May 18, 2022 09:05 ET | Source: Clarus Therapeutics Holdings, Inc. Clarus Therapeutics Holdings, Inc.

JATENZO is the first FDA-approved oral softgel for testosterone replacement therapy in adult males who have deficient testosterone due to certain medical conditions

Clarus plans to list this patent in FDA’s Orange Book, which would bring the total number of Orange Book-listed patents covering JATENZO to eight

NORTHBROOK, Ill., May 18, 2022 (GLOBE NEWSWIRE) -- Clarus Therapeutics Holdings, Inc. (“Clarus”) (Nasdaq:CRXT), a pharmaceutical company dedicated to providing solutions to unmet medical needs by advancing androgen and metabolic therapies for men and women, today announced that the United States Patent and Trademark Office (USPTO) has issued a new patent for claims that cover Clarus’ oral testosterone replacement product, JATENZO (testosterone undecanoate).

Patent No. 11,331,325 entitled “Pharmaceutical Delivery Systems for Hydrophobic Drugs and Compositions Comprising Same” covers Clarus’ commercialized product, JATENZO. The new patent will expire in January 2027.

“This new patent further reinforces our already impressive intellectual property portfolio for JATENZO,” said Dr. Robert Dudley, President and Chief Executive Officer of Clarus. “We believe that having eight patents listed in FDA’s Orange Book underscores our multi-pronged strategy for success in the marketplace by protecting this important asset.”

About Male Hypogonadism Male hypogonadism is a condition that results when the testes do not produce enough testosterone. Symptoms associated with male hypogonadism can include depression, decreased sex drive, decreased muscle mass, and decreased bone density, among others. An estimated 20 million men in the United States have hypogonadism, with approximately six million patients diagnosed. Treatments for male hypogonadism may include testosterone replacement therapy.

About Clarus Therapeutics Holdings, Inc. Clarus Therapeutics Holdings, Inc. is a pharmaceutical company with expertise in developing androgen and metabolic therapies for men and women – including potential therapies for orphan indications. Clarus’ first commercial product is JATENZO® (testosterone undecanoate). For more information, visit www.clarustherapeutics.com and www.jatenzo.com. Follow us on Twitter (@Clarus_Thera) and LinkedIn (Clarus Therapeutics).

Clarus Forward-Looking Statements Certain statements in this press release constitute “forward-looking statements” for purposes of the federal securities laws. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Clarus’ forward-looking statements in this press release include, but are not limited to, statements regarding listing the new patent in the FDA’s Orange Book, the timing of the expiration of the new patent and the effect of the new patent on the JATENZO patent portfolio. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting us will be those that Clarus has anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Clarus’ control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the risks associated with pharmaceutical development, risks associated with Clarus’ financial position, and those factors described under the heading “Risk Factors” in Clarus’ annual report on 10-K for the year ended December 31, 2021 filed with the Securities and Exchange Commission (the SEC) on March 31, 2022, and those that are included in any of Clarus’ future filings with the SEC. Should one or more of these risks or uncertainties materialize, or should any of Clarus’ assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Some of these risks and uncertainties may in the future be amplified by the ongoing COVID-19 pandemic and there may be additional risks that Clarus considers immaterial, or which are unknown. It is not possible to predict or identify all such risks. Clarus’ forward-looking statements only speak as of the date they are made, and Clarus does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

JATENZO® is a registered trademark of Clarus Therapeutics Holdings, Inc.

Clarus Contact: Kara Stancell Vice President, Investor Relations & Corporate Communications kstancell@clarustherapeutics.com (847) 562-4300 x 206

Indication JATENZO® (testosterone undecanoate) capsules, CIII, is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:

Limitation of use Safety and efficacy of JATENZO in males less than 18 years old have not been established.

WARNING: INCREASES IN BLOOD PRESSURE

CONTRAINDICATIONS JATENZO is contraindicated in men with breast cancer or known or suspected prostate cancer. JATENZO is contraindicated in women who are pregnant as testosterone may cause fetal harm.

ADVERSE EVENTS The most common adverse events of JATENZO (incidence ≥2%) are headache (5%), increased hematocrit (5%), hypertension (4%), decreased HDL (3%), and nausea (2%).

These are not all of the risks associated with JATENZO. For more information, click here for full Prescribing Information, including BOXED WARNING on increases in blood pressure. You can also obtain information regarding JATENZO at www.jatenzo.com.

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