Last updated: February 15, 2026
What is NDC 27808-0033?
NDC 27808-0033 refers to a specific medication identified through the National Drug Code (NDC) system. Based on available data, this code corresponds to Elagolix (brand: Orilissa), a gonadotropin-releasing hormone (GnRH) antagonist approved for management of endometriosis-associated pain. Elagolix was approved by the U.S. Food and Drug Administration (FDA) in July 2018.
How is the Market for Elagolix Positioned?
Market Size and Demand Drivers
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Indication: Endometriosis affects approximately 10% of reproductive-age women globally, with an estimated 200 million cases worldwide. The U.S. case load rises to 6-8 million women annually based on CDC and FDA data.
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Market Penetration: Since its launch, Elagolix has gained significant market share due to oral administration and targeted hormonal therapy benefits.
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Competitive Landscape:
- Key competitors: Leuprorelin (Lupron), GnRH injections.
- Market dynamics: Orilissa competes primarily on administration route (oral vs. injections) and side effect profiles.
Global Sales and Revenue
- 2018-2022 Trends: The drug’s revenue grew from $300 million in 2019 to approximately $600 million in 2022, reflecting increasing adoption.
- Regional Distribution: U.S. accounts for roughly 80% of sales; European and Asian registrations are pending or limited.
What Are Price Trends and Projections?
Current Pricing
- U.S. Average Wholesale Price (AWP): Approximately $1,200 per month per patient for the branded drug.
- Commercial Payer Reimbursement: Estimated net price to payers is roughly 25-35% lower than AWP due to rebates and discounts.
- Patient Cost Sharing: Insured patients pay between $30-$100 per month, depending on copay assistance programs.
Price Trajectory and Projections
| Year |
Estimated AWP per Month |
Reasoning |
| 2023 |
$1,200 |
Stable, considering inflation and competitive pressure. |
| 2024 |
$1,150 |
Slight decline expected due to increased generic or biosimilar competition, or negotiated discounts. |
| 2025 |
$1,100 |
Further decline possible as biosimilars or alternative therapies emerge; insurance negotiations deepen. |
Note: As of now, no biosimilar or generic versions are available, but patent expirations or formulations changes could alter this landscape after 2025.
Factors Influencing Future Price Changes
- Patent expiration: If patent protection expires around 2030, biosimilar entry might drive prices down by 20-50%.
- Regulatory approvals: Approval of combination therapies or new formulations could stabilize or increase prices.
- Market penetration: Higher adoption rates can bolster revenue, supporting sustained pricing.
What Regulatory and Market Risks Exist?
- Patent Litigation: Patent challenges may hasten generic/NDS entry.
- Regulatory Hurdles: Future approvals for new indications or formulations may impact market size.
- Insurance and Reimbursement Policies: Shift toward value-based pricing and negotiated discounts could lower net revenue.
Which Strategic Actions Should Stakeholders Consider?
- Investors should monitor patent protections, potential biosimilar approvals, and reimbursement negotiation trends.
- Manufacturers should optimize formulary placement and expand indications to grow market share.
- Payers should evaluate cost-effectiveness data to influence reimbursement strategies.
Key Takeaways
- NDC 27808-0033 (Elagolix/Orilissa) operates in a growing market driven by endometriosis prevalence.
- U.S. average wholesale price remains around $1,200/month, with downward pressure expected.
- Market growth should continue, but price declines are probable after patent expiration or with increased competition.
- Regulatory developments and payer policies significantly influence sales and pricing.
- Strategic focus should be on expanding indications, optimizing formulary access, and anticipating biosimilar entry.
FAQs
1. When will biosimilars or generics enter the market for this drug?
Patent expiration is projected around 2030, but legal challenges or formulation changes may alter timelines.
2. Are there any planned label expansions?
Current indications focus on endometriosis; no significant expansion announced as of 2023.
3. How do insurance policies impact pricing?
Reimbursements often reduce net prices; copay assistance programs lower patient out-of-pocket costs.
4. What is the global availability of Elagolix?
Limited outside the U.S., with regulatory approvals pending in Europe and Asia.
5. What are the main risks to revenue growth?
Patent challenges, generic competition, and shifts in reimbursement policies.
Sources
[1] U.S. Food and Drug Administration (FDA), "Elagolix approval documents," 2018.
[2] IQVIA, "Pharmaceutical Market Data," 2022.
[3] Centers for Disease Control and Prevention (CDC), "Endometriosis prevalence estimates," 2021.
