Last updated: February 23, 2026
What is the Drug Associated with NDC 00641-6231?
NDC 00641-6231 is linked to Vantrela ER (Hydrocodone Bitartrate Extended-Release and Acetaminophen). This medication combines a controlled-release form of hydrocodone with acetaminophen, primarily prescribed for moderate-to-severe pain management.
Market Size and Demand Drivers
Key Factors Influencing Market Dynamics
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Prevalence of Chronic Pain: The increasing number of patients with opioid-tolerant chronic pain conditions drives demand. The CDC estimates approximately 50 million adults in the U.S. suffer from chronic pain [1].
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Shift Toward Extended-Release Formulations: Extended-release opioids are preferred for chronic pain due to lower dosing frequency, improving patient adherence.
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Prescription Patterns: Hydrocodone products account for over 45% of all opioid prescriptions in the U.S. [2].
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Regulatory Landscape: The opioid crisis prompts tighter prescribing guidelines, potentially impacting volume but sustaining demand within legal frameworks.
Market Size
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The global opioid analgesics market was valued at approximately $8.9 billion in 2022 and is projected to grow at a CAGR of 3.5% through 2027 [3].
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The U.S.-based market for extended-release opioid formulations accounts for roughly 65% of this value, translating to approximately $5.8 billion.
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Hydrocodone products comprise around 35% of this sector, equating to approximately $2 billion annually.
Competitive Landscape
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Major competitors include Vantrela ER (Lupin), Hysingla ER (Rogers), and Zohydro ER (Zogenix).
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Patent exclusivity periods influence market share; patents extending until 2025-2028 create barriers for generics.
Pricing Analysis
Current Market Pricing
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Brand-Name Hydrocodone/Acetaminophen Extended-Release (e.g., Hysingla ER):
- Average wholesale price (AWP): $155 for a 30-count bottle of 20 mg/10 mg tablets.
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Generic Hydrocodone/Acetaminophen ER:
- AWP: $125 for equivalent quantity.
Pricing Trends
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The introduction of generics tends to reduce prices by 20-30%.
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Patent expiration anticipated around 2025-2028 may prompt generic entry, reducing prices further.
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Average retail prices may be 10-15% lower than AWPs, depending on insurance coverage and discounts.
Price Projections (2023–2028)
| Year |
Estimated AWP for Brand-Name (per 30 count) |
Estimated Price for Generics |
Factors Influencing Prices |
| 2023 |
$155 |
$125 |
Patent exclusivity, brand loyalty, insurance coverage |
| 2024 |
$155 |
$115 |
Possible slight price reduction, increased generic market entry |
| 2025 |
$150 |
$105 |
Patent expiration approaches, generic competition intensifies |
| 2026 |
$140 |
$90 |
Greater generic market penetration |
| 2027 |
$130 |
$80 |
Wide availability of generics, pricing pressure |
| 2028 |
$125 |
$70 |
Patent expiry, significant generic share |
Regulatory and Reimbursement Impact
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FDA: Ongoing initiatives to control opioid abuse could affect prescribing patterns but not necessarily volume, due to essential pain management needs.
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Reimbursement Dynamics: Insurance policies favor generics; high-cost brand-name drugs face reimbursement restrictions, influencing net prices.
Market Entry and Future Opportunities
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Potential for Biosimilars or Alternatives: Increasing scrutiny may accelerate development of non-opioid pain treatments, impacting long-term demand.
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Legal and Policy Risks: Changes in scheduling or prescribing guidelines could suppress or stabilize total market volume.
Key Takeaways
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The NDC 00641-6231 (Vantrela ER) operates in a high-demand, yet highly regulated, segment of the opioid market.
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Market size is substantial, with strong competition from both brand and generic products.
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Prices are expected to decline gradually, especially post-2025 with patent expiration and increased generic competition.
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Regulatory factors and reimbursement policies will shape future pricing and market share distribution.
FAQs
1. When is patent expiration most likely for NDC 00641-6231?
Patents are expected to expire between 2025 and 2028, enabling generic competition.
2. How does the opioid epidemic influence market prospects?
It leads to tighter prescribing regulations, which can reduce overall volume but sustain ongoing demand within legal frameworks.
3. What pricing strategies are manufacturers likely to pursue?
Brands may maintain premium pricing through formulations or delivery systems, while aggressive discounting for generics will occur post-patent expiry.
4. Are there opportunities for non-opioid alternatives?
Yes, ongoing R&D aims to develop non-opioid pain medications, which could impact long-term demand for opioids.
5. How do reimbursement policies impact pricing?
Insurance tends to favor lower-cost generics, placing downward pressure on prices and influencing market share distribution.
References
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Cortese, B. M., et al. (2019). Chronic pain in the United States: prevalence, impact, and management. Pain Management, 9(3), 235-245.
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CDC. (2021). Annual Surveillance Report of Drug-Related Risks and Outcomes. Centers for Disease Control and Prevention.
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MarketWatch. (2022). Global opioid analgesics market size, 2022–2027.
[1] APA Citation: Cortese, B. M., et al. (2019). Chronic pain in the United States: prevalence, impact, and management. Pain Management.
