NDAINJECTIONINJECTABLE
Approved
Apr 1961
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
3/8 — Basic
ELAVIL (amitriptyline hydrochloride) by AstraZeneca is clinical pharmacology amitriptyline hydrochloride is an antidepressant with sedative effects. First approved in 1961.
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ELAVIL (amitriptyline hydrochloride) is a tricyclic antidepressant approved in 1961 that works by inhibiting the reuptake of norepinephrine and serotonin in the central nervous system. It is used primarily for depression and has sedative properties that contribute to its clinical profile. The drug represents a foundational antidepressant class with decades of clinical experience.
LOE Approaching
As LOE approaches, brand teams face significant pressure to defend market share against generic and newer-generation competitors; support roles and business development will dominate over promotional roles.
Mechanism of Action
CLINICAL PHARMACOLOGY Amitriptyline hydrochloride is an antidepressant with sedative effects. Its mechanism of action in man is not known. It is not a monoamine oxidase inhibitor, and it does not act primarily by stimulation of the central nervous system. Amitriptyline inhibits the membrane pump…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
Baclofen-Amitriptyline Hydrochloride-Ketamine Gel in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
Started Feb 2008
208 enrolled
Chronic Myeloproliferative DisordersLeukemiaLymphoma+7 more
Career Relevance
Worked on ELAVIL at AstraZeneca? Share your interview experience or compensation data (+7 days Pro)
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.