Lipocine Inc., a biopharmaceutical company focused on oral delivery of therapeutics, announced that its licensing partner, Verity Pharma, has filed a New Drug Submission (NDS) for TLANDO® in Canada. TLANDO is the first and only oral testosterone replacement therapy $(TRT)$ approved by the U.S. FDA that does not require dose titration. This submission represents a significant step towards making TLANDO available in the Canadian market, which sees over 700,000 TRT prescriptions written annually. If approved, TLANDO could capture a substantial market share due to its unique oral administration and the limited promotional activities for current TRTs. Lipocine and Verity Pharma entered an exclusive licensing agreement in January 2024 for commercial rights in the United States and Canada.
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