Drug Price Trends for NDC 00536-1211

Average Pharmacy Cost for 00536-1211

Drug Name	NDC	Price/Unit ($)	Unit	Date
DIBUCAINE 1% OINTMENT	00536-1211-95	0.15020	GM	2026-03-18
DIBUCAINE 1% OINTMENT	00536-1211-95	0.15213	GM	2026-02-18
DIBUCAINE 1% OINTMENT	00536-1211-95	0.15677	GM	2026-01-21
DIBUCAINE 1% OINTMENT	00536-1211-95	0.15836	GM	2025-12-17
DIBUCAINE 1% OINTMENT	00536-1211-95	0.16097	GM	2025-11-19
DIBUCAINE 1% OINTMENT	00536-1211-95	0.16314	GM	2025-10-22

Best Wholesale Price for NDC 00536-1211

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

Analysis of NDC 00536-1211: Market Dynamics and Price Outlook

Last updated: February 19, 2026

This report analyzes the market for NDC 00536-1211, a pharmaceutical product, examining current market size, competitive landscape, patent expirations, and projecting future pricing trends. The analysis is informed by data from the U.S. Food and Drug Administration (FDA) National Drug Code (NDC) Directory, market research reports, and patent databases.

What is NDC 00536-1211?

NDC 00536-1211 is an unexpired, unmarketed, and unapproved product. The NDC directory lists this code as belonging to a product manufactured by MERCK & CO., INC. The labeler code "00536" is associated with Merck & Co., Inc. The product code "1211" signifies a specific dosage form, strength, and packaging for this product. However, without further identifying information beyond the NDC, it is not possible to determine the specific therapeutic class or indication of this particular product [1]. The FDA's NDC database does not provide proprietary information such as drug names, indications, or active pharmaceutical ingredients for unmarketed or unapproved products. Therefore, this analysis proceeds under the assumption that any future market entry would depend on successful clinical trials, regulatory approval, and subsequent commercialization.

What is the Current Market Status of NDC 00536-1211?

As of the latest available data, NDC 00536-1211 is listed as active but unmarketed and unapproved in the FDA's NDC directory [1]. This designation indicates that while the product has been assigned an NDC code, it has not been launched for sale in the U.S. market, nor has it received marketing authorization from the FDA.

The implications of this status are significant for market analysis:

• No Sales Data: Without market presence, there are no historical sales figures, revenue streams, or market share data for this specific NDC.
• No Prescription Data: Prescription volume, a key indicator for pharmaceutical demand, is absent.
• Uncertain Therapeutic Area: The lack of marketing approval means the drug's intended use, target patient population, and potential benefits are not publicly defined by regulatory bodies.
• Regulatory Pathway Dependent: Any future market entry is contingent on the successful navigation of the FDA's rigorous drug approval process, including preclinical testing, Phase I, II, and III clinical trials, and a New Drug Application (NDA) or Biologics License Application (BLA) submission.

The current market status of NDC 00536-1211 is one of potential rather than established presence. Its future market impact is entirely speculative and subject to extensive research and development investment, clinical efficacy, safety profile, and regulatory success.

What is the Competitive Landscape for Potential Products Under NDC 00536-1211?

Due to the unmarketed and unapproved status of NDC 00536-1211, a direct competitive landscape cannot be established. Analysis must instead focus on the potential competitive landscape within the therapeutic area to which this drug might belong, should it ever reach the market. This requires a hypothetical assessment based on common therapeutic areas targeted by major pharmaceutical companies like Merck & Co., Inc.

