Market Analysis and Price Projections for TLANDO
Introduction to TLANDO
TLANDO (testosterone undecanoate) is a groundbreaking oral treatment for testosterone replacement therapy (TRT) in adult males, approved by the U.S. Food and Drug Administration (FDA) on March 28, 2022. Developed by Lipocine Inc. using their proprietary Lip'ral drug delivery technology, TLANDO is the first and only oral TRT option that does not require dose titration[4].
Market Size and Growth
The testosterone replacement therapy market is expected to grow at a compound annual growth rate (CAGR) of 3.1% from 2022 to 2027. This growth is driven by increasing awareness of hypogonadism, an aging population, and the introduction of new treatment options like TLANDO[3].
Commercialization and Licensing
As of February 1, 2024, the commercialization of TLANDO in the U.S. has been transitioned to Verity Pharmaceuticals, Inc. under an exclusive licensing agreement. This agreement ensures continuity of patient access to TLANDO and aligns with Verity Pharma's focus on men's health. Lipocine will receive a license fee, development and sales-based milestone payments, and tiered royalties on net sales of TLANDO franchise products[4][5].
Pricing and Cost
TLANDO is available as a brand name drug only, with no generic version currently available. The cost for TLANDO undecanoate 112.5 mg oral capsules is approximately $793 for a supply of 120 capsules, depending on the pharmacy. This price is for cash-paying customers and does not apply to insurance plans[2].
Price Projections
Given the growing demand in the TRT market and the unique positioning of TLANDO as an oral treatment without the need for dose titration, here are some key points to consider for price projections:
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Market Demand: With around 8 million annual prescriptions for TRT in the U.S. and 650,000 in Canada, the market potential for TLANDO is significant. As more patients and healthcare providers become aware of the convenience and efficacy of TLANDO, demand is likely to increase[5].
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Competitive Landscape: TLANDO competes with other TRT products, including injectables and transdermal patches. However, its oral formulation and lack of dose titration requirements could make it more appealing to some patients, potentially driving up demand and stabilizing or increasing prices.
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Licensing Agreement: The licensing agreement with Verity Pharma includes tiered royalties ranging from 12% to 18% on net sales of TLANDO franchise products. This suggests that Lipocine anticipates significant revenue from TLANDO sales, which could influence pricing strategies to maximize profitability[5].
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Regulatory and Market Factors: Any changes in regulatory requirements, insurance coverage, or market competition could impact the pricing of TLANDO. For instance, if more insurance plans cover TLANDO, this could increase demand and potentially stabilize or reduce prices.
Adverse Reactions and Safety Considerations
While evaluating the market and price projections, it is crucial to consider the safety profile of TLANDO. Common adverse reactions include increased blood prolactin, hypertension, increased hematocrit, upper respiratory tract infection, weight increase, headache, and musculoskeletal pain. These factors could influence patient and prescriber preferences, thereby affecting market demand and pricing[1][4].
Future Developments
Lipocine and Verity Pharma are also working on a next-generation product, LPCN 1111 (TLANDO XR), a once-daily oral TRT candidate. The success of this product could further expand the market share of the TLANDO franchise and impact pricing strategies for the current and future products[5].
Key Takeaways
- Growing Market: The TRT market is expected to grow at a CAGR of 3.1% from 2022 to 2027.
- Unique Positioning: TLANDO is the first oral TRT option without dose titration, offering a competitive advantage.
- Pricing: Currently priced around $793 for 120 capsules, with potential for adjustments based on market demand and competition.
- Licensing Agreement: Verity Pharma's involvement is expected to enhance market reach and revenue through tiered royalties.
- Safety Profile: Common adverse reactions need to be considered in market and pricing strategies.
FAQs
Q: What is TLANDO used for?
A: TLANDO is used for testosterone replacement therapy in adult males with conditions associated with a deficiency or absence of endogenous testosterone, such as primary or hypogonadotropic hypogonadism[1][4].
Q: How is TLANDO administered?
A: TLANDO is administered orally, with a recommended dose of 225 mg twice daily with morning and evening meals[1][4].
Q: What are the common adverse reactions associated with TLANDO?
A: Common adverse reactions include increased blood prolactin, hypertension, increased hematocrit, upper respiratory tract infection, weight increase, headache, and musculoskeletal pain[1][4].
Q: Is TLANDO available as a generic?
A: No, TLANDO is currently available only as a brand name drug, with no generic version available[2].
Q: Who is responsible for the commercialization of TLANDO in the U.S.?
A: As of February 1, 2024, Verity Pharmaceuticals, Inc. is responsible for the commercialization of TLANDO in the U.S. under an exclusive licensing agreement with Lipocine Inc.[4][5].
Sources
- Halozyme Announces Commercial Launch of TLANDO™, an Oral Treatment for Testosterone Replacement Therapy - PR Newswire
- Tlando Prices, Coupons, Copay Cards & Patient Assistance - Drugs.com
- Testosterone Replacement Therapy Market Size & Share Analysis - Mordor Intelligence
- Lipocine Announces Continued Commercialization of TLANDO® through Verity Pharmaceuticals - Lipocine Inc.
- Lipocine and Verity Pharma Enter into License Agreement for TLANDO® Franchise in the U.S. and Canada - Lipocine Inc.
