Breckenridge obtains FDA blessing for generic Saphris

Patients with a certain type of bipolar disorder have a new generic treatment.

The Food and Drug Administration has cleared Breckenridge’s asenapine sublingual tablets in dosage strengths of 2.5 mg and 10 mg. Additionally, the FDA granted tentative approval for the 5-mg strength. 

The product, which was developed with MSN Labs, is the generic of AbbVie’s Saphris.

Breckenridge plans to launch these strengths immediately. 

Saphris had a market value of $239 million during the 12 months ended September 2020, according to industry data.