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Last Updated: January 5, 2025

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JATENZO Drug Patent Profile


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When do Jatenzo patents expire, and when can generic versions of Jatenzo launch?

Jatenzo is a drug marketed by Tolmar and is included in one NDA. There are ten patents protecting this drug.

This drug has twenty-nine patent family members in fourteen countries.

The generic ingredient in JATENZO is testosterone undecanoate. There are sixty-nine drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the testosterone undecanoate profile page.

DrugPatentWatch® Generic Entry Outlook for Jatenzo

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 14, 2026. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (testosterone undecanoate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for JATENZO
Drug Prices for JATENZO

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for JATENZO
Generic Entry Date for JATENZO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for JATENZO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
St. Louis UniversityPhase 2
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsPhase 2
Clarus TherapeuticsPhase 2

See all JATENZO clinical trials

Pharmacology for JATENZO
Drug ClassAndrogen
Mechanism of ActionAndrogen Receptor Agonists

US Patents and Regulatory Information for JATENZO

JATENZO is protected by ten US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of JATENZO is ⤷  Subscribe.

This potential generic entry date is based on patent ⤷  Subscribe.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Tolmar JATENZO testosterone undecanoate CAPSULE;ORAL 206089-001 Mar 27, 2019 RX Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Tolmar JATENZO testosterone undecanoate CAPSULE;ORAL 206089-002 Mar 27, 2019 RX Yes No ⤷  Subscribe ⤷  Subscribe Y Y ⤷  Subscribe
Tolmar JATENZO testosterone undecanoate CAPSULE;ORAL 206089-003 Mar 27, 2019 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y Y ⤷  Subscribe
Tolmar JATENZO testosterone undecanoate CAPSULE;ORAL 206089-003 Mar 27, 2019 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Tolmar JATENZO testosterone undecanoate CAPSULE;ORAL 206089-003 Mar 27, 2019 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 5 of 5 entries

International Patents for JATENZO

When does loss-of-exclusivity occur for JATENZO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 06236564
Estimated Expiration: ⤷  Subscribe

Patent: 11201422
Estimated Expiration: ⤷  Subscribe

Brazil

Patent: 0607549
Estimated Expiration: ⤷  Subscribe

Canada

Patent: 04943
Estimated Expiration: ⤷  Subscribe

China

Patent: 1217963
Estimated Expiration: ⤷  Subscribe

Denmark

Patent: 85026
Estimated Expiration: ⤷  Subscribe

European Patent Office

Patent: 71384
Estimated Expiration: ⤷  Subscribe

Patent: 79699
Estimated Expiration: ⤷  Subscribe

Patent: 85026
Estimated Expiration: ⤷  Subscribe

Hungary

Patent: 61300
Estimated Expiration: ⤷  Subscribe

Japan

Patent: 78705
Estimated Expiration: ⤷  Subscribe

Patent: 87044
Estimated Expiration: ⤷  Subscribe

Patent: 51713
Estimated Expiration: ⤷  Subscribe

Patent: 08537960
Estimated Expiration: ⤷  Subscribe

Patent: 13121986
Estimated Expiration: ⤷  Subscribe

Patent: 16074677
Estimated Expiration: ⤷  Subscribe

Poland

Patent: 85026
Estimated Expiration: ⤷  Subscribe

Portugal

Patent: 85026
Estimated Expiration: ⤷  Subscribe

Russian Federation

Patent: 29850
Estimated Expiration: ⤷  Subscribe

Patent: 23206
Estimated Expiration: ⤷  Subscribe

Patent: 07142204
Estimated Expiration: ⤷  Subscribe

Patent: 11119796
Estimated Expiration: ⤷  Subscribe

South Korea

Patent: 1382725
Estimated Expiration: ⤷  Subscribe

Patent: 1432466
Estimated Expiration: ⤷  Subscribe

Patent: 080009201
Estimated Expiration: ⤷  Subscribe

Patent: 130119518
Estimated Expiration: ⤷  Subscribe

Patent: 130124414
Estimated Expiration: ⤷  Subscribe

Spain

Patent: 30658
Estimated Expiration: ⤷  Subscribe

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering JATENZO around the world.

CountryPatent NumberTitleEstimated Expiration
Australia 2006236564 Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same ⤷  Subscribe
Canada 2604943 ⤷  Subscribe
Japan 2008537960 ⤷  Subscribe
Russian Federation 2429850 ФАРМАЦЕВТИЧЕСКИЕ СИСТЕМЫ ДОСТАВКИ ДЛЯ ГИДРОФОБНЫХ ЛЕКАРСТВЕННЫХ СРЕДСТВ И КОМПОЗИЦИЙ, ИХ СОДЕРЖАЩИХ (PHARMACEUTICAL DELIVERY SYSTEMS FOR HYDROPHOBIC THERAPEUTIC AGENTS AND COMPOSITIONS CONTAINING IT) ⤷  Subscribe
World Intellectual Property Organization (WIPO) 2006113505 ⤷  Subscribe
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 5 of 5 entries

JATENZO Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for JATENZO

Introduction to JATENZO

JATENZO, developed by Clarus Therapeutics, Inc., is a groundbreaking oral softgel testosterone undecanoate approved by the FDA in 2020 for the treatment of testosterone deficiency (hypogonadism) in adult males. This approval marked the first oral softgel testosterone medicine in the US in over 60 years[4].

