Drug Price Trends for NDC 54838-0116

Average Pharmacy Cost for 54838-0116

Drug Name	NDC	Price/Unit ($)	Unit	Date
SILACE 50 MG/5 ML LIQUID	54838-0116-80	0.02038	ML	2024-11-20
SILACE 50 MG/5 ML LIQUID	54838-0116-80	0.02099	ML	2024-10-23
SILACE 50 MG/5 ML LIQUID	54838-0116-80	0.02083	ML	2024-09-18

Best Wholesale Price for NDC 54838-0116

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type
No data available in table

Market Analysis and Price Projections for Silace (NDC: 54838-0116)

Introduction to Silace and Its Market Position

Silace, with the National Drug Code (NDC) 54838-0116, is an oral liquid medication containing docusate sodium, primarily used as a stool softener. Manufactured and distributed by Lannett Company, Inc., this over-the-counter (OTC) drug plays a significant role in the treatment of constipation and prevention of hard stools[7]. As we delve into the market analysis and price projections for Silace, it's crucial to understand its position within the pharmaceutical landscape and the factors influencing its pricing and availability.

Understanding the National Drug Code (NDC) System

Before we dive deeper into Silace's market analysis, let's briefly explore the NDC system, which is fundamental to drug identification and pricing in the United States.

What is the National Drug Code?

The National Drug Code is a unique, three-segment number assigned by the U.S. Food and Drug Administration (FDA) to human drugs in the United States. It serves as a universal product identifier for drugs and is crucial for various aspects of drug management, including listing, reimbursement, and tracking[1].

The Structure of NDC 54838-0116

The NDC for Silace (54838-0116) can be broken down as follows:

• 54838: Labeler code (Lannett Company, Inc.)
• 0116: Product code and package code

This unique identifier helps healthcare professionals, insurers, and regulators to accurately identify and track the product throughout its lifecycle.

Current Market Status of Silace

As of the latest available information, Silace (NDC 54838-0116) is actively marketed in the United States. It's important to note that its availability can be influenced by various factors, including manufacturing capabilities, regulatory decisions, and market demand.

Lannett has Silace available.[5]

This statement from the American Society of Health-System Pharmacists (ASHP) indicates that Silace is currently in production and available for distribution, which is a positive sign for its market presence.

Factors Influencing Silace's Market Position

Several factors contribute to Silace's position in the pharmaceutical market:

1. Competition in the Stool Softener Market

Silace competes with other docusate sodium products and alternative stool softeners. Its market share is influenced by factors such as brand recognition, pricing, and effectiveness compared to competitors.

2. Regulatory Environment

As an OTC drug, Silace is subject to FDA regulations, which can impact its production, labeling, and distribution. Any changes in regulatory requirements could affect its market availability and pricing.

3. Manufacturing and Supply Chain Considerations

The availability of raw materials, production capacity, and supply chain efficiency all play roles in determining Silace's market presence and price point.

4. Healthcare Policies and Reimbursement

While Silace is an OTC product, healthcare policies and insurance coverage for similar products can indirectly influence its market demand and pricing strategy.

Price Analysis of Silace (NDC 54838-0116)

Analyzing the price of Silace requires considering various pricing metrics and market factors.

Wholesale Acquisition Cost (WAC)

The Wholesale Acquisition Cost is a crucial metric in pharmaceutical pricing. While specific WAC data for Silace is not provided in the search results, it's important to note that:

The lowest WAC price from the last three CYs if the price increased by 40 percent during that last 3 CYs. This WAC is NOT necessarily the same price as the current WAC.[10]

This information suggests that significant price increases can occur over time, and historical WAC data is considered when evaluating drug prices.

Market Dynamics Affecting Silace Pricing

Several factors can influence the pricing of Silace:

1. Production costs
2. Market demand
3. Competitor pricing
4. Regulatory changes
5. Economic conditions

Comparative Analysis with Other Docusate Sodium Products

To better understand Silace's market position, it's helpful to compare it with similar products:

Akorn's Docu Liquid

• NDC: 50383-0771-16
• Strength: 150 mg/15 mL
• Package: 473 mL bottle[5]

Geri-Care's Diocto (Discontinued)

• NDC: 57896-0403-16 (liquid)
• NDC: 57896-0409-16 (syrup)
• Strengths: 150 mg/15 mL (liquid), 60 mg/15 mL (syrup)
• Package: 473 mL bottle[5]

The discontinuation of Geri-Care's products may have created an opportunity for Silace to capture a larger market share.

