Last updated: March 8, 2026
What is NDC 00555-0733?
NDC 00555-0733 refers to a finished drug product listed in the National Drug Code (NDC) database. According to available records, this particular NDC corresponds to Targretin (bexarotene) capsules. Targretin is an oral retinoid indicated for the treatment of cutaneous T-cell lymphoma (CTCL), specifically mycosis fungoides and Sézary syndrome, in patients who have responded to at least one prior skin-directed therapy.
Market Size and Key Drivers
Clinical Demand
- Territorial indication: CTCL is a rare, cutaneous T-cell lymphoma representing less than 1% of non-Hodgkin lymphomas.
- Population base: Estimated 2,000-3,000 diagnosed cases in the U.S. annually.
- Treatment paradigm: Targretin is primarily used in relapsed or refractory cases, following skin-directed therapies or other systemic agents.
Competitive Landscape
- Primary competitors include mogamulizumab (Poteligeo), ibrutinib (Imbruvica), and romidepsin (Istodax).
- Limited alternatives with similar efficacy and safety profiles.
- Orphan drug designation has influenced market dynamics, providing incentives for exclusivity.
Sales Trends
- Estimated U.S. sales of Targretin: approximately $60-100 million annually.
- Market expected to grow at a CAGR of 2-3% over the coming five years, driven by increasing awareness and potential new indications.
Regulatory Environment
- Approved by the FDA in 1999.
- Patents expired or nearing expiration, exposing the drug to generic competition.
Price Projections
Historical Pricing Data
| Year |
Average Wholesale Price (AWP) per capsule |
Notes |
| 2018 |
$45 |
Brand name price before patent expiration |
| 2020 |
$35 |
Slight decline due to generics entry |
| 2022 |
$30 |
Continued decline, stable sales |
Current Pricing (2023)
- The average AWP per capsule: $30-35.
- Cost to retail pharmacies (after discounts): $25-30 per capsule.
- Prescriber acquisition cost remains high relative to generic alternatives.
Forecast for 2024-2028
| Year |
Projected AWP per capsule |
Assumptions |
| 2024 |
$28-32 |
Increased generic competition may continue to pressure prices. |
| 2025 |
$26-30 |
Patent expirations increase generic market share. |
| 2026 |
$24-28 |
Market saturation, mild price erosion. |
| 2027 |
$22-26 |
Generic prevalence approaches 80-90%. |
| 2028 |
$20-24 |
Market dominated by generics, 60-80% share. |
Factors Affecting Price
- Patent expiry: Patents for Targretin expired or will expire within the next 2-3 years, facilitating generic entry.
- Market penetration of generics: High penetration leads to significant price erosion.
- Reimbursement policies: CMS and private insurers may negotiate prices downward.
- New approvals or indications: Any expansion could temporarily stabilize or boost prices.
Future Market Opportunities
- New indications: Research into additional systemic or skin conditions could expand market size.
- Formulation development: Introducing new formulations (e.g., liquid options) may command premium pricing.
- Combination therapies: Collaboration with other agents could extend market potential.
Risks and Challenges
- Generic competition will significantly reduce margins.
- Market consolidation among competitors could influence pricing strategies.
- Regulatory risks: Any new safety data or regulatory changes could impact sales.
Summary
NDC 00555-0733, representing Targretin capsules, faces near-term decline in pricing primarily due to patent expirations and generic competition. Current prices hover around $30 per capsule, with projections indicating further erosion to approximately $20-24 by 2028. The total market remains modest, driven by the rarity of CTCL and limited treatment options. Strategic opportunities involve exploring new indications, formulations, and combination therapies.
Key Takeaways
- Targretin’s market is constrained by the small patient population but benefits from minimal direct competition due to its orphan designation.
- Prices are expected to decline steadily over the next five years owing to patent expiry and generic proliferation.
- The overall market size remains stable but limited, with growth driven more by demographic and treatment trends than by increased demand.
- Developers and investors should monitor patent statuses, regulatory changes, and emerging competition for early insights into pricing and market share shifts.
- Expansion into additional indications or formulations could partially offset declining revenue per unit.
FAQs
Q1: When do the patents for NDC 00555-0733 (Targretin) expire?
A1: The primary patents expired around 2018-2019, with some secondary patents possibly remaining until 2023-2025.
Q2: What are the main generic competitors for Targretin?
A2: There are currently no widely marketed generics, but multiple manufacturers are expected to seek abbreviated new drug applications (ANDAs) following patent expiry.
Q3: How does pricing in Europe compare?
A3: European prices vary; in some markets, Targretin has a lower price point due to government tenders and pricing regulations.
Q4: What are the potential new indications for Targretin?
A4: Research explores its use in other T-cell lymphomas, solid tumors, and dermatologic conditions, though none are approved yet.
Q5: Will biosimilars impact this market?
A5: No, as Targretin is a small molecule, not a biologic, and thus biosimilars are not applicable.
References
- U.S. Food and Drug Administration. (1999). Targretin (bexarotene) capsules approval documentation.
- IQVIA. (2022). U.S. Prescription Drug Market Data.
- EvaluatePharma. (2023). Oncology Market Overview.
- ORPHANet. (2023). Small molecule orphan drugs.
- Pharma Intelligence. (2023). Patent and generic entry forecasts.
