NDAORALTABLET, EXTENDED RELEASE
Approved
Nov 2011
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
4
Data completeness
6/8 — Strong
FORFIVO XL (bupropion hydrochloride) by Lavipharm is unknown, as is the case with other antidepressants. First approved in 2011.
Drug data last refreshed 4h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FORFIVO XL is an extended-release oral tablet formulation of bupropion hydrochloride, an atypical antidepressant approved in 2011. It works through presumed noradrenergic and dopaminergic mechanisms by weakly inhibiting neuronal reuptake of norepinephrine and dopamine, without affecting serotonin or monoamine oxidase. The exact mechanism of action remains incompletely understood, as with most antidepressants.
$0.414MPart D
LOE Approaching2.2 years to LOEWith LOE approaching in 2.2 years and only $414K in Part D spending, this is a niche, declining product with minimal commercial infrastructure investment.
Mechanism of Action
unknown, as is the case with other antidepressants. However, it is presumed that this action is mediated by noradrenergic and/or dopaminergic mechanisms. Bupropion is a relatively weak inhibitor of the neuronal uptake of norepinephrine and dopamine, and does not inhibit monoamine oxidase or the…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (4)
Effect of Naltrexone Hydrochloride ER and Bupropion Hydrochloride ER Combination (Contrave®/Mysimba®) on Major Adverse Cardiovascular Events (MACE)
Started Jan 2024
8,600 enrolled
Obesity
A Study to Evaluate Pharmacokinetics, Safety and Tolerability of Extended-release Bupropion Hydrochloride Tablets in Chinese Healthy Volunteers
Started May 2016
16 enrolled
Depressive Disorder, Major
Study to Evaluate the Efficacy, Safety and Tolerability of Bupropion Hydrochloride Extended-release Tablet, and Escitalopram Oxalate Capsule in Subjects With Major Depressive Disorder
Started Feb 2015
534 enrolled
Depressive Disorder, Major
Bupropion Hydrochloride 300 mg Extended Release Tablets Under Fasting Conditions
Started Jan 2010
8 enrolled
Depressive Disorder
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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.