Alembic obtains FDA green light for generic Sinequan

Patients with certain mental disorders will soon have a new generic treatment.

Alembic has received the Food and Drug Administration’s stamp of approval for doxepin hydrochloride capsules in dosage strengths of 10 mg, 25 mg, 50 mg, 75 mg and 100 mg.

The product is the generic of Pfizer’s Sinequan capsules. 

It is used to treat psychoneurotic patients with depression and/or anxiety; depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol); depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly; and psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.

Doxepin hydrochloride capsules had a market value of $41 million for the 12 months ended December 2020, according to IQVIA.