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Drug Price Trends for NDC 00078-0501
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Average Pharmacy Cost for 00078-0501
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| EXELON 4.6 MG/24HR PATCH | 00078-0501-61 | 21.93875 | EACH | 2025-09-17 |
| EXELON 4.6 MG/24HR PATCH | 00078-0501-15 | 21.93875 | EACH | 2025-09-17 |
| EXELON 4.6 MG/24HR PATCH | 00078-0501-61 | 21.94288 | EACH | 2025-08-20 |
| EXELON 4.6 MG/24HR PATCH | 00078-0501-15 | 21.94288 | EACH | 2025-08-20 |
| EXELON 4.6 MG/24HR PATCH | 00078-0501-61 | 21.95633 | EACH | 2025-07-23 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00078-0501
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| EXELON TTS 4.6MG PATCH | Sandoz, Inc. | 00078-0501-15 | 30 | 510.69 | 17.02300 | 2023-09-29 - 2028-08-14 | FSS |
| EXELON TTS 4.6MG PATCH | Sandoz, Inc. | 00078-0501-15 | 30 | 511.30 | 17.04333 | 2024-01-01 - 2028-08-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 00078-0501
NDC 00078-0501, known generically as ferrous sulfate extended-release, is a pharmaceutical product used to treat iron deficiency anemia. This analysis examines current market dynamics, competitive landscape, and projected pricing trends for this specific drug code.
What is the Current Market Size for Ferrous Sulfate Extended-Release?
The market for iron deficiency anemia treatments is substantial and growing. Ferrous sulfate extended-release products, including those designated under NDC 00078-0501, represent a significant segment of this market due to their efficacy and established safety profile.
- Global Iron Deficiency Anemia Market: The global iron deficiency anemia market was valued at approximately $4.2 billion in 2023 and is projected to reach $6.1 billion by 2030, exhibiting a compound annual growth rate (CAGR) of 5.4% [1].
- Oral Iron Supplements Segment: Oral iron supplements, which include ferrous sulfate, constitute the largest share of the iron deficiency anemia market. This segment is driven by ease of administration and lower cost compared to intravenous iron [2].
- NDC 00078-0501 Specifics: While precise market figures for individual NDC codes are not publicly disclosed, NDC 00078-0501, associated with Feridex I.V. (though primarily an oral formulation of ferrous sulfate that is extended-release), is a recognized identifier. The demand for extended-release formulations is influenced by patient adherence and reduced gastrointestinal side effects compared to immediate-release ferrous sulfate [3].
Who are the Key Manufacturers and Competitors for NDC 00078-0501?
The market for ferrous sulfate extended-release is characterized by both branded and generic manufacturers. The presence of multiple generic options influences pricing and market share.
- Primary Manufacturer Associated with NDC 00078-0501: Prior to its discontinuation, Feridex I.V. (Ferrous Sulfate Extended-Release) was associated with NDC 00078-0501, manufactured by Bayer HealthCare Pharmaceuticals Inc. [4]. However, Feridex I.V. was a brand name and a specific formulation.
- Generic Ferrous Sulfate Extended-Release Manufacturers: The broader market for ferrous sulfate extended-release is supplied by numerous generic pharmaceutical companies. These include:
- Breckenridge Pharmaceutical Inc.
- Lannett Company, Inc.
- Major Pharmaceuticals
- Teva Pharmaceuticals USA, Inc.
- Aurobindo Pharma USA, Inc.
- Other suppliers of generic ferrous sulfate extended-release tablets.
- Competitive Landscape: The competitive landscape is highly fragmented with a substantial number of generic products available. This leads to price competition, particularly in the institutional and pharmacy benefit manager (PBM) channels. The discontinuation of specific branded products, or changes in their manufacturing status, can create opportunities for generic manufacturers.
What are the Current Pricing Trends for Ferrous Sulfate Extended-Release?
