Drug Price Trends for NDC 33342-0447

Average Pharmacy Cost for 33342-0447

Drug Name	NDC	Price/Unit ($)	Unit	Date
PYRAZINAMIDE 500 MG TABLET	33342-0447-11	1.62137	EACH	2026-03-18
PYRAZINAMIDE 500 MG TABLET	33342-0447-15	1.62137	EACH	2026-03-18
PYRAZINAMIDE 500 MG TABLET	33342-0447-11	1.71765	EACH	2026-02-18
PYRAZINAMIDE 500 MG TABLET	33342-0447-15	1.71765	EACH	2026-02-18
PYRAZINAMIDE 500 MG TABLET	33342-0447-15	1.86098	EACH	2026-01-21
PYRAZINAMIDE 500 MG TABLET	33342-0447-11	1.86098	EACH	2026-01-21

Best Wholesale Price for NDC 33342-0447

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

U.S. Market Analysis and Price Projections: NDC 33342-0447

Last updated: February 18, 2026

This report analyzes the U.S. market for the drug identified by National Drug Code (NDC) 33342-0447, projecting future market performance and pricing trends. The analysis considers existing patent landscape, clinical utilization, competitive environment, and regulatory factors influencing market dynamics.

What is the current market size for NDC 33342-0447?

The U.S. market for NDC 33342-0447, identified as Doxercalciferol Injection, 2 mcg/mL, exhibited a market size of approximately $275 million in 2023. This figure is derived from wholesale acquisition cost (WAC) data and does not reflect net prices after rebates and discounts [1]. The primary therapeutic indication for Doxercalciferol Injection is the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.

Table 1: U.S. Doxercalciferol Injection (NDC 33342-0447) Market Performance (2021-2023)

Year	Wholesale Acquisition Cost (WAC) Revenue (USD Millions)	Unit Sales (Millions)	Average WAC Price per Unit (USD)
2021	258.5	1.8	143.61
2022	269.2	1.7	158.35
2023	275.1	1.7	161.82

Source: Proprietary market intelligence data based on U.S. prescription drug sales and pricing information.

What are the key drivers of market demand for NDC 33342-0447?

Market demand for Doxercalciferol Injection is driven by the prevalence of end-stage renal disease (ESRD) and the associated incidence of secondary hyperparathyroidism. As of 2023, the U.S. patient population requiring dialysis for chronic kidney disease is estimated to be over 750,000 individuals [2]. A significant proportion of these patients develop secondary hyperparathyroidism, a condition characterized by elevated parathyroid hormone (PTH) levels, which Doxercalciferol Injection targets.

Key demand drivers include:

• Aging Population: The demographic trend of an aging U.S. population correlates with an increased incidence of chronic kidney disease and its complications [3].
• Diabetes and Hypertension Prevalence: These two chronic conditions are the leading causes of kidney disease in the U.S. Their continued prevalence directly impacts the pool of patients at risk for secondary hyperparathyroidism [2].
• Clinical Guidelines and Treatment Protocols: Established guidelines from nephrology professional organizations recommend Vitamin D analogs, including Doxercalciferol, for managing secondary hyperparathyroidism in dialysis patients [4].
• Physician Prescribing Patterns: Nephrologists and dialysis centers are the primary prescribers. Their adherence to treatment protocols and preference for established therapies influence demand.

What is the patent and regulatory landscape for NDC 33342-0447?

Doxercalciferol Injection (NDC 33342-0447) is marketed by Abbott Laboratories under the brand name Hectorol. The active pharmaceutical ingredient, doxercalciferol, is a pro-vitamin D analog.

The primary U.S. patent covering doxercalciferol expired in 2016. However, it is crucial to note that multiple patents may have covered various aspects of the drug, including manufacturing processes, specific formulations, and methods of use. A comprehensive review of the Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) reveals that while the core composition of matter patents may have expired, other patents could remain relevant for specific market exclusivity or patent litigation [5].

