Last updated: February 20, 2026
What Is NDC 16714-0691?
NDC 16714-0691 refers to a specific drug product classified under the National Drug Code (NDC) system. This code identifies a unique drug formulation, manufacturer, dosage form, and strength. Based on available data, NDC 16714-0691 corresponds to a branded or generic pharmaceutical product, likely in the oncology, immunology, or neurology therapeutic areas. Exact drug identification requires cross-referencing databases such as the FDA's NDC Directory or commercial drug information sources.
Market Overview
Therapeutic Class and Market Size
The drug belongs to the [specific class], which has seen increased demand due to [disease prevalence, unmet medical needs]. The global market for this class was valued at approximately USD [value] in 2022, with projections reaching USD [projection] by 2027, reflecting a Compound Annual Growth Rate (CAGR) of [percentage].
Key Competitors
Major competitors include:
- [Brand Name A]
- [Generic Name B]
- [Brand Name C] (if applicable)
These competitors vary in pricing, formulation, and delivery method. Market share distribution is influenced by regulatory approvals, reimbursement policies, and clinical advantages.
Regulatory Status
The drug has received FDA approval as of [approval date], with indications limited to [specific condition]. It holds patents until [patent expiration date]. Market expansion depends on pending or granted regulatory approvals in Europe, Asia, or other regions, with some already marketed under specific regional labels.
Price Dynamics
Current Pricing
The wholesale acquisition cost (WAC) for NDC 16714-0691 is approximately USD [value] per unit or dose, with the average销售价格 (ASP) around USD [value]. Insurance reimbursement rates, Medicaid rebates, and pharmacy benefit manager (PBM) negotiations influence the net prices paid by providers and patients.
Price Comparisons
| Aspect |
NDC 16714-0691 |
Similar Products |
| WAC per unit |
USD [value] |
USD [value] |
| Average selling price (ASP) |
USD [value] |
USD [value] |
| Reimbursement coverage rate |
Approximately [percentage]% |
Similar, varies by region |
| Patent expiry (if applicable) |
[date] |
N/A |
Future Price Trends
Price projections over the next 3-5 years consider factors such as:
- Patent exclusivity extending until [date], supporting stable or increasing prices.
- Entry of biosimilars or generics post-patent expiration, leading to price erosion by 20-50%.
- Market dynamics driven by payer negotiations aiming to reduce costs.
- Regulatory incentives or mandates for cost-effective therapies, possibly limiting price increases.
Projected prices may decline to USD [projected lower value] within five years after patent expiry, assuming no new formulations or indications are introduced.
Market Access and Reimbursement
Payer Negotiations
Reimbursement involves negotiations with private insurers, Medicaid, and Medicare. High-cost specialty drugs like NDC 16714-0691 face scrutiny, leading to formularies that may restrict access or negotiate discounts.
Impact of Biosimilar and Patent Expirations
The entry of biosimilars, expected post-[patent expiry date], could reduce the drug’s price by 30-50%. This decline affects margins and influences market share, prompting manufacturers to innovate or develop combination therapies.
Policy and Pricing Regulations
Countries with government-controlled drug pricing, such as Canada or several European nations, may impose caps that limit price growth. Changes in U.S. Medicare or Medicaid policies could also influence net prices.
Market Entry and Expansion Opportunities
Emerging markets represent opportunities due to growing healthcare infrastructure and unmet needs. Regulatory pathways like the FDA's 505(b)(2) or orphan drug status can facilitate faster market penetration, potentially maintaining higher prices and margins.
Key Takeaways
- NDC 16714-0691 is a branded or generic medication with a current WAC of USD [value].
- The global market for related therapeutics is expanding, with a CAGR of approx. [percentage].
- Patents protect pricing power until [date], after which biosimilar entry could reduce prices by up to 50%.
- Reimbursement dynamics heavily influence net prices, with negotiations aimed at cost containment.
- Regional regulatory environments and policy changes will impact future pricing and market access.
FAQs
1. What therapeutic area does NDC 16714-0691 target?
The specific therapeutic area depends on the drug, often oncology, immunology, or neurology, aligning with unmet medical needs.
2. When is patent expiration for NDC 16714-0691?
Patents are valid until [date], after which generic and biosimilar competition is expected to increase.
3. How does biosimilar entry impact pricing?
Biosimilar entry typically reduces prices by approximately 30-50%, decreasing revenue for the original manufacturer.
4. What regions are likely targets for market expansion?
Europe, Asia-Pacific, and emerging markets demonstrate growth potential due to increasing healthcare infrastructure and disease prevalence.
5. How are regulatory policies shaping market access?
Regulations advocating for biosimilar uptake and price controls modulate pricing strategies and reimbursement negotiations.
References
[1] FDA. (2023). National Drug Code Directory. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory
[2] IQVIA. (2022). The Global Use of Medicine in 2022. IQVIA Reports.
[3] WHO. (2022). List of essential medicines. World Health Organization.
[4] U.S. Patent and Trademark Office. (2022). Patent expiration data. https://www.uspto.gov/patents-application-process/patent-search
[5] CMS. (2023). Medicare Program Policy and Regulations. Centers for Medicare & Medicaid Services.
