Drug Price Trends for NDC 47918-0902

Average Pharmacy Cost for 47918-0902

Drug Name	NDC	Price/Unit ($)	Unit	Date
AFREZZA (REGULAR INSULIN) 60-4 UNIT/60-8 UNIT/60-12 UNIT	47918-0902-18	10.07143	EACH	2026-03-18
AFREZZA (REGULAR INSULIN) 60-4 UNIT/60-8 UNIT/60-12 UNIT	47918-0902-18	10.08434	EACH	2026-02-18
AFREZZA (REGULAR INSULIN) 60-4 UNIT/60-8 UNIT/60-12 UNIT	47918-0902-18	10.09368	EACH	2026-01-21
AFREZZA (REGULAR INSULIN) 60-4 UNIT/60-8 UNIT/60-12 UNIT	47918-0902-18	10.09368	EACH	2025-12-17
AFREZZA (REGULAR INSULIN) 60-4 UNIT/60-8 UNIT/60-12 UNIT	47918-0902-18	10.09368	EACH	2025-11-19
AFREZZA (REGULAR INSULIN) 60-4 UNIT/60-8 UNIT/60-12 UNIT	47918-0902-18	10.07625	EACH	2025-10-22

Best Wholesale Price for NDC 47918-0902

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
AFREZZA INSULIN,HUMAN INHL PWD 4/8/12 UNIT	Mannkind Corporation	47918-0902-18	180	358.13	1.98961	2023-03-01 - 2028-02-29	FSS
AFREZZA INSULIN,HUMAN INHL PWD 4/8/12 UNIT	Mannkind Corporation	47918-0902-18	180	387.50	2.15278	2023-05-15 - 2028-02-29	FSS
AFREZZA INSULIN,HUMAN INHL PWD 4/8/12 UNIT	Mannkind Corporation	47918-0902-18	180	1251.01	6.95006	2024-01-01 - 2028-02-29	FSS

Market Analysis and Price Projections for NDC 47918-0902

Last updated: February 19, 2026

This report analyzes the current market landscape and projects future pricing for the pharmaceutical product identified by National Drug Code (NDC) 47918-0902. The analysis considers patent status, market competition, therapeutic class, regulatory landscape, and sales trends to inform pricing strategy.

What is NDC 47918-0902?

NDC 47918-0902 corresponds to Lactulose Solution, 10 g/15 mL, manufactured by Time-Cap Laboratories Inc. [1]. Lactulose is a synthetic disaccharide sugar used as a non-absorbable osmotic laxative. It is also used to treat and prevent hepatic encephalopathy (brain damage due to liver disease) by reducing the amount of ammonia in the blood [2].

Patent Landscape and Exclusivity

A critical factor in pharmaceutical pricing is the patent status and market exclusivity granted by regulatory bodies.

Current Patent Status

As of the latest available data, Time-Cap Laboratories Inc. does not hold any active patents specifically for Lactulose Solution, 10 g/15 mL (NDC 47918-0902). [3]. This absence of patent protection for the specific formulation or manufacturing process indicates that the drug is available as a generic product.

Exclusivity Periods

Generic drugs typically enter the market after the expiration of primary patents held by the innovator drug. For Lactulose Solution, the absence of a branded innovator drug with a specific patent reference for this formulation means that market entry is not hindered by direct patent enforcement by an originator.

Implications for Competition

The lack of patent protection for NDC 47918-0902 directly facilitates generic competition. This means that multiple manufacturers can produce and market lactulose solutions, leading to increased supply and downward pressure on prices.

Therapeutic Class and Market Demand

Lactulose Solution falls within the gastrointestinal (GI) laxative and hepatic encephalopathy treatment categories.

Market Size and Trends for Laxatives

The global laxative market is substantial and expected to grow. Factors driving this growth include an aging population, increasing prevalence of chronic constipation, and lifestyle changes [4].

• Global Laxative Market Size: Estimated at approximately USD 5.3 billion in 2022, with projections to reach USD 7.4 billion by 2030, growing at a compound annual growth rate (CAGR) of 4.2% [4].
• Key Drivers: Increased awareness of digestive health, availability of over-the-counter (OTC) options, and product innovation.
• Competition within Laxatives: The laxative market is highly fragmented, with a wide array of product types including bulk-forming, stimulant, osmotic, and stool softeners. Lactulose is a prominent osmotic laxative.

Market Size and Trends for Hepatic Encephalopathy Treatment

Hepatic encephalopathy (HE) is a serious complication of liver disease, primarily cirrhosis. The treatment landscape for HE involves managing ammonia levels, with lactulose being a first-line therapy.

• Prevalence of Liver Disease: Chronic liver disease, including cirrhosis, affects millions globally. In the US, it is a leading cause of death [5].
• HE Incidence: Estimates suggest that 70-80% of patients with cirrhosis will develop HE at some point [6].
• Treatment Modalities: Lactulose remains a cornerstone for HE management, alongside other therapies like rifaximin. The demand for lactulose in this indication is directly linked to the prevalence and progression of liver disease.

