About amoxapine
Amoxapine manufacturers include US generic producers, following the original Asendin from Lederle (later Pfizer), and Chinese generic makers. Amoxapine is a tricyclic antidepressant, chemically a dibenzoxazepine, used for major depression. It is the N-demethylated metabolite of the antipsychotic loxapine. Pharmaceutical companies can source amoxapine tablets through out-licensing, supply or technology transfer. Dossiers are available in US ANDA format.
Amoxapine key facts
|
Property |
Amoxapine |
|---|---|
|
INN |
Amoxapine |
|
Molecular formula / weight |
C17H16ClN3O / 313.8 g/mol |
|
CAS number |
14028-44-5 |
|
ATC code |
N06AA17 |
|
Drug class |
Tricyclic antidepressant (dibenzoxazepine) |
|
Brand name |
Asendin (discontinued) |
|
Originator |
Lederle Laboratories (later Pfizer) |
|
Dosage forms and strengths |
Tablets 25, 50, 100 and 150 mg |
|
Indication |
Major depressive disorder, including depression with anxiety or agitation |
|
Typical dose |
200–300 mg per day; maximum 400 mg (outpatients) or 600 mg (inpatients) |
|
First approval |
US FDA, 22 September 1980 |
|
Patent status |
US compound patent expired 1992 |
|
Boxed warning |
Suicidal thoughts and behaviour in people under 25 |
Amoxapine manufacturers and licensing history
Lederle Laboratories developed amoxapine and sold it as Asendin. The FDA approved it on 22 September 1980, 10 to 20 years after most other tricyclic antidepressants. Asendin is now discontinued, and generic tablets remain available in four strengths.
Amoxapine was reported to work faster than other tricyclics, with effects in four to seven days. Because it is a metabolite of loxapine, it also blocks dopamine receptors, which gives it some antipsychotic-like effects.
In China, several domestic companies market generic amoxapine. Amoxapine API is produced by a small number of companies, so buyers should confirm GMP status, a US DMF and supply reliability before choosing a dossier partner.
Amoxapine dosage forms and dossier types
Amoxapine is approved as 25, 50, 100 and 150 mg tablets. Generic amoxapine manufacturers develop all four strengths.
|
Form |
Strengths |
Typical dossier |
Notes |
|---|---|---|---|
|
Amoxapine tablets |
25, 50, 100, 150 mg |
US ANDA; CTD |
Main form for licensing; Asendin discontinued |
|
Amoxapine API |
Bulk |
US DMF |
Few producers |
|
Target market |
Dossier format |
Key requirement |
|---|---|---|
|
United States |
ANDA (eCTD) |
Reference to the FDA reference standard |
|
China |
NMPA (CTD-based) |
Domestic generics only |
|
European Union |
EU CTD |
Few or no current national authorisations |
|
Other markets |
CTD |
Reference to US approval |
Amoxapine regulatory and patent status
The FDA approved amoxapine on 22 September 1980, and the US compound patent expired in 1992. The brand Asendin is discontinued, and generic tablets serve the US market. Like all antidepressants, amoxapine carries a boxed warning about suicidal thoughts in children and young adults. It is not widely marketed in Europe.
Amoxapine mechanism of action and therapeutic use
Amoxapine blocks the reuptake of noradrenaline and, to a lesser extent, serotonin. It also blocks dopamine D2 receptors, which can cause movement side effects similar to antipsychotics. Amoxapine is used for major depression, including depression with anxiety or agitation. Overdose can cause seizures and can be fatal.
Amoxapine licensing and sourcing
Amoxapine suppliers and licensing partners typically offer dossier out-licensing, finished-product supply or technology transfer. Buyers usually compare GMP status (US FDA, EU GMP), dossier format and readiness, API source and territory availability. Current offers and supplier contacts are listed among the amoxapine manufacturers on Pipelinepharma.
Frequently asked questions about amoxapine
Who are the main amoxapine manufacturers? Amoxapine was developed by Lederle as Asendin, which is now discontinued. Generic tablets are made by US producers and by several Chinese companies.
Is there a generic version of amoxapine? Yes. Generic amoxapine tablets are available in 25, 50, 100 and 150 mg strengths in the US.
Is an amoxapine dossier available for licensing? Amoxapine tablet dossiers are available in US ANDA and CTD formats.
How is amoxapine different from other tricyclic antidepressants? Amoxapine also blocks dopamine receptors, because it is a metabolite of loxapine. This gives it antipsychotic-like effects and a risk of movement side effects.
When was amoxapine approved? The US FDA approved amoxapine on 22 September 1980.
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