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. Five 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:	5
Patent Applications:	1,428
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

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
ICON plc	PHASE4
Tolmar Inc.	PHASE4
St. Louis University	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.

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			Y	Y
Tolmar	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-003	Mar 27, 2019		RX	Yes	Yes			Y
Tolmar	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-001	Mar 27, 2019		RX	Yes	No			Y
Tolmar	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-002	Mar 27, 2019		RX	Yes	No			Y	Y
Tolmar	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-003	Mar 27, 2019		RX	Yes	Yes
Tolmar	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-001	Mar 27, 2019		RX	Yes	No

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
World Intellectual Property Organization (WIPO)	2006113505
Australia	2011201422	Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same
China	101217963
Russian Federation	2007142204	ФАРМАЦЕВТИЧЕСКИЕ СИСТЕМЫ ДОСТАВКИ ДЛЯ ГИДРОФОБНЫХ ЛЕКАРСТВЕННЫХ СРЕДСТВ И КОМПОЗИЦИЙ, ИХ СОДЕРЖАЩИХ
Poland	2985026
Japan	5778705

Market Dynamics and Financial Trajectory for JATENZO (Testosterone Undecanoate)

Last updated: December 12, 2025

Executive Summary

JATENZO, an oral testosterone undecanoate developed by Clarus Therapeutics, received FDA approval for the treatment of adult males with hypogonadism in 2019. Its innovative oral delivery system addresses limitations of injectable and transdermal testosterone therapies, promising to reshape treatment paradigms. The drug's market potential hinges on demographic trends, competitive landscape, regulatory considerations, and evolving prescribing practices. This report analyzes these dynamics and projects the financial trajectory for JATENZO over the next five years.

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Introduction to JATENZO

Product Overview

• Active Ingredient: Testosterone undecanoate
• Formulation: Oral, lipid-based softgel capsule
• Approval Date: August 2019 (FDA)
• Indication: Idiopathic hypogonadism in adult males
• Key Benefits: Oral administration, avoiding injections, transdermal patches, gels

Unique Selling Point:

• Oral bioavailability via lymphatic absorption, bypassing first-pass metabolism
• Dosing flexibility akin to daily oral medications
• Potential for improved compliance and patient convenience

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Market Landscape for Testosterone Replacement Therapy (TRT)

Segment	Key Players	Market Share (estimated, 2022)	Delivery Forms	Price Range (per month)
Injectable	Testosterone enanthate, cypionate	~55%	Injectables	$30 - $80
Transdermal	Gels (AndroGel, Testim), patches	~35%	Gels, patches	$300 - $700
Buccal & Pellets	Striant, Testopel	~5%	Buccal, subcutaneous pellets	$200 - $600
Oral (new entrants)	JATENZO, others (e.g., Tlando)	~5%	Oral capsules	$200 - $400

Note: The oral TRT market is nascent but growing, with JATENZO as an early entrant.

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Market Drivers for JATENZO

1. Growing Incidence of Hypogonadism

• Prevalence estimates: 4-5 million American men aged 40+; rising with aging populations [1].
• Market growth rate: Approx. 4-6% CAGR projected globally through 2030.

2. Demand for Non-invasive Administration

• Preference shift away from injections and gels due to convenience, skin irritation, and compliance concerns.
• Oral formulations offer a familiar and simplified regimen.

3. Competitive Advantages

• Oral route with consistent absorption
• Lower risk of transference (e.g., gels transferring through skin/contact)
• Flexibility for dose titration

4. Regulatory Environment

• Strict testosterone scheduling (Schedule III in the U.S.)
• Emphasis on post-marketing surveillance to ensure safety and efficacy

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Competitive Landscape and Challenges

Competitor	Product	Formulation	Market Share	Price (per month)	Status
AbbVie	AndroGel	Transdermal gel	~25%	$600	Established
Endo	Testim	Transdermal gel	~15%	$400	Established
Pfizer	Depo-Testosterone	Injectable	~15%	$80	Established
Sweeping entrants	Tlando (Testosterone capsule)	Oral	N/A	~$250	Approved 2020
Clarus	JATENZO	Oral	Emerging	~$300	Approved 2019

Challenges:

• Competition from established therapies
• Concerns over oral testosterone hepatotoxicity (minimized with current formulations)
• Pricing pressures and reimbursement policies
• Vigilance on cardiovascular and prostate safety profiles

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Financial Trajectory and Market Penetration

Initial Market Penetration (2019-2022)

Year	Estimated Prescriptions	Revenue (USD millions)	Key Factors
2019	20,000	$6	Launch phase, limited awareness
2020	60,000	$20	Growing awareness, new prescribers
2021	100,000	$35	Increased market acceptance
2022	150,000	$50	Expanded provider education

Assumptions: Average monthly dose of $300, prescriptions growing at ~50% annually.

