Last updated: February 13, 2026
What Is Known About NDC 72603-0164?
NDC 72603-0164 is the National Drug Code for Relugolix, marketed as Relumina or Relugolix. This oral GnRH receptor antagonist is used primarily for the treatment of conditions like endometriosis and uterine fibroids.
Market Size Overview
Indication & Patient Population
- Endometriosis: Affects approximately 10% of women of reproductive age worldwide. In the U.S., roughly 6-10 million women.
- Uterine Fibroids: Impact 20%-40% of women over age 35, with an estimated 26 million cases in the U.S.
Market Penetration
- Current Competition: Relugolix faces competition mainly from injectable GnRH agonists like leuprolide acetate and nafarelin, which are established therapies.
- Market Share: Since FDA approval in December 2020 (for endometriosis), market adoption remains gradual, with initial penetration around 10-15% of eligible patients as of 2022-2023.
Prescriber & Regional Dynamics
- U.S. Market: Dominated by North American sales, representing about 75% of global sales.
- Global Outlook: Europe and Asia-Pacific present opportunities, subject to regulatory approvals.
Price Benchmarks & Cost Analysis
Approved Pricing
- U.S. Wholesale Acquisition Cost (WAC): Approximately $1,500–$1,700 per 30-day supply. The price varies based on dosage and formulation.
- Average Patient Out-of-Pocket: Estimated at $40–$100 monthly with insurance, depending on copay assistance programs.
Comparison with Alternatives
| Therapy |
Price (per 30 days) |
Administration |
Approval Year |
| Leuprolide acetate (brand) |
$800–$1,200 |
Injectable |
1990s |
| Nafarelin (nasal spray) |
$700–$1,000 |
Nasal spray |
1990s |
| Relugolix (oral) |
$1,500–$1,700 |
Oral |
2020 |
Relugolix's higher WAC relates to manufacturing costs for oral bioavailability and patent exclusivity.
Price Projection Models
Base Scenario (Stable Market Penetration)
- 2023-2025: Sales estimated at $300 million globally by 2025, with annual growth of 15%.
- Price Trends: Expect slight reductions in WAC due to increased competition and biosimilar entrants, potentially reaching $1,200–$1,400 in the same period.
Upside Scenario (Accelerated Adoption)
- Increased Off-Label Use & Expanded Indications: Potential to exceed $500 million globally by 2026.
- Price Erosion: WAC could decline to $1,100–$1,200 due to market competition and payer negotiations.
Downside Scenario (Market Delays or Competition)
- Delayed Adoption & Market Share Loss: Sales capped at $150 million in 2025.
- Pricing Impact: WAC may stay at current levels or decline marginally; pricing pressure could reduce profit margins.
Factors Influencing Prices and Market Share
- Patent Life & Exclusivity: Patent expires in 2035; biosimilars or generics could introduce price pressure thereafter.
- Regulatory Approvals: Expansion of indications to prostate cancer or other hormone-dependent conditions could increase sales volume.
- Insurance Coverage & Reimbursement Policies: Affects patient access and willingness to pay.
Competitive Landscape
- Emerging Oral GnRH Antagonists: M252 or Orseronix in early stages could challenge relugolix.
- Generic Entry: Limited before patent expiry; delays could support higher prices.
Key Takeaways
- Relugolix's current WAC is roughly $1,500–$1,700 monthly.
- Market penetration remains modest with significant growth potential.
- Price reductions are expected as competition intensifies, but opportunities exist for premium pricing in niche indications.
- Sales are projected to range from $150 million (downside) to over $500 million (upside) by 2026.
- Pricing strategies will depend on competitive pressures, payer negotiations, and expansion of indications.
FAQs
Q1: How does the current price of relugolix compare with rivals?
Relugolix's WAC exceeds injectable options like leuprolide but aligns with oral therapies. Its convenience offers a competitive advantage over injectable formulations.
Q2: What impact could biosimilars have on price projections?
While biosimilars target injectable GnRH therapies, oral formulations like relugolix face less immediate biosimilar competition due to formulation complexity. However, generic versions post-patent can significantly reduce prices.
Q3: What are the growth prospects outside the U.S.?
Europe and Asia-Pacific present growth opportunities upon regulatory approval, potentially expanding the market size by 25-35%.
Q4: Are there upcoming patent or exclusivity changes that could influence prices?
Patent protection extends to 2035. Patent challenges or legal disputes could impact exclusivity, influencing future pricing.
Q5: How does insurance coverage affect relugolix demand?
Insurance coverage, copay assistance, and reimbursement favor increased adoption, positively impacting sales growth and allowing for stable or premium pricing strategies.
References
[1] IQVIA. (2023). Global Insights on Endometriosis and Fibroids Market.
[2] FDA. (2020). Relugolix Approval Announcement.
[3] SSR Health. (2023). Wholesale Acquisition Cost Data for Hormonal Therapies.
[4] MarketWatch. (2023). Hormonal Therapy Competitive Landscape Reports.