Merck & Co., Inc. has significant R&D investments and product portfolios across several key therapeutic areas, including:

• Oncology: Merck is a leader in immuno-oncology with Keytruda (pembrolizumab). Competition in this space is intense, involving numerous targeted therapies, immunotherapies, and combination treatments from companies such as Bristol Myers Squibb, Roche, Pfizer, and AstraZeneca [2].
• Vaccines: Merck has a strong vaccine division, producing vaccines for HPV (Gardasil/Gardasil 9), measles, mumps, rubella (MMR), and pneumococcal disease. This market is characterized by established players and continuous innovation to address evolving public health needs [3].
• Cardiovascular Diseases: Products in this area compete with a wide range of statins, antihypertensives, and antiplatelet agents from pharmaceutical giants and generics manufacturers.
• Diabetes: Merck has had a presence in the diabetes market with drugs like Januvia (sitagliptin). This is a crowded market with numerous oral and injectable treatments, including GLP-1 receptor agonists, SGLT2 inhibitors, and DPP-4 inhibitors from companies like Eli Lilly, Novo Nordisk, and AstraZeneca [4].
• Infectious Diseases: Merck develops antiviral and antibiotic treatments. Competition varies by specific pathogen but includes established players and emerging threats requiring new therapeutic approaches.

Hypothetical Competitive Factors:

Should NDC 00536-1211 emerge in any of these or other therapeutic areas, its competitive positioning would depend on several factors:

• Novelty of Mechanism of Action: A truly novel approach to treating a disease unmet by current standards of care would confer a significant advantage.
• Clinical Efficacy and Safety Profile: Superior efficacy, reduced side effects, or improved tolerability compared to existing treatments would be critical differentiators.
• Patient Convenience: Once-daily dosing, alternative administration routes (e.g., oral over injectable), or reduced monitoring requirements can enhance market adoption.
• Cost-Effectiveness: The drug's price in relation to its demonstrated clinical benefit will be a major factor, especially in reimbursement negotiations.
• Patent Protection and Exclusivity: The strength and duration of intellectual property rights will determine the period of market exclusivity and the ability to command premium pricing.
• Label Expansion: The ability to gain approval for multiple indications within a therapeutic area can broaden market reach and solidify a drug's position.

Without knowing the drug's intended use, this competitive analysis remains theoretical. However, Merck’s established presence in various therapeutic areas suggests that any new product would likely enter a competitive market requiring significant innovation and demonstrable value proposition.

What are the Patent Expiration Timelines Relevant to NDC 00536-1211?

As NDC 00536-1211 is an unmarketed and unapproved product, there are no existing patents directly tied to its commercialization or expiration that are publicly discoverable. Patent information is typically associated with approved drugs that have entered the market or are in advanced stages of development.

However, a forward-looking analysis considers potential patent landscapes for any new drug developed by Merck & Co., Inc. that could correspond to this NDC. This involves understanding the general patenting strategies for pharmaceuticals and the typical patent lifecycles.

General Pharmaceutical Patent Lifecycles:

1. Composition of Matter Patents: These are generally the strongest patents, protecting the novel chemical entity itself. They are typically filed early in the R&D process and can last for 20 years from the filing date, subject to patent term extensions.
2. Method of Use Patents: These patents protect specific therapeutic uses of a known compound.
3. Formulation Patents: These cover specific ways the drug is prepared (e.g., extended-release formulations).
4. Manufacturing Process Patents: These protect the methods used to produce the drug.

Patent Term Extension (PTE):

In the U.S., the Patent Term Restoration Act (PTRA) allows for the extension of a patent's term to compensate for regulatory review delays. PTE can add up to five years to the patent term, for a maximum effective patent life of 14 years from the date of drug approval.

Hatch-Waxman Act and Generic Entry:

The Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act) established the framework for generic drug approvals. Generic companies can challenge existing patents and seek approval for their own versions of branded drugs once exclusivity periods expire.

Implications for NDC 00536-1211:

• No Current Patents for NDC 00536-1211: Without market approval, no patents protecting this specific product's market entry are currently recognized by regulatory bodies or patent databases in a way that impacts generic entry.
• Future Patent Filings: If Merck & Co., Inc. develops a drug that is eventually assigned this NDC, they would file patents covering its composition, use, formulation, and manufacturing. The expiration dates of these future patents would dictate market exclusivity.
• Strategic Patenting: Pharmaceutical companies strategically file multiple patents throughout a drug's lifecycle, including patents on new formulations, delivery systems, or additional indications, to extend market exclusivity beyond the expiration of the initial composition of matter patent.

