Last updated: February 24, 2026
What is the Drug Associated with NDC 69238-1421?
NDC 69238-1421 corresponds to Sobi’s Orilissa (elagolix), a gonadotropin-releasing hormone (GnRH) antagonist indicated for the management of endometriosis pain and uterine fibroids. Its primary therapeutic class targets hormonal regulation to suppress estrogen production, reducing endometrial tissue growth.
Market Overview
Current Market Size
The global endometriosis treatment market was valued at approximately USD 930 million in 2022 and is projected to reach USD 1.4 billion by 2027, growing at a compound annual growth rate (CAGR) of 8%. Key drivers include increased diagnosis rates, limited existing non-hormonal options, and a patient preference for minimally invasive therapies.
Key Competitors
- AbbVie’s Orilissa (elagolix)
- AbbVie’s Oriahnn (elagolix + estradiol/norethindrone acetate)
- Ferring’s Linzagolix
- AbbVie’s Gonadotropin-releasing hormone receptor antagonists (GnRH antagonists)
Patent and Regulatory Status
- Orilissa received FDA approval in 2018 for treatment of endometriosis-associated pain.
- The drug's patent protection extended until approximately 2030, with additional formulations and combination therapies under patent or exclusivity considerations.
- Ongoing trials seek approval for broader indications, including uterine fibroids.
Market Penetration
Elagolix, marketed as Orilissa, accounts for roughly 40% of the endometriosis treatment market in the US, with growth driven by:
- Increasing awareness of endometriosis
- A shift toward oral, non-invasive therapies
- Expansion into combination therapies (e.g., with estradiol/norethindrone acetate)
Price Analysis
Current Pricing for NDC 69238-1421 (Elagolix)
- The average wholesale price (AWP) per 30-day supply ranges from USD 950 to USD 1,200.
- Actual negotiated pharmacy or Medicaid prices are typically 20-40% lower.
- The average retail cash price ranges approximately USD 1,080.
Comparative Pricing
| Product |
Formulation |
Monthly Cost (USD) |
Availability |
| Orilissa (elagolix) |
150 mg once daily |
USD 950 - 1,200 |
Commercial and Medicaid |
| Linzagolix (competitor) |
Similar oral dose |
TBD |
Under clinical approval |
| Lupron (leuprolide) |
injectable, depot |
USD 4,000+ annually |
Established alternative |
Pricing Trends and Projections
- The price for Orilissa has remained stable since 2018, with minor fluctuations related to manufacturing costs and payer negotiations.
- Future price reductions are possible due to increased competition and biosimilar entries, expected around 2025-2026.
- Price declines of 10-15% are projected over the next five years, assuming market saturation and generic or biosimilar competition.
Market Potential and Revenue Projections
Sales Forecasts
| Year |
Estimated US Sales (USD millions) |
Key Factors |
| 2023 |
250 |
Growing adoption, expanding indications |
| 2025 |
330 |
Market stabilization, potential price reductions |
| 2027 |
400 |
Increased competition, new formulation approvals |
Assumptions
- Market penetration increases by 5-7% annually through physician adoption and insurance coverage.
- Price erosion occurs as patents expire, or biosimilar products enter the market.
- Expansion into developing markets could add USD 50–100 million over the forecast period.
Risks and Opportunities
- Risks: Patent challenges, biosimilar competition, regulatory delays, insurance restrictions.
- Opportunities: Combination therapies, expanding indications, geographical expansion.
Key Takeaways
- NDC 69238-1421 (elagolix) is a leading therapy for endometriosis, with an established market presence since 2018.
- US market prices hover around USD 950-1,200 per month, likely to decline slightly due to competition.
- Market size is projected to grow at 8% CAGR, with revenues reaching USD 400 million by 2027.
- Competition from biosimilars or oral GnRH antagonists could significantly impact pricing and market share.
- Expansion into uterine fibroids and international markets presents growth opportunities.
FAQs
Q1: What is the primary indication for NDC 69238-1421?
A1: Treatment of endometriosis-associated pain.
Q2: How does the price of elagolix compare to other hormonal therapies?
A2: It is less expensive than injectable options like leuprolide, priced at USD 950–1,200 per month versus USD 4,000+ annually for injectables.
Q3: When might biosimilars or generics enter the market?
A3: Potential entries are expected around 2025-2026, contingent on patent litigations and regulatory approval.
Q4: What are the key factors influencing the growth of the endometriosis drug market?
A4: Increasing diagnosis rates, physician preference for oral therapies, and expanding indications.
Q5: Are there opportunities for price reductions in the future?
A5: Yes, especially with biosimilar competition and market saturation, with an estimated 10-15% decline over five years.
References
- MarketsandMarkets (2022). Endometriosis Market – Global Forecast to 2027.
- U.S. Food and Drug Administration (2018). FDA approves new treatment for endometriosis.
- IQVIA (2022). NDC Product & Pricing Data.
- Patent and exclusivity filings (2018–2022).
