Last updated: March 2, 2026
What is NDC 68968-0172?
The National Drug Code (NDC): 68968-0172 corresponds to Oliceridine, a synthetic opioid marketed as Olinvyk by Avadel Pharmaceuticals. Approved by the FDA in August 2020, Oliceridine is indicated for managing moderate-to-severe acute pain in adult patients. It is administered via intravenous infusion.
Market Overview
Current Market Size
The immediate market for Olinvyk is concentrated in hospitals and outpatient facilities specializing in pain management. The drug's launch followed its FDA approval, with initial sales focusing on major healthcare providers and pain management clinics.
Based on 2022 data:
- Total opioid prescriptions in hospitals: Approximately 160 million units annually (IQVIA, 2022).
- Opioid alternatives in acute pain management: Morphine, fentanyl, hydromorphone, oxycodone.
- Market share for new opioid drugs (2020-2022): Less than 3%, due to the dominance of established opioids and ongoing regulatory scrutiny.
Competitive Position
Oliceridine is positioned as a potentially safer opioid alternative, with a mechanism designed to reduce adverse effects like respiratory depression and gastrointestinal issues common with traditional opioids. However, its market penetration remains limited amid regulatory concerns and clinician familiarity with existing drugs.
Regulatory and Clinical Considerations
- The FDA approved Oliceridine based on its reduced respiratory depression risk profile.
- Several clinical trials show improved safety over traditional opioids, but uptake depends on prescriber education and hospital formulary decisions.
- Insurance coverage and reimbursement policies influence adoption rates.
Price Projections
Current Pricing
As of late 2022, the wholesale acquisition cost (WAC) per vial of Oliceridine ranges from $250 to $400, depending on pack size and pharmacy contracts [1].
- Typical dosing: 1.5 mg to 3 mg per administration.
- Cost per treatment course: Depending on the length and dosing frequency, a 3-day inpatient course could cost $1,200 to $2,000 per patient.
Future Price Trends
Factors influencing price trajectories:
- Market penetration: Higher adoption could lead to volume discounts, lowering per-unit costs.
- Competitive dynamics: Introduction of generic opioids and biosimilars could exert downward pressure.
- Regulatory environment: Stringent opioid regulations could restrict prescribing, potentially limiting volume but maintaining high per-unit prices for specialized use.
- Manufacturing costs: Efficiencies in production could enable price reductions over time.
Projected price ranges over the next three years:
| Year |
Estimated WAC per vial |
Estimated Treatment Course Cost |
| 2023 |
$250 – $370 |
$1,200 – $2,000 |
| 2024 |
$230 – $360 |
$1,100 – $2,000 |
| 2025 |
$220 – $340 |
$1,050 – $1,900 |
(Note: These are estimates based on historical drug pricing trends, market dynamics, and inflationary factors; actual prices depend on negotiations and regulatory shifts.)
Market Growth Projections
Assuming a conservative adoption rate:
- 2023: 10,000 treatment courses globally.
- 2024: 20,000 courses.
- 2025: 40,000 courses.
This growth is modest, constrained by healthcare provider familiarity, regulatory environment, and competitive alternatives.
Total revenue estimates:
| Year |
Revenue Range (at median price of $1,600 per course) |
| 2023 |
$16 million |
| 2024 |
$32 million |
| 2025 |
$64 million |
Assuming no major market disruptions, revenue growth aligns with the increase in treatment courses.
Key Market Risks
- Regulatory constraints: Increased scrutiny over opioid prescriptions could limit market expansion.
- Reimbursement challenges: Payers may restrict coverage based on safety profiles or cost.
- Market competition: Established opioids with lower costs and broader prescriber familiarity might hinder market share growth.
- Formulary positioning: Lack of preferred formulary status can impact sales volume.
Summary
Oliceridine (NDC: 68968-0172) has a niche market focused on safer pain management within acute hospital settings. Its price range remains relatively high compared to traditional opioids due to safety benefits, but market penetration faces significant constraints. Expect modest revenue growth over the next three years, heavily reliant on clinical acceptance and regulatory developments.
Key Takeaways
- Current drug price: $250–$400 per vial; treatment course costs approximately $1,200–$2,000.
- Market share remains limited due to entrenched competition and regulatory barriers.
- Price reductions are possible if market volume increases and biosimilar options emerge.
- Revenue projections suggest a peak of approximately $64 million by 2025 assuming moderate adoption.
- Regulatory and payor policies will significantly influence future market size and pricing dynamics.
Frequently Asked Questions
1. How does Oliceridine compare to conventional opioids in cost?
Oliceridine's higher unit price reflects its safety profile, leading to higher initial costs but potentially lower costs associated with adverse event management.
2. Is there a potential for generic versions of Oliceridine?
Pending patent status and market success, generic development could reduce prices; however, as a novel drug with specific safety features, patent protection may extend for several years.
3. How sensitive are the market projections to regulatory changes?
Substantial; stricter controls could limit prescribing and lower market size, while easing regulations could expand adoption.
4. What is the geographic scope of the market for NDC 68968-0172?
Initially US-focused, with potential expansion into select international markets depending on approval and reimbursement policies.
5. What factors could accelerate market adoption?
Inclusion in clinical guidelines, favorable payor coverage, and demonstrated superior safety profiles could move adoption rates higher than conservative estimates.
References
[1] IQVIA. (2022). Pharmaceutical Market Data.
[2] FDA. (2020). FDA approves Olinvyk (oliceridine) for opioid pain management.
[3] Avadel Pharmaceuticals. (2022). Olinvyk product overview.
