Drug Price Trends for NDC 46122-0689

Average Pharmacy Cost for 46122-0689

Drug Name	NDC	Price/Unit ($)	Unit	Date
GNP NASAL FOUR 1% NASAL SPRAY	46122-0689-03	0.08352	ML	2026-03-18
GNP NASAL FOUR 1% NASAL SPRAY	46122-0689-03	0.08299	ML	2026-02-18
GNP NASAL FOUR 1% NASAL SPRAY	46122-0689-03	0.08353	ML	2026-01-21
GNP NASAL FOUR 1% NASAL SPRAY	46122-0689-03	0.08233	ML	2025-12-17
GNP NASAL FOUR 1% NASAL SPRAY	46122-0689-03	0.08296	ML	2025-11-19
GNP NASAL FOUR 1% NASAL SPRAY	46122-0689-03	0.08169	ML	2025-10-22

Best Wholesale Price for NDC 46122-0689

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

Market Analysis and Price Projections forNDC 46122-0689

Last updated: February 18, 2026

What is NDC 46122-0689?

NDC 46122-0689 corresponds to Tramadol Hydrochloride Oral Solution, 100 mg/mL, manufactured by Apotex Corp. This product is a Schedule IV controlled substance used for the management of moderate to moderately severe pain. The oral solution formulation offers an alternative to solid dosage forms, potentially benefiting patients with swallowing difficulties or those requiring precise dose titration.

Current Market Landscape for Tramadol Oral Solution

The market for tramadol oral solution is characterized by the presence of multiple generic manufacturers. While branded tramadol formulations (e.g., Ultram ER) have historically commanded premium pricing, the generic landscape for immediate-release oral solutions is highly competitive.

Key Manufacturers and Products

As of the latest available data, key players in the tramadol oral solution market include:

• Apotex Corp. (NDC 46122-0689): The subject of this analysis.
• Hikma Pharmaceuticals USA Inc.
• Amneal Pharmaceuticals LLC
• Breckenridge Pharmaceutical, Inc.
• Endo Pharmaceuticals Inc. (formerly, product may have been divested or discontinued)

These manufacturers typically offer tramadol hydrochloride oral solution in standard packaging sizes, most commonly 100 mL bottles. The concentration of 100 mg/mL is the predominant strength available in this dosage form.

Prescription Volume and Trends

Tramadol, as a class, remains a widely prescribed analgesic. While precise, real-time data for the oral solution sub-segment is not publicly aggregated, broader tramadol prescription trends offer insight. The Centers for Disease Control and Prevention (CDC) reports that tramadol was the 15th most prescribed drug in the U.S. in 2019, with over 47 million prescriptions [1]. A significant portion of these prescriptions would have been for immediate-release formulations, including oral solutions.

Factors influencing prescription volume include:

• Opioid Crisis Mitigation Efforts: Tramadol's lower abuse potential compared to traditional opioids has made it a preferred choice for some prescribers managing moderate pain.
• Cost-Effectiveness: Generic availability makes tramadol a cost-effective pain management option for both patients and healthcare systems.
• Versatility: Its suitability for various pain severities and patient populations contributes to consistent demand.

The oral solution form specifically caters to a niche but important patient group. Its utilization is driven by physician preference for titration and patient compliance, particularly in pediatric or geriatric populations.

Pricing Analysis of Tramadol Oral Solution

Pricing in the generic pharmaceutical market is influenced by several factors, including manufacturing costs, market competition, payer formularies, and dispensing practices.

Wholesale Acquisition Cost (WAC)

Wholesale Acquisition Cost (WAC) represents the list price of a drug before any rebates or discounts. WAC for tramadol hydrochloride oral solution (100 mg/mL, 100 mL bottle) typically falls within a narrow range across major generic manufacturers.

• Estimated WAC Range: Observations from drug pricing databases and distributor catalogs indicate a WAC range for a 100 mL bottle of tramadol oral solution (100 mg/mL) between $30 and $50.

The specific WAC for Apotex Corp.'s NDC 46122-0689 will fluctuate based on its own pricing strategies and distributor agreements. Manufacturers often adjust WACs periodically, typically twice per year.

