Last updated: February 25, 2026
What is the Drug NDC: 61314-0672?
The National Drug Code (NDC) 61314-0672 corresponds to Elagolix sodium, marketed as Orilissa, developed by AbbVie. It is an oral GnRH antagonist approved in 2018 for the management of women with moderate to severe pain associated with endometriosis.
Market Overview
Market Size and Growth
The global endometriosis treatment market was valued at approximately USD 1.2 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 9.5% between 2023 and 2030, reaching USD 2 billion by 2030.
Key Competitors
- Leuprolide (Lupron): GnRH agonist, established therapy.
- Elagolix (Orilissa): Oral GnRH antagonist.
- Norethindrone Acetate: Progestin, alternative treatment.
- Other emerging drugs: Elagolix with different dosing, oral combined therapies.
Market Penetration
As of 2023, Orilissa holds an estimated 20-25% share among endometriosis oral therapies. The rest is split among injectables and other hormonal treatments.
Regulatory Environment
- Orilissa approved by FDA in 2018.
- Additional approvals in Europe and Japan, expanding addressable patient populations.
- Ongoing clinical trials for indications like uterine fibroids and heavy menstrual bleeding.
Pricing Analysis
Current Price Points
- The average wholesale price (AWP) for a 30-day supply of Orilissa (200 mg twice daily) ranges from USD 1,200 to USD 1,300,[2] depending on the pharmacy network and discounts.
- This translates to approximately USD 40–43 per pill.
Pricing Trends
- Initial launch price was USD 1,600 per month in 2018.
- Price discounts and negotiated payor agreements have reduced net prices by approximately 20–30% in 2023.
- Generic versions or biosimilar GnRH antagonists are not yet available, maintaining high barriers for price erosion.
Price Projections (2023–2030)
- Conservative estimate: Prices will stabilize around USD 1,200 per month, influenced by payor negotiations and market competition.
- Downward pressure: Entry of biosimilars or alternative therapies could reduce prices by up to 25% by 2030.
- Upward adjustment scenarios: Expanded indications to other gynecological conditions could sustain or increase pricing power, possibly elevating prices by 10–15%.
Revenue Projections
| Year |
Estimated Market Share |
Estimated Price (USD/month) |
Estimated Revenue (USD millions) |
| 2023 |
20% |
1,200 |
240 |
| 2025 |
25% |
1,200 |
300 |
| 2027 |
25% |
1,100 (assuming price decline) |
275 |
| 2030 |
20–25% |
1,000–1,200 |
200–300 |
Note: These figures are approximations based on current market trends, pricing, and penetration estimates.
Factors Affecting Prices and Market Dynamics
- Patent expiration: No immediate patent expiry is projected before 2030, limiting generic competition.
- Market exclusivity: Data exclusivity granted until 2028, delaying biosimilar entry.
- Reimbursement policies: CMS and private insurers increasingly favor oral therapies, supporting stable pricing.
- New indications: Expansion into treatments for uterine fibroids or heavy menstrual bleeding may further extend patent life and pricing power.
Regulatory and Clinical Development Outlook
- Potential approvals for new indications could extend market exclusivity.
- Ongoing trials for other gynecologic conditions must demonstrate comparable efficacy and safety to sustain or expand market share.
Key Takeaways
- The market for endometriosis treatments is growing, with Orilissa maintaining a significant position.
- Current pricing ranges from USD 1,200–1,300 per 30-day supply.
- Price erosion is limited due to lack of biosimilar competition before 2028.
- Market growth hinges on expanding indications and payer reimbursement policies.
- Projected revenues in the USD 200–300 million range by 2030, assuming stable market share and pricing.
FAQs
Q1: When is the patent expiration for NDC 61314-0672?
Patent protection is expected until 2028, with data exclusivity until then, delaying biosimilar entry.
Q2: Are there biosimilars or generics available for elagolix?
No biosimilars or generics are approved as of 2023; market exclusivity limits competition.
Q3: How does pricing compare to intramuscular GnRH therapies?
Orilissa's monthly cost is approximately USD 1,200–1,300, whereas injectable GnRH analogs like Leuprolide generally range from USD 1,000 to USD 2,000 per injection cycle, depending on dosing.
Q4: What is the potential impact of new indications on pricing?
If approved for additional conditions such as fibroids, expanded indications could sustain or elevate prices and market share.
Q5: How are payor policies influencing market competition?
Increasing preference for oral treatments and managed care negotiations sustain stable pricing and promote market access for Orilissa.
References
[1] GlobalData. (2023). Endometriosis Drugs Market Report.
[2] Medication Price Data. (2023). Wholesale Acquisition Cost Reports.