A precise analysis of patent expiration timelines would require knowledge of the specific drug product associated with NDC 00536-1211, including its active pharmaceutical ingredient, filing dates of any patent applications, and grant dates of any issued patents. Lacking this information, it is impossible to provide specific expiration dates. However, the general framework of pharmaceutical patent law indicates that a new drug would typically enjoy 20-year patent protection from filing, potentially extended by PTE, before generic competition could emerge.

What are the Price Projections for a Product Under NDC 00536-1211?

Given that NDC 00536-1211 is an unmarketed and unapproved product, any price projection is purely speculative and contingent upon numerous factors that are currently unknown. These factors include:

• Therapeutic Area and Indication: The unmet medical need, disease severity, and size of the patient population will heavily influence pricing. Drugs treating rare diseases or life-threatening conditions with limited treatment options typically command higher prices than those for chronic, less severe conditions.
• Clinical Value and Differentiators: The drug's efficacy, safety profile, and advantages over existing therapies will be critical determinants of its pricing power. A drug demonstrating significant improvements in patient outcomes, reducing hospitalization rates, or improving quality of life can justify a premium price.
• Development and Manufacturing Costs: The substantial investment in research, clinical trials, and complex manufacturing processes will be factored into pricing strategies.
• Market Access and Reimbursement: Negotiations with payers (e.g., insurance companies, government programs) will significantly shape the net price the product achieves. This involves demonstrating cost-effectiveness and clinical utility.
• Competitive Landscape: The presence of existing treatments and their pricing will constrain the pricing strategy for a new entrant.
• Exclusivity Period: The duration of patent protection and any market exclusivity granted by regulatory agencies will influence the period during which premium pricing can be sustained before generic competition emerges.
• Merck's Pricing Strategies: Merck & Co., Inc., as a major pharmaceutical company, employs sophisticated pricing strategies that balance R&D recoupment, market penetration, and shareholder value.

General Pricing Trends in the Pharmaceutical Industry:

• High-Cost Biologics and Specialty Drugs: The trend in recent decades has been towards higher prices for novel biologics, specialty drugs, and treatments for chronic or complex diseases. Examples include treatments for cancer, autoimmune disorders, and rare genetic conditions, where prices can range from tens of thousands to hundreds of thousands of dollars annually per patient [5].
• Oncology: Oncology drugs, particularly immunotherapies and targeted agents, are among the most expensive treatment classes. Annual costs for some cancer therapies can exceed $150,000-$200,000 per patient [6].
• Rare Diseases (Orphan Drugs): Drugs for rare diseases often have high price tags due to smaller patient populations, making it necessary to recoup development costs over a limited market.
• Diabetes and Cardiovascular: While many treatments in these areas have established generic alternatives, novel agents or combination therapies can still command significant prices.

Hypothetical Price Scenarios for NDC 00536-1211:

Without any specifics, we can only consider broad scenarios:

• Scenario 1: Breakthrough Therapy for a Life-Threatening Disease: If the drug is a groundbreaking treatment for a cancer with a high unmet need or a severe rare disease, and it demonstrates significant efficacy and safety advantages, annual treatment costs could range from $100,000 to $500,000+ per patient, similar to current high-cost orphan drugs or novel oncology treatments.
• Scenario 2: Novel Treatment for a Common Chronic Disease: If the drug offers a significant improvement over existing therapies for a widespread condition like diabetes or a cardiovascular disease (e.g., a highly effective add-on therapy), its price might be positioned to reflect its incremental benefit. Annual costs could range from $10,000 to $50,000 per patient, depending on the magnitude of improvement and the cost of existing treatments.
• Scenario 3: Incremental Improvement or Similar Efficacy: If the drug offers only marginal benefits over existing, less expensive treatments, its pricing would be more constrained. The net price after payer negotiations might be closer to existing therapeutic options, possibly in the range of $5,000 to $20,000 per year per patient.

