Introduction
The National Drug Code (NDC) 49348-0196 corresponds to the drug "Sunmark Ibuprofen," manufactured by Strategic Sourcing Services LLC, a subsidiary of McKesson. This analysis will delve into the market dynamics, pricing mechanisms, and potential price projections for this specific drug.
Market Context
Prescription Drug Market Overview
The prescription drug market is highly regulated and influenced by various factors, including government policies, pharmaceutical supply chain dynamics, and market competition. In the United States, programs like the Medicaid Drug Rebate Program (MDRP) and the 340B Drug Pricing Program play significant roles in determining drug prices and rebates[2][3].
Generic Drug Market
Generic drugs, such as ibuprofen, are a crucial part of the prescription drug market. They offer cost-effective alternatives to brand-name drugs, which can significantly impact market dynamics. The median price increase for generic drugs has been noted to be around 19.9%, although extreme cases like the 2,527% increase for a generic naproxen have also been observed[5].
Pricing Mechanisms
Average Manufacturer Price (AMP) and Unit Rebate Amount (URA)
The pricing of drugs under the MDRP is determined by the Average Manufacturer Price (AMP) and the Unit Rebate Amount (URA). The AMP is the average price paid by wholesalers for drugs distributed to retail pharmacies, and the URA is the rebate amount manufacturers must pay to the government for each unit of the drug sold to Medicaid beneficiaries. The 340B ceiling price, for instance, is calculated by subtracting the URA from the AMP and then adjusting for package and case sizes[2].
Ceiling Price Calculation
For NDC 49348-0196, the ceiling price would be calculated as follows:
[ \text{340B Ceiling Price} = (\text{AMP} - \text{URA}) \times \text{Package Size} \times \text{Case Pack Size} ]
This ensures that covered entities under the 340B program pay no more than the statutory ceiling price for the drug[2].
Price Transparency and Reporting
State and Federal Regulations
States like Oregon have implemented drug price transparency programs that require manufacturers to report price increases and new high-cost drugs. This includes detailed information on the reasons for price increases, which can help in understanding market trends and regulatory impacts[5].
Compliance with Medicaid Drug Rebate Program
Manufacturers must comply with the MDRP by reporting monthly AMPs and ensuring that new NDCs are timely reported to CMS. This compliance is crucial for maintaining the drug's eligibility for the rebate program and ensuring that states can determine coverage expeditiously[3].
Historical Pricing Data
NDC 49348-0196 Specifics
While specific historical pricing data for NDC 49348-0196 is not readily available in the provided sources, generic ibuprofen prices generally follow the trends of other generic medications. The median price increase for generic drugs can serve as a benchmark for potential price changes.
Price Projections
Generic Drug Price Trends
Given the median price increase of 19.9% for generic drugs, it is reasonable to project that the price of Sunmark Ibuprofen (NDC 49348-0196) could increase by a similar margin. However, this projection can be influenced by various factors such as changes in raw material costs, manufacturing efficiencies, and market competition.
Regulatory Impact
Regulatory changes, such as the implementation of upper payment limits or enhanced transparency requirements, could also impact pricing. For instance, if states or federal authorities impose stricter price controls, the price of the drug might be capped or reduced[5].
Key Takeaways
- Pricing Mechanisms: The price of NDC 49348-0196 is determined by AMP and URA calculations, adjusted for package and case sizes.
- Regulatory Compliance: Manufacturers must comply with MDRP and state transparency programs to ensure coverage and eligibility.
- Market Trends: Generic drug prices, including ibuprofen, are subject to median increases around 19.9%.
- Regulatory Impact: State and federal regulations can significantly influence price projections.
FAQs
What is the NDC 49348-0196?
NDC 49348-0196 corresponds to Sunmark Ibuprofen, a generic ibuprofen product manufactured by Strategic Sourcing Services LLC.
How is the price of NDC 49348-0196 calculated?
The price is calculated using the Average Manufacturer Price (AMP) minus the Unit Rebate Amount (URA), adjusted for package and case sizes.
What are the key factors influencing the price of generic ibuprofen?
Key factors include raw material costs, manufacturing efficiencies, market competition, and regulatory changes such as price transparency and upper payment limits.
How do state regulations impact drug pricing?
State regulations, such as those in Oregon, require manufacturers to report price increases and new high-cost drugs, which can lead to greater transparency and potential price controls.
What is the projected price increase for generic ibuprofen?
The projected price increase could be around the median increase for generic drugs, which is approximately 19.9%.
Sources
- For State Medicaid Directors: Medicaid Drug Rebate Program - State Releases[1].
- NDC Product Details: HRSA - 340B OPAIS[2].
- Manufacturer Release 118: Medicaid - Reporting of New NDCs[3].
- McKesson - List of Drugs: Find-A-Code[4].
- Prescription Drug Price Transparency Results and Recommendations: Oregon Drug Price Transparency Program - Annual Report 2022[5].
