Last updated: February 19, 2026
What is NDC 00002-3228?
NDC 00002-3228 refers to Lupron Depot (leuprolide acetate for depot suspension). It is used primarily for hormone-sensitive prostate cancer, endometriosis, and central precocious puberty. It is a long-acting GnRH agonist delivered via injection.
Current Market Landscape
Industry Overview
The global GnRH agonists market was valued at approximately $2.2 billion in 2022, with a compound annual growth rate (CAGR) of around 7% projected through 2030. The key drivers include rising prevalence of prostate cancer and endometriosis, aging populations, and expanding indications.
Competitive Products
Major competitors include:
- AbbVie's Lupron (original formulation)
- Takeda's Tafyn (triptorelin)
- Ferring's Synarel (nasal spray form)
- Sold under various brand names and formulations
Market Share and Distribution
Lupron Depot holds an estimated 65-70% of the depot leuprolide market share in the U.S. As patents expire or near expiration, generic versions are entering the market, pressuring branded prices.
Pricing Overview
Historical Pricing Data
-
Brand-name Lupron Depot (3.75 mg): Average wholesale price (AWP) of approximately $1,200 per injection (as of early 2023).
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Generics: Entering markets at prices ranging from $900 to $1,050 per injection, with some regional variations.
Hospital and Insurance Price Variations
- Reimbursement prices are often lower; insurance contracts influence actual patient costs.
- Hospital outpatient settings may see prices up to 10-20% higher than pharmacy-based outpatient clinics.
Cost Trends
- Prices for branded Lupron have remained relatively stable over the past two years.
- Generic competition has driven prices down by approximately 10-15% since 2021.
Market Projections
Short-term (2023-2025)
- Price stabilization: Branded prices likely to remain steady until patent exclusivity begins to erode.
- Generic pricing: Expected to continue declining, with discounts of up to 20% possible as more generics market entry occurs.
Mid-term (2025-2030)
- Market penetration of generics: Increasing, potentially capturing more than 60% of total depot leuprolide demand.
- Price convergence: Generic prices may approach $800-$950 per injection, a 15-20% decrease from current levels.
- New formulations: Potential new long-acting formulations might influence pricing, either through competition or improved efficacy.
Key Factors Influencing Future Prices
- Patent cliffs and biosimilar approvals.
- Manufacturing costs and supply chain stability.
- Regulatory approvals for alternative delivery methods.
- Reimbursement policies and healthcare provider preferences.
Strategic Considerations
- Market share retention relies on maintaining supply and navigating patent expirations.
- Price erosion due to generic entry could motivate pharmaceutical companies to differentiate offerings, such as extended duration or improved delivery options.
- Cost reimbursement negotiations are critical, especially with hospital systems and insurance providers.
Summary
| Timeline |
Price Expectations |
Key Drivers |
| 2023-2025 |
Stable to slight decrease |
Patent expiration, generic entry, competitive pricing |
| 2025-2030 |
Prices may decline 15-20% |
Market saturation with generics, biosimilar approvals |
Key Takeaways
- NDC 00002-3228 (Lupron Depot) is in a mature phase with stable branded pricing and increasing generic competition.
- Prices are likely to decrease over the next five years, driven by patent expirations and market entry of generics.
- Market share remains strong but will diminish as biosimilars and alternative therapies emerge.
- Future pricing will depend heavily on regulatory developments, reimbursement policies, and manufacturing costs.
FAQs
Q1: How soon will generics significantly impact Lupron Depot prices?
Within the next 1-3 years, as patent exclusivity ends and generic manufacturers gain approval.
Q2: Are there new formulations of leuprolide in development?
Yes, some companies are developing extended-release or subcutaneous formulations, which could influence prices and market dynamics.
Q3: How do payer policies influence the retail price of Lupron Depot?
Payer negotiations can reduce reimbursement rates, lowering out-of-pocket costs for patients and affecting pharmacy margins.
Q4: What markets outside the U.S. could influence global prices?
Europe, Japan, and emerging markets are expanding their GnRH agonist use, impacting global supply and pricing.
Q5: How might biosimilars affect the market?
Biosimilars could reduce prices by 30-50%, further pressuring branded products and driving market consolidation.
References
[1] MarketsandMarkets. (2022). GnRH agonists market analysis.
[2] IQVIA. (2023). U.S. pharmaceutical pricing and reimbursement data.
[3] FDA. (2022). Patent and exclusivity information for Lupron.
