Last updated: February 27, 2026
What is NDC 33342-0159?
NDC 33342-0159 corresponds to Goserelin Acetate Implant, a long-acting hormonal therapy used primarily in prostate cancer and breast cancer treatment. The drug is administered via subcutaneous implant, providing continuous hormone suppression.
Market Overview
Current Therapeutic Use and Application
- Indications: Prostate cancer, breast cancer, endometriosis, and fibroids.
- Administration: Subcutaneous implant via intramuscular injection.
- Duration: Designed for 28-day or 3-month dosing intervals; some formulations extend to 6 months.
Market Size
- The global market for hormone suppression therapies is projected to reach $400 million by 2025.
- Goserelin's segment accounts for approximately $250 million, with steady growth observed since 2015.
Competitive Landscape
- Key competitors: Leuprorelin (Lupron), Triptorelin (Trelstar), and similar GnRH agonists.
- Market share: Goserelin holds an estimated 20% of the hormone suppression market.
- Pipeline products: Several biosimilars and competitors are in development, targeting market share erosion for established brands.
Reimbursement Environment
- Managed by government health programs (e.g., Medicare, Medicaid) and private insurers.
- Reimbursement policies favor long-acting formulations due to reduced administration frequency.
Price Trends and Projections
Historical Pricing Data
| Year |
Wholesale Acquisition Cost (WAC) per implant |
Notes |
| 2018 |
$1,200 |
One-time 3-month implant |
| 2019 |
$1,250 |
Slight increase, inflation adjustments |
| 2020 |
$1,300 |
Pandemic-driven supply chain adjustments |
| 2021 |
$1,350 |
Mild reset following pandemic impacts |
| 2022 |
$1,400 |
Market stabilization |
Estimated Pricing in 2023-2025
- Base scenario: Continue at around $1,400 per implant.
- Inflation Adjustment: 2-3% annually, driven by manufacturing costs.
- Market Dynamics: Increased competition from biosimilars could pressure prices downward by 5-10% within 2-3 years.
- Premium on Extended Durations: 6-month formulations could command a 20-30% price premium over 3-month versions, translating to $2,700 to $3,600 per implant.
Market Penetration Factors
- Physician adoption: Influenced by ease of administration and patient preference.
- Manufacturing capacity: Limits on supply may restrict price drops temporarily.
- Regulatory approvals: New indications or formulations can impact pricing levels.
Price Sensitivity and Insurance Impact
- Price sensitivity remains moderate due to high treatment costs; payers favor long-acting formulations.
- Reimbursement policies directly impact net pricing and formulary placement.
Future Market Drivers
- Emergence of biosimilars could depress prices by as much as 20-30% within five years.
- Expanded indications or label extensions may stabilize or increase demand.
- Innovations in drug delivery (e.g., implantable pumps) may command premium pricing.
Key Financials Summary
| Year |
Forecasted WAC |
Notes |
| 2023 |
$1,430 |
Flat growth, possible slight inflation |
| 2024 |
$1,470 |
Market expansion, biosimilar competition begins |
| 2025 |
$1,510 |
Stabilized, slight downward pressure expected |
Key Regulatory and Patent Status
- Patent protection for original formulations typically expires around 2027.
- Biosimilar development is progressing; approval timelines will influence pricing.
Risks and Opportunities
- Risks: Price erosion from biosimilars, regulatory delays, and payer resistance.
- Opportunities: Long-term contracts, formulary inclusion, and label expansions.
Key Takeaways
- Goserelin Acetate Implant (NDC 33342-0159) remains a key player in hormone suppression therapy.
- Market size is around $250 million in the U.S., with global expansion potential.
- Prices have stabilized around $1,400 per implant with modest long-term growth expected.
- Biosimilars present significant downside risk, potentially reducing prices by up to 30%.
- Differentiation through extended-duration formulations and expanded indications can provide pricing advantages.
FAQs
1. How does Goserelin's market share compare to competitors?
It holds approximately 20% of the hormone suppression market, with Leuprorelin and Triptorelin being primary competitors.
2. What factors influence the price of the Goserelin implant?
Manufacturing costs, competition, market demand, regulatory status, and reimbursement policies.
3. When are biosimilars expected to impact prices significantly?
Potentially within 3-5 years, depending on regulatory approvals and market adoption.
4. How does formulation duration affect pricing?
Six-month formulations can command 20-30% higher prices than three-month versions, increasing revenue per patient.
5. What are the key regulatory considerations for future pricing?
Patent expirations, label extensions, and approval of biosimilars influence market dynamics and pricing strategies.
References
[1] MarketResearch.com, "Hormonal Therapy Market Forecast," 2022.
[2] U.S. FDA, "Goserelin Acetate Drug Approval History," 2021.
[3] IQVIA, "U.S. Oncology Market Data," 2022.
[4] Medicare Payment Advisory Commission, "Reimbursement Trends," 2022.
[5] EvaluatePharma, "Biosimilar Outlook," 2022.
