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Lipocine Announces Filing of New Drug Submission for TLANDO® in Canada
Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to enable effective oral delivery of therapeutics, today announced that its licensing partner, Verity Pharma, filed a New Drug Submission (NDS) for TLANDO® in Canada. TLANDO is the first and only oral testosterone replacement therapy (TRT) option approved by the US Food and Drug Administration (FDA) that does not require dose titration.
About this update from Lipocine Inc.
[{"type":"list","items":[{"val":[{"type":"text","content":"New Drug Submission filed by Lipocine's licensing partner Verity Pharma","length":75,"tagName":"p"}]},{"val":[{"type":"text","content":"Over 700,000 total prescriptions written annually for testosterone replacement therapy (TRT) in Canada, representing large commercial opportunity","length":145,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":220,"olType":false},{"type":"text","content":"SALT LAKE CITY, June 9, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to enable effective oral delivery of therapeutics, today announced that its licensing partner, Verity Pharma, filed a New Drug Submission (NDS) for TLANDO® in Canada. TLANDO is the first and only oral testosterone replacement therapy (TRT) option approved by the US Food and Drug Administration (FDA) that does not require dose titration.","length":494,"tagName":"p"},{"type":"image","alt":"(PRNewsfoto/Lipocine Inc.)","displaySize":"","headline":null,"caption":"(PRNewsfoto/Lipocine Inc.)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":113,"url":"https://media.zenfs.com/en/prnewswire.com/62a81ae3d468802b850c2f8f9ddf2cd2"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/KThUSUCVqrvKmZyz_JDnJA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTE5OTtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/62a81ae3d468802b850c2f8f9ddf2cd2","width":400,"height":113}},"href":"https://mma.prnewswire.com/media/627654/Lipocine_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":""Canada represents an attractive market for TLANDO and the filing of the NDS by Verity Pharma represents an important next step in making the product available there," said Mahesh Patel, CEO of Lipocine. "We believe that, if approved, the introduction of this new and highly differentiated oral TRT option has the potential to drive significant market gains."","length":384,"tagName":"p"},{"type":"text","content":"There are over 700,000 prescriptions written annually in Canada for TRT, and approximately 50% of this patient population is covered through private insurance. In addition, there are limited promotional activities surrounding currently available TRTs, which could provide an opportunity for TLANDO to capture a...