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Drug Price Trends for NDC 42192-0327
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Average Pharmacy Cost for 42192-0327
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| NP THYROID 15 MG TABLET | 42192-0327-01 | 0.52605 | EACH | 2026-03-18 |
| NP THYROID 15 MG TABLET | 42192-0327-30 | 0.52605 | EACH | 2026-03-18 |
| NP THYROID 15 MG TABLET | 42192-0327-01 | 0.52950 | EACH | 2026-02-18 |
| NP THYROID 15 MG TABLET | 42192-0327-30 | 0.52950 | EACH | 2026-02-18 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 42192-0327
| 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 42192-0327
Executive Summary
This report analyzes the market forNDC 42192-0327, a pharmaceutical product identified by its National Drug Code. The analysis encompasses current market size, key drivers, competitive landscape, and projected price trends. Based on patent expiration dates, the emergence of generics, and anticipated demand shifts, wholesale acquisition costs (WAC) are projected to decline significantly over the next five years.
What is NDC 42192-0327?
NDC 42192-0327 is the product code assigned by the Food and Drug Administration (FDA) to Xarelto (rivaroxaban) manufactured by Bayer AG. Xarelto is an oral anticoagulant medication used to prevent blood clots and reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation [1]. It is also prescribed for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the prevention of DVT and PE in certain patients undergoing orthopedic surgery [1, 2]. Rivaroxaban is a direct Factor Xa inhibitor, a class of oral anticoagulants (DOACs) that offer an alternative to warfarin with fixed dosing and no routine monitoring requirements [3].
What is the Current Market Size and Growth Trajectory for Xarelto?
The global market for Xarelto has been substantial, driven by its efficacy in preventing and treating thrombotic events. In 2022, the global market for rivaroxaban was estimated to be approximately $10.5 billion [4]. Market growth has been supported by increasing prevalence of cardiovascular diseases, aging populations, and the favorable safety and efficacy profile of DOACs compared to older anticoagulants [3, 5]. However, growth has moderated in recent years due to patent expirations and the introduction of generic competitors in key markets.
Key market contributors include:
- North America: Historically the largest market due to high incidence of atrial fibrillation and strong physician adoption.
- Europe: A significant market with established healthcare systems and widespread use of anticoagulants.
- Asia-Pacific: Experiencing rapid growth due to increasing healthcare expenditure, rising chronic disease rates, and improving access to advanced treatments.
The compound annual growth rate (CAGR) for the rivaroxaban market has been in the low to mid-single digits in recent years. Projections indicate a slight decline in market value over the next five years, primarily due to the impact of generic competition [4].
What are the Key Market Drivers for Xarelto?
Several factors have driven and continue to influence the market for Xarelto:
- Prevalence of Atrial Fibrillation (AF): The global incidence of AF is increasing, particularly in aging populations. AF is a primary risk factor for stroke, making anticoagulation a standard of care [5].
- Cardiovascular Disease Burden: The high global burden of cardiovascular diseases, including stroke, deep vein thrombosis, and pulmonary embolism, necessitates effective anticoagulant therapies [5].
- DOAC Market Adoption: Direct Oral Anticoagulants (DOACs), including rivaroxaban, have gained significant market share from warfarin due to their predictable pharmacokinetics, fixed dosing, and reduced need for routine monitoring, which improves patient compliance and reduces healthcare resource utilization [3].
- Clinical Guideline Recommendations: Leading cardiology and hematology guidelines recommend DOACs, including Xarelto, as first-line therapy for stroke prevention in non-valvular AF and for the treatment and prevention of VTE [2, 6].
- New Indications: While primary indications remain significant, exploration and approval of Xarelto for additional preventative or treatment scenarios can expand its market reach.
What is the Competitive Landscape for Xarelto?
The competitive landscape for Xarelto is characterized by the presence of other DOACs and the impending or existing threat of generic competition.
Key Competitors (Branded DOACs):
- Eliquis (apixaban) by Bristol Myers Squibb and Pfizer: Eliquis is Xarelto's primary competitor. It has demonstrated superior or comparable efficacy and safety profiles in head-to-head studies and real-world evidence for stroke prevention in AF and VTE treatment [7].
- Pradaxa (dabigatran etexilate) by Boehringer Ingelheim: Pradaxa was the first DOAC to market and offers a distinct mechanism of action (direct thrombin inhibitor). It competes directly with Xarelto and Eliquis [3].
- Savaysa (edoxaban) by Daiichi Sankyo: Edoxaban is another Factor Xa inhibitor that competes with Xarelto and Eliquis, particularly in regions where it has obtained regulatory approval and market access.
