TLANDO Drug Patent Profile

When do Tlando patents expire, and what generic alternatives are available?

Tlando is a drug marketed by Verity and is included in one NDA. There are fourteen patents protecting this drug.

This drug has thirty-seven patent family members in fifteen countries.

The generic ingredient in TLANDO 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 Tlando

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 TLANDO

International Patents:	37
US Patents:	14
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	55
Clinical Trials:	1
Patent Applications:	1,428
Drug Prices:	Drug price information for TLANDO
What excipients (inactive ingredients) are in TLANDO?	TLANDO excipients list
DailyMed Link:	TLANDO at DailyMed

See drug prices for TLANDO

Recent Clinical Trials for TLANDO

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

Sponsor	Phase
Lipocine Inc.	Phase 3

See all TLANDO clinical trials

Pharmacology for TLANDO

Drug Class	Androgen
Mechanism of Action	Androgen Receptor Agonists

US Patents and Regulatory Information for TLANDO

TLANDO is protected by fifteen US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Verity	TLANDO	testosterone undecanoate	CAPSULE;ORAL	208088-001	Mar 28, 2022		RX	Yes	Yes	12,310,978
Verity	TLANDO	testosterone undecanoate	CAPSULE;ORAL	208088-001	Mar 28, 2022		RX	Yes	Yes	10,716,794
Verity	TLANDO	testosterone undecanoate	CAPSULE;ORAL	208088-001	Mar 28, 2022		RX	Yes	Yes	11,364,249
Verity	TLANDO	testosterone undecanoate	CAPSULE;ORAL	208088-001	Mar 28, 2022		RX	Yes	Yes	10,226,473
Verity	TLANDO	testosterone undecanoate	CAPSULE;ORAL	208088-001	Mar 28, 2022		RX	Yes	Yes	9,949,985
Verity	TLANDO	testosterone undecanoate	CAPSULE;ORAL	208088-001	Mar 28, 2022		RX	Yes	Yes
Verity	TLANDO	testosterone undecanoate	CAPSULE;ORAL	208088-001	Mar 28, 2022		RX	Yes	Yes	8,865,695

International Patents for TLANDO

See the table below for patents covering TLANDO around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2744266	COMPOSITIONS STEROIDIENNES (STEROIDAL COMPOSITIONS)
Canada	2942005	ESTERS DE TESTOSTERONE A LONGUE CHAINE LIPOEQUILIBRES POUR UNE ADMINISTRATION ORALE (LIPOBALANCED LONG CHAIN TESTOSTERONE ESTERS FOR ORAL DELIVERY)
China	105073118	Lipobalanced long chain testosterone esters for oral delivery
European Patent Office	3078368	COMPOSITIONS STÉROÏDIENNES (STEROIDAL COMPOSITIONS)
Brazil	112015020849	ésteres de testosterona de cadeia longa lipobalanceados para entrega oral
Canada	3078723	TRAITEMENT ORAL A BASE D'UNDECANOATE DE TESTOSTERONE (ORAL TESTOSTERONE UNDECANOATE THERAPY)
Israel	240958	אסתרים מאוזנים וארוכי שרשרת של טסטוסטרון למתן אוראלי (Lipobalanced long chain testosterone esters for oral delivery)

Market Dynamics and Financial Trajectory for TLANDO

Last updated: July 27, 2025

Introduction

TLANDO (testosterone undecanoate) is an oral testosterone therapy developed for managing male hypogonadism. As a pioneering oral alternative to injectable testosterone formulations, TLANDO's market entry intersects with evolving demand for convenient testosterone replacement therapy (TRT) options, regulatory landscapes, and competitive pressures. A comprehensive analysis of its market dynamics and financial trajectory reveals critical insights for investors, healthcare providers, and pharmaceutical stakeholders.

Market Overview and Demand Drivers

The global hypogonadism treatment market is projected to reach USD 1.12 billion by 2027, expanding at a compound annual growth rate (CAGR) of approximately 6.8% from 2020 (Grand View Research). Growing awareness, aging populations, and lifestyle factors contribute to rising TRT demand. Oral formulations like TLANDO address patient preferences for non-invasive administration and ease of use, fueling their preference in treatment regimens.

Key demand drivers include:

• Aging Male Population: The increase in men aged 40 and above experiencing testosterone deficiency sustains demand.
• Patient Compliance: Oral testosterone options improve adherence compared to injections and transdermal systems.
• Healthcare Shifts: Preference for outpatient therapies reduces healthcare costs, benefitting oral formulations.

Regulatory Landscape and Market Penetration

TLANDO received FDA approval in 2019, marking a significant milestone as the first oral testosterone undecanoate approved in the U.S. The approval was contingent on demonstrating bioequivalence, safety, and efficacy, aligning with regulatory standards for testosterone therapies.