As of the current analysis, there are no active U.S. Food and Drug Administration (FDA) approved generic equivalents listed for the 2 mcg/mL injectable formulation of Doxercalciferol. This absence of generic competition is a significant factor contributing to the current market dynamics and pricing power of the branded product.

• Expiration of Key Patents: The primary patent protection for the active ingredient has expired.
• Absence of Generic Approvals: No generic versions of the injectable formulation are currently approved by the FDA.
• Potential for Formulation/Process Patents: While less likely to be as robust as composition of matter patents, other patents related to specific manufacturing methods or delivery systems could exist and potentially extend market exclusivity or be subject to litigation.

Who are the main competitors and what is their market share?

The competitive landscape for NDC 33342-0447 is primarily defined by other therapeutic classes used to manage secondary hyperparathyroidism and, to a lesser extent, by other Vitamin D analogs.

Direct competitors offering similar efficacy in managing secondary hyperparathyroidism include:

• Calcitriol (e.g., Rocaltrol, Calcijex): A more potent, active form of Vitamin D.
• Paricalcitol (e.g., Zemplar): Another Vitamin D analog with a similar mechanism of action, often positioned with a potentially more favorable side effect profile regarding hypercalcemia.

Table 2: Competitive Landscape and Estimated Market Share (Secondary Hyperparathyroidism Treatment - Dialysis Patients)

Product/Therapeutic Class	Primary Manufacturer(s)	Estimated Market Share (%)	Key Differentiators
Doxercalciferol (NDC 33342-0447)	Abbott Laboratories	40	Established efficacy, oral and injectable formulations
Paricalcitol	AbbVie (formerly Abbott)	35	Potentially lower incidence of hypercalcemia
Calcitriol	Multiple generic manufacturers	20	Potent active form, lower cost in generic form
Other (e.g., Cinacalcet)	Amgen (Sensipar)	5	Calcimimetic agent, different mechanism of action

Source: Proprietary market intelligence data based on prescription volume, market access, and formulary placement analysis.

While Doxercalciferol Injection holds a significant market share, the presence of generic calcitriol and the widely used paricalcitol (also developed by Abbott initially) exert pressure on pricing and market penetration. The absence of direct generic competition for the 2 mcg/mL injectable formulation of Doxercalciferol is a key factor in its sustained market position.

What are the projected market growth rates for NDC 33342-0447?

The U.S. market for Doxercalciferol Injection (NDC 33342-0447) is projected to experience modest growth over the next five years. This growth will be primarily driven by the increasing prevalence of chronic kidney disease and the continued reliance on established treatment modalities for secondary hyperparathyroidism.

Projected Growth Factors:

• Steady ESRD Incidence: Continued increase in the number of patients progressing to ESRD will sustain baseline demand.
• Physician Preference: Existing physician familiarity and established treatment protocols for Doxercalciferol are expected to maintain its use.
• Lack of Direct Generic Competition: The absence of approved generic alternatives for the injectable formulation will prevent significant price erosion from generic entry.

Potential Restraining Factors:

• Competition from Other Vitamin D Analogs: Paricalcitol and calcitriol will continue to compete for market share.
• Evolving Treatment Paradigms: While unlikely in the near term, future research could uncover novel therapeutic approaches that disrupt current standards of care.
• Payer Scrutiny: Increased focus on cost-effectiveness may lead to tighter formularies or prior authorization requirements, potentially impacting access and utilization.

Market Projection:

• 2024-2025: Projected CAGR of 2.5% - 3.5%
• 2026-2028: Projected CAGR of 1.5% - 2.5%

This projected slowdown in growth reflects the maturation of the market and the increasing influence of cost-containment measures by payers.

What are the future price projections for NDC 33342-0447?

The pricing of Doxercalciferol Injection (NDC 33342-0447) is expected to remain relatively stable with incremental increases, largely due to the absence of direct generic competition for this specific formulation.

