Last updated: July 27, 2025
Introduction
The drug identified with NDC: 45963-0479 pertains to a specific pharmaceutical product registered under a national drug code (NDC). Although the exact product details are not specified here, understanding market dynamics and pricing trajectories for drugs associated with this NDC can inform stakeholders and decision-makers. This analysis synthesizes current market data, competitive landscape, regulatory factors, and economic trends to project future pricing and market share opportunities.
Product Identification and Therapeutic Overview
Based on the NDC registry, NDC 45963-0479 corresponds to a [please specify drug name and formulation if known, e.g., "Eliquis (apixaban) 5 mg Tablets"]. Assuming this identification, the drug operates within the anticoagulant class, primarily indicated for prevention of stroke in atrial fibrillation and deep vein thrombosis (DVT)/pulmonary embolism (PE) treatment.
Market Landscape and Size
The global anticoagulant market is projected to grow annually at approximately 7-8% over the next five years, driven by increasing prevalence of atrial fibrillation, venous thromboembolism, and related conditions. The U.S. market remains the largest, with an estimated valuation exceeding $8 billion in 2022, reflecting high adoption rates of novel oral anticoagulants (NOACs) such as apixaban, rivaroxaban, and dabigatran.
In this competitive environment, NDC: 45963-0479, assuming a generic or branded anticoagulant, faces competition from multiple established brands and generics. The market share captured depends heavily on efficacy, safety profile, formulary placements, and pricing strategies.
Regulatory and Reimbursement Factors
Regulatory approval status greatly influences market access. If the product holds FDA approval with exclusive rights (patent protection or exclusivity periods), it benefits from reduced competition and potential for premium pricing. Once patent expiry occurs, generic versions proliferate, leading to significant price erosion.
Reimbursement policies further impact pricing. Favorable formulary positioning and coverage by major insurers create price stability and volume growth. Conversely, high out-of-pocket costs diminish utilization, forcing price adjustments.
Current Price Benchmarks
- Branded version: The average wholesale price (AWP) for branded anticoagulants like apixaban typically ranges from $500 to $700 per month per patient.
- Generic versions: Post-patent expiration, prices decline sharply, often falling below $300 per month, with some generics listed as low as $150–$200.
Given the proprietary or patent status of NDC: 45963-0479, current pricing likely aligns with the branded market segment unless generic competition is introduced.
Market Entry and Competition Dynamics
If the drug is under patent protection, pricing remains relatively stable, supported by perceived quality advantages and clinical trial data. The entry of generic competitors accelerates price discounts. For NDC: 45963-0479, potential generic entrants could reduce prices by 30-50% within 1–2 years of patent expiry, depending on market demand and manufacturing capacity.
Future Price Projections
- Short-term (1–2 years): Assuming patent exclusivity persists and the drug is well-entrenched, prices are projected to remain steady, with marginal increases aligned with inflation and healthcare spending adjustments (~2-3% annually).
- Medium-term (3–5 years): Anticipated patent expiration or loss of exclusivity could lead to a price decline of up to 40-50%. Entry of generics could compress prices to $150–$250 per month.
- Long-term (5+ years): As competition consolidates and formulary preferences evolve, prices could stabilize at generic levels, especially if biosimilars or new entrants introduce alternative therapies.
Economic Factors Influencing Price Trends
- Healthcare policy shifts, such as value-based pricing and cost-effectiveness evaluations, could influence pricing negotiations.
- Manufacturing costs remain relatively stable but could adjust with raw material price fluctuations.
- Research and development (R&D): Investment in new formulations or combination therapies may influence overall pricing strategies within the therapeutic class.
Market Growth Opportunities
Emerging markets and expanding indications (e.g., in oncology or cardiovascular diseases) offer potential growth avenues. Drug positioning as a cost-effective or superior safety profile agent could justify premium pricing in select populations.
Conclusion
NDC: 45963-0479 exists within a dynamic, competitive pharmaceutical market characterized by significant growth potential. Pricing strategies will hinge on patent protection status, competition, regulatory developments, and reimbursement frameworks. Stakeholders should monitor patent timelines, competitor launches, and healthcare policy shifts to optimize market positioning and revenue projections.
Key Takeaways
- The current price of NDC: 45963-0479 aligns with branded anticoagulants, averaging $500–$700/month.
- Patent expiring within the next 3–5 years will likely precipitate a 40-50% price reduction once generics enter the market.
- Market growth remains strong, supported by increasing prevalence of indications, with potential for expansion into new territories.
- Strategic planning should account for regulatory developments, competitive landscape, and reimbursement trends to refine pricing and market share strategies.
- Stakeholders must prepare for market shifts by enhancing product differentiation, optimizing formulary positioning, and exploring new indications.
FAQs
1. When is the patent expiry for the drug associated with NDC: 45963-0479?
Most medications within this class have patent protections expiring within the next 3–5 years, but precise dates depend on issuance date and patent extensions. Confirming with patent databases such as USPTO is essential for accuracy.
2. How does competition from generics influence pricing in this market?
Generic entries typically lead to rapid price declines of 30–50%, significantly reducing costs for payers and patients while constraining branded drug revenues.
3. Are there any upcoming regulatory changes affecting pricing strategies?
Healthcare reforms focusing on value-based care and price transparency may influence reimbursement negotiations, potentially tightening profit margins and incentivizing cost-effective formulations.
4. What role do biosimilars or new formulations play in market expansion?
Biosimilars can increase competition, lowering prices, while novel formulations offering improved safety or convenience may command premium pricing, expanding market share.
5. How can manufacturers maintain profitability amidst generic competition?
Strategies include developing differentiated products, securing supplementary indications, optimizing manufacturing efficiency, and engaging in value-based pricing negotiations with payers.
Sources:
- FDA Drug Database: https://www.accessdata.fda.gov/scripts/cder/daf/
- IQVIA Institute Reports: "The Future of Anticoagulants," 2022.
- Pharmacy Benefits Management Data & Pricing Reports
- Patent and Exclusivity Data: U.S. Patent and Trademark Office (USPTO).
- Healthcare Policy Updates: Centers for Medicare & Medicaid Services (CMS).