Market Trends and Future Projections

While specific projections for Silace are not provided in the search results, we can infer some trends based on the available information:

1. Steady Demand for Stool Softeners

The consistent presence of docusate sodium products in the market suggests a steady demand for stool softeners, which bodes well for Silace's future.

2. Potential for Price Fluctuations

Given the historical trends in pharmaceutical pricing, it's reasonable to expect some price fluctuations for Silace over time.

3. Impact of Generic Competition

As an established product, Silace may face increasing competition from generic alternatives, which could impact its pricing and market share.

Regulatory Considerations for Silace

Understanding the regulatory landscape is crucial for projecting Silace's market future:

FDA Oversight

As an FDA-regulated product, Silace must comply with ongoing regulatory requirements, which can influence its production and marketing strategies[1].

Potential Changes in NDC Format

The FDA has proposed changes to the NDC format, which could affect how Silace is identified and tracked in the future:

On July 22, 2022, FDA announced the availability of Proposed Rule on Revising the National Drug Code Format.[1]

These changes, if implemented, could have implications for Silace's labeling and database management.

Market Opportunities and Challenges for Silace

Opportunities

1. Expanding market share due to competitor product discontinuations
2. Potential for new formulations or package sizes to meet evolving consumer needs
3. Leveraging OTC status for direct-to-consumer marketing

Challenges

1. Managing production costs to maintain competitive pricing
2. Navigating potential regulatory changes
3. Differentiating from generic alternatives

Strategies for Market Growth

To maintain and potentially grow its market position, Lannett Company, Inc. could consider the following strategies for Silace:

1. Invest in marketing to increase brand awareness
2. Explore new distribution channels
3. Develop value-added services or packaging
4. Monitor and adapt to regulatory changes proactively

The Role of Data in Market Analysis

Accurate and up-to-date data is crucial for conducting thorough market analysis and making informed pricing decisions. Resources such as the FDA's NDC Directory and CMS's Open Payments system provide valuable data for stakeholders in the pharmaceutical industry[1][9].

Key Takeaways

• Silace (NDC 54838-0116) is an actively marketed docusate sodium oral liquid produced by Lannett Company, Inc.
• The NDC system plays a crucial role in drug identification and tracking, with potential format changes on the horizon.
• Market dynamics, including competition, regulatory environment, and manufacturing considerations, significantly influence Silace's positioning and pricing.
• While specific price projections are not available, historical trends suggest the potential for price fluctuations and the impact of generic competition.
• Opportunities for growth exist, but challenges such as cost management and regulatory compliance must be navigated.
• Accurate data and ongoing market analysis are essential for making informed decisions about Silace's future in the pharmaceutical market.

FAQs

1. Q: How often is the NDC Directory updated? A: The FDA's NDC Directory is updated daily to reflect the most current drug listing information[1].

2. Q: Can the NDC for Silace change in the future? A: While it's possible, changes to NDCs are typically rare. However, the FDA's proposed rule on revising the NDC format could potentially affect how NDCs are structured in the future[1].

3. Q: How does the discontinuation of competing products affect Silace's market position? A: The discontinuation of similar products, such as Geri-Care's Diocto, may create opportunities for Silace to capture a larger market share, potentially influencing its pricing and availability.

4. Q: Are there any known supply chain issues affecting Silace production? A: Based on the available information, there are no reported supply chain issues for Silace. Lannett has indicated that the product is available[5].

5. Q: How can healthcare providers stay informed about Silace's pricing and availability? A: Healthcare providers can monitor resources such as the FDA's NDC Directory, ASHP's Drug Shortages database, and communications from Lannett Company, Inc. for the most up-to-date information on Silace's status and pricing.

Sources cited: [1] https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory [5] https://www.ashp.org/drug-shortages/current-shortages/drug-shortage-detail.aspx?id=585 [7] https://fda.report/NDC/54838-116 [9] https://www.cms.gov/openpayments/downloads/drug-name-and-ndc-reference-data-instructions.pdf [10] https://www.dshs.texas.gov/prescription-drug-price-disclosure-program/glossary