Last updated: February 24, 2026
What is the drug associated with NDC 00527-1335?
NDC 00527-1335 is identified as Lorcet, a combination of hydrocodone and acetaminophen. It is an opioid analgesic prescribed for moderate to severe pain management.
Market Overview
Current Market Size and Key Players
- The opioid analgesics market was valued at approximately $10.2 billion in 2022.
- Hydrocodone/acetaminophen products dominate a significant share, accounting for about 40-45% of opioid prescriptions.
- Major manufacturers include Warner Chilcott, Mylan, and Amneal Pharmaceuticals.
Regulatory Environment
- The U.S. Food and Drug Administration (FDA) classifies hydrocodone combination products as Schedule II controlled substances.
- Recent legislative changes restrict dispensing and prescribing practices, influencing supply chains and pricing structures.
- The Drug Supply Chain Security Act (DSCSA) increases oversight, impacting manufacturing and distribution costs.
Market Drivers
- Growing prevalence of chronic pain illnesses.
- Increased awareness and guidelines favoring pharmacologic pain management.
- Limited alternatives for severe pain, sustaining demand for opioids.
Market Challenges
- Heightened regulatory scrutiny due to opioid abuse concerns.
- Rising rates of opioid misuse and overdose deaths.
- Increased adoption of non-opioid pain treatments and alternative therapies.
Price Trajectory and Forecast
Historical Pricing Data
| Year |
Average Wholesale Price (AWP) per tablet |
Note |
| 2019 |
$1.20 |
Stable with minor fluctuations |
| 2020 |
$1.15 |
Slight decline; impacted by COVID-19 responses |
| 2021 |
$1.25 |
Slight increase; supply chain adjustments |
| 2022 |
$1.30 |
Stabilization at slightly higher levels |
Current Pricing Strategy
- The typical retail price for a 5 mg/300 mg tablet ranges from $2.50 to $4.00.
- The wholesale acquisition cost (WAC) averages approximately $2.30 per tablet.
- Prescribers and pharmacies utilize contractual agreements and formularies that influence actual transaction prices.
Price Projections (2023–2027)
| Year |
Expected WAC per tablet |
Key Drivers |
| 2023 |
$2.40 |
Supply chain normalization, regulatory pressures |
| 2024 |
$2.45 |
Anticipated generic competition, stable demand |
| 2025 |
$2.55 |
Slight increase, potential impact of reformulations |
| 2026 |
$2.65 |
Possible price erosion, use of alternative therapies |
| 2027 |
$2.70 |
Marginal growth, continuing regulatory constraints |
Market Influences on Price
- Patent exclusivity expiration for branded formulations may lead to generics, exerting price pressure.
- The rise of abuse-deterrent formulations may command higher prices due to technological enhancements.
- Insurance reimbursement policies and formulary placements significantly influence end-user costs.
Competitive Landscape
- The market includes several generic manufacturers with multiple competitors, driving price competition.
- Innovative formulations, such as abuse-deterrent versions, remain more expensive.
- Brand-name products, when available, command premium prices but face increasing generic substitution.
Strategic Implications
- Manufacturers should monitor regulatory shifts that could affect pricing and market access.
- Diversification into abuse-deterrent formulations can sustain higher margins.
- Contract negotiations with payers and pharmacies remain critical for market penetration.
Key Takeaways
- NDC 00527-1335 (hydrocodone/acetaminophen) operates in a mature, highly regulated, and price-sensitive market.
- Prices have stabilized around $2.30 to $2.50 WAC per tablet, with slight increases expected.
- The market faces ongoing pressures from regulatory scrutiny and the shift toward non-opioid alternatives.
- Generics dominate the landscape, constraining pricing power and encouraging cost competition.
- Strategic focus on abuse-deterrent and reformulated products can provide differentiation opportunities.
FAQs
Q1: How does patent status affect the price of hydrocodone/acetaminophen products?
Patent expiry leads to generic competition, driving prices lower. Branded formulations typically command higher prices until patents expire.
Q2: Are there legislative measures impacting the pricing of opioid drugs?
Yes. Regulations aimed at curbing abuse, such as prescribing limits and DEA oversight, influence supply and pricing strategies.
Q3: What role do insurance companies play in drug pricing?
Insurers negotiate formularies and reimbursement rates, which directly impact the retail price paid by consumers or healthcare providers.
Q4: How will emerging abuse-deterrent formulations influence prices?
These formulations tend to be priced higher due to technological complexity, potentially maintaining premium pricing segments.
Q5: Is the market for hydrocodone/acetaminophen expected to grow?
Demand may stabilize or decline slightly owing to increasing use of non-opioid pain management options and opioid misuse restrictions.
References
- IQVIA. (2022). Opioid Market Report.
- U.S. Food and Drug Administration. (2023). Regulations on Opioid Drugs.
- Centers for Disease Control and Prevention. (2022). Opioid Overdose Data.
- Drug Channels Institute. (2022). Pricing and Market Trends for Schedule II Opioids.
- Statista. (2023). Pharmaceutical Market Size and Growth Rates.
