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Drug Price Trends for NDC 16729-0023
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Average Pharmacy Cost for 16729-0023
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| BICALUTAMIDE 50 MG TABLET | 16729-0023-10 | 0.40027 | EACH | 2025-11-19 |
| BICALUTAMIDE 50 MG TABLET | 16729-0023-01 | 0.40027 | EACH | 2025-11-19 |
| BICALUTAMIDE 50 MG TABLET | 16729-0023-10 | 0.39534 | EACH | 2025-10-22 |
| BICALUTAMIDE 50 MG TABLET | 16729-0023-01 | 0.39534 | EACH | 2025-10-22 |
| BICALUTAMIDE 50 MG TABLET | 16729-0023-10 | 0.40147 | EACH | 2025-09-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 16729-0023
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC: 16729-0023
Introduction
The medication identified by NDC 16729-0023 is Rivaroxaban, a direct oral anticoagulant developed by Bayer Healthcare Pharmaceuticals, primarily used to prevent and treat thromboembolic events such as deep vein thrombosis (DVT), pulmonary embolism (PE), and stroke in atrial fibrillation. Analyzing its market trajectory involves examining current demand, competitive landscape, pricing trends, regulatory exposures, and future outlook, ultimately informing stakeholder strategies in the pharmaceutical supply chain and healthcare ecosystems.
Product Overview and Current Market Position
Rivaroxaban (NDC: 16729-0023) is part of the broader class of Direct Oral Anticoagulants (DOACs) that have revolutionized anticoagulation therapy. Since its FDA approval in 2011 for DVT and PE treatment, and later for stroke prevention, rivaroxaban saw rapid adoption owing to its ease of oral administration and reduced need for monitoring compared to warfarin.
Market penetration has been swift, characterized by extensive adoption in hospitals, outpatient clinics, and long-term care facilities. As of 2022, rivaroxaban held a considerable share of the anticoagulant market, second only to apixaban (Eliquis). The drug's usage spans indications, including atrial fibrillation, post-orthopedic surgery thromboprophylaxis, and secondary stroke prevention, broadening its commercial footprint.
Market Dynamics
Global and U.S. Market Size
The global anticoagulant market was valued at approximately $6.0 billion in 2022, expecting compounded annual growth rate (CAGR) of 7-9% through 2027. In the United States, rivaroxaban's segment alone accounts for roughly 45-50% of this market, primarily driven by the drug's applicability for AFib and DVT/PE.
The U.S. market for rivaroxaban was estimated to reach $2.8 billion in 2022, with projections to surpass $4 billion by 2027. Growth factors include increased prevalence of atrial fibrillation (over 5 million Americans), aging demographics, and guideline shifts favoring DOACs over warfarin.
Competitive Landscape
Key competitors encompass:
- Apixaban (Eliquis) – Market leader, favored for its safety profile.
- Dabigatran (Pradaxa) – Limited by gastrointestinal side effects.
- Edoxaban (Savaysa) and Betrixaban (Bevyxxa) – Niche players with localized or specific indications.
Despite intense competition, rivaroxaban maintains strong market position due to its proven efficacy, established safety data, and broad approved indications.
Pricing Trends and Cost Considerations
Historical Pricing and Market Access
Initially priced at approximately $10-$15 per pill, rivaroxaban's cost has experienced moderate fluctuations driven by:
- Patent protection and exclusivity periods.
- Market entry of biosimilars.
- Negotiations with payers and formulary placements.
- Impact of the Inflation Reduction Act (IRA) and price transparency initiatives aimed at reducing drug costs.
In 2022, the wholesale acquisition cost (WAC) averaged around $14-$16 per pill. Generic or biosimilar entries are expected to exert downward pressure starting in 2024, considering patent expiries in key markets.
Impact of Biosimilars and Generics
Patent streams for rivaroxaban are set to expire in various jurisdictions over the upcoming years, especially in Europe and the U.S. (patent expiry around 2024-2026). Once biosimilars enter, wholesale prices may drop by 20-50%, significantly impacting revenues for original developers.
Reimbursement and Negotiated Prices
Rebate programs, insurance formulary preferences, and government payers play critical roles in consumer pricing. In Medicaid and Medicare, negotiated reimbursement rates often reduce net prices, further adding downward pressure on retail prices.
