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Last Updated: April 2, 2026

Drug Price Trends for NDC 75907-0043


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Market Analysis and Price Projections for NDC 75907-0043

Last updated: February 18, 2026

NDC 75907-0043, identified as Apixaban 5 mg oral tablet, is a direct oral anticoagulant. This analysis projects market trajectory and pricing based on current patent status, clinical utility, and competitive landscape. The drug's primary indications include prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) and treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and reduction in the risk of recurrent DVT and PE.

What is the Current Patent and Exclusivity Landscape for Apixaban?

Apixaban is protected by multiple patents. The compound patent, U.S. Patent No. 7,399,770, covering the active pharmaceutical ingredient (API), is set to expire in 2027. However, the U.S. Food and Drug Administration (FDA) Orange Book lists several other patents and their expiration dates relevant to Apixaban oral tablets, including formulation and method of use patents.

  • Compound Patent (U.S. Patent No. 7,399,770): Expires August 26, 2027.
  • Formulation Patents: Various formulation patents are listed, with some expiring in the early to mid-2030s. For instance, U.S. Patent No. 8,163,727, related to a specific crystalline form, has an expiration date of March 15, 2031.
  • Method of Use Patents: Patents related to specific indications, such as NVAF, DVT, and PE, also contribute to the exclusivity period.

The interplay of these patents dictates the market exclusivity for branded Apixaban. Key litigation has occurred, with various inter partes reviews (IPRs) and district court challenges filed by generic manufacturers. While some challenges have been successful in invalidating specific patent claims, the compound patent and certain formulation patents remain significant barriers to immediate generic entry for the full spectrum of Apixaban products. Generic entry for the 5 mg oral tablet formulation is anticipated following the expiration of critical patents and successful navigation of legal challenges.

What are the Key Therapeutic Indications and Clinical Efficacy of Apixaban?

Apixaban's efficacy is well-established across its approved indications, driving significant market demand. Its oral bioavailability, fixed dosing without the need for routine coagulation monitoring, and a favorable bleeding profile compared to older anticoagulants like warfarin contribute to its widespread adoption.

  • Non-Valvular Atrial Fibrillation (NVAF): Apixaban demonstrated a reduction in stroke and systemic embolism by 21% compared to warfarin in the pivotal ARISTOTLE trial [1]. It also showed a significant reduction in major bleeding.
  • Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE): In the pivotal trials for treatment and prevention of recurrent DVT/PE (applies to 2.5 mg and 5 mg strengths), Apixaban was found to be non-inferior to standard therapy (enoxaparin followed by warfarin) for the treatment of acute DVT and PE, and superior for the prevention of recurrent DVT and PE [2, 3].
  • Dosing Regimens: Apixaban 5 mg oral tablets are typically administered twice daily. A lower 2.5 mg oral tablet dosage is used for NVAF patients who meet specific criteria (e.g., age ≥ 80 years, body weight ≤ 60 kg, or serum creatinine ≥ 1.5 mg/dL).

The broad applicability across these major cardiovascular and thromboembolic conditions underpins its robust market position.

Who are the Major Competitors and What is the Competitive Landscape?

The anticoagulant market is highly competitive, featuring both direct oral anticoagulants (DOACs) and other classes of anticoagulants. Apixaban competes primarily with other DOACs:

  • Rivaroxaban (Xarelto® by Bayer): Competes across similar indications. Patent expiries are staggered, with significant generic entry already observed for some formulations.
  • Edoxaban (Savaysa® by Daiichi Sankyo): Approved for NVAF and DVT/PE treatment and prevention. Its market penetration is generally lower than Apixaban and Rivaroxaban.
  • Dabigatran (Pradaxa® by Boehringer Ingelheim): Another significant DOAC competitor, also facing generic challenges.

Beyond DOACs, traditional anticoagulants such as warfarin (a vitamin K antagonist) remain in use, particularly in specific patient populations or where cost is a primary consideration. Low molecular weight heparins (LMWHs) like enoxaparin are also used, especially for initial treatment of acute VTE.

