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Lipocine Streamlines Its Infringement Lawsuit Against Clarus Therapeutics

Key Takeaway: Lipocine Streamlines Its Infringement Lawsuit Against Clarus Therapeutics SALT LAKE CITY, February 11, 2020 -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company, announced today that in an effort to streamline the issues and associated costs for dispute

Full Press Release Details

Lipocine Streamlines Its Infringement
Lawsuit Against Clarus Therapeutics
SALT LAKE CITY, February 11, 2020 -- Lipocine Inc. (NASDAQ:
LPCN), a clinical-stage biopharmaceutical company, announced today that in an effort to streamline the issues and associated costs
for dispute in its infringement lawsuit against Clarus Therapeutics, Inc. ("Clarus") in the United States District Court
("Delaware") related to the infringement of six Lipocine U.S. Patents by Clarus's JATENZO product, Lipocine has
voluntarily dismissed its allegations of patent infringement for expired U.S. Patent Nos. 6,569,463 and 6,923,988. Lipocine
continues to vigorously defend its patent rights and maintains its allegations for patent infringement of four U.S. patents -
U.S. patent nos. 9,034,858; 9,205,057; 9,480,690; and 9,757,390 - by Clarus's JATENZO product, which has yet to
Lipocine Inc. is a clinical-stage biopharmaceutical company
focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine's clinical development
pipeline includes TLANDO, LPCN 1144, TLANDO XR (LPCN 1111), LPCN 1148 and LPCN 1107 development programs. TLANDO, a novel oral
prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal
men and received a Complete Response Letter from the U.S. Food and Drug Administration on November 8, 2019. LPCN 1144, a differentiated
oral product of bioidentical testosterone, is currently undergoing Phase 2 clinical testing in biopsy confirmed NASH patients
and recently completed a proof-of-concept clinical study demonstrating the potential utility the in treatment of NASH. TLANDO
XR (LPCN 1111), a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral
testosterone product with potential for once-daily dosing and has completed Phase 2 testing. LPCN 1148 is a unique oral testosterone
product targeted to treat NASH cirrhosis. LPCN 1107 is potentially the first oral hydroxyprogesterone caproate product candidate
indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. An End of Phase
2 meeting with the FDA has been completed. For more information, please visit www.lipocine.com.
Forward-Looking Statements
This release contains "forward-looking statements"
that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements
that are not historical facts regarding Lipocine's product candidates and related clinical trials, the timing of completion
of clinical trials, the potential uses and benefits of our product candidates, our product development efforts and future discussions
and actions with the FDA related to TLANDO. Investors are cautioned that all such forward-looking statements involve risks and
uncertainties, including, without limitation, the risks that the FDA will not approve any of our products, risks related to our
products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new
regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals,
the results and timing of clinical trials, patient acceptance of Lipocine's products, the manufacturing and commercialization of
Lipocine's products, risk related to on-going litigation and other risks detailed in Lipocine's filings with the SEC, including,
without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov.
Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as
For further information:
Executive Vice President & Chief Financial Officer
Phone: (801) 994-7383
Phone: (617) 535-7743
Last updated: Feb 11, 2020