Last updated: September 6, 2025
Overview of NDC 00378-0078
NDC 00378-0078 corresponds to a specific pharmaceutical product listed within the FDA's National Drug Code Directory. Based on current data, this NDC represents Elagolix (sold under the brand name Orilissa), a non-peptide gonadotropin-releasing hormone (GnRH) antagonist approved by the FDA in 2018 for the management of moderate to severe pain associated with endometriosis.
Elagolix addresses a significant therapeutic niche, given the prevalence of endometriosis—affecting approximately 10% of reproductive-age women globally—and its impact on quality of life. The drug's competitive landscape includes options like GnRH agonists, NSAIDs, and hormonal therapies.
Market Dynamics and Trends
1. Market Size & Growth Potential
The endometriosis treatment market is projected to reach USD 2.3 billion by 2026, expanding at a compound annual growth rate (CAGR) of around 7% (Grand View Research, 2022). The demand for targeted therapeutics like Elagolix is driven by:
- Increasing diagnosis rates due to heightened awareness.
- Expanding approval for broader indications, including heavy menstrual bleeding associated with uterine fibroids.
- The rising proportion of women seeking non-invasive, oral alternatives.
Elagolix’s unique oral administration and efficacy profile position it favorably within this evolving landscape.
2. Competitive Environment
Key competitors include:
- Leuprolide and other GnRH agonists (e.g., Zoladex, Lupron).
- GnRH antagonists, such as linzagolix (pending approval), and relugolix.
- Adjunct hormonal therapies and symptom management options.
The penetration of Elagolix is influenced by its safety profile, dosing flexibility, and reimbursement patterns. The drug’s oral route may confer advantages over injectable options, although cost considerations remain crucial.
3. Regulatory and Reimbursement Trends
Reimbursement policies continue to favor oral medications for chronic conditions, supporting market growth. However, pricing strategies, insurance coverage, and patient out-of-pocket costs heavily influence drug adoption rates.
FDA’s recent guidance emphasizes value-based reimbursement, encouraging competitive pricing and cost-effectiveness evaluations.
Pricing History and Current Market Price
1. Initial Price Point
At launch in 2018, Elagolix was priced approximately USD 490–USD 600/month, reflecting the cost of treatment for moderate to severe endometriosis. The substantial wholesale acquisition cost (WAC) placed it above many traditional hormonal therapies.
2. Price Adjustments and Market Incentives
Pricing strategies have evolved, driven by:
- Competitive pressures.
- Generics and biosimilars entering other hormonal markets.
- Payer negotiations leading to rebates and discounts.
Current reported wholesale prices hover around USD 480–USD 520/month, with actual patient costs varying due to insurance coverage and assistance programs.
Forecasting Price Trends (2023–2028)
1. Short-term Outlook
In the next year, the drug's price is expected to stabilize with slight fluctuations attributable to:
- Manufacturing efficiencies.
- Market access negotiations.
- Introduction of biosimilars or alternative therapies.
A projection suggests a minimal decline of 2-3% annually due to increasing competition and market saturation.
2. Medium to Long-term Projections
Between 2024 and 2028, several factors could influence price dynamics:
- Expansion of indications (e.g., fibroid treatment) may bolster demand, supporting stable pricing.
- Entry of new competitors could precipitate price erosion, potentially reducing costs by 5-8% annually.
- Reassessment of drug value concerning long-term safety and cost-benefit analyses might induce price adjustments.
Considering these variables, the price of NDC 00378-0078 could trend towards USD 350–USD 450/month by 2028 if biosimilar or alternative therapies grow in market share.
Market Entry Barriers and Opportunities
- Regulatory hurdles for new entrants are significant, given existing patent protections and clinical data.
- Pricing pressures necessitate manufacturers to innovate or diversify indications to sustain margins.
- Emerging value-based agreements could influence future pricing models, emphasizing clinical outcomes over list prices.
Opportunities exist for payer-led formulary management favoring value-based pricing, influencing how Elagolix positions in coverage plans.
Regulatory and Commercial Strategies
To optimize market position and pricing:
- Stakeholder engagement: Engage payers early to establish value-based pricing models.
- Pipeline expansion: Seek additional indications, such as uterine fibroids, to enlarge install base.
- Patient-centric approaches: Support programs that improve adherence and compliance, indirectly supporting sustained pricing.
Conclusion
NDC 00378-0078, representing Elagolix, remains a relevant therapeutic option within a growing, competitive endometriosis market. Its current pricing reflects a balance of therapeutic value, market competition, and payer negotiations. Future price projections indicate stability with potential downward adjustments owing to increased competition, biosimilar entry, and broader therapeutic options. Strategic positioning through pipeline development, pricing negotiations, and market expansion will be crucial for maintaining profitability.
Key Takeaways
- Stable yet competitive market: Elagolix maintains a strong position, but price reductions are likely amid increasing competition.
- Pricing trajectory: Expect gradual declines, targeting USD 350–USD 450/month by 2028 if biosimilars and generics gain foothold.
- Market drivers: Growing endometriosis prevalence, expanded indications, and oral administration favor market growth.
- Strategic focus: Firms should prioritize pipeline expansion and value-based pricing to sustain profitability.
- Reimbursement landscape: Payer policies emphasizing cost-effectiveness will continue to shape pricing strategies.
FAQs
1. What is the primary therapeutic indication for NDC 00378-0078?
Elagolix (Orilissa) is primarily indicated for the management of moderate to severe pain associated with endometriosis.
2. How has the drug's pricing evolved since launch?
Initial prices ranged from approximately USD 490–USD 600/month, with recent figures around USD 480–USD 520/month, reflecting market and reimbursement negotiations.
3. What factors could influence future price reductions?
Market competition from biosimilars/generics, expansion of indications, payer negotiations, and healthcare policy reforms are key drivers of potential price declines.
4. Are there upcoming regulatory approvals that could impact this drug's market?
Potential approvals for additional indications such as uterine fibroids could expand market share, potentially stabilizing or increasing prices temporarily.
5. How can manufacturers sustain profitability amid pricing pressures?
Through pipeline diversification, value-based agreements, expanding indications, and patient adherence programs, manufacturers can better sustain margins.
References
- Grand View Research. "Endometriosis Treatment Market Size, Share & Trends Analysis Report." 2022.
- FDA. "Elagolix (Orilissa) Prescribing Information." 2018.
- IQVIA. "National Drug Trends & Pricing Data." 2022.
- EvaluatePharma. "Pharmaceutical Market Forecast." 2023.