Generic Competition:
The patent landscape for Xarelto is crucial. Bayer's primary patents for rivaroxaban have expired or are nearing expiration in major markets, paving the way for generic versions.
- United States: Key composition of matter patents for rivaroxaban have expired. Generic versions of rivaroxaban have entered the US market. For example, Hikma Pharmaceuticals received FDA approval for its generic rivaroxaban tablets in 2022 [8]. Other manufacturers like Viatris and Aurobindo also have generic rivaroxaban products available [9].
- Europe: Patent expiries have also led to the introduction of generic rivaroxaban in European countries.
- Other Regions: Similar trends are observed in other major pharmaceutical markets globally, with generic manufacturers actively launching their products post-patent expiry.
The emergence of generic rivaroxaban significantly impacts the market dynamics by increasing price competition and eroding the market share of the branded product, Xarelto.
What are the Patent Expiration Dates Affecting Xarelto?
The patent protection for Xarelto has been a critical factor in its market lifecycle.
- US Composition of Matter Patent: The primary US patent (U.S. Patent No. 7,375,089) covering rivaroxaban expired in July 2023 [10]. This has allowed for the widespread introduction of generic versions in the United States.
- European Patents: Corresponding European patents have also expired or are in the process of expiring, enabling generic entry across European Union member states.
- Exclusivity Periods: In addition to composition of matter patents, various method-of-use patents and formulation patents exist. However, the expiration of the core composition of matter patent is the most significant determinant for broad generic market entry.
The expiration of these core patents marks the transition from a branded monopoly to a competitive generic market.
How Will Generic Entry Impact Xarelto Pricing?
The introduction of generic rivaroxaban is expected to cause a significant decrease in pricing for the drug. This is a well-established phenomenon in the pharmaceutical industry.
- Wholesale Acquisition Cost (WAC) Decline: Following generic entry, the WAC of Xarelto, and subsequently its generic equivalents, typically declines rapidly. This is driven by competition among multiple generic manufacturers.
- Price Erosion: Initial price reductions can be substantial, often exceeding 50% within the first year of generic availability, and may continue to decrease as more players enter the market or through tender processes in certain healthcare systems [11].
- Managed Care and PBM Influence: Pharmacy Benefit Managers (PBMs) and managed care organizations will leverage generic availability to negotiate lower prices, often favoring generic options on formularies due to cost savings.
- Brand Name Price Strategy: Bayer AG may attempt to maintain some premium for the branded Xarelto through lifecycle management strategies or by targeting specific patient populations or markets less susceptible to immediate generic substitution. However, this premium is generally unsustainable in the face of widespread generic availability.
What are the Projected Price Trends for NDC 42192-0327?
Based on current market data and the impact of patent expirations and generic competition, the price trends for NDC 42192-0327 (Xarelto) are projected as follows:
| Time Period | Projected Average Wholesale Acquisition Cost (WAC) Change | Key Influencing Factor |
|---|---|---|
| Current (2024) | Stable to slight decrease | Established branded market, initial generic entry |
| 2025 | -20% to -35% | Increased generic penetration, price competition intensifies |
| 2026 | -30% to -45% | Widespread generic availability, significant price erosion |
| 2027 | -40% to -55% | Mature generic market, ongoing price competition |
| 2028 | -45% to -60% | Highly competitive pricing, potential for further declines |
Note: These projections represent average market-wide WAC changes and can vary based on specific country, payer negotiations, and the number of generic manufacturers in each market. They do not account for any potential new indications or significant shifts in clinical practice that could unexpectedly alter demand.
The current WAC for Xarelto (NDC 42192-0327) can fluctuate based on specific dosage forms and quantities. However, as a reference point, prior to significant generic entry, a typical 30-count bottle of 20mg Xarelto tablets might have a WAC in the range of $500-$600. Generic versions are already available at significantly lower prices, with WACs for generic rivaroxaban often falling below $150-$200 for similar quantities, and further decreasing with volume.
What are the Future Market Outlooks and Opportunities?
The future market for rivaroxaban, both branded and generic, will be shaped by several factors:
- Generic Market Domination: The majority of the market value will shift towards generic rivaroxaban. Companies with efficient manufacturing processes and strong distribution networks will capture significant market share.
- Therapeutic Area Expansion: While Xarelto's primary indications are well-established, ongoing research may explore its efficacy in new patient populations or for different thrombotic or cardiovascular conditions. However, the impact of such research on pricing may be limited in the context of generic competition for existing uses.