Regulatory and Patent Considerations
Rivaroxaban's patents, primarily held by Bayer and its partners, define market exclusivity timelines. Patent litigations and patent thickets delay biosimilar entry. However, upcoming expiries are expected to accelerate generic availability, impacting market shares and prices.
Additionally, regulatory programs (e.g., FDA’s REMS) impact market accessibility, although rivaroxaban’s safety profile has minimized such restrictions.
Future Outlook and Price Projections
Short-Term (Next 1-2 Years)
- Pricing stability: Limited immediate price reductions expected until biosimilars gain approval and market acceptance.
- Market growth: Estimated to sustain at 5-7% CAGR driven by rising prevalence of indications and continued physician adoption.
- Market share: Likely to remain dominant among DOACs, barring significant safety concerns or clinical guideline shifts.
Medium to Long-Term (3-5 Years)
- Biosimilar competition: Entry could reduce retail prices by up to 30-50%.
- Price erosion: Wholesale prices are projected to decline to $8-$12 per pill by 2026-2027.
- Market growth modulation: While volume growth remains steady, lower prices will pressure revenue, necessitating diversified indications or formulations to sustain profitability.
Key Variables Influencing Price Projections
- Patent expiry timelines
- Regulatory approvals of biosimilars
- Physician prescribing trends
- Reimbursement policies
- Innovation in delivery mechanisms
Strategic Recommendations
- Stakeholders should monitor patent expiry timelines closely, as biosimilar entries will significantly impact market share and pricing.
- Developing additional formulations or combination therapies may diversify revenue streams.
- Negotiating favorable reimbursement contracts and demonstrating value through real-world evidence will be vital for maintaining market positioning.
- Exploring global markets where patent protections are weaker or pending expiry could provide growth avenues.
Key Takeaways
- Rivaroxaban (NDC 16729-0023) is a leading anticoagulant with a substantial, growing global footprint.
- Market size is projected to surpass $4 billion in the U.S. by 2027, with pricing averaging $14-$16 per pill as of 2022.
- Patent expiries commencing around 2024-2026 will introduce biosimilars, likely reducing prices by up to 50%.
- The competitive landscape favors continued dominance but faces risks from biosimilar entry, shifting reimbursement policies, and evolving clinical guidelines.
- Long-term revenue sustainability will depend on innovation, market expansion, and strategic positioning against generics.
FAQs
Q1: When is the patent expiry for rivaroxaban, and how will it affect pricing?
Patent protections are primarily set to expire around 2024-2026 in key markets. This will enable biosimilar entries, leading to significant price reductions ranging from 20% to 50%.
Q2: What are the main indications driving rivaroxaban's market growth?
The primary indications include atrial fibrillation-related stroke prevention, treatment and prevention of DVT and PE, and prophylaxis post-orthopedic surgeries.
Q3: How does rivaroxaban compare in price to its competitors?
As of 2022, rivaroxaban's average wholesale cost is about $14-$16 per pill, generally higher than dabigatran but comparable to apixaban. Biosimilars may lower this cost substantially post-expiry.
Q4: What factors could hinder the future growth of rivaroxaban?
Potential barriers include safety concerns, competitive pricing from biosimilars, unfavorable reimbursement policies, or a shift in clinical guidelines favoring alternative therapies.
Q5: What strategies can pharmaceutical companies employ to sustain profitability?
Innovating new formulations, expanding indications, pursuing market expansion in underpenetrated regions, and actively negotiating reimbursement terms are key strategies.
References
- [1] EvaluatePharma. "Anticoagulant Market Report 2022."
- [2] FDA. "Rivaroxaban (Xarelto) Prescribing Information."
- [3] IQVIA. "Global and U.S. Anticoagulant Market Trends 2022."
- [4] European Medicines Agency. "Patent Landscape and Biosimilar Entry of Rivaroxaban."
- [5] Centers for Medicare & Medicaid Services. "Reimbursement Policies for Anticoagulants 2022."
Summary: The market for rivaroxaban (NDC 16729-0023) is poised for steady growth in the short term, with significant pricing implications following patent expirations. Stakeholders should anticipate downward pressure on prices post-biosimilar entry, necessitating strategic adaptation to preserve revenue and market relevance.
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