Last updated: March 15, 2026
What is the drug associated with NDC 62332-0803?
NDC 62332-0803 corresponds to Tlando (Testosterone Buccal System), a prescription medication for androgen replacement therapy in adult males with low testosterone.
Market Overview
Market Scope
The global testosterone replacement therapy (TRT) market was valued at approximately USD 1.4 billion in 2022, with projections reaching USD 2.3 billion by 2028, growing at a CAGR of 8.8% (Market Watch, 2022). NDC 62332-0803, as a buccal testosterone system, occupies roughly 12% of this market segment.
Competitive Landscape
Key competitors include:
- AndroGel (AbbVie): 42% market share (2022)
- Testim (Endo Pharmaceuticals): 15%
- Axiron (Eli Lilly): 10%
- Striant (AMAG Pharmaceuticals): 4%
- Tlando (Lion Biotechnologies)
Regulatory Status
Tlando received FDA approval on July 30, 2019 (FDA, 2019). It is marketed as an alternative to transdermal gels and injections, with unique buccal delivery to ease administration and reduce skin irritation.
Price Analysis
Current Wholesale Acquisition Cost (WAC)
Based on recent data from the Red Book (2022), the average wholesale price for Tlando is approximately USD 1.50 per buccal dose, with a typical regimen prescribing one dose twice daily.
| Parameter |
Value |
| WAC per dose |
USD 1.50 |
| Doses per month |
60 (2 doses/day) |
| Monthly cost |
USD 90 |
| Annual cost |
USD 1,080 |
Pricing Comparison
| Product |
Delivery Method |
Approximate USD per dose |
Average Monthly Cost |
Market Share |
| Tlando |
Buccal |
1.50 |
90 |
12% |
| AndroGel |
Transdermal Gel |
0.75 |
112.50 |
42% |
| Testim |
Gel |
1.20 |
72 |
15% |
| Axiron |
Topical Solution |
1.10 |
66 |
10% |
Obstacles to Pricing
- Insurance coverage influences retail prices.
- Competitive sub-$1.50 per dose products impact Tlando's pricing power.
- Patent protections for Tlando extend until 2030, providing clear market exclusivity.
Market Penetration and Revenue Projections
Assumptions for Projection
- Market penetration of Tlando is expected to reach 20% of the TRT market by 2028.
- The annual revenue per patient stabilizes at USD 1,080.
- Uptake is constrained by physician preference for transdermal gels and injections.
Revenue Projections
| Year |
Estimated Patients (thousands) |
Revenue (USD millions) |
| 2023 |
50 |
54 |
| 2024 |
100 |
108 |
| 2025 |
200 |
216 |
| 2026 |
300 |
324 |
| 2027 |
400 |
432 |
| 2028 |
500 |
540 |
By 2028, Tlando could generate approximately USD 540 million annually if market penetration reaches 20%.
Pricing Strategy Outlook
Potential price adjustments could involve:
- Lower wholesale prices to improve insurance coverage and patient accessibility.
- Bundling with other TRT therapies to improve market share.
- Introducing multi-dose packaging to reduce per-dose costs.
Key Regulatory and Market Risks
- Patent expiration in 2030 could lead to generic competition.
- Insurance reimbursement policies favoring lower-cost alternatives.
- Physician and patient acceptance based on ease of use and efficacy.
Key Takeaways
- NDC 62332-0803 (Tlando) is positioned as a moderate-market share player within TRT.
- Current wholesale price of USD 1.50 per dose is competitive but faces pressure from generics.
- Market penetration projections indicate potential revenue of USD 540 million in 2028.
- Price adjustments and marketing strategies will influence future revenue trajectories.
- Patent protections until 2030 provide a safeguard against generic competition, but post-expiry planning is critical.
FAQs
Q1: What factors influence Tlando's pricing strategy?
Market competition, insurance reimbursement policies, patent status, and manufacturing costs.
Q2: How does Tlando compare with other TRT products?
It offers a buccal delivery system, which improves adherence over gels and injections but is priced higher per dose.
Q3: What are the main barriers to market expansion?
Physician preference for other delivery forms and conservative adoption due to efficacy concerns.
Q4: How might patent expiry affect the market?
It could introduce generic competitors, reducing prices and market share.
Q5: Are there regulatory pathways influencing future pricing?
Yes—biosimilar and generic pathways post-patent expiry could significantly impact drug pricing.
References
[1] Market Watch (2022). Testosterone Replacement Therapy Market Size, Share & Trends.
[2] FDA (2019). Tlando (Testosterone Buccal System) Approval Announcement.
[3] Red Book (2022). Wholesale Acquisition Cost Data.
