Glenmark obtains FDA OK for generic Buphenyl

The Food and Drug Administration has given Glenmark the green light for sodium phenylbutyrate tablets in a dosage strength of 500 mg.

The medication is the generic of Horizon’s Buphenyl.

Buphenyl is indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamyl phosphate synthetase, ornithine transcarbamylase, or argininosuccinic acid synthetase; and in all patients with neonatal-onset deficiency (complete enzymatic deficiency, presenting within the first 28 days of life).

[Read more: Hikma, Glenmark Specialty launch generic Ryaltris] 

It is also indicated in patients with the late-onset disease (partial enzymatic deficiency, presenting after the first month of life) who have a history of hyperammonemic encephalopathy.

Buphenyl had a market value of roughly $8.7 million for the 12-month period ending September 2022, according to IQVIA.