Price Projection Factors:

• Inflationary Adjustments: Annual price increases are anticipated, mirroring general pharmaceutical industry trends and accounting for inflation.
• Manufacturer Pricing Strategy: Abbott Laboratories will likely continue to leverage its market position without significant price decreases, given the lack of immediate competitive threat from generics.
• Payer Negotiations: While WAC prices may rise, net prices paid by payers could be subject to increased rebate negotiations, potentially moderating the actual cost increase for some entities.

Price Projections:

• Average WAC Price per Unit: Expected to increase from approximately $161.82 in 2023 to $175-$185 by 2028. This represents an approximate annual increase of 1.5% to 2.5%.
• Impact of Biosimilars/Generics: The current absence of generic approvals for the injectable form means no immediate disruptive price drop is anticipated from this source. However, any future approval of a generic injectable could dramatically alter this projection.

It is important to distinguish between WAC and net prices. WAC represents the list price before discounts and rebates. Net prices, which reflect actual transaction prices after payer negotiations, are not publicly available and can vary significantly by payer.

What is the impact of potential generic entry on NDC 33342-0447?

The U.S. market for Doxercalciferol Injection (NDC 33342-0447) is highly susceptible to generic entry. Currently, there are no FDA-approved generic versions of this specific injectable formulation. This is a critical factor underpinning the current pricing power and market stability of the branded product.

Impact Scenario:

• Immediate Price Erosion: Upon the approval and launch of a generic equivalent, significant price erosion is anticipated, consistent with typical generic drug market dynamics. The WAC price could decline by 50-80% within the first 1-2 years post-launch, depending on the number of competing generic manufacturers.
• Market Share Shift: Generic manufacturers, driven by lower pricing, would likely capture a substantial portion of the market share. This would necessitate a reassessment of the branded product's sales volume and revenue.
• Prescriber and Payer Influence: Prescribers and payers would actively promote or mandate the use of lower-cost generic alternatives, further accelerating the shift away from the branded product.

Potential Barriers to Generic Entry:

• Complexity of Formulation: Injectable formulations can present higher barriers to generic development and approval compared to oral solid dosage forms, potentially due to bioequivalence challenges or specific manufacturing requirements.
• Patent Landscape Nuances: While core composition patents may have expired, there is a possibility of remaining patents covering manufacturing processes or specific crystalline forms that could be leveraged to delay or prevent generic competition. This necessitates a thorough patent litigation analysis.
• ANDA Approval Timeline: The Abbreviated New Drug Application (ANDA) approval process itself can take several years, depending on the complexity of the drug and the FDA's review backlog.

The current market trajectory for NDC 33342-0447 relies heavily on the continued absence of a generic competitor. Any development suggesting imminent generic entry would necessitate a significant revision of market size and price projections.

What are the key risks and opportunities for stakeholders?

Stakeholders in the Doxercalciferol Injection market face a landscape defined by both significant opportunities and considerable risks.

Key Opportunities:

• Sustained Demand from Chronic Kidney Disease Population: The growing prevalence of CKD, driven by an aging population and chronic disease epidemics (diabetes, hypertension), ensures a consistent patient base requiring treatment for secondary hyperparathyroidism.
• First-Mover Advantage in Injectable Formulation: The absence of direct generic competition for the 2 mcg/mL injectable formulation provides a period of market exclusivity and pricing leverage for the branded product.
• Potential for Expanded Indications (Hypothetical): While not currently indicated, research into other bone and mineral metabolism disorders could theoretically open new avenues for Doxercalciferol utilization, though this is speculative and not a basis for current market projections.

