We have been building and continue to expand our intellectual property portfolio relating to
JATENZO. We strive to protect and enhance the proprietary technologies that we believe are important to our business and seek patent protection, where appropriate, in the United States and internationally for compositions related to JATENZO, its
methods of use and any other inventions that are important to the development of our business. Our policy is to actively seek to protect our proprietary position by, among other things, filing patent applications in the United States and abroad,
including Europe and other major countries when appropriate, relating to proprietary technologies that are important to the development of our business.
However, patent protection may not afford us with complete protection against competitors who seek to circumvent our patents. We cannot be
sure that patents will be granted with respect to any of our pending patent applications or with respect to any patent applications filed by us in the future, nor can we be sure that any of our existing patents or any patents that may be granted to
us in the future will be commercially useful in protecting our technology. There is also the risk that third parties have patents or may obtain patents having claims that also cover JATENZO. For example, Lipocine asserted the use of JATENZO
infringed its patents, and attacked patents and applications in our portfolio by provoking patent interferences, see Note 13 Commitments and Contingents, to the consolidated financial statements included elsewhere in this prospectus.
Our success will depend significantly on our ability to obtain and maintain patent and other proprietary protection for the technologies,
inventions, know-how and products we consider important to our business, defend our patents, preserve the confidentiality of our trade secrets and operate our business without infringing the patents and
proprietary rights of third parties.
Our U.S. patent portfolio on JATENZO currently includes seven issued patents: U.S. Patent
No. 11,179,402, which expires in April 2026, U.S. Patent No. 8,241,664, which expires in March 2029; U.S. Patent No. 8,492,369, which expires in December 2030, as well as U.S. Patent Nos. 8,778,916, 10,543,219, 10,617,696, and
11,179,403 each of which expires in April 2030. The issued U.S. patents contain claims to both pharmaceutical compositions and methods of treatment using our proprietary pharmaceutical composition and all are listed in the FDA Orange Book: Approved
Drug Products with Therapeutic Equivalence Evaluations. In addition, we have several patent applications pending in the United States and other countries that, if issued, will cover pharmaceutical compositions, methods of treatment and other
features of JATENZO, and have the potential to extend patent coverage beyond 2030.
We also have issued patents covering JATENZO in
Australia, Canada, China, Costa Rica, Europe, Hong Kong, India, Indonesia, Israel, Japan, Mexico, New Zealand, Philippines, Russia, Singapore, South Africa and South Korea.
Our portfolio also contains pending applications around the world, including in the United States, Canada and Europe. These patent
applications, if they were to issue, have the potential to extend the patent coverage beyond 2030.
We solely own all the issued patents
and the pending patent applications in our JATENZO patent portfolio. However there is risk that the USPTO could declare other interference proceedings involving patent claims that cover JATENZO as discussed in more detail in Note 13
Commitments and Contingents, to the consolidated financial statements included elsewhere in this prospectus.
TU, the active
pharmaceutical ingredient in JATENZO, as well as its use for treating hypogonadism, are well known in this field. Accordingly, The TU active ingredient, standing alone, is not protected by any valid and unexpired third-party patents, although there
are third party patents with claims that are alleged to cover use of TU in treating hypogonadism and the use of JATENZO as discussed in more detail in Note 13 Commitments and Contingents, to the consolidated financial statements included
elsewhere in this prospectus.
Competition
There are several approved T-replacement therapies on the market, as well as several therapies under
review by the FDA. The TRT market is highly competitive, and our future success will depend on our ability to capture
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