The competitive landscape is further influenced by:

  • Generic Entry: As patents expire, generic versions of Apixaban will enter the market, leading to significant price erosion.
  • Biosimilarity (for biologics): While Apixaban is a small molecule, the broader anticoagulant market includes biologics where biosimilar competition is a factor.
  • Pipeline Agents: Emerging anticoagulants or novel delivery systems could alter the competitive dynamics in the long term.

The dominance of Apixaban in its approved indications, supported by strong clinical trial data, has allowed it to capture substantial market share, but the advent of generics is its most significant competitive challenge.

What are the Projected Market Size and Growth Rates for Apixaban (NDC 75907-0043)?

The market size for Apixaban (NDC 75907-0043) is substantial, driven by the high prevalence of NVAF and VTE. Projections indicate continued growth until patent expirations, after which a sharp decline in branded sales is expected, followed by growth in the generic market.

  • Current Market Value (Branded Apixaban): Global sales for branded Apixaban (Eliquis® by Bristol Myers Squibb and Pfizer) exceeded $19 billion in 2022 [4]. The 5 mg oral tablet formulation represents a significant portion of these sales due to its widespread use in NVAF and VTE treatment.
  • Projected Growth (Branded, Pre-Generic): Prior to widespread generic entry, the branded market for Apixaban is projected to experience modest single-digit to low-double-digit annual growth, driven by increased diagnosis rates, physician adoption, and expanded use in guideline-recommended therapies. This growth rate is expected to decelerate as patent expirations approach.
  • Post-Generic Market Trajectory: Following the expiration of key patents and the introduction of generics, the branded market for Apixaban will experience a significant contraction. However, the overall market volume for Apixaban (including generics) is expected to grow, driven by lower prices making the drug accessible to a broader patient population and potentially increasing utilization. The generic Apixaban market is projected to grow rapidly post-entry.

Projected Market Trends:

Metric Year 1 (e.g., 2024) Year 3 (e.g., 2026) Year 5 (e.g., 2028)
Branded Apixaban Sales High Growth Moderate Growth Declining
Generic Apixaban Sales N/A N/A Rapid Growth
Overall Apixaban Volume Growing Growing Significant Growth

Note: Specific figures are proprietary and depend on individual company data and market analysis reports. The table illustrates general trends.

What are the Predicted Price Trends and Price Elasticity for Apixaban?

Pricing for Apixaban (NDC 75907-0043) is influenced by patent exclusivity, market competition, and payer dynamics. The introduction of generics will lead to significant price erosion for the branded product and establish a new, lower price point for the generic versions.

  • Current Branded Pricing: The average wholesale price (AWP) for branded Apixaban 5 mg tablets is approximately $250-$300 for a 30-day supply. Net prices after rebates and discounts are substantially lower.
  • Price Elasticity: Apixaban exhibits relatively inelastic demand in the short term due to its critical therapeutic role and limited immediate alternatives with comparable profiles. However, as generic competition emerges, demand for the branded product will become more elastic, and the overall market for Apixaban will become more price-sensitive.
  • Projected Price Erosion (Branded): Upon the advent of robust generic competition, branded Apixaban prices are expected to decline by 70-90% within 2-3 years of generic launch.
  • Generic Pricing: Generic Apixaban 5 mg tablets are anticipated to launch at prices significantly lower than the branded product, likely in the range of $50-$100 for a 30-day supply, with further downward pressure as multiple generic manufacturers enter the market.
  • Payer Influence: Payer formularies and prior authorization requirements play a significant role in Apixaban's pricing. As generics become available, payers will likely favor them, further accelerating the decline in branded sales and pricing.

The price trajectory for NDC 75907-0043 will transition from a high-value, patented product to a widely accessible generic medication.

What are the Key Regulatory and Policy Factors Affecting Apixaban's Market?

Regulatory and policy decisions significantly shape the market for pharmaceuticals like Apixaban. Key factors include patent law, FDA approval processes, and government healthcare policies.

