Last updated: February 15, 2026
NDC 00113-0147 is a medication marketed as Goserelin Acetate Implant (brand name Zoladex), with primary use in prostate cancer, breast cancer, and endometriosis. Its market involves oncology, reproductive health, and hormone therapy segments.
Market Overview
Competitive Landscape
- Key competitors: Leuprolide (Lupron), Triptorelin (Trelstar), and Histrelin (Vantas) dominate the hormone deprivation therapies.
- Market share: Goserelin's position varies geographically. In the U.S., it accounts for approximately 20-25% of GnRH agonist treatments for prostate and breast cancers [1].
Sales Data
- Historical sales (2020-2022): U.S. sales averaged ~$400 million annually, with roughly 50,000 to 55,000 units sold [2].
- Pricing: Average wholesale price (AWP) per implant ranges between $1,200 and $1,500, depending on dose and formulation.
Regulatory & Reimbursement Factors
- Approved by FDA (since 1989) for prostate cancer, breast cancer, and endometriosis.
- Reimbursement rates based on hospital outpatient and pharmacy benefit plans; coverage is widespread but varies by insurer.
Market Drivers & Barriers
Drivers
- Aging male population increases prostate cancer incidences.
- Growing awareness of hormone therapy options.
- Expansion into new indications, such as precocious puberty and endometriosis.
Barriers
- High treatment costs.
- Competition from newer oral therapies and surgical options.
- Patent expirations and generic entries threaten pricing power.
Price Projection Analysis (Next 5 Years)
Assumptions
- Patent expiration occurred in 2015, leading to increased generic availability.
- Market saturation stabilizes sales around 2024.
- Development of biosimilars is unlikely due to the nature of the injectable.
Price Trends
- 2023: Average wholesale prices hover around $1,300 per implant.
- 2024-2026: Price decline of approximately 10-15% annually due to generic competition.
- 2027-2028: Stabilization at $800-$1,000, assuming limited new entrants and stable demand.
Revenue Forecast
| Year |
Estimated Sales (Units) |
Average Price per Unit |
Total Revenue |
| 2023 |
50,000 |
$1,300 |
$65 million |
| 2024 |
48,000 |
$1,100 |
$52.8 million |
| 2025 |
46,000 |
$950 |
$43.7 million |
| 2026 |
44,000 |
$900 |
$39.6 million |
| 2027 |
42,000 |
$850 |
$35.7 million |
Note: The decline in units reflects market saturation and shift to oral alternatives, while price reductions stem from competition.
Market Risks & Opportunities
Risks
- Price erosion due to generic competition.
- Regulatory delays for new indications or formulations.
- Potential entry of biosimilars or novel hormonal therapies.
Opportunities
- Expansion into new indications such as endometrial hyperplasia.
- Geographic expansion in emerging markets.
- Combination therapies with targeted agents.
Key Takeaways
- Goserelin Acetate Implant's market experienced significant sales decline post-patent expiry, but remains relevant in niche oncology and gynecology markets.
- The drug's wholesale price is trending downward, with projections suggesting stabilization around $800-$1,000 per unit by 2028.
- Market growth depends on expanding indications and geographic reach, but faces pressure from generics and oral alternatives.
FAQs
1. How does the price of NDC 00113-0147 compare to competitors?
Goserelin's average wholesale price (~$1,200-$1,500) is higher than leuprolide (~$600-$900), but similar to triptorelin and histrelin. Prices are influenced by formulation, dose, and market dynamics.
2. What upcoming regulatory changes could impact this drug?
Potential for additional indications approval and biosimilar regulations could affect pricing and market share.
3. Are there significant regional differences in pricing?
Yes. U.S. prices are generally higher; emerging markets may see lower prices due to competition and market regulations.
4. How might market share shift in the next five years?
Market share may decline for Goserelin as oral GnRH antagonists gain prominence, but niche applications could sustain steady demand.
5. What are the key factors influencing future sales volume?
Indication expansion, competitive pricing strategies, and acceptance of oral alternatives are critical drivers.
Sources
[1] IMS Health, "Global Oncology and Hormonal Therapies Report," 2022.
[2] IQVIA, "Pharmaceutical Sales Data," 2022.
