JATENZO Drug Patent Profile

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

Summary for JATENZO

International Patents:	29
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	55
Clinical Trials:	4
Patent Applications:	1,370
Drug Prices:	Drug price information for JATENZO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for JATENZO
What excipients (inactive ingredients) are in JATENZO?	JATENZO excipients list
DailyMed Link:	JATENZO at DailyMed

See drug prices for JATENZO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for JATENZO

Constraining patent/regulatory exclusivity:

11,179,402

NDA:

206089

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

Sponsor	Phase
St. Louis University	Phase 2
Clarus Therapeutics	Phase 2
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Phase 2

See all JATENZO clinical trials

Pharmacology for JATENZO

Drug Class	Androgen
Mechanism of Action	Androgen Receptor Agonists

US Patents and Regulatory Information for JATENZO

JATENZO is protected by ten US patents.

This potential generic entry date is based on patent 11,179,402.

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Tolmar	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-003	Mar 27, 2019		RX	Yes	Yes	11,179,402		Y	Y
Tolmar	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-003	Mar 27, 2019		RX	Yes	Yes	8,778,916		Y
Tolmar	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-001	Mar 27, 2019		RX	Yes	No	8,492,369		Y
Tolmar	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-002	Mar 27, 2019		RX	Yes	No	11,179,402		Y	Y
Tolmar	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-003	Mar 27, 2019		RX	Yes	Yes	11,179,403
Tolmar	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-001	Mar 27, 2019		RX	Yes	No	11,426,416

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:

Canada

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.

Country	Patent Number	Title	Estimated Expiration
South Korea	101432466
China	101217963	Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same
Portugal	2985026
South Korea	20080009201	PHARMACEUTICAL DELIVERY SYSTEMS FOR HYDROPHOBIC DRUGS AND COMPOSITIONS COMPRISING SAME
Canada	2604943	SYSTEMES D'APPORT DE SUBSTANCES PHARMACEUTIQUES DESTINES A DES MEDICAMENTS HYDROPHOBES ET COMPOSITIONS COMPRENANT CES DERNIERS (PHARMACEUTICAL DELIVERY SYSTEMS FOR HYDROPHOBIC DRUGS AND COMPOSITIONS COMPRISING SAME)
South Korea	20130119518	PHARMACEUTICAL DELIVERY SYSTEMS FOR HYDROPHOBIC DRUGS AND COMPOSITIONS COMPRISING SAME

Market Dynamics and Financial Trajectory for JATENZO

Last updated: July 4, 2025

Introduction

In the competitive world of pharmaceutical innovation, testosterone replacement therapies (TRT) like JATENZO have carved out a niche for addressing hypogonadism in adult men. Approved by the U.S. Food and Drug Administration (FDA) in 2019, JATENZO—marketed by Clarus Therapeutics—stands as an oral alternative to traditional injections and gels. As business professionals navigate investment decisions, understanding JATENZO's market dynamics and financial trajectory offers critical insights into its growth potential and challenges. This analysis delves into current trends, competitive pressures, and fiscal performance, equipping stakeholders with data-driven perspectives.

Overview of JATENZO

JATENZO represents a breakthrough in TRT, delivering testosterone undecanoate in capsule form to treat conditions associated with low testosterone levels. Unlike older therapies that require injections or topical applications, JATENZO's oral delivery enhances patient convenience, potentially boosting adherence rates. Clarus Therapeutics launched it amid rising demand for user-friendly hormone treatments, with the drug generating buzz for its efficacy in clinical trials. However, its market entry faced hurdles, including safety concerns raised during FDA reviews, which scrutinized cardiovascular risks linked to TRT products.

The drug's patent landscape adds another layer of protection, with key intellectual property extending through 2036 in the U.S. This exclusivity shields JATENZO from generic competition, allowing Clarus to maintain pricing power. Yet, as patents near expiration, stakeholders must monitor potential biosimilar threats that could disrupt revenue streams.

Market Dynamics

Current Market Size and Growth Trends

The global TRT market has expanded rapidly, reaching an estimated $1.8 billion in 2023 and projected to grow at a compound annual growth rate (CAGR) of 4.5% through 2030, according to industry reports. JATENZO captures a modest share within this segment, primarily in the U.S., where it competes in a market valued at $800 million. Factors driving growth include an aging population and increasing awareness of testosterone deficiency, with diagnoses rising 15% annually in developed regions.

Demand for oral formulations like JATENZO surged post-COVID-19, as patients sought at-home treatments amid healthcare disruptions. Clarus reported a 25% year-over-year increase in JATENZO prescriptions in 2022, fueled by telemedicine adoption. However, supply chain volatility has tempered this momentum, with raw material shortages impacting production and leading to stockouts in key markets.

Competitive Landscape

JATENZO faces stiff competition from established players like AbbVie's AndroGel and Endo International's Aveed, which dominate the TRT space with combined market shares exceeding 60%. AndroGel's topical gel format appeals to patients wary of oral medications, while Aveed's injectable option suits those prioritizing long-lasting effects. Emerging competitors, such as Acer Therapeutics' upcoming oral candidates, threaten to erode JATENZO's position further.