Forecast (2023-2027)

Year	Prescriptions	Estimated Revenue	CAGR	Key Drivers
2023	200,000	$70	40%	Broadened physician acceptance
2024	300,000	$105	50%	Insurance coverage expansion
2025	420,000	$150	43%	Repeat patient growth
2026	560,000	$200	34%	Potential new formulations/utilization
2027	700,000	$250	25%	Market maturation

Potential Revenue Boosters

• Formulation improvements: Extended-release versions
• Combination therapies: Co-administration with other agents
• Global expansion: Europe, Asia markets

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Impact of Regulatory and Policy Developments

• FDA Safety Communications: Ongoing monitoring limits negative impact.
• Pricing Reforms & Reimbursement: Payer negotiations and formulary placements critical.
• Off-label Use Restrictions: Controls on non-approved indications.

Comparative Analysis: JATENZO vs. Alternative TRT Options

Parameter	JATENZO	Gels (e.g., AndroGel)	Injections (e.g., Testosterone Cypionate)
Administration	Oral	Topical	Intramuscular injection
Dosing Frequency	Daily	Daily	Every 2-4 weeks
Absorption Route	Lymphatic	Transdermal	Parenteral
Onset of Action	Rapid	Rapid	Delayed (peak 2 days post-injection)
Safety Profile	Good, minimal liver impact	Skin irritation risk	Fluctuations in serum testosterone

Key: Oral therapy reduces treatment adherence barriers but requires careful safety monitoring.

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Future Opportunities and Risks

Opportunities

• Line extensions: Different dosing regimens, pediatric hypogonadism.
• Digital health integration: Monitoring adherence via apps.
• Combination Therapy: Co-administration with agents enhancing efficacy or reducing side effects.

Risks

• Safety Concerns: Cardiovascular events, prostate health risks.
• Generic Entry: Potential for biosimilar or generic competition.
• Market Saturation: Slow adoption due to conservative prescribing habits.

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Conclusion and Strategic Implications

JATENZO exhibits promising growth prospects as an innovative oral TRT solution. Key success factors include strategic physician education, reimbursement negotiations, and expanding indications. The market size, projected to reach 700,000 prescriptions by 2027, positions JATENZO as a significant player in the evolving testosterone replacement market. However, competition, safety concerns, and policy shifts necessitate vigilant adaptation.

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Key Takeaways

• Market Potential: The oral TRT segment remains underpenetrated, with an estimated CAGR of 40-50% over the next five years.
• Revenue Opportunities: Up to $250 million in annual sales projected by 2027, contingent on market acceptance.
• Differentiation: Oral, patient-friendly regimen serves as a competitive advantage over injections and gels.
• Challenges: Safety protocols, regulatory scrutiny, and payer policies may temper growth.
• Strategic Focus: Emphasize safety data dissemination, broaden indications, and optimize commercial collaborations.

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FAQs

1. How does JATENZO differ from other testosterone therapies?
JATENZO offers an oral formulation that bypasses first-pass liver metabolism via lymphatic absorption, providing convenient, daily dosing—unlike injectables or transdermal patches.

2. What are the safety concerns associated with oral testosterone?
Potential hepatotoxicity, cardiovascular risks, and prostate health issues are areas under close regulatory and clinical scrutiny, though current formulations have minimized liver impact.

3. What is the market outlook for JATENZO?
With expanding awareness and acceptance, prescriptions are expected to grow at a CAGR of ~45%, reaching over 700,000 annually by 2027.

4. What are the main barriers to market penetration?
Established therapies' dominance, safety concerns, pricing pressures, and reimbursement policies can hinder rapid adoption.

5. Will JATENZO face generic competition?
Possible within 5-7 years post-patent expiration, emphasizing the importance of continuous innovation and brand differentiation.

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References

[1] Feldman HA, et al. Prevalence and correlates of hypogonadism in men (J Clin Endocrinol Metab, 2002).