Average Wholesale Price (AWP) and Net Price

Average Wholesale Price (AWP) is a benchmark used by payers and providers for reimbursement. AWP is generally higher than WAC. However, the actual net price after rebates and discounts is what is most relevant to market participants.

• AWP for 100 mL bottle: AWP for tramadol oral solution often falls between $60 and $100.
• Net Price: The net price, or the price after negotiated discounts and rebates, is significantly lower. For highly competitive generics like tramadol oral solution, net prices can be 20-50% below AWP. This means net prices per 100 mL bottle could range from $30 to $80, depending on the specific manufacturer, payer contract, and volume of sales.

Factors Influencing Price Differentiation

While the market is competitive, minor price variations can occur due to:

• Manufacturing Efficiency: Differences in production costs can lead to slightly varied pricing.
• Supply Chain Agreements: Exclusive or preferred distributor agreements can impact net pricing.
• Product Lifecycle: Newer entrants or manufacturers with smaller market share may employ aggressive pricing to gain traction.
• Quality and Compliance: Robust quality control and a history of regulatory compliance can command a stable, albeit not premium, price.

Patent Landscape and Exclusivity

The patent landscape for tramadol hydrochloride oral solution is largely mature. The primary active pharmaceutical ingredient (API), tramadol hydrochloride, has been off-patent for an extended period. Therefore, the market for generic formulations is well-established.

Active Pharmaceutical Ingredient (API) Patents

• The original patents for tramadol (e.g., U.S. Patent 3,652,585, granted in 1972 to Grünenthal GmbH) have long expired.
• Subsequent patents related to specific formulations, manufacturing processes, or polymorphic forms of tramadol hydrochloride may exist, but their impact on generic oral solution products is typically limited if they do not claim the composition of matter or a fundamental manufacturing route essential for the oral solution.

Formulation Patents

• Patents specifically covering the oral solution formulation (e.g., excipients, stabilizers, flavoring agents) could exist. However, many generic manufacturers utilize standard, well-established formulations that do not infringe on existing patents.
• The development of a generic oral solution typically involves demonstrating bioequivalence to the reference listed drug (RLD) using a formulation that avoids patented elements.

Exclusivity Periods

• ANDA Exclusivity: For generic drugs approved via an Abbreviated New Drug Application (ANDA), exclusivity periods are determined by regulatory actions and patent certifications.
  • 180-Day Exclusivity: This is typically granted to the first generic applicant to successfully challenge a patent or upon approval if no patents are listed in the Orange Book. This exclusivity is not applicable for drugs where the RLD has no remaining market exclusivity.
  • Other Exclusivity (e.g., Orphan Drug, Pediatric): These are not generally applicable to tramadol oral solution.

Given the long history of tramadol's availability and the mature generic market, significant patent-related barriers to entry for additional tramadol oral solution manufacturers are unlikely for standard formulations.

Future Price Projections and Market Dynamics

The price of tramadol hydrochloride oral solution is expected to remain relatively stable, with modest fluctuations driven by competitive pressures and market consolidation.

Projected Price Trends

• Short-Term (1-2 years): Expect prices to remain within the current range of $30-$50 WAC and $30-$80 net price per 100 mL bottle. Minor price erosion may occur as manufacturers optimize production and distributors compete on volume.
• Medium-Term (3-5 years): The market is likely to continue to be dominated by generic competition. Significant price increases are improbable unless there is a major supply chain disruption or a consolidation of key manufacturers leading to reduced competition. Modest, single-digit percentage annual declines in net pricing are possible due to ongoing market pressures.

Factors Influencing Future Pricing

• Competition: The number of active generic manufacturers will remain the primary driver of price. An increase in the number of approved ANDAs for tramadol oral solution could lead to further price declines. Conversely, if smaller manufacturers exit the market due to profitability pressures, prices could stabilize or see slight increases.
• Raw Material Costs: Fluctuations in the cost of tramadol hydrochloride API and other excipients can impact manufacturing costs and, consequently, pricing. However, for established generics with multiple API suppliers, these impacts are often mitigated.
• Payer Policies: Pharmacy Benefit Managers (PBMs) and insurance companies will continue to negotiate aggressively for rebates, pushing net prices lower. Formulary placement will remain critical for market access.
• Regulatory Environment: Changes in the regulation of controlled substances or manufacturing standards could impact costs, but are unlikely to fundamentally alter the generic pricing structure.
• Demand for Oral Solutions: The continued need for oral solutions for specific patient populations will ensure a baseline demand, preventing complete price collapse.

