Market Analysis and Price Projections for Sulfasalazine (NDC: 59762-0104)
Introduction
Sulfasalazine, a medication used primarily for the treatment of ulcerative colitis and rheumatoid arthritis, is a significant player in the pharmaceutical market. This analysis will delve into the current market dynamics, historical price trends, and projections for the drug identified by the NDC code 59762-0104.
Market Overview
The pharmaceutical market, particularly for prescription drugs, is characterized by high prices and frequent price increases. In the United States, prescription drug prices are notably higher compared to other high-income countries. For instance, U.S. prices for brand-name drugs are approximately 422% of prices in other OECD countries[4].
Current Market Status of Sulfasalazine
Sulfasalazine is available in various formulations, including delayed-release tablets. The NDC code 59762-0104 corresponds to sulfasalazine delayed-release tablets, each containing 500 mg of the active ingredient, formulated by Greenstone LLC[5].
Historical Price Trends
Prescription drug prices, including those for sulfasalazine, have seen significant increases over the years. Here are some key points:
- Frequency of Price Increases: Most prescription drug price increases occur in January and July each year. In 2022, the average price increase in January was nearly $150 per drug (10% increase), and in July, it was $250 (7.8% increase)[2].
- Magnitude of Increases: Some drugs, including sulfasalazine, have experienced substantial price hikes. For example, the price of sulfasalazine (500 mg tablet) increased from $1,000 to $2,000 per 1000 tablets, a 100% increase[2].
Price Comparisons
International price comparisons highlight the disparity in drug prices between the U.S. and other countries. U.S. prices for prescription drugs are nearly three times as high as those in 33 OECD comparison countries. This gap is widening due to faster growth in U.S. drug prices[4].
Regulatory and Market Factors
Several factors influence the pricing of prescription drugs like sulfasalazine:
- Regulatory Environment: The regulatory landscape is evolving to address high drug prices. For instance, the Inflation Reduction Act (IRA) includes provisions aimed at reducing drug price increases and capping out-of-pocket costs for Medicare beneficiaries[2].
- Market Competition: The presence of generic and branded versions of sulfasalazine affects pricing. Generic versions, while cheaper, still see price increases, though generally less severe than those for branded drugs[4].
Predictions and Projections
Given the current trends and factors, here are some predictions and projections for sulfasalazine prices:
- Continued Price Increases: It is likely that sulfasalazine will experience further price increases, particularly in January and July, aligning with historical trends[2].
- Impact of Regulatory Changes: The IRA and other regulatory measures may mitigate the extent of price increases but are unlikely to reverse the overall trend of rising drug prices[2].
- Global Market Dynamics: The gap between U.S. and international drug prices is expected to persist, with U.S. prices remaining significantly higher[4].
Patient and Healthcare System Impact
High and increasing drug prices pose significant challenges for patients and the healthcare system:
- Affordability: Patients may face increased financial burdens due to higher copayments and coinsurance, affecting adherence to treatment[2].
- Healthcare System Costs: Rising drug prices contribute to higher healthcare costs, straining budgets for both private and public healthcare systems[2].
Key Takeaways
- Sulfasalazine prices are likely to continue increasing, particularly in January and July.
- Regulatory changes may slow but not halt these increases.
- The U.S. market will likely maintain higher prices compared to other OECD countries.
- Patient affordability and healthcare system costs will remain significant concerns.
FAQs
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What is the current formulation of sulfasalazine under NDC code 59762-0104?
- Sulfasalazine delayed-release tablets, each containing 500 mg of the active ingredient[5].
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How often do prescription drug prices, including sulfasalazine, typically increase?
- Most price increases occur in January and July each year[2].
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Why are U.S. prescription drug prices higher than in other countries?
- U.S. prices grow faster than in other countries, and the mix of drugs sold in the U.S. contributes to this disparity[4].
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What regulatory measures are being implemented to address high drug prices?
- The Inflation Reduction Act (IRA) includes provisions to cap price increases and reduce out-of-pocket costs for Medicare beneficiaries[2].
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How do high drug prices affect patients and the healthcare system?
- High prices increase financial burdens on patients and contribute to higher healthcare costs, affecting treatment adherence and straining healthcare budgets[2].
Sources
- FDA Report: Sulfasalazine TABLET; Marketing Category, ANDA; Application Number, ANDA040349[1].
- ASPE Issue Brief: Price Increases for Prescription Drugs, 2016-2022[2].
- TFS CRO Predictions: 5 Predictions for the Biopharma and Biotech Industries in 2025[3].
- ASPE International Price Comparisons: Estimates Using IQVIA MIDAS Data[4].
- DailyMed Label: SULFASALAZINE tablet, delayed release[5].