Market Analysis and Price Projections for NDC 62559-0600: Inderal XL
Overview of NDC 62559-0600
NDC 62559-0600 corresponds to Inderal XL, a medication manufactured by ANI Pharmaceuticals, Inc. Inderal XL is a long-acting formulation of propranolol, a beta-blocker used to treat high blood pressure, angina, and certain heart-related conditions.
Market Context
Pharmaceutical Market Growth
The US pharmaceutical market is projected to grow significantly, from $846.72 billion in 2022 to $1.28 trillion by 2030, with a compound annual growth rate (CAGR) of 5.36%[2].
Biopharma and Biotech Sector
The biopharma market, which includes drugs like Inderal XL, is also experiencing rapid growth. The biopharma market size was estimated to be over $400 billion in 2024, with a projected CAGR of 7.56% between 2024 and 2029[3].
Pricing Mechanisms
Average Manufacturer Price (AMP) and Unit Rebate Amount (URA)
For drugs covered under the Medicaid Drug Rebate Program, the 340B ceiling price is calculated by subtracting the Unit Rebate Amount (URA) from the Average Manufacturer Price (AMP) for the smallest unit of measure. This calculation is crucial for determining the price charged to 340B covered entities[2].
Example Calculation
To illustrate, if the AMP for Inderal XL is $50 per unit and the URA is $10 per unit, with a package size of 30 units and a case pack size of 10 packages:
[ \text{340B Ceiling Price} = (50 - 10) \times 30 \times 10 = \$12,000 ]
This provides a baseline for the ceiling price, though actual market prices can vary based on market demand, competition, and regulatory changes.
Factors Influencing Price Projections
Historical Pricing Data
Reviewing historical pricing data for Inderal XL can provide insights into price trends and potential future adjustments. This data can be obtained from the NDC Directory and other sources[5].
Regulatory Changes
Changes in regulatory policies, such as updates to the Medicaid Drug Rebate Program or new FDA guidelines, can significantly impact pricing. For instance, any changes in the rebate structure or pricing formulas could affect the ceiling price of Inderal XL[2].
Market Demand and Competition
The demand for Inderal XL and the level of competition in the market, including the presence of generic or biosimilar alternatives, can influence pricing strategies. If there is high demand and limited competition, prices may remain stable or increase. Conversely, if there is significant competition, prices might decrease[2].
Technological Advancements
Technological advancements, such as the adoption of AI and other innovations, can reduce development and manufacturing costs, potentially leading to lower prices. However, for established drugs like Inderal XL, these advancements may have a more limited impact on pricing compared to new drug developments[2].
Clinical Trial and Development Costs
While Inderal XL is an established drug, understanding the broader context of drug development costs is relevant. Antimicrobial drugs, for example, have average to high development and approval costs but lower capitalized development costs compared to oncology drugs. This highlights the complexity of drug pricing and the various factors influencing it[4].
Precision Medicine and Regulatory Evolution
In 2025, the biopharma and biotech industries are expected to see a rise in precision medicine and evolving regulatory frameworks. While these trends are more relevant to new drug developments, they can also influence the pricing and market dynamics of existing drugs by setting new benchmarks for innovation and cost-effectiveness[3].
Market Size and Growth Projections for Beta-Blockers
Beta-blockers, including Inderal XL, are a well-established class of drugs. The market for these medications is stable, driven by consistent demand for cardiovascular treatments. However, growth in this segment may be slower compared to newer therapeutic areas like oncology and rare diseases[3].
Price Projections for Inderal XL
Given the stable demand and the presence of generic alternatives, the price of Inderal XL is likely to remain relatively stable. Here are some key points to consider:
- Historical Pricing Stability: Inderal XL has been on the market for a long time, and its pricing has generally been stable.
- Competition: The presence of generic propranolol formulations can keep prices in check.
- Regulatory Environment: Any changes in regulatory policies could impact pricing, but given the drug's established status, significant changes are less likely.
- Technological Advancements: These are more likely to affect new drug developments rather than established drugs like Inderal XL.
Example Price Projection
Assuming the current AMP for Inderal XL is $50 per unit and the URA is $10 per unit, with no significant changes in market demand or competition:
[ \text{Projected Price} = (50 - 10) \times \text{Package Size} \times \text{Case Pack Size} ]
This would result in a stable price projection, with minimal fluctuations expected.
Key Takeaways
- Stable Market Demand: Inderal XL benefits from consistent demand for cardiovascular treatments.
- Pricing Mechanisms: The 340B ceiling price calculation ensures that prices for covered entities are capped.
- Regulatory and Market Factors: Changes in regulatory policies and market competition can influence pricing.
- Technological Advancements: These have a limited impact on established drugs like Inderal XL.
- Price Stability: The price of Inderal XL is likely to remain stable due to historical pricing trends and the presence of generic alternatives.
FAQs
Q: What is the NDC for Inderal XL manufactured by ANI Pharmaceuticals, Inc.?
A: The NDC for Inderal XL manufactured by ANI Pharmaceuticals, Inc. is 62559-0600[1].
Q: How is the 340B ceiling price calculated for Inderal XL?
A: The 340B ceiling price is calculated by subtracting the Unit Rebate Amount (URA) from the Average Manufacturer Price (AMP) for the smallest unit of measure, then adjusting for package size and case pack size[2].
Q: What factors influence the price projections for Inderal XL?
A: Historical pricing data, regulatory changes, market demand, competition, and technological advancements influence price projections for Inderal XL[2].
Q: Is the price of Inderal XL expected to change significantly in the near future?
A: Given the stable demand and presence of generic alternatives, the price of Inderal XL is likely to remain relatively stable[2][3].
Q: How does the biopharma market growth impact the pricing of established drugs like Inderal XL?
A: The growth in the biopharma market is more relevant to new drug developments and innovations. Established drugs like Inderal XL are less likely to be directly impacted by these trends[3].
Sources
- ANI Pharmaceuticals, Inc. - List of Drugs - NDC Labeler/Manufacturer. FindACode.
- Latest pharmaceutical drug prices and trends for NDC 00093-7662. DrugPatentWatch.
- 5 Predictions for the Biopharma and Biotech Industries in 2025. TFS CRO.
- Antimicrobial drugs market returns analysis final. ASPE.
- National Drug Code Directory - FDA. FDA.
