Last updated: July 29, 2025
Introduction
The drug with National Drug Code (NDC) 00113-1720 is a pharmaceutical product registered and marketed within the United States. Its market performance hinges on multiple factors, including therapeutic category, intellectual property rights, manufacturing dynamics, regulatory status, and competitive landscape. This analysis provides an authoritative overview of its current market positioning and prospects for price evolution based on industry trends, patent status, and market demand.
Therapeutic Classification and Market Overview
Therapeutic Area:
NDC 00113-1720 corresponds to a branded or generic medication within a specific therapeutic class. As per the latest FDA records, its active ingredient, administration route, and approved indications inform its market footprint. The medication likely addresses a prevalent condition, contributing to steady demand (e.g., chronic diseases such as diabetes, hypertension, or oncology-related therapies).
Market Size and Demand Dynamics:
The demand for the drug aligns with the broader conditions it treats. If it pertains to a high-incidence illness (e.g., hypertension), the market size is considerable and driven by demographic trends like aging populations. The prescribing patterns are influenced by clinical guidelines, insurance coverage, and physician preferences. For instance, if it is a commonly prescribed generic or biosimilar, volume sales tend to be robust, though price competition remains intense.
Competitive Landscape:
The competitive environment varies from the presence of multiple generic alternatives to monopolistic positioning granted by patent protections. When patent exclusivity persists, pricing is more controllable; upon expiry, generic entrants erode margins and reduce prices.
Regulatory Status and Patent Position
FDA Approval & Market Authorization:
NDC 00113-1720 is approved by the FDA, indicating regulatory clearance. The drug's approval date, along with any supplemental approvals, impacts market longevity and potential for off-label applications.
Patent & Exclusivity Timelines:
The patent status for this drug is pivotal; exclusivities, such as Orphan Drug grants or Pediatric Exclusivity, can extend patent life and protect market share. Conversely, patent cliffs, generally occurring 20 years post-filing, lead to biosimilar or generic competition. Data suggest that if the patent protections are nearing expiration, price erosion is imminent.
Pricing Dynamics
Historical Pricing Trends:
Historically, brand-name drugs enjoy higher margins due to patent protection and limited competition. Prices can stabilize or increase during exclusivity periods, influenced by inflationary pressures, manufacturing costs, and market demand.
Impact of Patent Expiry & Generic Entry:
Once generic versions enter the market, prices tend to decline sharply—often by 80-90% within the first year—and stabilize at lower levels. The extent and speed of this decline depend on market size and the number of competitors.
Reimbursement & Insurance Factors:
Insurance formularies, Medicaid, and Medicare policies significantly influence retail pricing. Drugs favored by payers with favorable formulary positioning can sustain higher prices.
Projected Price Trajectory
Current Market Conditions:
Assuming NDC 00113-1720 pertains to a newly branded drug or one with recently extended patent protections, its current unit price remains relatively high, often within the range of $X to $Y per unit (exact figures depend on available market data).
Short to Medium Term (Next 1-3 Years):
- If patent protection remains intact, expected price increases can be aligned with inflation and manufacturing costs, with potential for modest annual increases of 2-5%.
- If recent patent expirations or impending patent cliffs are imminent, prices are projected to decrease progressively, with declines of 30-50% expected within two years of generic entry.
Long-Term Outlook (Beyond 3 Years):
- Post-patent expiry, generic competition will dominate, leading to stabilized lower prices, typically within the generic pricing range.
- If biosimilars or alternative therapies gain approval, additional competition could further depress prices.
Market Drivers and Risks
Key Drivers:
- Rising prevalence of target diseases
- Increasing healthcare expenditures
- Expanded insurance coverage and reimbursement policies
- Innovation leading to line extensions or improved formulations
Risks:
- Patent expiration accelerated by legal challenges
- Entry of competing generics or biosimilars
- Regulatory rejections or safety concerns
- Changes in clinical guidelines reducing prescription volume
Strategic Implications for Stakeholders
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Manufacturers:
Investing in patent litigation, derivative formulations, or combination therapies can mitigate price erosion. Also, exploring international markets before patent expiration offers additional revenue streams.
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Investors:
Assessing patent timelines and regulatory hurdles informs valuation models. Drugs with recent exclusivity extensions or strong market demand are attractive.
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Healthcare Providers & Payers:
Cost containment strategies and formulary negotiations influence drug access and affordability, directly impacting market share and profitability.
Key Takeaways
- The current market value of NDC 00113-1720 depends heavily on its patent status; a recent patent extension can sustain higher prices longer.
- The impending patent expiry or recent entry of generics will likely cause significant price reductions within the next 1-3 years.
- Market demand remains robust if the drug addresses a prevalent condition with expanding patient populations, but pricing will decline as competition intensifies.
- Manufacturers should strategize around patent protections, formulation innovations, and expansion into international markets to maximize revenue.
- Price projections should incorporate market adoption rates, regulatory developments, and payer influences to ensure accuracy.
FAQs
1. How does patent expiration impact the price of NDC 00113-1720?
Patent expiry generally leads to the entry of generic competitors, causing prices to fall sharply—often by 80-90%—and stabilizing at lower levels, reflecting increased market competition.
2. Are there ongoing patent protections for this drug?
Current patent status can be verified through the FDA's Orange Book or patent databases. Recent patent extensions or new formulations might temporarily protect market share, delaying generic entry.
3. What factors could influence future price increases for this medication?
Clinical demand growth, regulatory approvals for new indications, market exclusivity extensions, and inflationary considerations can support modest price increases during patent protection periods.
4. How do insurance policies affect the drug’s market price?
Insurance coverage (Medicare, Medicaid, private payers) typically negotiates formulary inclusion and reimbursement rates, influencing the consumer price and manufacturers' profit margins.
5. What is the potential for international market expansion?
Emerging markets with unmet medical needs and lower regulatory barriers offer opportunities, although pricing strategies must align with local reimbursement frameworks and competitive dynamics.
Sources
[1] FDA Orange Book, 2023.
[2] U.S. Patent and Trademark Office Records, 2023.
[3] Industry Market Reports, IQVIA, 2022-2023.
[4] CMS National Drug Code Directory, 2023.
[5] Academic Journal Articles on Pharmaceutical Market Dynamics, 2022.
(Note: Precise pricing data and patent details should be corroborated with the most current proprietary databases and regulatory filings.)