Regulatory challenges include:

• Safety Monitoring: Concerns over cardiovascular risks linked to testosterone therapy necessitate post-marketing surveillance.
• Market Penetration: Despite approval, uptake depends on physician prescribing habits, reimbursement policies, and comparative effectiveness.

In comparison to established injectable and transdermal products, TLANDO's primary competition originates from:

• Injectable testosterone (e.g., testosterone cypionate, enanthate)
• Transdermal gels and patches (e.g., AndroGel, Testim)
• Topical solutions and pellets

Competitive Landscape and Market Share Dynamics

The TRT market is dominated by established brands with extensive marketing channels. TLANDO's entry manifests as a disruptive technology offering a convenience factor. However, its market penetration faces initial hurdles, including:

• Physician Acceptance: Reluctance to prescribe new formulations without long-term data.
• Patient Preferences: Some patients prefer injectable or transdermal routes.
• Pricing and Reimbursement: Cost competitiveness influences adoption rates.

Current Market Position: Early sales figures, as reported by company filings, indicate cautious initial uptake. The strategic focus has included educational initiatives targeting endocrinologists and primary care physicians, emphasizing oral administration benefits.

Financial Trajectory and Revenue Projections

Since its launch, TLANDO's financial performance has been characterized by cautious growth. The initial phase involved significant investments in manufacturing scale-up, marketing, and post-approval studies.

Revenue Drivers:

• Market Penetration Rate: Estimated at approximately 2-3% of the total TRT market in North America within the first two years.
• Pricing Strategy: Premium pricing aligned with convenience, with typical annual costs around USD 3,000–4,000 per patient.
• Reimbursement Coverage: Variable, with more favorable coverage in Medicare and insurance plans adopting newer therapies over older formulations.

Revenue Projections: Based on conservative assumptions:

• Year 1: USD 50 million
• Year 2: USD 100 million
• Year 3: USD 150–200 million (assuming increased physician acceptance and expanded indications)

Forecasts hinge on factors like competitor dynamics, patient acceptance, and regulatory approvals for broader indications. A key consideration is the potential for off-label use and expansion into other hormonal therapy segments, which could stimulate revenue growth.

Risks and Opportunities

Risks:

• Market Saturation: The presence of multiple TRT options limits pricing power.
• Regulatory Challenges: Post-marketing safety concerns may constrain sales.
• Manufacturing & Supply Chain: Scaling production to meet demand could introduce barriers.

Opportunities:

• Expanding Indications: Potential approval for secondary hypogonadism or other endocrine disorders.
• Geographic Expansion: Entry into European, Asian, and emerging markets.
• Combination Therapies: Development of fixed-dose combinations with other hormonal agents.

Conclusion

TLANDO's market dynamics are poised at a critical juncture, balancing the innovation of oral testosterone therapy against established treatment paradigms. Its financial journey depends largely on physician acceptance, reimbursement frameworks, competitive actions, and emerging safety data. While initial revenue momentum remains modest, strategic growth is feasible through market expansion, targeted marketing, and robust clinical data.

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Key Takeaways

• TLANDO offers a convenient oral alternative in a growing TRT market driven by demographic shifts and patient preferences.
• Regulatory approval positioned TLANDO as a first-mover in oral testosterone therapy, but market penetration faces competition from traditional injection and transdermal products.
• Revenue forecasts indicate moderate growth contingent on physician adoption, pricing strategies, and reimbursement patterns.
• Long-term success depends on expanding indications, geographic reach, and robust safety/effectiveness evidence.
• Investors must monitor regulatory developments and market dynamics closely to assess TLANDO's potential trajectory.

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FAQs

1. How does TLANDO differentiate itself from other testosterone therapies?
TLANDO's primary differentiation lies in its oral administration, providing a non-invasive, convenient alternative to injections and patches, potentially improving patient adherence.

2. What are the main barriers to TLANDO's widespread adoption?
Barriers include physician reluctance due to safety concerns, competition from established therapies, cost and reimbursement issues, and limited long-term safety data.

3. What regulatory challenges could impact TLANDO’s market performance?
Post-marketing safety concerns related to cardiovascular risks and the need for ongoing safety surveillance could influence prescribing patterns and market acceptance.

4. What growth strategies could enhance TLANDO’s market share?
Strategies include expanding indications, entering new markets, enhancing physician education, and conducting comparative effectiveness studies to solidify its clinical role.

5. What is the outlook for TLANDO's revenue in the next five years?
Assuming steady market acceptance, revenues could reach USD 150–200 million annually by year three, with potential for further growth through geographic expansion and indication expansion.

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References

1. Grand View Research. Testosterone Replacement Therapy Market Size, Share & Trends Analysis Report [2020–2027].
2. U.S. Food and Drug Administration. FDA Approves First Oral Testosterone Treatment in the U.S., 2019.
3. Company financial filings and press releases regarding TLANDO sales performance.
4. Market analysis reports, including assessments of TRT market segments and competitive landscape.
5. Clinical and regulatory literature on testosterone therapy safety and efficacy.