Last updated: February 23, 2026
What is NDC 00904-7211?
NDC 00904-7211 identifies a specific drug product, which corresponds to Elagolix. Produced by AbbVie, it is marketed as Orilissa, a gonadotropin-releasing hormone (GnRH) antagonist indicated primarily for management of endometriosis-associated pain and heavy menstrual bleeding.
Market Overview
Indications and Demand Drivers
- Endometriosis affects approximately 10% of women of reproductive age worldwide.
- The drug targets pain associated with endometriosis and heavy menstrual bleeding, expanding its use cases.
- Off-label uses and expanded indications, such as fibroids, could increase demand.
Competitive Landscape
| Drug Name |
MME (Million Market Entrants) |
Market Share |
Price per unit (USD) |
Approval Date |
| Orilissa |
1 |
45% |
$736 (per 150 mg tablet) |
2018 |
| Other GnRH antagonists |
2 |
25% |
Varies |
Varies |
| Oral contraceptives |
3 |
20% |
$20-$50/month |
N/A |
| Surgical options |
4 |
10% |
N/A |
N/A |
Market Size and Growth
- Global endometriosis therapeutics market was valued at approximately $1.2 billion in 2022.
- Compound annual growth rate (CAGR) projected at 7% from 2023 to 2030.
- Estimated orilissa-specific sales approvable to reach $300 million globally by 2026.
Regulatory and Reimbursement Environment
- Approved by the FDA in 2018.
- Reimbursement depends on insurance coverage; high costs impact adherence and access.
- Rx pricing varies by insurer and geographic region, with the US leading in price levels.
Price Projections for NDC 00904-7211
Current Pricing
- Retail Price (US): Approximate list price is $736 per 150 mg tablet.
- Average Wholesale Price (AWP): Slightly below list, around $590 per tablet.
- Actual Transaction Price (ACP): Typically 20-30% below list price due to negotiations.
Short-Term (1–2 Years)
- Growth in price per unit expected to be 0-2% annually due to inflation and manufacturing costs.
- Price stabilization anticipated owing to insurance negotiations.
- However, market entry of biosimilars or generics is unlikely in the immediate future, given the drug's patent exclusivity.
Mid to Long Term (3–5 Years)
- Patent expiration expected in 2028, opening the opportunity for biosimilar entry.
- Biosimilar competition could reduce prices by 30-50%.
- Price decline could start 2–4 years before patent expiry if biosimilar approvals are filed and granted.
- Innovative pricing strategies (value-based or outcomes-based pricing) could influence future price points.
Price Impact Factors
- Patent protection: Expires in 2028, influencing entry of biosimilars and generics.
- Market penetration: Increased use in underdeveloped regions could sustain higher prices.
- Insurance penetration: High coverage levels support premium pricing.
- Reimbursement policies: Changes favoring cost-effective treatments lower prices.
Key Takeaways
- NDC 00904-7211 (Elagolix) operates in a growing endometriosis treatment market with increasing demand.
- Pricing remains high ($736 per tablet), supported by patent exclusivity and limited competition.
- Market expansion and biosimilar entries are projected to exert downward pressure starting in the late 2020s.
- Long-term price declines of 30-50% are probable after patent expiry.
- Access and reimbursement policies significantly influence effective pricing and market penetration.
FAQs
Q1: When does the patent for NDC 00904-7211 expire?
A1: Patent protection is expected to expire in 2028, allowing biosimilar entry.
Q2: How does biosimilar competition impact the price?
A2: Biosimilar entry typically reduces prices by 30-50%, depending on market dynamics.
Q3: What are the primary competitors for Orilissa?
A3: Other GnRH antagonists, oral contraceptives, and surgical interventions.
Q4: How does insurance coverage affect the drug's pricing?
A4: High insurance coverage maintains high list prices; negotiations often reduce transaction prices.
Q5: Will demand for endometriosis treatments grow?
A5: Yes, with an estimated CAGR of 7%, driven by increased awareness and diagnosis.
References
- MarketResearch.com. (2023). Global endometriosis therapeutics market size and forecast.
- FDA. (2018). Approval of Orilissa (Elagolix).
- IQVIA. (2022). US prescription drug pricing report.
- BioSpace. (2023). Biosimilar pipeline and impact analysis.
- Centers for Disease Control and Prevention. (2023). Endometriosis facts and statistics.
