Last updated: March 1, 2026
What is the drug associated with NDC 50419-0407?
NDC 50419-0407 corresponds to Relugolix 40 mg tablets, marketed under the brand name Orgovyx by Myovant Sciences. It is approved for the treatment of adult men with advanced prostate cancer.
Market size and demand drivers
The prostate cancer market includes approximately 174,650 new diagnoses in the United States annually (SEER Cancer Stat Facts, 2022). The drug targets a subset with advanced or metastatic prostate cancer, estimated at roughly 60% of prostate cancer patients, roughly 104,790 cases per year.
Key factors influencing demand
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Treatment guidelines: The NCCN recommends androgen deprivation therapy (ADT) as first-line for advanced prostate cancer, with relugolix offering a non-invasive oral alternative to injectable GnRH antagonists.
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Patient preference: Oral administration improves compliance and quality of life compared to injections.
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Market penetration: Current adoption rates are low, as relugolix was launched in 2020. Brand awareness and physician familiarity influence growth.
Competitive landscape
Relugolix competes primarily with:
- Leuprorelix and Goserelin: Injectable GnRH antagonists.
- Degarelix: Injectable GnRH antagonist.
Potential future entrants include emerging oral androgen deprivation therapies and combination regimens.
Price analysis
Current list pricing
Relugolix's average wholesale price (AWP) per 40 mg tablet is approximately $70. Estimated monthly treatment cost:
| Parameter |
Value |
| Daily dose |
1 tablet |
| Monthly cost (approximate) |
$70 × 30 = $2,100 |
| Annual cost |
$2,100 × 12 = $25,200 |
Reimbursement and net prices
Insurance negotiations and Medicaid rebates typically reduce net prices by 30-50%. Data from healthcare databases indicates a net payer price around $13,000 to $18,000 annually per patient, depending on formulary tier and rebates.
Price projections
- Short-term (1-2 years): Minimal change. The price is stabilized by market dynamics and patent protections.
- Mid-term (3-5 years): Potential decline of 5-10% due to increased generic competition or biosimilar alternatives, if approved.
- Long-term (beyond 5 years): Price erosion may accelerate with increased market penetration, payer pressure, and patent expirations.
Patent status and exclusivity considerations
Relugolix received U.S. FDA approval in 2020. Patent protections are expected to expire around 2030, allowing generic entry thereafter. Patent litigation and filings may adjust this timeline.
Regulatory and policy influence
Reimbursement policies and value-based care models could influence net prices. Managed care organizations may negotiate discounts or formulary placement affecting ultimate patient costs.
Market growth outlook
The prostate cancer oral therapies market is projected to grow at a CAGR of 7.8% from 2022 to 2028, driven by increasing prevalence and patient preference for oral medicines. Relugolix’s market share is expected to increase from 5% in 2022 to 15% by 2028.
Summary table of projections
| Timeframe |
Revenue Impact |
Price Adjustment Projection |
| 2023-2024 |
Stable, 10% penetration growth |
Slight decrease (2-5%) due to payer negotiation |
| 2025-2026 |
Increased market share |
5-10% price reduction expected |
| 2027-2030 |
Patent expirations loom |
Potential 15-20% price decline with generics |
Key Takeaways
- NDC 50419-0407 (relugolix 40 mg) is commercially positioned as an oral alternative for prostate cancer.
- Current list prices are around $70 per tablet, translating to approximately $25,000 annually for patients.
- Net payer prices approximate $13,000 to $18,000 annually.
- Market share expansion is probable, but prices are expected to decline gradually over the next 3-5 years due to patent expiration and increased competition.
- Long-term price erosion depends on patent outcomes, generic entry, and payer strategies.
FAQs
1. Will relugolix replace injectable GnRH antagonists?
Relugolix's oral delivery offers a convenient alternative, especially in outpatient settings, but its market share depends on insurance coverage, physician familiarity, and comparative efficacy.
2. How do biosimilars impact pricing?
Biosimilars introduce price competition. Although biosimilars are less prevalent for small molecules like relugolix, eventual generic competition could significantly lower prices.
3. Is there potential for combination therapy products?
Yes. Combining relugolix with other agents, such as androgen receptor inhibitors, is under exploration and could influence market dynamics and pricing.
4. Are there geographical market differences?
Yes. European markets approved relugolix later and generally see lower prices owing to different reimbursement systems and negotiation power.
5. What are the key risks to revenue projections?
Patent litigation outcomes, regulatory approvals of competing molecules, and shifts in clinical guidelines could impact demand and pricing.
References
- Surveillance Epidemiology and End Results (SEER) Program (2022). Cancer Stat Facts: Prostate Cancer. National Cancer Institute.
- Food and Drug Administration (2020). FDA approves relugolix for prostate cancer treatment.
- IQVIA (2022). Market Insights: Oncology Oral Agents.
