Last updated: February 23, 2026
What is NDC 27437-0056?
NDC 27437-0056 identifies a prescription drug. It is marketed by Sagent Pharmaceuticals, Inc., with the product labeled as Hydromorphone Hydrochloride Injection, USP. The drug is used for managing severe pain, typically in inpatient settings. It is a generic formulation of hydromorphone, a potent opioid analgesic.
Market Overview
Market Size and Demand
The demand for opiate analgesics like hydromorphone has historically been influenced by opioid prescribing trends, regulatory changes, and pandemic-related shifts in healthcare practices.
- U.S. Market: Hydromorphone products had approximately $200 million in sales annually as of 2022, according to IQVIA data.
- Prescribing Trends: Prescriptions declined from a peak in 2016, due to tighter regulations and CMS initiatives but have plateaued in recent years.
- Hospital Use: Hydromorphone injection remains integral to inpatient pain management protocols, particularly in surgical and trauma units.
Competition
Hydromorphone injection faces competition from:
- Morphine sulfate injection
- Fentanyl formulations
- Other opioid IV formulations
Large manufacturers like Pfizer, Teva, and Fresenius compete alongside generics like Sagent.
Regulatory Environment
The drug operates under strict opioid regulations, influencing manufacturing, distribution, and sales. Changes to federal opioid policies impact market access and demand.
Price Trajectory Analysis
Historical Price Trends
- Minimum wholesale acquisition cost (WAC) for hydromorphone injection ranged from $2.00 to $4.00 per vial in 2020.
- Prices for generic injectable formulations tend to decrease over time due to generic competition, though supply constraints or manufacturing issues can cause price fluctuations.
Current Price Estimates
| Parameter |
Estimated Price (per vial) |
Notes |
| Average WAC |
$2.50 – $3.50 |
Based on recent TPGs and pharmacy data |
| Average ASP |
$3.00 – $4.00 |
Reflects pharmacy discounts and rebates |
| Contract Price |
~$2.00 |
For hospital systems with negotiated agreements |
Forecasted Trajectory (Next 3 Years)
- Price stability expected if supply remains adequate and regulatory pressures stay constant.
- Possible increases of 5-10% if supply disruptions occur, as seen in recent sodium bicarbonate shortages.
- Pricing could decrease further by 10-15% over the next 2 years if additional competitors enter the injectable opioids market or if regulatory measures lower reimbursement rates.
Market Drivers Affecting Pricing
- Supply Chain Stability: Major factor influencing prices. Shortages in 2022 led to price increases.
- Regulatory Changes: Heightened oversight may limit manufacturing or increase compliance costs, affecting price.
- Reimbursement Policies: CMS policies favoring newer or alternative analgesics could pressure price reductions for generics.
Investment and Strategic Implications
- Generic Sterilants: The product’s low-cost profile makes it attractive for hospital formularies, especially if supply levels are stable.
- Market Entry Barriers: Strict manufacturing standards and patent barriers reduce new competitors.
- Pricing Power: Limited, due to the commoditized nature of injectable opioids; manufacturers depend on volume management.
Key Takeaways
- NDC 27437-0056, hydromorphone hydrochloride injection, commands prices generally between $2.00 and $4.00 per vial.
- The market is mature with limited growth but steady demand in hospital settings.
- Price stability is expected under current regulatory and supply chain conditions but remains vulnerable to disruptions.
- Competition from other opioids and generics constrains significant price increases.
- Future pricing depends heavily on regulatory developments, supply chain resilience, and hospital procurement strategies.
FAQs
1. What factors influence the price of hydromorphone injection?
Supply chain conditions, market competition, regulatory changes, and hospital purchasing agreements directly impact prices.
2. How could regulatory changes affect this drug’s market?
Stricter opioid regulations could reduce supply, increase costs, or limit usage, potentially raising prices temporarily or decreasing demand long-term.
3. What are the main competitors to NDC 27437-0056?
Morphine sulfate injection, fentanyl injections, and other generic opioid formulations.
4. What is the outlook for generic injectable opioids over the next five years?
Market saturation and cost competition will likely keep prices stable or lead to slight declines, barring supply disruptions.
5. How does hospital formulary behavior influence pricing strategies?
Hospitals often negotiate bulk purchase discounts, which lower effective prices, and prefer suppliers with consistent supply and quality compliance.
Sources:
[1] IQVIA. (2022). Prescription drug sales data.
[2] U.S. Food and Drug Administration. (2023). Opioid prescribing guidelines.
[3] Medicaid and Medicare reimbursement data.
[4] Drug Shortages Database. (2022). Injectable opioid supply reports.
[5] IMS Health. (2022). Market share analysis.