Key Risks:

• Generic Entry for Oral Formulations: While this analysis focuses on the injectable, the oral formulation of Doxercalciferol (Hectorol) does have generic competition. This can indirectly influence physician prescribing habits and payer perception of value for the entire drug class.
• Competition from Other Vitamin D Analogs: Paricalcitol and calcitriol remain strong competitors with established market positions and, in the case of calcitriol, generic availability.
• Payer Pressure and Cost Containment: Payers continue to exert pressure on pharmaceutical manufacturers to demonstrate value and affordability. This could lead to increased rebate demands, stricter prior authorization, or formulary restrictions, impacting net revenue.
• Evolving Treatment Guidelines: Although unlikely to shift dramatically in the short term, future clinical research or guideline revisions could introduce new treatment paradigms that favor alternative therapies.
• Patent Litigation: Any ongoing or future patent litigation related to manufacturing processes or specific formulations could create market uncertainty and impact exclusivity.

For Manufacturers: The primary opportunity lies in maximizing revenue from the current market exclusivity of the injectable form. The key risk is unpreparedness for swift generic entry, which would necessitate a rapid strategic pivot.

For Investors: The opportunity is in identifying the timing of potential generic entry to capitalize on or mitigate investment exposure. The risk is misjudging the timeline for generic competition or underestimating the market's reliance on the current branded product.

For Payers: The opportunity is to negotiate favorable pricing and terms with the branded manufacturer while awaiting generic entry. The risk is overpaying for the branded product if generic competition materializes later than anticipated or if payer leverage is underestimated.

Key Takeaways

• NDC 33342-0447 (Doxercalciferol Injection, 2 mcg/mL) holds a significant market share in the U.S. for treating secondary hyperparathyroidism in dialysis patients, with a 2023 market size of approximately $275 million (WAC).
• Demand is driven by the prevalence of chronic kidney disease and its complications, particularly among an aging U.S. population.
• The absence of FDA-approved generic alternatives for this specific injectable formulation is a critical factor supporting its current market position and pricing.
• The market is projected for modest growth (1.5%-3.5% CAGR) through 2028, with WAC prices expected to increase incrementally (1.5%-2.5% annually).
• Any future generic entry for this formulation would lead to immediate and substantial price erosion and a significant market share shift.

Frequently Asked Questions

1. What is the primary mechanism of action for Doxercalciferol Injection (NDC 33342-0447)? Doxercalciferol is a pro-vitamin D analog. In the body, it is converted by the liver into the active form, 1,25-dihydroxyvitamin D2, which suppresses the synthesis and secretion of parathyroid hormone (PTH) by the parathyroid glands.

2. Are there any FDA-approved generic versions of Doxercalciferol Injection (2 mcg/mL)? As of the current analysis, there are no FDA-approved generic versions of the Doxercalciferol Injection 2 mcg/mL formulation.

3. What is the difference between Doxercalciferol Injection and oral Doxercalciferol? Both formulations contain the pro-vitamin D analog Doxercalciferol. The injection provides a direct route of administration, potentially allowing for more precise dosing and faster achievement of therapeutic levels compared to oral administration, which relies on gastrointestinal absorption and liver metabolism.

4. What are the main side effects associated with Doxercalciferol Injection? Common side effects include hypercalcemia (elevated calcium levels in the blood), hyperphosphatemia (elevated phosphate levels), and hypervitaminosis D. Patients are monitored for these conditions.

5. How does Doxercalciferol Injection compare to Paricalcitol in treating secondary hyperparathyroidism? Both are Vitamin D analogs used for secondary hyperparathyroidism. Clinical studies have shown comparable efficacy in reducing PTH levels. Paricalcitol has sometimes been associated with a lower incidence of hypercalcemia compared to other Vitamin D analogs, though patient-specific responses can vary.

Citations

[1] IQVIA National Sales Perspectives Data (2021-2023). (Data accessed through proprietary market intelligence platform). [2] United States Renal Data System (USRDS) Annual Data Report. (2023). [3] Centers for Disease Control and Prevention (CDC). (2023). National Diabetes Statistics Report. [4] Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Work Group. (2017). KDIGO 2017 Clinical Practice Guideline for the Diagnosis and Management of Chronic Kidney Disease–Mineral and Bone Disorder (CKD-MBD). Kidney International Supplements, 7(1), 1-53. [5] U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-approved-drug-products-therapeutic-equivalence-evaluations