You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: April 3, 2026

TLANDO Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Tlando, and when can generic versions of Tlando launch?

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

< Available with Subscription >

  Start Trial

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for TLANDO?
  • What are the global sales for TLANDO?
  • What is Average Wholesale Price for TLANDO?
Summary for TLANDO
International Patents:37
US Patents:14
Applicants:1
NDAs:1

US Patents and Regulatory Information for TLANDO

TLANDO is protected by fifteen US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TLANDO is ⤷  Start Trial.

This potential generic entry date is based on patent 11,304,960.

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 12,310,978 ⤷  Start Trial ⤷  Start Trial
Verity TLANDO testosterone undecanoate CAPSULE;ORAL 208088-001 Mar 28, 2022 RX Yes Yes 10,716,794 ⤷  Start Trial ⤷  Start Trial
Verity TLANDO testosterone undecanoate CAPSULE;ORAL 208088-001 Mar 28, 2022 RX Yes Yes 11,364,249 ⤷  Start Trial ⤷  Start Trial
Verity TLANDO testosterone undecanoate CAPSULE;ORAL 208088-001 Mar 28, 2022 RX Yes Yes 10,226,473 ⤷  Start Trial ⤷  Start Trial
Verity TLANDO testosterone undecanoate CAPSULE;ORAL 208088-001 Mar 28, 2022 RX Yes Yes 9,949,985 ⤷  Start Trial ⤷  Start Trial
Verity TLANDO testosterone undecanoate CAPSULE;ORAL 208088-001 Mar 28, 2022 RX Yes Yes 8,865,695 ⤷  Start Trial ⤷  Start Trial
Verity TLANDO testosterone undecanoate CAPSULE;ORAL 208088-001 Mar 28, 2022 RX Yes Yes 11,433,083 ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Patent: 5538
Estimated Expiration: ⤷  Start Trial

Australia

Patent: 10203457
Estimated Expiration: ⤷  Start Trial

Patent: 14232475
Estimated Expiration: ⤷  Start Trial

Patent: 19200097
Estimated Expiration: ⤷  Start Trial

Brazil

Patent: 1007025
Estimated Expiration: ⤷  Start Trial

Patent: 2015020849
Estimated Expiration: ⤷  Start Trial

Canada

Patent: 44266
Estimated Expiration: ⤷  Start Trial

Patent: 42005
Estimated Expiration: ⤷  Start Trial

China

Patent: 2271665
Estimated Expiration: ⤷  Start Trial

Patent: 5073118
Estimated Expiration: ⤷  Start Trial

European Patent Office

Patent: 73295
Estimated Expiration: ⤷  Start Trial

Patent: 68363
Estimated Expiration: ⤷  Start Trial

Patent: 78368
Estimated Expiration: ⤷  Start Trial

Patent: 97762
Estimated Expiration: ⤷  Start Trial

Israel

Patent: 0958
Estimated Expiration: ⤷  Start Trial

Japan

Patent: 58812
Estimated Expiration: ⤷  Start Trial

Patent: 07711
Estimated Expiration: ⤷  Start Trial

Patent: 12514653
Estimated Expiration: ⤷  Start Trial

Patent: 15120700
Estimated Expiration: ⤷  Start Trial

Patent: 16514706
Estimated Expiration: ⤷  Start Trial

Mexico

Patent: 11007351
Estimated Expiration: ⤷  Start Trial

Patent: 15010594
Estimated Expiration: ⤷  Start Trial

Russian Federation

Patent: 22592
Estimated Expiration: ⤷  Start Trial

Patent: 15128028
Estimated Expiration: ⤷  Start Trial

South Africa

Patent: 1507700
Estimated Expiration: ⤷  Start Trial

South Korea

Patent: 2238478
Estimated Expiration: ⤷  Start Trial

Patent: 150129671
Estimated Expiration: ⤷  Start Trial

Taiwan

Patent: 1521731
Estimated Expiration: ⤷  Start Trial

Uruguay

Patent: 445
Estimated Expiration: ⤷  Start Trial

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
World Intellectual Property Organization (WIPO) 2012075081 ⤷  Start Trial
World Intellectual Property Organization (WIPO) 2018098501 ⤷  Start Trial
Russian Federation 2722592 ⤷  Start Trial
Argentina 095538 ⤷  Start Trial
Australia 2010203457 ⤷  Start Trial
World Intellectual Property Organization (WIPO) 2010081032 ⤷  Start Trial
South Korea 102238478 ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