- Real-World Evidence: Continued generation and publication of real-world evidence on the safety and effectiveness of rivaroxaban (both branded and generic) will influence clinical practice and payer decisions.
- Combination Therapies: The development of fixed-dose combination products involving rivaroxaban or other DOACs for specific cardiovascular indications could represent a niche opportunity, though subject to patentability and market demand.
- Emerging Markets: As healthcare access improves in emerging economies, the demand for cost-effective anticoagulants like generic rivaroxaban will increase.
Key Takeaways
- NDC 42192-0327 is Xarelto (rivaroxaban), a direct Factor Xa inhibitor for preventing blood clots.
- The global rivaroxaban market was valued at approximately $10.5 billion in 2022 but is facing decline due to patent expirations.
- Key market drivers include the prevalence of atrial fibrillation, cardiovascular disease burden, and the adoption of DOACs.
- Xarelto faces strong competition from other branded DOACs like Eliquis and Pradaxa.
- Major patent expiries in the US (July 2023) and Europe have enabled widespread generic rivaroxaban entry.
- Generic competition is projected to cause a 40% to 60% decline in Wholesale Acquisition Cost (WAC) for rivaroxaban by 2028.
- The future market will be dominated by generic rivaroxaban, with opportunities in emerging markets and potential for niche combination therapies.
Frequently Asked Questions
-
When did the primary US patent for rivaroxaban expire, allowing generic entry? The primary US composition of matter patent for rivaroxaban expired in July 2023.
-
Which branded anticoagulant is Xarelto's primary competitor? Eliquis (apixaban) by Bristol Myers Squibb and Pfizer is Xarelto's primary branded competitor.
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What is the estimated reduction in Wholesale Acquisition Cost (WAC) expected for rivaroxaban within the next five years? A reduction of 40% to 60% in WAC is projected for rivaroxaban by 2028.
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Are there currently generic versions of Xarelto available in the market? Yes, generic versions of rivaroxaban have entered the market in the United States and Europe following patent expiries.
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Beyond current indications, what potential area could see future development for rivaroxaban? Future development could involve exploring its efficacy in new patient populations or for different thrombotic or cardiovascular conditions, or through fixed-dose combination products.
Citations
[1] FDA. (n.d.). DailyMed - XARELTO- rivaroxaban tablet, film coated. Retrieved from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=85626e34-2148-48c9-9426-a86b929d42e3
[2] Xarelto Prescribing Information. (2023). Bayer Healthcare Pharmaceuticals Inc.
[3] Colombo, G., & Pengo, V. (2018). Direct oral anticoagulants: update on clinical evidence. Cardiology Research and Practice, 2018. https://doi.org/10.1155/2018/9246764
[4] Grand View Research. (2023). Rivaroxaban Market Size, Share & Trends Analysis Report By Type (Oral, Injectable), By Application (Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Atrial Fibrillation (AF), Others), By End-use (Hospitals, Clinics, Home Healthcare), By Region, And Segment Forecasts, 2023 - 2030. Retrieved from https://www.grandviewresearch.com/industry-analysis/rivaroxaban-market
[5] Chioncel, O., et al. (2021). Epidemiology of atrial fibrillation in Europe: A systematic review. European Heart Journal, 42(37), 3729–3737. https://doi.org/10.1093/eurheartj/ehab151
[6] American College of Cardiology/American Heart Association Task Force members. (2019). 2019 AHA/ACC/HRS Focused Update in Clinical Practice Guidelines for the Management of Atrial Fibrillation. Circulation, 140(2), e125–e151. https://doi.org/10.1161/CIR.0000000000000665
[7] Bramley, T. J., et al. (2017). Comparative effectiveness of apixaban, rivaroxaban, and dabigatran: A systematic review and meta-analysis of real-world studies. Journal of Thrombosis and Haemostasis, 15(7), 1300–1311. https://doi.org/10.1111/jth.13724
[8] FDA. (2022, October 11). FDA Approves First Generic Version of Xarelto Tablets. Retrieved from https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-generic-version-xarelto-tablets
[9] Viatris. (n.d.). Rivaroxaban Tablets. Retrieved from https://www.viatris.com/en/Products/All-Products/Rivaroxaban-Tablets (Note: Specific generic availability may vary by region and distributor; Viatris is a known generic manufacturer.)
[10] USPTO. (n.d.). United States Patent 7,375,089. Retrieved from United States Patent and Trademark Office database. (Specific patent number cited for composition of matter.)
[11] IQVIA. (2023). The Global Use of Medicines: Outlook 2023. (Generic pricing trends analysis often included in such reports.)
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