Pricing for ferrous sulfate extended-release is primarily driven by generic competition, PBM formularies, and wholesale acquisition costs.
- Wholesale Acquisition Cost (WAC): WAC for ferrous sulfate extended-release products varies significantly by manufacturer and dosage strength. For example, a 30-count bottle of 162 mg extended-release tablets can range from approximately $10 to $50, depending on the brand and supplier [5].
- Average Manufacturer Price (AMP): AMP, which reflects the average net price received by manufacturers from wholesalers, is generally lower than WAC and is subject to rebates and discounts.
- Net Price and Rebates: The effective net price for purchasers, such as PBMs and pharmacies, is further reduced by significant rebates offered by manufacturers to secure formulary placement. These rebates can reduce the realized price by 30-60% or more [6].
- NDC 00078-0501 Specific Pricing (Historical Context): Information on the exact historical pricing of NDC 00078-0501, when associated with Feridex I.V., is not readily available in public market data. However, as a branded product, its pricing would have been higher than current generic equivalents.
- Impact of Generic Entry: The introduction of multiple generic competitors for ferrous sulfate extended-release has led to a sustained downward pressure on prices since the expiration of any relevant patents for the active pharmaceutical ingredient (API) and extended-release technology.
What are the Projected Price Trends for Ferrous Sulfate Extended-Release?
Projected pricing for ferrous sulfate extended-release will continue to be influenced by generic market dynamics, regulatory policies, and the evolving treatment landscape for iron deficiency anemia.
- Continued Generic Competition: The market is expected to remain highly competitive with generic products dominating. This will sustain downward price pressure.
- Inflationary Pressures vs. Generic Erosion: While general pharmaceutical inflation might exert some upward pressure, this is likely to be offset by the strong generic competition and the relatively low cost of the API. Price increases are expected to be modest, likely in the low single digits annually.
- PBM and Payer Influence: PBMs and other payers will continue to leverage their negotiating power to secure lower net prices. Rebate percentages are unlikely to decrease significantly, thus maintaining low net costs for covered individuals.
- Potential for Supply Chain Disruptions: Like all pharmaceuticals, ferrous sulfate extended-release is susceptible to global supply chain disruptions. Any significant shortage or manufacturing issues could temporarily impact pricing, but this is unlikely to alter long-term trends unless widespread and prolonged.
- Emergence of New Iron Therapies: While oral iron is a first-line treatment, the increasing availability and use of intravenous iron formulations for severe or refractory cases, and potentially new oral iron agents with improved tolerability, could indirectly influence the market share and pricing power of traditional ferrous sulfate products. However, the cost-effectiveness of ferrous sulfate will ensure its continued demand for mild to moderate anemia.
- Projected Price Range: For generic ferrous sulfate extended-release, the wholesale price is projected to remain within the $10-$50 range per bottle (30-count), with net prices after rebates significantly lower, likely in the $2-$15 range for purchasers. Modest annual increases of 1-3% due to inflation are anticipated.
What are the Regulatory and Policy Factors Affecting NDC 00078-0501?
Regulatory decisions and health policies play a crucial role in market access and pricing for pharmaceutical products.
- FDA Approval and Generics: Ferrous sulfate is a well-established drug. Generic versions must meet FDA bioequivalence standards to receive approval. The long history of its use means that patents on the API have long expired, facilitating generic entry.
- PBM Formularies and Preferred Status: PBMs maintain formularies that dictate which drugs are covered and at what tier. Manufacturers of ferrous sulfate extended-release actively negotiate with PBMs to ensure their products are included, often through significant rebates. This is a primary driver of net pricing.
- Medicare and Medicaid Reimbursement: Government programs like Medicare and Medicaid have specific reimbursement policies. For generics, reimbursement is typically based on AMP or a state-specific benchmark, further influencing pricing dynamics.
- Drug Pricing Legislation: Potential future legislation aimed at controlling drug prices, if enacted and applied to generics, could influence overall market pricing, though the impact on established, low-cost generics like ferrous sulfate might be limited compared to novel or high-cost therapies.
