Lipocine Inc. (LPCN) announced that its licensing partner, Verity Pharma, has submitted a New Drug Submission - NDS for TLANDO in Canada.
TLANDO is the only FDA-approved oral testosterone replacement therapy - TRT that requires no dose titration.
Lipocine CEO Mahesh Patel stated that Canada offers a promising market for TLANDO, and the submission marks a key milestone in expanding the therapy's availability. He noted that, if approved, TLANDO could significantly impact the market due to its distinct advantages.
With over 700,000 TRT prescriptions written annually in Canada—half of which are covered by private insurance—TLANDO has strong market potential. The current TRT market faces minimal promotional efforts, giving TLANDO an edge in gaining traction.
In January 2024, Lipocine granted Verity Pharma exclusive rights to commercialize TLANDO in the U.S. and Canada under a licensing agreement.
LPCN is currently trading at $3.4031 or 7.3533% higher on the Nasdaq Capital Market.
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