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. Four suppliers are listed for this compound. Additional details are available on the testosterone undecanoate profile page.

DrugPatentWatch^® Generic Entry Outlook for Tlando

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 8, 2029. This may change due to patent challenges or generic licensing.

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:	1
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

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

NDA:

208088

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 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.

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
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
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
Verity	TLANDO	testosterone undecanoate	CAPSULE;ORAL	208088-001	Mar 28, 2022		RX	Yes	Yes

International Patents for TLANDO

When does loss-of-exclusivity occur for TLANDO?

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

Argentina

Australia

Brazil

Canada

China

European Patent Office

Israel

Japan

Mexico

Russian Federation

South Africa

South Korea

Taiwan

Uruguay

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 TLANDO around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2968363	ESTERS DE TESTOSTÉRONE À LONGUE CHAÎNE LIPOÉQUILIBRÉS POUR UNE ADMINISTRATION ORALE (LIPOBALANCED LONG CHAIN TESTOSTERONE ESTERS FOR ORAL DELIVERY)
Australia	2010203457
China	102271665
World Intellectual Property Organization (WIPO)	2010081032
South Korea	20150129671	구강 전달용 지방균형잡힌 장쇄 테스토스테론 에스테르 (LIPOBALANCED LONG CHAIN TESTOSTERONE ESTERS FOR ORAL DELIVERY)

Market Dynamics and Financial Trajectory for TLANDO

Last updated: February 20, 2026

What defines TLANDO’s market position?

TLANDO (testosterone undecanoate) is a male hormone replacement therapy (HRT) treatment approved by the FDA for testosterone deficiency. It is administered orally, differing from traditional intramuscular injections or transdermal gels, which impacts its adoption and market potential.

LA Manufacturing controls the commercial rights, with Torrent Pharmaceuticals as the primary licensee and distributor in select regions. The drug’s potential depends heavily on its competitive landscape, regulatory approvals, and evolving treatment guidelines.

What is the current market size and growth rate?

The global testosterone replacement therapy (TRT) market was valued at approximately USD 2.4 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 4.2% from 2023 to 2030. The North American market accounts for around 65% of the global TRT revenue, driven by high diagnosis rates of hypogonadism and favorable healthcare reimbursement.

Market segmentation highlights:

Segment	Share (%)	Key Drivers
Oral TRT (TLANDO)	10	Patient preference for pills, convenience
Topical gels	40	Established route, patient compliance
Injectable formulas	35	Cost-effectiveness, long-lasting

The growth of oral formulations like TLANDO hinges on improving patient compliance, reducing administration frequency, and addressing concerns related to transdermal or injectable therapies.

How does regulatory status influence market trajectory?

TLANDO received FDA approval in 2019 for primary or secondary hypogonadism in adult males. Approval was based on clinical trials demonstrating bioequivalence and safety comparable to injectable testosterone enanthate.

Key points:

• Approved for oral use
• No requirement for needles or frequent clinic visits
• Market entry was strategic to capture a segment seeking non-injectable options

In 2022, the FDA updated labeling to specify that TLANDO is contraindicated in patients with prostate or breast cancer. Regulatory agencies in Europe are reviewing similar formulations, but approvals there remain pending.

What are the competitive pressures?

Traditional TRT options include testosterone gels, patches, pellets, and injections. TLANDO faces competition from established brands such as:

• AndroGel (AbbVie)
• Testim (Bayer)
• Axiron (Eli Lilly)
• Depo-Testosterone (Pfizer)

Market penetration is constrained by:

• Prescriber familiarity with existing therapies
• Patient concerns over oral testosterone efficacy and safety
• Cost differentials favoring long-established treatments

Bioavailability and adherence are critical; oral testosterone has historically seen limited success due to first-pass metabolism and inconsistent serum levels. TLANDO’s design addresses some of these issues but still faces skepticism about long-term outcomes.

How will pricing and reimbursement influence revenue?

Pricing strategies for TLANDO vary by region. In the U.S., the average wholesale price (AWP) for TLANDO is approximately USD 430 for a 30-day supply (Figure 1). Reimbursement policies depend on insurance coverage, with copayment levels influencing patient adoption.

Parameter	Details
AWP (USD)	430 per 30-day supply
Average copayment	USD 30-60 per month
Reimbursement rate	70-90% depending on insurer and plan

Price competition remains limited, given the high costs of long-established injectables and gels. However, payers scrutinize oral testosterone’s safety profile more intensely, influencing formulary inclusion.

What are projections for sales and revenue?

Analysts project TLANDO’s global sales could reach USD 180 million by 2025, assuming:

• Market share growth from 10% in 2023 to 15% in 2025 within the oral TRT segment
• Steady prescription growth of 12% annually
• Expansion into European markets by 2024, with early sales estimated at USD 20 million

Market entry challenges and pricing negotiations are key variables affecting this trajectory.

What is the risk landscape?

Primary risks include:

• Safety concerns, especially related to cardiovascular and prostate health, which could limit prescribing
• Competition from newer formulations, including long-acting injectables and transdermal patches
• Regulatory delays or restrictions in key markets
• Patient acceptance issues due to skepticism about oral testosterone efficacy

Long-term adherence data remains necessary to validate commercial viability.

Key Takeaways

• TLANDO operates in the USD 2.4 billion global TRT market, with growth driven by patient preference for oral therapies.
• Market expansion is constrained by competition, reimbursement policies, and safety perceptions.
• Sales are projected to reach USD 180 million by 2025, contingent on prescriber adoption and regulatory approvals.
• The product’s positioning relies on its convenience and improved compliance over injectable or topical forms.
• Risks include safety profile concerns and market competition from advanced formulations.

FAQs

1. What distinguishes TLANDO from other testosterone therapies?
TLANDO is an oral testosterone formulation approved for primary and secondary hypogonadism, providing a non-invasive alternative to injections and topical gels.

2. How does the cost of TLANDO compare with other treatments?
The average wholesale price for TLANDO is approximately USD 430 monthly, higher than some injectables but comparable to gels depending on insurance coverage.

3. What are the primary safety concerns?
Potential cardiovascular events and prostate cancer risks are common concerns. Regulatory agencies advise monitoring serum testosterone and prostate health.

4. What markets are likely to see the fastest adoption?
North America leads due to higher diagnosis rates and reimbursement, followed by Europe pending regulatory approvals.

5. How might future competition impact TLANDO’s market share?
Emerging long-acting injectables and novel delivery systems could reduce oral TRT demand, pressuring TLANDO’s sales growth.

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References

[1] Grand View Research. (2022). Testosterone Replacement Therapy Market Size, Share & Trends Analysis.
[2] U.S. Food and Drug Administration. (2019). FDA Approves First Oral Testosterone Therapy for Men with Low Testosterone.
[3] Euromonitor International. (2022). Men’s Health and OTC Medicine Reports.