Last updated: August 11, 2025
Introduction
NDC 00713-0937 refers to a specific pharmaceutical product registered under the National Drug Code system maintained by the U.S. Food and Drug Administration (FDA). Its market performance, competitive positioning, and pricing dynamics hinge on multiple factors, including the drug’s therapeutic category, patent status, manufacturing landscape, and regulatory environment. This analysis aims to unpack these components, provide price projections, and offer strategic insights for stakeholders.
Product Overview
While explicit details about NDC 00713-0937 are limited without access to proprietary registries, NDCs coded under the “00713” prefix generally correspond to products manufactured by GlaxoSmithKline (GSK). Assuming the product in question is a prescription medication in a common therapeutic area such as oncology, immunology, or infectious diseases, the landscape and pricing biology can be extrapolated from comparable drug classes.
Market Landscape
Therapeutic Area Context
Assuming that NDC 00713-0937 is a biologic or small-molecule drug, key contemporaneous market drivers include:
- Prevalence of Target Disease: Rising incidence rates—for example, in conditions like rheumatoid arthritis or oncology—drive demand.
- Unmet Medical Need: Drugs addressing refractory cases or offering better safety profiles command premium pricing.
- Competitive Landscape: Established biologics or biosimilars impact market share and price levels.
Regulatory and Patent Status
- Patent Expiry: If the patent protection extends beyond 2023, the drug maintains exclusivity, supporting higher prices. Patent expiration invites biosimilar competition, exerting downward pressure.
- FDA Approvals: Orphan drug designation or breakthrough therapy status elevate market exclusivity and, consequently, pricing potential.
Market Dynamics
- Pricing Trends: The average wholesale price (AWP) for similar drugs in the classified therapeutic area ranges broadly, with biologics often retailing between $5,000 and $20,000 per infusion or treatment course.
- Reimbursement Environment: Payers favor cost-effective treatments, influencing net pricing and formulary placement.
- Manufacturing and Supply Chain: Approval of manufacturing facilities and supply chain stability influence price fluctuations, especially with global disruptions.
Current Pricing Status
Based on comparable medications, the average list price (ALP) for drugs in similar classes varies:
- Biologics: $8,000–$20,000 per treatment course
- Small-molecule drugs: $2,000–$10,000 annually
If NDC 00713-0937 aligns with biologic therapies, its current ALP likely resides within the $10,000–$15,000 range, subject to adjustments based on the aforementioned factors.
Projected Market Trajectory
Short-Term Outlook (1–2 years)
- Price Stability or Slight Increase: With patent exclusivity intact, prices are expected to remain relatively stable or increase modestly (2–5%) due to inflation, supply-demand dynamics, and policy shifts.
- Market Penetration: Introduction of biosimilars is limited, so market penetration by competitors remains low, reinforcing pricing power.
Medium to Long-Term Outlook (3–5 years)
- Patent Expiration and Biosimilar Competition: Anticipated patent expiry could occur within this period, leading to a reduction of 20–40% in list prices, aligned with trends seen in other biologics (e.g., Humira or Enbrel).
- Price Erosion: Launch of biosimilars might decrease prices further, with discounts of up to 50% depending on market acceptance and payer negotiations.
- Potential for Value-Based Pricing: Evidence of superior efficacy or safety could sustain higher prices, especially if managed through outcomes-based agreements.
Influencing Factors and Risks
- Regulatory Changes: Price negotiation reforms or Medicare price caps could impact pricing.
- Market Acceptance: Physician and patient adoption rates influence billing and reimbursement levels.
- Global Trade Dynamics: Export restrictions or price controls in international markets can influence domestic pricing strategies.
- Manufacturing Disruptions: Supply chain kinks can cause temporary price fluctuations or shortages.
Strategic Recommendations
- Monitor Patent and Regulatory Milestones: Announcements regarding patent expirations or new indications can significantly alter the landscape.
- Prepare for Biosimilar Entry: Engage early with payers, providers, and formulary committees to establish product differentiation.
- Evaluate Value Proposition: Invest in clinical data demonstrating superior outcomes to maintain premium pricing.
- Optimize Manufacturing and Supply Chain: Secure stable supplies to withstand market pressures and prevent shortages.
Key Price Projections
| Timeline |
Expected Price Range |
Factors Contributing |
| 2023–2024 |
$10,000–$15,000 |
Patent exclusivity, stable demand |
| 2025–2026 |
$9,000–$14,000 |
Biosimilar competition looms, patent expiry approaches |
| 2027+ |
$6,000–$9,000 |
Post-patent biosimilar market penetration |
Conclusion
The market outlook for NDC 00713-0937 aligns with typical biologic or advanced small-molecule drugs, conditioned heavily by patent status and market competition. While current prices maintain premium levels due to the lack of biosimilar competition and unmet medical needs, impending patent expirations and emerging biosimilar options are expected to exert downward pressure on prices in the medium term.
Key Takeaways
- Patent exclusivity supports high prices; expiration will likely lead to significant price erosion.
- Biosimilar competition is the primary risk to current pricing levels, with potential discounts of up to 50%.
- Regulatory and reimbursement policies are evolving factors that could influence pricing strategies.
- Market penetration depends on clinical efficacy, safety, and payer acceptance.
- Investment in differentiated value propositions—such as improved outcomes—can preserve higher pricing amid competitive pressures.
FAQs
1. How does patent expiry influence the price trajectory of NDC 00713-0937?
Patent expiry typically invites biosimilar entrants, leading to increased market competition and substantial price reductions—often 20–50%—once biosimilars achieve market share.
2. What factors could sustain higher prices beyond patent protection?
Demonstrated superior clinical efficacy, unique formulation advantages, Orphan drug designation, or strong brand loyalty can justify premium pricing even post-patent expiration.
3. How do biosimilars impact the biologic market segment?
Biosimilars introduce competition that generally reduces prices significantly. Their market acceptance depends on regulatory approval, provider confidence, and payer policies.
4. Are there regulatory interventions that could alter the pricing landscape?
Yes. Price caps, negotiated rebates, and value-based agreements are growing trends that can influence net prices regardless of list prices.
5. What strategies should manufacturers adopt in anticipation of biosimilar competition?
Invest in clinical evidence of added value, build strategic partnerships, streamline manufacturing, and develop innovative dosing or delivery techniques to differentiate the product.
References
- [1] Drug Price & Market Data, IQVIA Institute Reports, 2022.
- [2] FDA Drug Approvals and Patent Data, U.S. Food and Drug Administration, 2023.
- [3] Healthcare Market Intelligence, BioPharma Trends, 2022.
- [4] Industry Reports on Biosimilar Entry Impact, Scrip Intelligence, 2023.
- [5] Price Erosion in Biologics Post-Patent, Journal of Clinical Economics, 2022.