Market Growth and Trends

The market for hormone replacement therapies, including testosterone replacement, is experiencing significant growth. The U.S. hormone replacement therapy market is projected to reach $16.39 billion by 2027, growing at a CAGR of 6.1% from 2020 to 2027. This growth is driven by technological advancements in drug delivery systems and the increasing prevalence of hormonal disorders[1].

Specifically, the testosterone replacement therapy market is expected to grow steadily, driven by factors such as precision medicine approaches, the increasing male wellness market, regulatory support, and health and fitness trends. Innovations in delivery systems, telemedicine, and customized treatment plans are also key drivers[3].

Financial Performance of Clarus Therapeutics

Before its acquisition, Clarus Therapeutics reported significant financial growth driven by the sales of JATENZO. Here are some key financial highlights:

  • Revenue Growth: In 2021, Clarus Therapeutics saw a 119% year-over-year increase in net revenue to $14.0 million, with the fourth quarter of 2021 showing an 88% increase to $4.6 million compared to the same period in 2020[2].
  • Gross Margin: The gross margin for 2021 was 80.5%, although it was negatively impacted by the write-off of obsolete inventory. The gross margin for the fourth quarter of 2021 was 71.7%[2].
  • Operating Expenses: Operating expenses increased by 13.6% to $51.0 million in 2021, primarily due to increased headcount and professional fees associated with financing activities and operating as a public company[2].
  • Net Loss: Despite revenue growth, Clarus Therapeutics reported a net loss of $40.6 million in 2021, compared to a net income of $4.3 million in 2020[2].

Acquisition by Tolmar Pharmaceuticals

In October 2022, Tolmar Pharmaceuticals, Inc. acquired all rights to JATENZO from Clarus Therapeutics Holdings, Inc. following a competitive auction process. This acquisition was part of Tolmar's strategy to strengthen its portfolio in urology and men's health[4].

Impact of the Acquisition

The acquisition of JATENZO by Tolmar Pharmaceuticals is expected to have several positive impacts:

  • Market Expansion: The addition of JATENZO to Tolmar's portfolio is anticipated to further strengthen its position as a leader in urology and men's health. Tolmar's successful urology field sales force is expected to drive fast and profitable growth for JATENZO[4].
  • Product Diversification: JATENZO offers a differentiated alternative to existing testosterone replacement therapies, expanding treatment options for patients and healthcare providers. This aligns with Tolmar's mission to advocate for patients through innovative therapies[4].

Clinical Efficacy and Safety

JATENZO has demonstrated strong clinical efficacy. In the pivotal inTUne clinical trial, 87% of hypogonadal men treated with JATENZO achieved a mean total testosterone concentration within the normal eugonadal range at the end of treatment. The efficacy and safety of JATENZO were evaluated in a 4-month, open-label study involving 166 adult, hypogonadal males[4].

Risks and Side Effects

While JATENZO has shown promising results, it is not without risks. Venous thromboembolic events (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), have been reported in patients using testosterone replacement products like JATENZO. Additionally, testosterone is subject to abuse, typically at doses higher than recommended and in combination with other anabolic androgenic steroids[4].

Future Outlook

The acquisition by Tolmar Pharmaceuticals positions JATENZO for continued growth and market penetration. With Tolmar's robust sales force and commitment to men's health, JATENZO is expected to become a significant player in the testosterone replacement therapy market.

Key Takeaways

  • Market Growth: The testosterone replacement therapy market is growing, driven by technological advancements and increasing prevalence of hormonal disorders.
  • Financial Performance: Clarus Therapeutics saw significant revenue growth from JATENZO sales before its acquisition.
  • Acquisition: Tolmar Pharmaceuticals acquired JATENZO to strengthen its portfolio in urology and men's health.
  • Clinical Efficacy: JATENZO has demonstrated strong clinical efficacy in treating hypogonadism.
  • Risks and Side Effects: JATENZO carries risks such as VTE and potential for abuse.

FAQs

Q: What is JATENZO and how is it unique? A: JATENZO is an oral softgel testosterone undecanoate approved by the FDA for treating testosterone deficiency in adult males. It is the first oral softgel testosterone medicine approved in the US in over 60 years[4].

Q: Who acquired JATENZO and why? A: Tolmar Pharmaceuticals, Inc. acquired JATENZO from Clarus Therapeutics Holdings, Inc. to strengthen its portfolio in urology and men's health[4].

Q: What are the key drivers of the testosterone replacement therapy market? A: The market is driven by precision medicine approaches, the increasing male wellness market, regulatory support, and innovations in delivery systems[3].

Q: What are the potential risks associated with JATENZO? A: JATENZO carries risks such as venous thromboembolic events (VTE) and potential for abuse at higher doses[4].

Q: How has the financial performance of Clarus Therapeutics been impacted by JATENZO sales? A: Clarus Therapeutics reported a 119% year-over-year increase in net revenue to $14.0 million in 2021, driven by JATENZO sales[2].

Sources

  1. Grand View Research: U.S. Hormone Replacement Therapy Market Worth $16.4 Billion By ...
  2. GlobeNewswire: Clarus Therapeutics Reports Fourth Quarter and Full Year 2021 Financial and Operating Results.
  3. The Business Research Company: Testosterone Replacement Therapy Global Market Report 2024.
  4. PR Newswire: Tolmar Announces Acquisition of JATENZO® (testosterone undecanoate) for the Treatment of Hypogonadism to Expand Its Market-Leading Urology Portfolio.
  5. GlobeNewswire: Clarus Therapeutics Reports Second Quarter 2022 Financial and Operating Results and Announces Workforce Reduction.

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