

CLINICAL PHARMACOLOGY Pharmacodynamics: Pharmacologically, loxapine is an antipsychotic for which the exact mode of action has not been established. However, changes in the level of excitability of subcortical inhibitory areas have been observed in several animal species in association with such…

Indications (2)

Schizophrenia

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.

Clinical Trials (4)

NCT04148963Phase 3Unknown

A Study of Staccato Loxapine (ADASUVE®) for Inhalation

Started Dec 2019

150 enrolled

Psychomotor AgitationSchizophreniaBipolar Disorder

NCT02525991Phase 4Completed

Phase IV to Evaluate the Safety of Self-administered ADASUVE® in Agitated Patients Outside the Hospital Setting

Started Sep 2016

323 enrolled

Agitation

NCT02877108N/AUnknown

Naturalistic Adasuve Clinical Trial Study

Started Apr 2016

100 enrolled

Agitation

NCT02184767Phase 1Completed

Study to Assess the Safety and Pharmacokinetics of ADASUVE® at Doses of 2.5, 5, or 10 mg in Children and Adolescents (10 Through 17 Years of Age) With Any Condition Warranting Chronic Use of an Antipsychotic Medication

Started Jul 2014

30 enrolled

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Career Relevance

ADASUVE offers limited career growth opportunity given its imminent LOE (October 2026) and lack of active pipeline expansion; positions are primarily defensive and focused on managed decline rather than market expansion. Professionals joining now should expect role transitions or lateral moves to growth-stage assets within 12–18 months, making this a short-term assignment best suited for those with transition or turnaround experience.

Brand ManagerField Sales RepresentativeMedical Science LiaisonMarket Access ManagerAssociate Product Manager

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Company

Teva

Israel - Petach Tikva

See all Teva products →

External Resources

Official Product Website

Patient information & support programs

ClinicalTrials.gov

Active clinical trials for this drug

DailyMed

Full prescribing information