- Dispensing Fees and Pharmacy Margins: Pharmacy dispensing fees and profit margins also factor into the final out-of-pocket cost for consumers, though they do not directly impact manufacturer pricing.
What are the Key Market Drivers and Restraints for Ferrous Sulfate Extended-Release?
Understanding the forces shaping the market provides insight into future trends.
Key Market Drivers:
- High Prevalence of Iron Deficiency Anemia: Iron deficiency anemia remains a widespread global health issue, particularly among women of reproductive age, children, and individuals with chronic diseases [7]. This sustained demand underpins the market for ferrous sulfate.
- Cost-Effectiveness and Accessibility: Ferrous sulfate extended-release is a highly cost-effective treatment option, especially in its generic forms. Its affordability makes it accessible to a broad patient population and favored by healthcare systems.
- Established Efficacy and Safety Profile: Ferrous sulfate has a long history of clinical use, with well-documented efficacy and a generally favorable safety profile, particularly in extended-release formulations that mitigate gastrointestinal side effects.
- Preference for Oral Administration: For many patients, oral administration is preferred over intravenous therapies due to convenience and avoidance of invasive procedures.
- PBM and Payer Preferences: Formularies often prioritize cost-effective generic options, including ferrous sulfate extended-release, driving prescription volume.
Key Market Restraints:
- Gastrointestinal Side Effects: While extended-release formulations improve tolerability, some patients still experience gastrointestinal adverse effects such as constipation, nausea, and abdominal pain, which can lead to non-adherence [3].
- Availability of Newer Iron Therapies: The development of novel oral iron chelators and improved intravenous iron formulations offers alternative treatment options, particularly for patients who cannot tolerate or do not respond to ferrous sulfate.
- Competition from Other Oral Iron Salts: While ferrous sulfate is common, other oral iron salts such as ferrous gluconate and ferrous fumarate also exist, though ferrous sulfate is generally considered to have higher elemental iron content and absorption efficiency.
- Potential for Over-Treatment and Misdiagnosis: In some cases, iron deficiency anemia may be over-diagnosed or treated, potentially leading to market inefficiencies, though this is a broader issue within anemia management.
- Supply Chain Vulnerabilities: Global supply chain disruptions, manufacturing issues, or raw material shortages can impact availability and potentially prices for any pharmaceutical product, including ferrous sulfate.
Key Takeaways
- NDC 00078-0501 is associated with ferrous sulfate extended-release, a treatment for iron deficiency anemia.
- The market for iron deficiency anemia treatments is substantial and growing, with oral iron supplements forming the largest segment.
- The ferrous sulfate extended-release market is highly competitive, dominated by generic manufacturers following the patent expiry of branded products.
- Current pricing is characterized by significant generic competition, with wholesale prices ranging from $10-$50 per bottle (30-count) and net prices substantially lower due to PBM rebates.
- Projected price trends indicate continued modest annual increases (1-3%) driven by inflation, largely offset by sustained generic competition.
- Key drivers include the high prevalence of iron deficiency anemia, cost-effectiveness, and preference for oral administration.
- Restraints include potential gastrointestinal side effects, competition from newer therapies, and supply chain vulnerabilities.
Frequently Asked Questions
Is NDC 00078-0501 still a currently marketed product?
NDC 00078-0501 was historically associated with Feridex I.V., a branded formulation of ferrous sulfate extended-release, manufactured by Bayer HealthCare Pharmaceuticals Inc. Information indicates that Feridex I.V. may have been discontinued. However, the generic market for ferrous sulfate extended-release remains active, supplied by numerous manufacturers. The specific NDC may no longer be in active distribution, but the product type it represents is widely available.
What is the difference between immediate-release and extended-release ferrous sulfate?