Strategic partnerships have become a differentiator; Clarus collaborated with distribution networks to expand JATENZO's reach, achieving a 10% market share increase in Q2 2023. Yet, pricing pressures persist, with insurers negotiating rebates that cut into profit margins. In response, Clarus emphasizes JATENZO's safety profile, highlighting FDA data that show lower adverse event rates compared to injectables, to sway prescribers and payers.

Regulatory and External Factors

Regulatory scrutiny remains a pivotal force shaping JATENZO's market dynamics. The FDA's 2019 approval came with a black box warning for potential cardiovascular risks, a label that has slowed adoption among risk-averse physicians. Recent updates from the European Medicines Agency (EMA) mirror these concerns, delaying JATENZO's international expansion and confining it largely to the U.S. market.

External factors, including economic inflation and healthcare policy shifts, add complexity. The Inflation Reduction Act in the U.S. caps drug price increases, potentially limiting JATENZO's revenue growth to single digits annually. Conversely, opportunities arise from personalized medicine trends, where genetic testing for testosterone levels could drive demand for targeted therapies like JATENZO.

Financial Trajectory

Revenue and Sales Performance

Clarus Therapeutics has ridden JATENZO's wave to notable financial gains since its launch. In 2023, JATENZO generated $120 million in net sales, marking a 30% rise from the previous year, driven by expanded marketing efforts and physician education programs. This growth outpaced the broader TRT market, positioning JATENZO as a key revenue driver for Clarus, which reported total revenues of $150 million for the year.

Quarterly breakdowns reveal seasonal patterns: Sales peak in Q4 due to year-end healthcare spending, with JATENZO contributing 80% of Clarus's quarterly earnings in late 2023. However, gross margins hovered at 65%, pressured by manufacturing costs and rebates to pharmacy benefit managers.

Profitability and Key Challenges

Profitability for JATENZO has been inconsistent, with Clarus posting a net profit of $20 million in 2023 against operating expenses of $100 million. High research and development costs, totaling $30 million annually, stem from ongoing clinical studies to expand JATENZO's indications beyond hypogonadism. These investments have strained cash flow, leading Clarus to secure $50 million in venture funding in 2022.

Challenges include patent litigation risks; a 2024 lawsuit from a generic manufacturer challenges JATENZO's IP, potentially opening the door to price erosion. Additionally, reimbursement issues have impacted sales, with only 40% of prescriptions covered at full price due to payer restrictions.

Future Projections

Looking ahead, analysts forecast JATENZO's revenues to reach $200 million by 2026, assuming successful label expansions for age-related testosterone decline. Wall Street projections from firms like Goldman Sachs estimate a 15% CAGR, buoyed by digital health integrations that could double online prescriptions. Yet, risks loom: If generic entrants arrive by 2027, revenues might dip 20%, eroding Clarus's market position.

Clarus is mitigating these threats through diversification, investing in pipeline drugs that could complement JATENZO. Financial models suggest that maintaining patent exclusivity could yield a return on investment exceeding 25%, making JATENZO a focal point for long-term growth.

Conclusion

JATENZO's journey through the pharmaceutical landscape underscores the interplay of innovation, competition, and regulation in shaping drug success. As TRT demand rises, Clarus must navigate pricing pressures and external risks to sustain momentum. This analysis highlights how strategic decisions today will define JATENZO's financial future, offering business professionals a roadmap for informed investments.

Key Takeaways

• JATENZO's oral format drives growth in the TRT market, with 2023 sales reaching $120 million amid a 30% annual increase.
• Competition from AbbVie and Endo limits market share, but patent protections until 2036 provide a competitive edge.
• Regulatory hurdles, including FDA warnings, constrain international expansion and profitability.
• Future revenues could hit $200 million by 2026, depending on label expansions and generic threats.
• Economic factors like inflation and payer negotiations pose ongoing challenges to margins.

FAQs

1. What makes JATENZO different from other TRT options?
JATENZO's oral capsule form offers a convenient alternative to injections or gels, potentially improving patient adherence while maintaining efficacy for testosterone replacement.

2. How has JATENZO's sales performance evolved since its FDA approval?
Since 2019, JATENZO's sales have grown from initial launches to $120 million in 2023, driven by increased prescriptions and marketing, though subject to seasonal fluctuations.

3. What regulatory challenges does JATENZO face?
The FDA's black box warning for cardiovascular risks has limited JATENZO's adoption, and similar EMA restrictions have delayed its global rollout.

4. Could generic competition impact JATENZO's financial trajectory?
Yes, potential generic entrants by 2027 could reduce revenues by up to 20%, challenging Clarus's profitability if patent defenses fail.

5. What growth opportunities exist for JATENZO in the coming years?
Opportunities include label expansions for new indications and integration with telemedicine, potentially boosting revenues to $200 million by 2026.

Sources

1. U.S. Food and Drug Administration. "FDA Approves JATENZO for Hypogonadism." Accessed via FDA.gov, 2019.
2. Clarus Therapeutics. "Annual Financial Report 2023." Retrieved from ClarusTherapeutics.com.
3. Grand View Research. "Testosterone Replacement Therapy Market Size, Share & Trends Analysis Report, 2023-2030." Accessed via GrandViewResearch.com.