FDA Approves TRAMADOL HYDROCHLORIDE — TruPharma, LLC

TruPharma, LLC announced on Monday the implementation of the 180-day generic exclusivity period for its 50 mg and 100 mg oral tramadol hydrochloride tablets (NDA 214044), a compounded version of Ultram, signaling a potential surge in generic market share even as patent challenges prevent the addition of the 200 mg strength. The Food and Drug Administration's approval, granted on September 1, 2020, further positions TruPharma to capture significant volume in the general analgesic sector despite the limited competitive landscape.