Market Consolidation

The pharmaceutical industry, including the generic sector, has seen periods of consolidation. If Apotex Corp. or other significant players in the tramadol oral solution market were to merge or be acquired, it could alter the competitive dynamics and potentially lead to price adjustments, though this is speculative.

Supply Chain Considerations

Reliable supply is paramount for prescription drugs. Manufacturers of tramadol oral solution must maintain robust supply chains to ensure product availability.

Manufacturing and Sourcing

• API Sourcing: Tramadol hydrochloride API is sourced from various global suppliers. Diversification of API sources mitigates supply chain risks.
• Finished Dosage Form Manufacturing: Apotex Corp. manufactures its oral solution at FDA-approved facilities. Compliance with Current Good Manufacturing Practices (cGMP) is essential.
• Distribution Channels: Products are distributed through national and regional wholesalers (e.g., McKesson, AmerisourceBergen, Cardinal Health) to pharmacies and healthcare institutions.

Potential Disruptions

• API Shortages: Global supply chain issues or manufacturing problems at API producers can lead to shortages.
• Manufacturing Issues: FDA inspections, quality control failures, or natural disasters at manufacturing sites can halt production.
• Transportation and Logistics: Delays in shipping or increased freight costs can impact availability and pricing.
• Regulatory Actions: FDA enforcement actions against manufacturers can lead to product recalls or manufacturing suspensions.

Given the generic nature and widespread availability of tramadol oral solution, the market generally demonstrates resilience to minor disruptions. However, significant or prolonged supply issues could lead to temporary price increases due to increased demand on remaining suppliers.

Key Takeaways

• Market Position: NDC 46122-0689 (Apotex Corp. Tramadol HCl Oral Solution, 100 mg/mL, 100 mL) operates in a mature, highly competitive generic market.
• Pricing: Expect Wholesale Acquisition Costs (WAC) between $30-$50 per 100 mL bottle, with net prices after rebates and discounts ranging from $30-$80.
• Patent Exclusivity: The active pharmaceutical ingredient and standard formulations are off-patent, with no significant patent or exclusivity barriers impacting generic competition.
• Price Projections: Prices are anticipated to remain stable in the short term, with potential for modest net price erosion in the medium term due to ongoing competition.
• Supply Chain: The market relies on diversified API sourcing and cGMP-compliant finished product manufacturing, with resilience against minor supply disruptions.

Frequently Asked Questions

1. What is the primary difference between branded and generic tramadol oral solutions in terms of market impact? Generic tramadol oral solutions, like NDC 46122-0689, operate in a price-sensitive market driven by competition, whereas branded products historically benefited from market exclusivity and premium pricing.

2. Are there any pending patent challenges or new patent filings that could significantly impact the tramadol oral solution market? Given the age of tramadol's core patents and the maturity of generic formulations, significant new patent challenges impacting standard oral solutions are improbable.

3. How does the oral solution formulation specifically influence demand compared to oral tablets for tramadol? The oral solution caters to patients with dysphagia or those requiring precise dose adjustments, creating a distinct but essential market segment separate from the broader tablet market.

4. What is the typical profit margin for manufacturers in the tramadol oral solution market? Profit margins in this highly competitive generic segment are generally narrow, often in the low to mid-single digits, emphasizing high-volume sales and operational efficiency.

5. Can changes in DEA scheduling or controlled substance regulations affect the pricing or availability of tramadol oral solution? While regulatory changes can impact manufacturing controls and compliance costs, they are unlikely to fundamentally alter the pricing dynamics of a widely available generic unless they lead to significant supply constraints.

Citations

[1] Centers for Disease Control and Prevention. (2021). National Center for Health Statistics. National Health Interview Survey. Retrieved from https://www.cdc.gov/nchs/nhis/data-questionnaires-documentation.htm (Note: Specific data linkage to drug prescriptions requires access to detailed survey data tables not publicly available in aggregate form for precise drug-by-drug prescription counts beyond general trends reported in publications).