Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company, today reported the United States Patent and Trademark Office (“USPTO”) issued U.S. Patent number 9,480,690, entitled “High-Strength Testosterone Undecanoate Compositions” on November 1, 2016. The claims in the issued patent relate to dosing regimens associated with the oral administration of Testosterone Undecanoate (“TU”) compositions. Bio-reversible TU is the key component in LPCN 1021.
“We are pleased with the patent issuance pertaining to dosing regimens associated with oral product candidates containing TU. We believe this additional patent strengthens our strong existing and pending intellectual property portfolio.” said Dr. Mahesh Patel, President and CEO of Lipocine Inc.
About LPCN 1021
LPCN 1021 is a novel twice-a-day oral Testosterone Replacement Therapy product candidate containing Testosterone Undecanoate that is designed to help restore normal testosterone levels in hypogonadal men. Lipocine expects LPCN 1021 will help fulfill an unmet need in the treatment of hypogonadism. The current testosterone market primarily uses short-acting injectable products as well as topical products that carry an FDA “black box” warning related to inadvertent transfer of testosterone to others. Per the IMS Health database, an average of 540,000 prescriptions a month have been dispensed so far in 2016 for testosterone products.
About Lipocine
Lipocine Inc. is a specialty pharmaceutical company developing innovative pharmaceutical products for use in men’s and women’s health using its proprietary drug delivery technologies. Lipocine’s clinical development pipeline includes three development programs LPCN 1021, LPCN 1111 and LPCN 1107. LPCN 1021, a twice-daily oral testosterone replacement therapy product candidate, was well tolerated and met the primary efficacy endpoint in Phase 3 testing, which utilized 24-hour pharmacokinetic data for dose adjustments. LPCN 1111, a novel prodrug of testosterone, originated with and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing and is currently in Phase 2 testing. LPCN 1107, the potentially first oral hydroxyprogesterone caproate product candidate indicated for the prevention of recurrent preterm birth, has been granted orphan drug designation by the FDA. An End of Phase 2 meeting with the FDA was recently completed. For more information, please visit www.lipocine.com.
