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Home » Testosterone » Clarus Therapeutics Announces Two Notices of Allowance for – GlobeNewswire

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

Upon issuance, Clarus plans to list these patents in FDAs Orange Book, which would bring the total number of Orange Book-listed patents covering JATENZO (testosterone undecanoate) to seven

NORTHBROOK, Ill., Oct. 26, 2021 (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 announcedthat it has received two notices of allowance from the United States Patent and Trademark Office (USPTO) for claims that cover its oral testosterone replacement product, JATENZO (testosterone undecanoate).

Patent application No. 16/656,157 entitled Oral Testosterone Ester Formulations and Methods of Treating Testosterone Deficiency Comprising Same and patent application No. 15/814,162 entitled Pharmaceutical Delivery Systems for Hydrophobic Drugs and Compositions Comprising Same both cover Clarus approved product JATENZO (testosterone undecanoate). The U.S. patents scheduled to issue from these applications will expire in 2030 and 2026, respectively.

These recent patent allowances by the USPTO are another important milestone in protecting the commercial potential of JATENZO and the life cycle management programs we have under development for this lead asset, said Dr. Robert Dudley, Founder, President and Chief Executive Officer of Clarus. Once issued, these two new patents will be listed in FDAs Orange Book and will bring the total number of patents that protect JATENZO to seven. These new patents will further strengthen the broad and robust intellectual property portfolio for JATENZO.

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 U.S. have hypogonadism, with approximately 6 million patients diagnosed. Treatments for male hypogonadism may include testosterone replacement therapy (TRT).

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 Therapeutics first commercial product is JATENZO. For more information, visit http://www.clarustherapeutics.comand http://www.jatenzo.com. Follow us on Twitter (@Clarus_Thera) and LinkedIn (Clarus Therapeutics).

Clarus Forward-Looking StatementsCertain 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 the issuance of these patents, listing in the FDAs Orange Book and the effect of these patents 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 the prospectus filed with the Securities and Exchange Commission (the SEC) under Rule 424(b)(3) on October7, 2021, 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 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.

Clarus Investor Relations Contact:Kara Stancellkstancell@clarustherapeutics.com(847) 562-4300 x 206

About JATENZO

IndicationJATENZO (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 useSafety and efficacy of JATENZO in males less than 18 years old have not been established.

IMPORTANT SAFETY INFORMATION

WARNING: INCREASES IN BLOOD PRESSURE

CONTRAINDICATIONSJATENZO 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.

WARNINGS AND PRECAUTIONS

ADVERSE EVENTSThe 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 http://www.jatenzo.com.

2021 Clarus Therapeutics, Inc. All rights reserved.

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Clarus Therapeutics Announces Two Notices of Allowance for - GlobeNewswire

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Home » Testosterone » Clarus Therapeutics Announces Two Notices of Allowance for – GlobeNewswire