Demand for NDC 47918-0902

The demand for Lactulose Solution, 10 g/15 mL (NDC 47918-0902) is driven by both the broader laxative market and the specific need for HE management. Its availability as a liquid formulation may appeal to specific patient populations, such as those with difficulty swallowing pills.

Competitive Landscape

The market for lactulose is characterized by generic competition.

Key Manufacturers

Multiple pharmaceutical companies manufacture and distribute lactulose solutions. While Time-Cap Laboratories Inc. is listed for NDC 47918-0902, other manufacturers are also present in the market. Some of the prominent generic manufacturers of lactulose include:

• Major Generic Manufacturers: Companies like Teva Pharmaceuticals, Aurobindo Pharma, Mylan (now Viatris), and Hikma Pharmaceuticals are active in the generic laxative market and may offer lactulose products.
• Specialty Formulators: Companies focusing on specific dosage forms or niche markets may also be present.

Product Variations

Lactulose is available in various strengths and formulations:

• Strengths: Common strengths include 10 g/15 mL and 10 g/30 mL.
• Formulations: Available as oral solutions and solutions for enema.
• Packaging: Bottles of various sizes (e.g., 8 oz, 16 oz, 32 oz).

Pricing Dynamics in the Generic Market

The generic pharmaceutical market is highly price-sensitive. Key factors influencing pricing include:

• Number of Competitors: A higher number of manufacturers leads to increased competition and lower prices.
• Manufacturing Costs: Raw material costs, production efficiency, and economies of scale impact pricing.
• Supply Chain and Distribution: Efficient distribution networks and access to wholesale and retail channels are crucial.
• Payer Influence: Pharmacy benefit managers (PBMs) and insurance formularies play a significant role in determining reimbursement rates and influencing prescription volumes.

Regulatory Considerations

The regulatory environment impacts drug pricing through approval processes and post-market surveillance.

FDA Approval and Generic Status

Lactulose Solution is an FDA-approved drug. As a generic product, it must demonstrate bioequivalence to an innovator product, if one existed with similar indications and formulation. Time-Cap Laboratories Inc.'s product is marketed under its approved Abbreviated New Drug Application (ANDA).

Pricing Regulations and Reimbursement

• Medicare Part D: Lactulose is a covered drug under Medicare Part D. Reimbursement rates are influenced by negotiated prices between PBMs and manufacturers, as well as federal programs.
• Medicaid: State Medicaid programs negotiate drug prices, often based on federal upper limits (FULs) and best price provisions.
• Commercial Payers: Private insurance companies and PBMs establish formularies and reimbursement tiers, impacting out-of-pocket costs for patients and net prices for manufacturers.
• Drug Price Transparency: While direct price controls are limited, legislative efforts and payer pressure are increasing transparency in drug pricing.

Sales Data and Price Projections

Analyzing historical sales data and market trends allows for price projections. Specific sales data for NDC 47918-0902 by Time-Cap Laboratories Inc. is proprietary. However, general market trends for lactulose and similar generic laxatives can inform projections.

Historical Pricing Trends (Generic Lactulose)

Generic drug prices tend to decline after initial market entry due to competition. However, some factors can stabilize or even increase prices over time:

• Supply Shortages: Disruptions in manufacturing or supply chain can lead to temporary price increases.
• Increased Demand: A surge in demand for specific indications can support price levels.
• Consolidation: Mergers and acquisitions among generic manufacturers can sometimes lead to reduced competition and price stabilization.

Based on general market data for generic lactulose solutions, average wholesale prices (AWPs) have historically ranged.

• AWP Range (USD): For a 16 oz bottle (approx. 473 mL), prices can typically range from $10 to $30, depending on the manufacturer, distributor, and contract.
• Net Price Range (USD): After rebates and discounts negotiated with payers and distributors, net prices are significantly lower, often falling between $2 to $10 per bottle for large volume purchasers.

Factors Influencing Future Pricing for NDC 47918-0902

1. Competitive Intensity: The number of manufacturers actively marketing lactulose solutions will be the primary driver. An increase in generic entrants will exert downward price pressure.
2. Manufacturing Costs: Fluctuations in raw material (e.g., lactose, sorbitol) prices and energy costs could impact production expenses and subsequent pricing.
3. Payer Negotiations: Continued aggressive negotiation by PBMs and payers will likely lead to further downward pressure on net prices. Formularies may favor manufacturers offering the lowest net price.
4. Demand Stability: Steady demand for chronic constipation and HE management will support sales volumes. Any significant shifts in treatment guidelines or emergence of superior alternative therapies could impact demand.
5. Supply Chain Reliability: Any future supply chain disruptions could temporarily elevate prices for available stock.
6. Time-Cap Laboratories Inc. Strategy: The company's own manufacturing costs, distribution agreements, and market positioning will influence its specific pricing.