Investment Scenario, Market Dynamics, and Financial Trajectory for TLANDO

Last updated: February 3, 2026

Summary

TLANDO (testosterone Undecanoate) is an oral testosterone replacement therapy (TRT) approved by the U.S. Food and Drug Administration (FDA) in 2019. Its unique oral formulation differentiates it from traditional injectable and topical testosterone treatments, positioning it within a rapidly evolving TRT market. This analysis examines the current market landscape, investment potential, competitive dynamics, revenue estimates, and growth projections for TLANDO.


What is TLANDO and Its Unique Position?

Attribute Details
Generic Name Testosterone Undecanoate
Brand Name TLANDO
Approval Date February 2019 (FDA)
Formulation Oral capsules (30 mg, 40 mg, 60 mg, 80 mg)
Indication Testosterone deficiency (hypogonadism) in adult men
Mechanism Oral prodrug designed for sublingual absorption, bypassing first-pass metabolism

Distinctiveness: Oral administration offers improved patient adherence relative to injectable or topical options, representing a strategic advantage for market penetration.


Market Dynamics

Global and U.S. Market Overview

Metric 2022 Data Forecast Source/Notes
Global TRT Market Size ~$3.3 billion CAGR: 4.2% (2022–2028) MarketsandMarkets[1]
U.S. TRT Market Size ~$1.2 billion CAGR: 4.5% IMARC[2]
Major Products Testosterone gels, patches, injections, oral agents (including TLANDO)

Market Drivers

  • Rising prevalence of hypogonadism, projected to affect 4-5 million men in the U.S. alone (per AUA[3])
  • Growing preference for oral therapies due to ease of use and discretion
  • Increased awareness and screening for low testosterone levels
  • Patent expiration on older injectable and topical formulations

Market Challenges

  • Provider hesitancy over cardiovascular risks associated with testosterone therapy (FDA advisories[4])
  • Variable insurance coverage and reimbursement dynamics
  • Competition from established delivery methods with long-term clinical validation

Competitive Landscape

Competitor Product Formulation Market Share (est.) Key Differentiators
AbbVie AndroGel Topical gel ~35% Established brand, extensive clinical data
Pfizer Depo-Testosterone Injectable ~25% Long-acting injectable, cost-effective
Mylan Testopel Injectable pellet ~10% Sustained release, infrequent dosing
Generic oral options Various Oral capsules Minor, niche Limited market presence

Regulatory and Patent Outlook

  • Original patent expiry for testosterone formulations varies; TLANDO's patent protecting its unique oral delivery expires around 2035 (subject to extensions)[5].
  • The FDA’s stance on testosterone safety influences market entry and acceptance.

Financial Trajectory Analysis

Revenue Estimates and Growth Potential

Parameter 2023 2024 2025 Assumptions
Market Penetration (U.S.) 2% 4% 7% Early adoption, expanding prescriber base
Annual Prescriptions (U.S.) ~60,000 ~120,000 ~200,000 Based on trend and increase in hypogonadism diagnosis
Average Price per Prescription $620 $620 $620 Based on current reimbursement patterns
Estimated Revenue (U.S.) ~$37 million ~$74 million ~$124 million Product adoption, payer reimbursement, physician acceptance

Note: International markets could contribute an additional 10–15% of revenues by 2025.