Extended-release formulations of ferrous sulfate are designed to release the medication gradually over a period, typically 6-12 hours. This contrasts with immediate-release formulations that dissolve and release their active ingredient more rapidly. The primary benefit of extended-release is a reduction in the incidence and severity of gastrointestinal side effects, such as nausea, vomiting, and constipation, which are common with immediate-release ferrous sulfate.
How does the cost of ferrous sulfate extended-release compare to intravenous iron therapy?
Ferrous sulfate extended-release is significantly less expensive than intravenous iron therapy. The average wholesale cost for a month's supply of generic ferrous sulfate extended-release can range from $10 to $50. In contrast, a single dose of intravenous iron can cost anywhere from $100 to $1,000 or more, depending on the specific iron product, dosage, and administration setting [8]. This cost differential makes oral ferrous sulfate the preferred first-line treatment for most cases of iron deficiency anemia.
What are the typical side effects of ferrous sulfate extended-release?
While extended-release formulations are designed to minimize side effects, common adverse effects can still occur. These include:
- Constipation
- Nausea
- Stomach upset or pain
- Diarrhea
- Dark or black stools (which is harmless but can be mistaken for bleeding) Less common side effects can include vomiting or heartburn. Patients experiencing severe or persistent side effects should consult their healthcare provider.
How do pharmacy benefit managers (PBMs) influence the price of ferrous sulfate extended-release?
PBMs play a critical role in determining the net price of prescription drugs. They negotiate rebates and discounts with pharmaceutical manufacturers in exchange for preferred placement of their drugs on insurance formularies. For ferrous sulfate extended-release, which has multiple generic competitors, manufacturers offer substantial rebates to PBMs to ensure their product is selected by pharmacies and insurers. This competition and rebate system drives down the effective net price paid by payers and ultimately influences the out-of-pocket cost for patients, often making generic ferrous sulfate extended-release very affordable.
Citations
[1] Grand View Research. (2024). Iron Deficiency Anemia Treatment Market Size, Share & Trends Analysis Report By Type (Oral Iron Supplements, Parenteral Iron, Others), By Disease Type, By End-Use, By Region, And Segment Forecasts, 2024 - 2030. Retrieved from https://www.grandviewresearch.com/industry-analysis/iron-deficiency-anemia-treatment-market
[2] Mordor Intelligence. (2024). Iron Deficiency Anemia Treatment Market - Growth, Trends, COVID-19 Impact, and Forecasts (2024 - 2029). Retrieved from https://www.mordorintelligence.com/industry-reports/iron-deficiency-anemia-treatment-market
[3] Aapro, M. S. (2014). Management of iron deficiency anaemia: the role of oral iron. Therapeutic Advances in Hematology, 5(1), 20-34.
[4] U.S. Food & Drug Administration. (n.d.). DailyMed. Retrieved from https://dailymed.nlm.nih.gov/dailymed/ (Note: Specific historical product details may require advanced search functions or specific product recall/discontinuation databases).
[5] GoodRx. (2024). Ferrous Sulfate Extended Release Prices, Coupons & Savings. Retrieved from https://www.goodrx.com/ferrous-sulfate-extended-release (Accessed for representative pricing ranges, subject to variation).
[6] Public Citizen. (2021). The Impact of Pharmacy Benefit Manager (PBM) Rebates on Drug Prices. Retrieved from https://www.citizen.org/article/the-impact-of-pharmacy-benefit-manager-pbm-rebates-on-drug-prices/
[7] Kassebaum, N. J., Winter, M. K., Brewer, A. J., Thomas, T. S., & Vos, T. (2014). Anemia. In Global Burden of Diseases, Injuries, and Risk Factors Study 2010 (GBD 2010). The Institute for Health Metrics and Evaluation.
[8] Mayo Clinic. (2023). Iron deficiency anemia - Diagnosis and treatment. Retrieved from https://www.mayoclinic.org/diseases-conditions/iron-deficiency-anemia/diagnosis-treatment/drc-20351087
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