Last updated: February 13, 2026
What is NDC 50881-0007?
NDC 50881-0007 is the National Drug Code identifier for Leuprolide Acetate (brand: Lupron Depot), a gonadotropin-releasing hormone (GnRH) agonist. Used primarily in prostate cancer, endometriosis, and central precocious puberty treatment, it is available in various formulations including depot injections.
Market Overview
Market Size and Key Players
- The global market for GnRH agonists, including leuprolide products, reached approximately $500 million in 2022 (Source: IQVIA).
- The United States accounts for around 60% of this figure due to high prevalence of prostate cancer, endometriosis, and related conditions.
Leading Manufacturers
| Manufacturer |
Market Share (2022) |
Product Variants |
| AbbVie (Lupron Depot) |
70% |
IM Depot injections |
| Tolmar, Endo, Ferring |
Remaining 30% |
Various formulations |
Regulatory Status
- FDA approval for Lupron Depot includes indications for prostate cancer, endometriosis, uterine fibroids, and central precocious puberty.
- Patent protections for branded formulations expire in the late 2020s, opening pathways for biosimilars.
Market Drivers
- Rising aging male population increases prostate cancer prevalence.
- Growing recognition of endometriosis among women of reproductive age.
- Expanding off-label use in other hormonal conditions.
Market Challenges
- Entry of biosimilars and generics threatens price competition.
- Pricing pressure from payers and healthcare systems.
- Supply chain disruptions impact availability.
Current Pricing Landscape
Pricing Benchmarks (2022-2023)
| Formulation |
Average Wholesale Price (AWP) |
Estimated Cost per Dose |
Notes |
| Lupron Depot 7.5 mg IM |
$2,200 |
$2,200 per injection |
Single dose, 1-month duration |
| Lupron Depot 22.5 mg IM |
$5,300 |
$5,300 per injection |
3-month duration |
| Generic/Biosimilar |
$1,800–$2,200 |
Varies |
Available as competition to brand |
Pricing Trends
- The unit price has decreased by approximately 15-20% over the past three years due to biosimilar entries.
- Manufacturers are shifting towards multi-dose and extended-release formulations to maintain margins.
Future Price Projections
| Year |
Projected Price Range (per dose) |
Key Factors Influencing Price |
| 2023 |
$1,800 – $2,200 |
Biosimilar competition, inflation |
| 2024 |
$1,700 – $2,000 |
Increased biosimilar market penetration |
| 2025 |
$1,600 – $1,900 |
Patent expiry for key formulations, cost reductions |
| 2026 |
$1,500 – $1,800 |
Further biosimilar approvals, market saturation |
Note: These estimates assume continued biosimilar launches and generic competition, pressure on pricing, and typical inflation adjustments.
Market Opportunity and Impact of Biosimilars
- Biosimilars for Leuprolide are expected to comprise 30% of the market share by 2024, leading to further price erosion.
- Manufacturers investing in extended-release and novel delivery systems aim to differentiate products and regain pricing power.
- New entrants face regulatory hurdles but could disrupt existing pricing structures if approved and adopted widely.
Regulatory and Commercial Trends
- Biosimilar pathway: FDA approval pathways for biosimilars became clearer post-2015, with more approvals in recent years (e.g., swedish biotech, Pyxis, Coherus).
- Pricing transparency initiatives could pressure list prices downward, especially from payers demanding discounts.
Key Takeaways
- The market for leuprolide (NDC 50881-0007) is mature, with a global value of around $500 million.
- The US dominates the market, particularly for prostate cancer and endometriosis.
- Prices have declined, mainly due to biosimilar entry, with projections indicating further reductions over the next three years.
- Future growth hinges on biosimilar approval, adoption of extended-release formulations, and payer-imposed discounts.
- Market dynamics will strongly influence profitability, with branded products maintaining premium pricing longer in niche indications.
FAQs
1. How will biosimilars impact the market for NDC 50881-0007?
Biosimilars are expected to capture up to 30% of market share by 2024, driving down prices and increasing price competition.
2. What are the primary indications for the drug?
Prostate cancer, endometriosis, uterine fibroids, and central precocious puberty.
3. What is the cost difference between branded and generic/biosimilar versions?
Branded Lupron Depot averages about $2,200 per dose, while biosimilars and generics can cost between $1,800 and $2,200, with some slightly lower.
4. When do patent expirations for key formulations occur?
Patent protections have begun to expire in the late 2020s, which will accelerate biosimilar entry.
5. What is the outlook for new formulations or delivery methods?
Extended-release formulations and novel delivery systems are in development to sustain pricing power and improve patient compliance.
References
- IQVIA Institute. “The Global Use of Medicine in 2022.”
- FDA. “Biosimilar Product Information.”
- Market Research Future. “GnRH Agonists Market Analysis.”
- National Cancer Institute. “Prostate Cancer Statistics,” 2022.
- Healthcare Cost and Utilization Project. “Endometriosis Treatment Trends,” 2022.
