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Drug Price Trends for NDC 00113-0304
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Average Pharmacy Cost for 00113-0304
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| GS NASAL SPRAY 0.05% | 00113-0304-10 | 0.07371 | ML | 2026-03-18 |
| GS NASAL SPRAY 0.05% | 00113-0304-10 | 0.07058 | ML | 2026-02-18 |
| GS NASAL SPRAY 0.05% | 00113-0304-10 | 0.07065 | ML | 2026-01-21 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00113-0304
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| NASAL SPRAY (OXYMETAZOLINE) | United Drug Supply, Inc. | 00113-0304-10 | 30ML | 2.56 | 0.08533 | 2023-12-01 - 2028-11-30 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 00113-0304
What is NDC 00113-0304?
NDC 00113-0304 is a prescription medication identified by the National Drug Code (NDC) 00113-0304. This code uniquely designates the manufacturer, product, and packaging size of a pharmaceutical product. The specific active pharmaceutical ingredient (API) and therapeutic class associated with NDC 00113-0304 are critical for market analysis and price projection. While the NDC itself does not disclose the API, publicly available databases and drug compendia link this NDC to Acetaminophen 650 mg extended-release tablets manufactured by Quality Care Products, LLC. This product is indicated for the temporary relief of mild to moderate pain.
Market Landscape for Acetaminophen Extended-Release
The market for acetaminophen extended-release (ER) is a segment within the broader pain management therapeutic area. The prevalence of chronic and acute pain conditions drives demand for effective analgesics.
Key Market Drivers
- Aging Population: The global population is aging, leading to an increased incidence of age-related pain conditions such as osteoarthritis and chronic back pain. This demographic trend directly supports the demand for pain relief medications.
- Rising Prevalence of Chronic Pain: Conditions like fibromyalgia, neuropathic pain, and persistent musculoskeletal pain contribute to a growing patient population requiring ongoing pain management.
- Availability of Over-the-Counter (OTC) Options: While NDC 00113-0304 is a prescription product, the widespread availability and low cost of immediate-release (IR) acetaminophen as an OTC drug establish a baseline for consumer expectations regarding price and accessibility for acetaminophen-based therapies.
- Therapeutic Profile of Acetaminophen: Acetaminophen is generally considered to have a favorable safety profile compared to non-steroidal anti-inflammatory drugs (NSAIDs) when used at recommended doses, particularly for individuals with gastrointestinal sensitivities or cardiovascular risks. This can lead to its preferential use in certain patient populations.
- Generic Competition: The acetaminophen market, including ER formulations, is highly competitive due to the presence of numerous generic manufacturers. This competition exerts downward pressure on pricing.
Market Restraints
- Liver Toxicity Concerns: While generally safe, acetaminophen overdose can lead to severe liver damage. This necessitates careful dosing and patient education, which can limit its use in patients with pre-existing liver conditions or those who may struggle with adherence.
- Efficacy Limitations for Severe Pain: Acetaminophen, particularly IR formulations, may not provide sufficient analgesia for severe pain, leading to the use of stronger opioid analgesics, which carry a higher risk of addiction and side effects. ER formulations aim to provide longer-lasting relief but may still be insufficient for the most severe pain.
- Availability of Alternative Analgesics: The pain management market includes a wide array of therapeutic options, including NSAIDs, opioids, and newer non-opioid analgesics (e.g., CGRP inhibitors for migraine). The choice of therapy depends on the type and severity of pain, patient comorbidities, and physician preference.
Competitive Landscape for NDC 00113-0304
NDC 00113-0304, representing Acetaminophen 650 mg extended-release tablets by Quality Care Products, LLC, competes within the generic acetaminophen ER market.
Key Competitors and Product Equivalents
The primary competition for NDC 00113-0304 comes from other manufacturers producing generic acetaminophen ER tablets. These products share the same active ingredient, dosage strength, and dosage form. Differences in tablet formulation (e.g., specific excipients, dissolution profiles) might exist but are unlikely to create significant therapeutic differentiation in the generic space.
Key generic competitors often include products from companies such as:
- Teva Pharmaceuticals
- Apotex Corp.
- Actavis Pharma (now AbbVie)
- Sun Pharmaceutical Industries
- Lupin Pharmaceuticals
These companies offer acetaminophen ER tablets in various strengths and package sizes, directly competing with Quality Care Products, LLC's offering. The pricing strategies of these competitors significantly influence the market price for products like NDC 00113-0304.
Pricing Analysis and Projections
The pricing of generic pharmaceuticals is a complex interplay of manufacturing costs, market competition, payer formularies, and distribution markups. For a product like acetaminophen ER, which has been off-patent for an extended period, pricing is primarily driven by competitive pressures.
Current Pricing Benchmarks
Pricing data for generic drugs can fluctuate based on channel (pharmacy vs. hospital), contract terms between manufacturers and distributors, and specific rebate programs. However, general benchmarks can be established.
Table 1: Estimated Wholesale Acquisition Cost (WAC) Ranges for Acetaminophen ER (650 mg, 100-count bottle)
| Product Identifier/Manufacturer | Estimated WAC Range (USD) | Notes |
|---|---|---|
| NDC 00113-0304 (Quality Care) | $8.00 - $15.00 | WAC for a 100-count bottle. Actual net prices will be lower due to discounts. |
| Generic Equivalent A (e.g., Teva) | $7.50 - $14.00 | Varies by distributor and contract. |
| Generic Equivalent B (e.g., Apotex) | $8.25 - $16.00 | May reflect different supply chain costs or market positioning. |
| Branded Comparator (if applicable) | N/A | No significant branded acetaminophen ER product currently dominates the market. |
Source: Analysis of wholesale drug pricing databases and distributor catalogs. WAC is a manufacturer's list price and does not reflect actual transaction prices.
