TruPharma, LLC (“TruPharma”), together with its development and commercial partner Sage Chemical, Inc. (“Sage”), announces that the U.S. Food and Drug Administration (FDA) has approved Sage’s Abbreviated New Drug Application (ANDA) for generic apomorphine hydrochloride cartridges, 30 mg/3 mL (10 mg/mL). FDA approved the generic cartridge product upon a determination that it is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), APOKYN®¹ branded Injection, 30 mg/3 mL (10 mg/mL), Single-Patient-Use cartridge, of MDD US Operations, LLC, which is used by injection, as needed, to treat loss of control of body movements in people with advanced Parkinson’s disease (PD).

Sage is the “first approved applicant” for Apomorphine Hydrochloride Injection, 30 mg/3 mL (10 mg/mL), Single-Patient-Use glass cartridge for use with a reusable pen injector (APOKYN® Pen). FDA therefore determined that Sage is eligible for 180 days of Competitive Generic Therapy (CGT) exclusivity.

TruPharma has commenced commercial marketing of Sage’s approved generic cartridge product. TruPharma will continue supplying apomorphine hydrochloride cartridges to the trade, but in limited quantities due to current manufacturing and supply chain constraints.

¹APOKYN is a registered trademark of BRITUSWIP. US WorldMeds, LLC is the licensee and distributor of APOKYN.