Cost Structure

Category % of Revenue Notes
R&D 10% Continued clinical studies and post-marketing surveillance
Manufacturing 25% Capsule production costs, scale efficiencies
Marketing & Sales 20% Physician education, advertising, direct-to-consumer campaigns
Regulatory & Compliance 5% Monitoring, adverse event reporting
Profit Margin 15–20% Estimated after accounting for operational costs

Investment Risk Factors

  • Market Adoption: Slow uptake due to provider or patient preferences
  • Regulatory Risks: Potential restrictions based on safety data
  • Competitive Risks: Entry of new oral or alternative delivery methods
  • Safety Profile: Long-term cardiovascular risks could impact demand

Comparison with Competing Therapies

Attribute TLANDO Injectable Testosterone Topical Gel Transdermal Patch
Administration Oral Intramuscular / subcutaneous Topical Transdermal
Dosing Frequency Once daily Weekly/monthly Daily Daily
Onset of Action Fast Variable Rapid Rapid
Patient Preference High Moderate Moderate Moderate
Adverse Events Risks Milder GI, compliance issues Fluctuating testosterone levels Skin irritation Skin irritation

Source: Clinical data review[6]


Market Entry and Growth Strategies

Targeting Key Demographics

  • Men aged 40–65 with hypogonadism symptoms
  • Patients preferring oral therapy over injections or gels
  • Healthcare providers seeking convenient and discreet options

Pricing and Reimbursement Strategies

  • Negotiation with payers for favorable formulary placement
  • Differentiation through educational campaigns emphasizing compliance benefits

Partnerships and Collaborations

  • Licensing agreements with regional distributors
  • Clinical research collaborations to demonstrate long-term safety and efficacy

Regulatory and Policy Environment

  • The FDA’s stance emphasizes cautious marketing due to cardiovascular and PSA concerns
  • Centers for Medicare & Medicaid Services (CMS) reimbursement policies influence adoption
  • Ongoing post-marketing surveillance commitments

Future Outlook and Projections

Year U.S. Market Share Estimated Revenue Key Drivers
2023 2% ~$37 million Initial market penetration
2024 4% ~$74 million Growing prescriber awareness, insurance coverage
2025 7% ~$124 million Expanded indications, increased patient acceptance

Global expansion could double these figures by 2030, driven by emerging markets’ rising prevalence of hypogonadism.


Key Takeaways

  • Market Positioning: TLANDO’s oral formulation provides a patient-preferred alternative in a growing TRT market, with early adoption promising significant growth potential.
  • Growth Drivers: Increasing hypogonadism diagnosis, patient demand for convenience, and marketing efforts will underpin revenue expansion.
  • Competitive Dynamics: While established injectables and topical agents dominate, oral therapies like TLANDO are gaining traction, especially among younger men seeking discretion.
  • Investment Risks: Safety profile concerns, payer reimbursement hurdles, and competitive innovations could challenge growth prospects.
  • Long-term Outlook: With patent protections until 2035 and expanding clinical data, TLANDO has the potential for sustained revenue growth, particularly if safety concerns are mitigated and prescribing patterns solidify.

FAQs

Q1: What differentiates TLANDO from other testosterone therapies?
A1: TLANDO is an oral testosterone undecanoate formulation that bypasses first-pass hepatic metabolism, offering a convenient, discreet alternative to injections and topical applications.

Q2: How does the safety profile of TLANDO compare to injectable testosterone?
A2: Early clinical data indicate a generally favorable safety profile; however, long-term cardiovascular safety remains under ongoing evaluation, aligning with trends seen across TRT options.

Q3: What are the main barriers to TLANDO’s wider adoption?
A3: Provider hesitancy due to safety concerns, insurance reimbursement challenges, and competition from well-established delivery methods serve as primary barriers.

Q4: What is the potential global market for TLANDO?
A4: While predominantly focused on the U.S., approximately 10–15% of revenues could eventually come from international markets, especially in regions with rising awareness of hypogonadism.

Q5: How might future regulatory decisions impact TLANDO’s market trajectory?
A5: Additional safety data and post-marketing surveillance outcomes could influence labeling, prescribing guidelines, and reimbursement policies, either supporting or constraining growth.


Sources

[1] MarketsandMarkets, "Testosterone Replacement Therapy Market," 2022.
[2] IMARC Group, "Global Testosterone Replacement Therapy Market," 2022.
[3] American Urological Association, "Hypogonadism: Prevalence and Management," 2020.
[4] FDA Drug Safety Communication, "Risks of Testosterone Use," 2015.
[5] Patent and patent extension data, 2023.
[6] Clinical trial publications and peer-reviewed articles on TLANDO and TRT safety profiles.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.