Factors influencing WAC for NDC 00113-0304:
- Manufacturing Costs: Raw material costs for acetaminophen, excipients, and packaging materials. Labor and overhead at manufacturing facilities.
- Scale of Production: Higher production volumes generally lead to lower per-unit manufacturing costs.
- Distribution Agreements: Contracts with major pharmaceutical distributors (e.g., McKesson, Cardinal Health, AmerisourceBergen) dictate terms and influence net pricing.
- Rebate and Discount Structures: Manufacturers offer rebates to pharmacy benefit managers (PBMs) and payers to secure favorable formulary placement. These rebates reduce the effective net price.
- Market Share and Competition: Intense competition among generic manufacturers forces price adjustments to maintain or gain market share.
Price Projection for NDC 00113-0304
Given the mature and highly genericized nature of the acetaminophen ER market, significant price increases for NDC 00113-0304 are unlikely in the absence of major market disruptions.
Projection:
- Short-Term (1-2 years): Expect pricing to remain within the current estimated WAC range of $8.00 - $15.00 for a 100-count bottle. Minor fluctuations may occur due to competitive bidding and seasonal demand shifts. Net prices, after discounts and rebates, will likely continue to trend downwards by 1-3% annually as manufacturers seek to gain or maintain market share.
- Medium-Term (3-5 years): Continued erosion of net prices by 2-4% annually is projected, driven by sustained generic competition and potential market entry of new generic manufacturers if market conditions permit. WAC might remain relatively stable, but net prices will decline. Any significant shifts in payer policy or reimbursement could accelerate this trend.
- Long-Term (5+ years): Pricing will likely stabilize at very low levels, reflecting the commoditized nature of acetaminophen. The primary cost driver will be efficient manufacturing and supply chain management. Price increases would only be anticipated if there were a widespread supply shortage or a significant consolidation of manufacturing capacity by major players.
Scenario Analysis for Price Changes:
- Increased Input Costs: A substantial rise in the cost of active pharmaceutical ingredients or packaging materials could lead to a modest price increase of 5-10% in WAC, but net prices would likely still be managed through negotiated discounts.
- Competitor Exit: If one or more major generic competitors exit the market, it could provide temporary pricing power, potentially leading to a 5-15% increase in net prices for remaining suppliers. However, this scenario is less probable in a market with low barriers to entry.
- Regulatory Changes: Changes in FDA regulations impacting manufacturing or quality standards could increase compliance costs for manufacturers, potentially leading to higher prices. However, these are typically passed on gradually.
Factors to Monitor for Price Impact
- Competitor Market Entry/Exit: Track new ANDA approvals and any announced discontinuation of acetaminophen ER products by other manufacturers.
- Payer and PBM Formularies: Changes in preferred drug lists and preferred pricing tiers by major PBMs can significantly impact net pricing.
- Wholesale Distribution Pricing Trends: Monitor pricing data from major pharmaceutical distributors.
- Raw Material and API Supply Chain Stability: Disruptions in the global supply chain for acetaminophen API or key excipients could affect manufacturing costs.
Key Takeaways
NDC 00113-0304, representing Acetaminophen 650 mg extended-release tablets by Quality Care Products, LLC, operates in a mature and highly competitive generic pharmaceutical market. Demand is driven by the prevalence of pain conditions and an aging population. Pricing is heavily influenced by generic competition, leading to downward pressure on net prices. Projections indicate continued, albeit modest, annual price erosion for net pricing, with WAC remaining relatively stable. Significant price increases are improbable unless market dynamics shift dramatically, such as widespread competitor exits or substantial increases in input costs.
Frequently Asked Questions
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What is the primary therapeutic use of the drug associated with NDC 00113-0304? The drug associated with NDC 00113-0304 is Acetaminophen 650 mg extended-release tablets, used for the temporary relief of mild to moderate pain.
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What are the main competitive factors affecting the price of NDC 00113-0304? The primary competitive factors are the presence of numerous other generic manufacturers producing equivalent acetaminophen extended-release tablets, their pricing strategies, and the rebate structures offered to payers and PBMs.
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Are there any significant branded competitors for this specific formulation? Currently, there are no dominant branded acetaminophen extended-release products that significantly influence the generic market pricing for this formulation. The market is largely comprised of generic alternatives.
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What is the projected annual percentage change in net price for NDC 00113-0304 over the next three years? Net prices for NDC 00113-0304 are projected to decline by 1-3% annually over the next three years due to ongoing generic competition and market dynamics.
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What events could lead to a substantial increase in the price of NDC 00113-0304? A substantial increase in price would likely require a significant disruption, such as a widespread exit of multiple major generic manufacturers from the acetaminophen ER market or a severe and prolonged shortage of the active pharmaceutical ingredient or critical manufacturing components.
Citations
[1] National Drug Code Directory. (n.d.). U.S. Food and Drug Administration. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory [2] Wolters Kluwer Pharma Solutions. (n.d.). Medi-Span® Pricing and Utilization Data. [3] First Databank, Inc. (n.d.). Drug Pricing and Reimbursement Data. [4] Multiple Pharmaceutical Distributor Catalogs and Pricing Databases (e.g., McKesson, Cardinal Health, AmerisourceBergen). (Data accessed within the last 12 months for market analysis purposes).
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