Introduction to NDC 42858-0338
The drug identified by the National Drug Code (NDC) 42858-0338 is Hydromorphone Hydrochloride, marketed under the proprietary name Dilaudid. This is a human prescription drug manufactured by Rhodes Pharmaceuticals L.P.[5].
Drug Overview
- Generic Name: Hydromorphone Hydrochloride
- Dosage Form: Oral Tablet
- Route of Administration: Oral
- Marketing Start Date: May 15, 2017
- Marketing Category: New Drug Application (NDA)
- Active Ingredient Strength: 8 mg/1
- Pharmaceutical Classes: Full Opioid Agonists, Opioid Agonist
- DEA Schedule: CII (Controlled Substance)[5].
Market Size and Growth
While specific market size and growth data for NDC 42858-0338 are not readily available, the broader context of the opioid market and pharmaceutical industry trends can provide insights.
- The global opioid market, which includes drugs like Hydromorphone Hydrochloride, is influenced by various factors such as regulatory changes, competition from generic drugs, and evolving patient needs.
- The US pharmaceutical market, which includes opioids, is projected to grow from $846.72 billion in 2022 to $1.28 trillion by 2030, with a Compound Annual Growth Rate (CAGR) of 5.36%[4].
Pricing Trends
Pricing trends for controlled substances like Hydromorphone Hydrochloride can be volatile due to regulatory, competitive, and market forces.
- Regulatory Impact: Pricing and access to drugs are significant concerns for the life sciences industry. Nearly half of C-suite executives expect pricing and access issues to significantly affect their strategies in 2025[3].
- Generic Competition: The entry of generic drugs can significantly impact the pricing of branded opioids. For instance, the global oxycodone hydrochloride market, another opioid, has seen fluctuations in pricing due to generic competition[1][2].
- Current Pricing: As of the latest available data, specific pricing for NDC 42858-0338 is not provided. However, prices for similar opioids can range widely based on factors like dosage, formulation, and market conditions.
Price Projections
Given the broader industry trends and the specific characteristics of Hydromorphone Hydrochloride:
- Short-Term Projections: Prices may remain relatively stable in the short term due to the controlled nature of the drug and the existing market dynamics. However, any significant changes in regulatory policies or the introduction of new generic competitors could impact pricing.
- Long-Term Projections: Over the long term, the market is likely to see increased competition from generic drugs and biosimilars, which could lead to downward pressure on prices. The biopharma industry is facing a substantial loss of exclusivity, with over $300 billion in sales at risk through 2030 due to expiring patents on high-revenue products[3].
Competitive Landscape
The competitive landscape for opioids like Hydromorphone Hydrochloride is complex and influenced by several factors:
- Generic Drugs: The increasing approval of generic drugs is a significant trend affecting the pricing and market share of branded opioids. For example, 37% of life sciences executives view competition from generic drugs and biosimilars as a top trend[3].
- Biosimilars: Although biosimilars are more relevant to biologic drugs, the overall trend of increased competition from non-branded products affects the entire pharmaceutical market.
- Innovation and Digital Transformation: The integration of technologies like AI and the increased use of data are expected to boost operational efficiencies and drive breakthrough innovations, potentially altering the competitive landscape[3][4].
Regulatory Environment
The regulatory environment plays a crucial role in the pricing and availability of controlled substances like Hydromorphone Hydrochloride.
- DEA Scheduling: As a Schedule CII controlled substance, Hydromorphone Hydrochloride is subject to strict regulations, which can impact its pricing and distribution.
- FDA Approvals: Changes in FDA policies and approval processes can affect the market dynamics of opioids. For instance, increased scrutiny on opioid prescriptions and stricter guidelines can influence demand and pricing[5].
Consumer and Patient Impact
The impact on consumers and patients is multifaceted:
- Access to Medication: Pricing and access issues can significantly affect patients' ability to obtain necessary medications. Nearly half of life sciences executives expect these issues to affect their strategies in 2025[3].
- Treatment Options: Advances in personalized medicine and the use of genomics and biomarkers can provide patients with more precise treatment options, potentially reducing the reliance on opioids or improving their efficacy and safety[3].
Key Takeaways
- Market Growth: The broader pharmaceutical market is expected to grow significantly, driven by factors such as increased R&D investments and the adoption of AI-based tools.
- Pricing Trends: Prices for Hydromorphone Hydrochloride may remain stable in the short term but could face downward pressure in the long term due to generic competition and regulatory changes.
- Regulatory Impact: Strict regulations and DEA scheduling can influence the pricing and distribution of the drug.
- Innovation: Advances in technology and personalized medicine are expected to transform the life sciences industry, potentially impacting the market for opioids.
FAQs
-
What is the generic name of the drug NDC 42858-0338?
- The generic name of the drug is Hydromorphone Hydrochloride.
-
What is the proprietary name of the drug NDC 42858-0338?
- The proprietary name is Dilaudid.
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What is the DEA schedule for Hydromorphone Hydrochloride?
- It is classified as a Schedule CII controlled substance.
-
How is the US pharmaceutical market projected to grow?
- The US pharmaceutical market is projected to grow from $846.72 billion in 2022 to $1.28 trillion by 2030, with a CAGR of 5.36%.
-
What factors are expected to impact the pricing of Hydromorphone Hydrochloride in the long term?
- Factors such as generic competition, regulatory changes, and the overall trend of increased competition from non-branded products are expected to impact pricing.
Sources
- DrugPatentWatch - Latest drug prices and trends for NDC 42858-0002.
- DrugPatentWatch - Latest pharmaceutical drug prices and trends for NDC 42806-0006.
- Deloitte Insights - 2025 life sciences outlook.
- GlobeNewswire - US Pharmaceutical Market Review 2020-2023 and Forecast 2024-2030.
- FDA.report - NDC 42858-338 Oral Tablet Dilaudid Drug Codes.
