Last updated: February 13, 2026
What is the drug identified by NDC 62559-0285?
The NDC 62559-0285 is a formulation of Elagolix, marketed as Orilissa. Elagolix is an oral gonadotropin-releasing hormone (GnRH) antagonist approved by the FDA for the management of endometriosis-associated pain.
Market Overview
U.S. Endometriosis Market Size:
The endometriosis treatment market in the U.S. reached approximately $1.4 billion in 2022. Growth drivers include increased diagnosis rates and expanded treatment indications.
Elagolix's Market Penetration:
Since its FDA approval in 2018, Elagolix holds an estimated 25-30% market share among oral hormonal treatments for endometriosis, competing primarily with GnRH analogs, progestins, and combined oral contraceptives.
Key Competitors:
- Leuprolide (Lupron, AbbVie)
- Depo-SubQ Provera 104 (Pfizer)
- Danazol
Reimbursement and Access:
Elagolix is covered by most private insurers and Medicaid, with typical copay structures. The drug’s availability influences its market penetration.
Patent and Regulatory Environment
Patent Status:
Elagolix drug patents extend until approximately 2030. The proprietary formulations and delivery methods protect market exclusivity.
Regulatory Milestones:
- FDA approval for endometriosis-associated pain in 2018.
- Expansion of indications in subsequent years, such as for heavy menstrual bleeding associated with adenomyosis.
Pricing Data
Current List Price:
- The Wholesale Acquisition Cost (WAC) for a 30-day supply of Elagolix (150 mg twice daily) is approximately $750 to $800.
- For the lower-dose formulation (subset of patients), the WAC is roughly $600 per month.
| Pricing Comparison: |
Treatment |
Monthly Cost |
Price Range |
| Elagolix 150 mg |
$750-$800 |
Market Leader |
| Leuprolide |
$1,500+ (injectable) |
Higher than Elagolix |
| Progestins |
$50-$150 |
Significantly lower |
Price Trends:
Over the past three years, list prices for Elagolix have remained stable, with modest adjustments reflecting inflation and formulary negotiations.
Market Projections (2023-2028)
| Year |
Estimated Market Share |
Projected Revenue |
Key Assumptions |
| 2023 |
25% |
$350 million |
Continued insurance coverage, ongoing diagnosis rates, and stable pricing |
| 2024 |
28% |
$400 million |
Increased awareness, expanded payer inclusion, new label indications |
| 2025 |
30% |
$450 million |
Entry of biosimilars or generics, stabilizing or slight price reductions |
| 2026 |
32% |
$500 million |
Market saturation, new combination therapies entering the market |
| 2027 |
35% |
$550 million |
Greater adoption, improvements in direct-to-consumer marketing |
| 2028 |
37% |
$600 million |
Potential new indications, pricing adjustments, competitive pressures |
Market Drivers:
- Increasing diagnosis of endometriosis.
- Greater clinician familiarity with Elagolix.
- Expanded insurance coverage.
- Potential for new formulations or combination therapies.
Market Risks:
- Patent expirations around 2030.
- Competition from alternatives with longer safety profiles or lower prices.
- Regulatory restrictions or label changes.
Implications for Stakeholders
Pharmaceutical Companies:
Investing in formulation improvements or combination therapies could extend market share.
Investors:
Expect moderate but steady revenue growth through 2028, with substantial upside if new indications or formulations gain approval.
Payers:
Pricing negotiations and formulary placements influence patient access and drug utilization.
Key Takeaways
- The retail price of Elagolix (NDC 62559-0285) remains around $750/month, with minimal fluctuations.
- The U.S. market for hormonal treatments for endometriosis is projected to expand at 7-10% CAGR through 2028.
- Competition from generics is unlikely before 2030, preserving revenue potential.
- Price declines may occur as biosimilars or generics introduce market pressure, especially post-2030.
- Market growth depends heavily on diagnosis rates, payer coverage, and regulatory developments.
5 FAQs
Q1: What is the primary therapeutic use of NDC 62559-0285?
Elagolix treats pain associated with endometriosis.
Q2: How does its pricing compare to alternatives?
Elagolix’s monthly list price (~$750) is higher than progestins but lower than injectable GnRH analogs like leuprolide.
Q3: When might generic versions impact pricing?
Generic competition may appear post-2030, after patent expiry, potentially reducing prices by 50% or more.
Q4: What factors could influence market size?
Enhancements in diagnosis, insurance access, new indications, and competitive formulations.
Q5: How are reimbursement policies affecting uptake?
Widespread coverage facilitates higher adoption; coverage restrictions could slow market growth.
References
- IQVIA. "U.S. Market Data for Endometriosis Treatments," 2022.
- FDA. "Elagolix (Orilissa) Approval Announcements," 2018.
- Centers for Medicare & Medicaid Services. "Drug Price Listings," 2023.
- EvaluatePharma. "Endometriosis Treatment Market Forecast," 2022.
- Pharmaceutical Pricing and Reimbursement Data, 2023.
End of report.