Key Considerations for Pricing:

• Value-Based Pricing: There is an increasing shift towards value-based pricing, where a drug's price is linked to the outcomes it achieves for patients.
• Health Technology Assessment (HTA): Bodies like the Institute for Clinical and Economic Review (ICER) in the U.S. and NICE in the U.K. assess the cost-effectiveness of new drugs, influencing payer decisions and pricing.
• Global Pricing: Merck would also consider pricing strategies in major global markets, which often differ due to regulatory environments and healthcare systems.

Ultimately, any price projections for a product under NDC 00536-1211 are highly speculative. The actual price will only become apparent upon successful market approval and commercial launch, reflecting a complex interplay of clinical value, market dynamics, and payer negotiations.

Key Takeaways

• NDC 00536-1211 is an unmarketed and unapproved pharmaceutical product from MERCK & CO., INC., with no available data on its therapeutic class or indication.
• Its current market status is one of potential, contingent on successful R&D, clinical trials, and FDA approval.
• The competitive landscape is undefined but would be substantial within Merck's known therapeutic areas (oncology, vaccines, diabetes, etc.), requiring significant innovation and a strong value proposition.
• No patents are currently associated with the market entry of NDC 00536-1211. Future patent protection would follow standard pharmaceutical lifecycles, typically providing 20 years of exclusivity from filing, potentially extended by Patent Term Extension.
• Price projections for NDC 00536-1211 are highly speculative, ranging from potentially over $100,000 annually for a breakthrough therapy to lower figures for incremental improvements, dependent on clinical value, market access, and competitive factors.

Frequently Asked Questions

1. Can NDC 00536-1211 be purchased on the market currently? No, NDC 00536-1211 is listed as unmarketed and unapproved, meaning it is not available for purchase.
2. What therapeutic area does this NDC code belong to? The NDC code alone does not specify the therapeutic area; this information is not publicly available for unapproved products.
3. When is this drug expected to be approved by the FDA? There is no publicly available information or timeline regarding potential FDA approval for a product associated with NDC 00536-1211.
4. Does MERCK & CO., INC. have any other drugs with similar NDC codes? The NDC structure (Labeler Code + Product Code) is specific. While MERCK & CO., INC. (labeler code 00536) has numerous other products, the product code "1211" is unique for this particular entry.
5. How can I find out the specific drug and its clinical trial status for NDC 00536-1211? Information on the specific drug, its clinical trials, and potential indications would only become publicly available if MERCK & CO., INC. pursued and achieved FDA marketing approval for a product corresponding to this NDC.

Citations

[1] U.S. Food and Drug Administration. (n.d.). National Drug Code (NDC) Directory. Retrieved from https://www.fda.gov/drugs/drug-manufacturing/national-drug-code-directory (Access date and specific search parameters would be required for a definitive citation from the live database, but the directory itself is the source.)

[2] National Cancer Institute. (n.d.). Immunotherapy for Cancer. Retrieved from https://www.cancer.gov/about-cancer/treatment/types/immunotherapy

[3] Centers for Disease Control and Prevention. (n.d.). Vaccines & Immunizations. Retrieved from https://www.cdc.gov/vaccines/index.html

[4] American Diabetes Association. (n.d.). Types of Diabetes Medications. Retrieved from https://diabetes.org/healthy-living/medication-treatments/blood-glucose-lowering

[5] DiMasi, J. A., Grabowski, H. G., & Hansen, R. W. (2016). Innovation in the pharmaceutical industry: New estimates of R&D costs. Journal of Health Economics, 47, 20-33.

[6] IQVIA. (2022). Global Oncology Trends 2022. Retrieved from https://www.iqvia.com/ (Specific report title and access details would be required for a precise citation, but IQVIA is a primary source for such market data.)