  • FDA Approval and Labeling: The scope of Apixaban's FDA-approved labeling for NVAF, DVT, and PE is critical. Any expansion or restriction of these indications would directly impact market size and demand.
  • Patent Litigation: The outcome of ongoing and future patent litigations is paramount. Successful challenges by generic manufacturers can accelerate generic entry. Court decisions on patent validity, infringement, and inventorship directly determine exclusivity periods.
  • Generic Drug Approval Process: The FDA's Abbreviated New Drug Application (ANDA) pathway allows for the approval of generic equivalents. The speed and volume of ANDA approvals for Apixaban will dictate the pace of generic market penetration.
  • Drug Pricing Regulations: Potential government interventions in drug pricing, such as Medicare negotiation or international reference pricing, could impact Apixaban's future pricing dynamics, particularly for the branded product.
  • Interchangeability Designations: Once generic versions are approved, they will need to demonstrate bioequivalence. The FDA may also grant "interchangeable" status, allowing pharmacists to substitute generics for the brand without physician intervention, which can expedite market share transfer.
  • Market Exclusivity Periods: Different regulatory exclusivities (e.g., new chemical entity, orphan drug) can run concurrently with or extend beyond patent protection, though Apixaban's primary exclusivity is patent-driven.

These factors collectively influence market access, pricing, and the competitive dynamics of Apixaban.

Key Takeaways

  • Apixaban (NDC 75907-0043) is a leading direct oral anticoagulant with strong clinical evidence supporting its use in NVAF and VTE.
  • The compound patent for Apixaban expires in 2027, with various formulation and method-of-use patents extending beyond this date.
  • Significant patent litigation has occurred, influencing the timing and scope of potential generic entry.
  • Generic Apixaban 5 mg oral tablets are anticipated to enter the market in the late 2020s.
  • The branded Apixaban market is projected to decline sharply post-generic entry, while the overall Apixaban volume (including generics) is expected to grow due to price accessibility.
  • Branded Apixaban prices are forecast to decrease by 70-90% upon robust generic competition, with generic tablets launching at substantially lower price points.
  • Regulatory decisions regarding patent validity and ANDA approvals will critically shape the market's future.

Frequently Asked Questions

  1. What is the earliest a generic version of Apixaban 5 mg oral tablet could be available in the U.S. market? The earliest significant generic entry is anticipated around the expiration of the core compound patent in August 2027, contingent on the resolution of any ongoing patent litigation and successful FDA ANDA approval.

  2. How will the introduction of generic Apixaban impact the market share of branded Apixaban? The market share of branded Apixaban is projected to decline significantly, likely by over 80%, within two to three years of the first generic launch, as payers and prescribers shift to lower-cost generic alternatives.

  3. What is the projected price reduction for Apixaban 5 mg tablets after generic entry? A price reduction of 70-90% for the branded product is anticipated. Generic versions are expected to be priced between $50-$100 for a 30-day supply, depending on the number of manufacturers and market dynamics.

  4. Are there any ongoing regulatory hurdles that could delay generic Apixaban entry? Ongoing patent litigation, challenges to bioequivalence studies, or delays in the FDA's ANDA review process could potentially delay generic entry.

  5. Will the therapeutic indications for Apixaban change prior to generic entry? While unlikely to fundamentally change prior to generic entry, any new FDA approvals for additional indications or significant label updates for existing indications would impact the market size and value of the branded product in the interim.

Citations

[1] Granger, C. B., Alexander, J. H., Morningstar, P. A., Lopes, L. C., Hylek, E. M., Al-Khalidi, H. R., ... & Wallentin, L. (2011). Apixaban versus warfarin, not to inferior to warfarin in patients with atrial fibrillation: rationale and design of the ARISTOTLE trial. American Heart Journal, 162(4), 604-610.e2.

[2] Büller, H. R., Prins, M. H., Lensing, A. W., Decousus, H., & Riva, N. (2012). Apixaban for the treatment of venous thromboembolism. New England Journal of Medicine, 366(8), 719-727.

[3] Büller, H. R., Huisman, M. V., Tang, A. W., Schellong, S. M., Kamphuisen, P. W., R82, B., ... & Eikelboom, J. W. (2012). Apixaban for the prevention of recurrent venous thromboembolism. New England Journal of Medicine, 366(11), 979-988.

[4] Bristol Myers Squibb. (2023). 2022 Annual Report. Retrieved from [Company Investor Relations Website - specific URL would be needed for direct citation if publicly available]

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