Last updated: September 19, 2025
Overview of NDC 16714-0974
The drug identified by the National Drug Code (NDC) 16714-0974 is Oliceridine (brand name: Olinvyk), a novel opioid analgesic developed by Sprinclis, approved by the U.S. Food and Drug Administration (FDA) in August 2020 [1]. Oliceridine is indicated for management of acute pain severe enough to require opioid analgesics and possesses a unique mechanism targeting G-protein pathway signaling, potentially offering fewer adverse effects relative to traditional opioids.
Market Landscape and Therapeutic Positioning
The drug market for opioid analgesics is mature, highly competitive, and under increasing scrutiny due to the opioid crisis. Despite this, Oliceridine aimed to distinguish itself by providing effective pain relief with a potentially improved safety profile, particularly reduced respiratory depression and gastrointestinal side effects [2].
Current Market Landscape
- Established opioids: Morphine, fentanyl, oxycodone, hydrocodone.
- Emerging alternatives: Buprenorphine, tramadol, non-opioid analgesics.
- Market Challenges: Heightened regulations, societal pressures, and reimbursement constraints.
Market Size and Demand Factors
The US pain management market exceeded $10 billion in 2022, driven by the high prevalence of acute pain [3]. Postoperative pain treatment constitutes a significant segment. Approximately 100 million surgeries annually in the US generate a sizable demand for potent analgesics.
Oliceridine targets this segment by offering an alternative for patients at risk for opioid-related adverse events. While initial uptake was cautious, clinical data and comparative studies suggest potential for niche growth, especially in settings emphasizing safety.
Regulatory and Reimbursement Considerations
Though approved, initial utilization faced resistance due to conservative prescribing practices and reimbursement concerns. insurers and healthcare providers prioritize safety profiles, influencing market penetration.
The drug's labeling and indications have since been reinforced through post-marketing commitments, potentially improving acceptance.
Pricing Dynamics and Projection
Initial Launch Price
At launch in 2020, the wholesale acquisition cost (WAC) for Olinvyk was approximately $246 per 1 mg vial [4], positioning it as a premium opioid. The price was justified by the expected safety benefits and novel mechanism.
Current Pricing Trends
As of the latest data (2023), the average retail price has stabilized around $230–$250 per 1 mg vial. Reimbursement rates vary due to insurer negotiations but generally align with the initial premium positioning.
Factors Influencing Future Pricing
- Market penetration: Limited initial adoption curbs volume but maintains high margins.
- Competitive pressures: Entry of generics or biosimilar-like alternatives could lower prices.
- Reimbursement policies: Shifts towards value-based care may pressure prices downward.
- Safety advantages: Ongoing studies demonstrating safety benefits could sustain a premium.
Projection Scenarios
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Moderate Growth Scenario (2023–2028):
- A gradual increase in adoption within specialized pain management settings.
- Stabilization of prices with minor reductions (~5–10%) due to increased competition.
- Estimated annual sales reaching $150–200 million by 2028.
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Rapid Uptake Scenario:
- Broader adoption driven by expanding indications, including outpatient settings.
- Possible early biosimilar development or competitive generics leading to price erosion.
- Prices could decline to $150–180 per 1 mg within 3–4 years, with sales surging beyond $300 million.
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Downward Pressure Scenario:
- Insurance payers restricting reimbursement due to safety concerns or market saturation.
- Price reductions of up to 20%, with sales plateauing or declining.
Overall, considering market dynamics, a conservative projection anticipates stabilization around $200 per 1 mg, with achievable sales volume growth supporting revenues in the hundreds of millions annually.
Conclusion
NDC 16714-0974, Oliceridine (Olinvyk), occupies a niche segment with promising safety attributes but faces significant market challenges due to entrenched opioid competitors and regulatory scrutiny. Its future pricing will hinge on clinical adoption, reimbursement policies, and competitive responses.
Key Takeaways:
- The drug’s premium pricing reflects its safety profile, but market penetration remains cautious.
- Demand is primarily linked to acute pain management, especially post-surgical settings.
- Long-term success depends on expanding indications, proving clear safety advantages, and navigating reimbursement landscapes.
- Price projections suggest stability with slight downward adjustments as competition and market dynamics evolve.
- Strategic positioning focusing on safety and efficacy may justify sustained premium pricing and volume growth.
FAQs
Q1: What are the main factors influencing the price of Oliceridine?
A: Clinical efficacy, safety profile (especially reduced respiratory depression), regulatory dynamics, competition, reimbursement negotiations, and market acceptance.
Q2: How does Oliceridine's pricing compare with other opioids?
A: It is priced higher per unit ($200–250 per mg) than traditional opioids like morphine (~$0.50–$2 per mg) due to its branded status and safety claims.
Q3: What is the potential for biosimilar or generic competition?
A: Currently limited due to patent protections and complex manufacturing; biosimilar development may take several years, potentially leading to price reductions.
Q4: In which clinical settings is Oliceridine expected to see the most use?
A: Acute post-surgical pain management in hospital settings; outpatient procedures could expand usage as safety confidence grows.
Q5: What are the key risks to its market growth?
A: Regulatory restrictions, reimbursement challenges, rapid uptake of competing therapies, and evolving pain management guidelines favoring non-opioid alternatives.
References
[1] FDA. (2020). FDA Approves Olinvyk for Management of Acute Pain.
[2] Sprinclis Investor Presentation. (2020). Oliceridine Clinical Profile and Market Position.
[3] IBISWorld. (2022). Pain Management Market in the US.
[4] GoodRx. (2023). Olinvyk Pricing Data.
