~ Buy the TLANDO (testosterone undecanoate) Drug Profile, 2024 PDF Report in the Report Store ~

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 thirteen patents protecting this drug.

This drug has thirty-six 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. Six 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 March 28, 2025. 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:	36
US Patents:	13
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	55
Clinical Trials:	1
Patent Applications:	1,479
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

Constraining patent/regulatory exclusivity:

NEW PRODUCT

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 fourteen US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW PRODUCT.

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	11,433,083
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	12,011,503		Y
Verity	TLANDO	testosterone undecanoate	CAPSULE;ORAL	208088-001	Mar 28, 2022		RX	Yes	Yes	9,943,527

International Patents for TLANDO

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

Country	Patent Number	Title	Estimated Expiration
Australia	2010203457	Steroidal compositions
Canada	2744266	COMPOSITIONS STEROIDIENNES (STEROIDAL COMPOSITIONS)
European Patent Office	2373295	COMPOSITIONS STÉROÏDIENNES (STEROIDAL COMPOSITIONS)
South Korea	20150129671	구강 전달용 지방균형잡힌 장쇄 테스토스테론 에스테르 (LIPOBALANCED LONG CHAIN TESTOSTERONE ESTERS FOR ORAL DELIVERY)

TLANDO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TLANDO

Introduction

TLANDO, an oral testosterone replacement therapy (TRT) developed by Lipocine and commercialized by Antares Pharma, has marked a significant milestone in the treatment of hypogonadism. Here, we delve into the market dynamics and financial trajectory of this innovative drug.

FDA Approval and Market Entry

In March 2022, the FDA approved TLANDO, an oral formulation of testosterone undecanoate, for the treatment of hypogonadism in adult males. This approval was a crucial step, as it introduced a convenient oral dosing option that does not require titration or injection, setting it apart from other TRT therapies like Xyosted, a weekly subcutaneous auto-injector also by Antares[1][3][4].

Commercial Launch and Sales Strategy

The commercial launch of TLANDO began in the second quarter of 2022. Antares Pharma expanded its sales force to 108 representatives to drive adoption, leveraging relationships with urologists and endocrinologists. This strategic move was aimed at capitalizing on the existing commercial infrastructure and physician relationships established through the success of Xyosted[1][3].

Market Positioning

TLANDO's oral formulation and convenient dosing schedule are key differentiators in the TRT market. Unlike other treatments that require injections or constant monitoring of testosterone levels, TLANDO offers a user-friendly alternative. This differentiation is expected to drive market share gains for Antares Pharma in the growing TRT therapeutic category[1][3].

Financial Projections and Performance

Analysts from Cantor Fitzgerald projected peak sales of TLANDO at $175 million by 2030, with Lipocine expected to receive $52 million in royalties and milestones. These projections underscore the potential financial impact of TLANDO on both Antares and Lipocine[1].

In the initial year following its launch, TLANDO contributed to the overall revenue growth of Antares Pharma. For instance, Xyosted, another TRT product by Antares, saw a 34% increase in sales from 2020 to 2021, reaching $62.2 million. The addition of TLANDO was expected to further bolster these figures[1].

Licensing and Commercialization Transition

In a strategic move, Lipocine transitioned the commercialization of TLANDO to Verity Pharma in 2024. This deal included an upfront license fee of $11 million, with additional payments due in 2025 and 2026. This structure provides Lipocine with immediate liquidity and a structured cash inflow, which can improve its financial health and operational efficiency[2].

Research and Development Expenses

Lipocine's financial reports indicate an increase in research and development expenses related to TLANDO manufacturing and other clinical studies. For the third quarter of 2023, research and development expenses were $2.9 million, up from $2.1 million in the same period of 2022. These costs reflect ongoing efforts to support TLANDO and other pipeline products[5].

General and Administrative Expenses

General and administrative expenses also saw an increase, primarily due to higher business development expenses, professional services, and legal fees. These increases were partially offset by decreases in other areas such as corporate insurance expenses[5].

Revenue and Operating Loss

Despite the positive market dynamics, Lipocine reported a net loss of $6.7 million for the third quarter of 2023. The total revenues were impacted by the reversal of variable consideration related to minimum guaranteed royalties, resulting in a net operating loss of $7.0 million for the quarter[5].

Future Growth and Market Share

The approval and commercialization of TLANDO reinforce Antares Pharma's commitment to the TRT market and its potential to drive share gains. With an expanded commercial portfolio including both TLANDO and Xyosted, Antares is well-positioned to continue its growth in this therapeutic category. Lipocine, with its focus on R&D and multiple pipeline products, is also poised for future success[1][3].

Key Takeaways

• FDA Approval: TLANDO received FDA approval in March 2022, offering an oral TRT option without the need for titration or injection.
• Commercial Launch: Launched in the second quarter of 2022, with an expanded sales force to drive adoption.
• Market Differentiation: TLANDO's oral formulation and convenient dosing differentiate it from other TRT therapies.
• Financial Projections: Projected peak sales of $175 million by 2030, with significant royalties for Lipocine.
• Licensing Transition: Commercialization transitioned to Verity Pharma in 2024, providing immediate liquidity and structured cash inflows.
• R&D and Administrative Expenses: Increased expenses related to TLANDO manufacturing and other clinical studies.

FAQs

What is TLANDO and how is it administered?

TLANDO is an oral testosterone replacement therapy (TRT) indicated for adult males with conditions associated with a deficiency or absence of testosterone. It is administered orally, twice daily, and does not require titration or injection.

Who are the key players involved in the development and commercialization of TLANDO?

The key players are Lipocine, the developer, and Antares Pharma, the initial commercial partner. In 2024, the commercialization was transitioned to Verity Pharma.

What are the financial projections for TLANDO?

Analysts project peak sales of $175 million by 2030, with Lipocine expected to receive $52 million in royalties and milestones.

How does TLANDO differentiate itself in the TRT market?

TLANDO differentiates itself through its oral formulation and convenient dosing schedule, which does not require titration or injection, setting it apart from other TRT therapies.

What is the impact of the commercialization transition to Verity Pharma on Lipocine?

The transition provides Lipocine with an upfront license fee and structured cash inflows, improving its financial health and operational efficiency. It also allows Lipocine to focus on its core competency in R&D.

Sources

1. FiercePharma: Antares, Lipocine expand testosterone therapy offerings with FDA nod for Tlando.
2. StockTitan: Lipocine Announces Continued Commercialization of TLANDO.
3. BioSpace: Antares Pharma Announces FDA Approval Of TLANDO™, an Oral Treatment for Testosterone Replacement Therapy.
4. PR Newswire: Halozyme Announces Commercial Launch of TLANDO™, an Oral Treatment for Testosterone Replacement Therapy.
5. Lipocine IR: Lipocine Announces Financial Results for the Third Quarter Ended September 30, 2023.