January 4, 2021

The U.S. FDA has approved an authorized generic, distributed by Par Pharmaceutical, for Mallinckrodt Pharmaceuticals’ Amitiza® (lubiprostone) 8mcg and 24mcg capsules. Lubiprostone is indicated for use in certain adults to treat chronic idiopathic constipation (CIC), opioid-induced constipation (OIC), and irritable bowel syndrome with constipation (IBS-C).

A chloride channel activator, lubiprostone helps to relieve constipation by increasing the amount of fluid in the bowels. This also helps to improve the function of the protective mucous membrane that lines the intestines. Recommended dosing is 24mcg twice daily for CIC OIC, and 8mcg twice daily for IBS-C. The capsules should be taken whole with food and water. For patients who have hepatic impairment, the dosage may need to be adjusted.

Amitiza first received FDA approval in 2006 and has a wholesale acquisition cost (WAC) of $577.88 per 60 capsules. Its authorized generic is available at a WAC of $296.88 per 60 capsules.

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