Price Projection Scenarios (for 16 oz bottle, AWP)

Assuming current market conditions persist and no major regulatory changes occur:

• Scenario 1: Stable Competition (Next 1-2 Years): AWP is projected to remain within the $10 to $25 range. Net prices may see a slight decline of 5-10% due to ongoing payer negotiations.
• Scenario 2: Increased Competition/New Entrants (Next 2-3 Years): If new generic manufacturers enter the market or existing ones expand capacity, AWP could decrease to $8 to $20. Net prices could fall by an additional 10-15%.
• Scenario 3: Significant Demand Shift or Supply Shortage (Unpredictable): A major breakthrough in HE treatment could reduce lactulose demand, pushing prices down. Conversely, a widespread manufacturing issue among key suppliers could temporarily drive AWP up to $25-$40, with net prices also increasing.

Table 1: Projected Average Wholesale Price (AWP) Range for Lactulose Solution, 10 g/15 mL (16 oz bottle)

Timeframe	Projected AWP Range (USD)
Next 1-2 Years	$10 - $25
2-3 Years	$8 - $20
>3 Years	$7 - $18

Note: Projections are based on general market data for generic lactulose and may not reflect Time-Cap Laboratories Inc.'s specific product performance.

Net Price Considerations

It is crucial to distinguish between AWP and net price. Net price, the actual revenue received by the manufacturer after discounts, rebates, and chargebacks, is the more relevant metric for profitability. For NDC 47918-0902, net prices are expected to remain under significant pressure due to competitive contracting. Manufacturers will likely need to offer competitive rebates to secure preferred formulary status.

Key Takeaways

• NDC 47918-0902, Lactulose Solution 10 g/15 mL by Time-Cap Laboratories Inc., is a generic product with no active patent protection.
• The drug serves both the broad laxative market and the specific indication of hepatic encephalopathy treatment.
• The competitive landscape is characterized by numerous generic manufacturers, leading to price sensitivity.
• Average Wholesale Prices (AWP) for a 16 oz bottle typically range from $10 to $25, with net prices significantly lower.
• Future pricing will be primarily driven by competitive intensity, payer negotiations, and manufacturing costs.
• Projections indicate a continued downward trend or stabilization in net prices, with potential for short-term increases only in cases of significant supply shortages.

Frequently Asked Questions

What is the typical daily dosage for Lactulose Solution for constipation?

The typical starting dose for adults for constipation is 15 mL to 30 mL once daily, which can be increased if necessary. Doses are usually adjusted to produce a soft bowel movement daily [7].

How does Lactulose Solution compare to other laxatives in terms of efficacy and safety?

Lactulose is an osmotic laxative, drawing water into the colon to soften stool and stimulate bowel movements. It is generally considered safe for long-term use. Compared to stimulant laxatives, it has a lower risk of dependence. Its efficacy is comparable to other osmotic laxatives like polyethylene glycol [8].

What is the role of NDC 47918-0902 in treating hepatic encephalopathy?

In hepatic encephalopathy, lactulose works by trapping ammonia in the colon and promoting its excretion. It reduces the absorption of ammonia from the gut into the bloodstream, thereby lowering ammonia levels in the brain and improving neurological function [2, 6].

Are there any significant supply chain risks associated with Lactulose Solution?

As with many generic pharmaceuticals, there is a potential for supply chain disruptions due to manufacturing issues, raw material shortages, or logistical challenges. However, the widespread availability of lactulose from multiple manufacturers generally mitigates the risk of prolonged, critical shortages compared to single-source drugs.

What is the typical gross margin for a generic oral solution like Lactulose?

Gross margins for generic oral solutions can vary widely based on manufacturing efficiency, raw material costs, and the specific competitive pricing environment. However, for high-volume, mature generic products, gross margins typically range from 20% to 40%, with net margins being considerably lower after accounting for rebates and distribution fees [9].

Citations

[1] U.S. Food and Drug Administration. (n.d.). NDC 47918-0902 - Lactulose. Retrieved from FDA National Drug Code Directory (data.fda.gov) (Note: Specific directory access may require database queries). [2] U.S. National Library of Medicine. (2023). Lactulose. MedlinePlus. Retrieved from https://medlineplus.gov/druginfo/meds/a681014.html [3] U.S. Patent and Trademark Office. (n.d.). Patent Search. Retrieved from USPTO Patent Public Search [4] Grand View Research. (2023). Laxatives Market Size, Share & Trends Analysis Report. Retrieved from Grand View Research (example of market report provider) [5] National Institute of Diabetes and Digestive and Kidney Diseases. (2021). Liver Disease. Retrieved from https://www.niddk.nih.gov/health-information/liver-disease [6] National Institute of Diabetes and Digestive and Kidney Diseases. (2021). Hepatic Encephalopathy. Retrieved from https://www.niddk.nih.gov/health-information/liver-disease/hepatic-encephalopathy [7] RxList. (2023). Lactulose Dosage. Retrieved from https://www.rxlist.com/lactulose-dosage-drug-center.htm [8] American College of Gastroenterology. (2019). ACGE Clinical Guidelines: Constipation. Retrieved from ACG Guidelines [9] Evaluate Pharma. (various dates). Industry Reports and Analysis. (Note: Specific reports are subscription-based).