Drug Price Trends for NDC 00597-0435

Average Pharmacy Cost for 00597-0435

Drug Name	NDC	Price/Unit ($)	Unit	Date

Best Wholesale Price for NDC 00597-0435

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type
PRADAXA 40MG PELLET PKT	Boehringer Ingelheim Pharmaceuticals, Inc.	00597-0435-96	60	3603.29	60.05483	2023-05-10 - 2027-09-14	Big4
PRADAXA 40MG PELLET PKT	Boehringer Ingelheim Pharmaceuticals, Inc.	00597-0435-96	60	4693.76	78.22933	2023-05-10 - 2027-09-14	FSS
PRADAXA 40MG PELLET PKT	Boehringer Ingelheim Pharmaceuticals, Inc.	00597-0435-96	60	3603.29	60.05483	2024-01-01 - 2027-09-14	Big4
PRADAXA 40MG PELLET PKT	Boehringer Ingelheim Pharmaceuticals, Inc.	00597-0435-96	60	4693.76	78.22933	2024-01-01 - 2027-09-14	FSS

Eliquis (Apixaban) NDC 00597-0435: Market Dynamics and Price Forecast

Last updated: February 19, 2026

This analysis examines the market position and price trajectory of Eliquis (apixaban), identified by NDC 00597-0435, a direct oral anticoagulant (DOAC). The drug faces a competitive landscape with evolving generic entry timelines and shifting payer policies. Current market share and projected demand indicate continued revenue generation for the branded product, albeit with increasing pressure from biosimilar alternatives in the medium term.

What is the Current Market Share of Eliquis (Apixaban) NDC 00597-0435?

Eliquis is a leading anticoagulant, holding a significant market share in its therapeutic class. In the United States, it is a top-selling drug by revenue.

• Market Position: Eliquis consistently ranks among the highest-grossing pharmaceuticals globally and within the U.S. [1]. Its market dominance is attributable to its efficacy, safety profile, and broad indication for stroke prevention in atrial fibrillation (AF) and treatment of venous thromboembolism (VTE) [2].
• Therapeutic Class Performance: Within the DOAC market, Eliquis competes with products such as Xarelto (rivaroxaban) and Pradaxa (dabigatran etexilate). Eliquis has captured a substantial portion of this market, often exceeding 30% by volume in key geographies [3].
• Revenue Generation: In 2023, Eliquis generated approximately $19.1 billion in worldwide sales [4]. U.S. sales constitute a significant portion of this figure, driven by the high prevalence of conditions it treats and its established position on formularies.

What are the Patent Expirations and Generic Entry Timelines for Eliquis?

The patent landscape for Eliquis is a critical factor influencing its future market dynamics and pricing. While core patents have faced challenges, significant patent protections remain in place, delaying widespread generic competition.

• Core Compound Patents: The primary patents covering the apixaban compound have expired in major markets, including the U.S. (expiring around 2026). However, the drug's market exclusivity is further supported by a robust portfolio of secondary patents.
• Secondary Patents: Bristol Myers Squibb and Pfizer hold numerous patents related to manufacturing processes, polymorphs, formulations, and methods of use. These patents have been the subject of litigation, with some challenges resulting in earlier than anticipated patent expiry dates for specific patents.
• Litigation Outcomes: In the U.S., litigation has been ongoing. While initial attempts to invalidate certain key patents by generic manufacturers were unsuccessful, further appeals and legal maneuvers are possible. Some agreements with generic manufacturers have been reached, potentially allowing for earlier market entry for specific generic versions under certain conditions [5].
• Projected Generic Entry: While exact dates are subject to ongoing legal proceedings and settlement agreements, U.S. market entry for authorized generic apixaban is anticipated around late 2026 to early 2027. Non-authorized generic entry could follow shortly thereafter, depending on the resolution of remaining patent disputes [5]. European market entry timelines may vary.

What are the Key Indications and Prescribing Trends for Eliquis?

Eliquis is approved for multiple indications, driving its widespread adoption and contributing to its market leadership.

• Primary Indications:
  • Stroke Prevention in Nonvalvular Atrial Fibrillation (NVAF): This is the largest indication for Eliquis, addressing a significant unmet need in a growing patient population.
  • Treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE): Eliquis is also used for the initial and ongoing treatment of these serious conditions.
  • Reduction in the risk of recurrent DVT and PE: Eliquis offers a long-term preventative option following initial treatment.
• Prescribing Patterns: Prescriptions for Eliquis have shown consistent growth since its launch, driven by physician confidence in its clinical trial data and favorable patient outcomes. The drug is widely prescribed across different healthcare settings, including hospitals and outpatient clinics.
• Market Penetration: Eliquis has achieved high market penetration in the U.S. and other developed markets, often becoming the preferred DOAC for new patients initiating anticoagulant therapy.
• Competition Impact: While competition exists, Eliquis has maintained its leading position due to its perceived balance of efficacy and safety, including a lower risk of major bleeding compared to some warfarin regimens and certain other DOACs in specific patient populations.

How Will Payer Policies and Reimbursement Affect Eliquis Pricing?

Payer policies and reimbursement strategies are increasingly influencing drug pricing and market access, impacting the revenue trajectory of Eliquis.

• Formulary Placement: Eliquis is generally well-positioned on most commercial and Medicare Part D formularies. However, payers are employing utilization management tools such as prior authorization and step therapy.
• Step Therapy: Payers often require patients to try older, less expensive anticoagulants (e.g., warfarin or potentially older DOACs) before approving Eliquis, particularly for new prescriptions. This can impact the rate of new patient initiations.
• Prior Authorization: For patients with specific medical histories or on certain insurance plans, prior authorization may be required, adding administrative burden and potentially delaying access.
• Rebate and Discounting: To maintain favorable formulary placement and competitive pricing, manufacturers engage in rebate negotiations with pharmacy benefit managers (PBMs) and health plans. The net price after rebates is significantly lower than the wholesale acquisition cost (WAC).
• Impact of Generic Entry: Upon the advent of generic apixaban, payers will likely expedite the transition to these lower-cost alternatives, significantly impacting Eliquis's market share and price realization. This will include updating formularies to favor generics and potentially increasing step-therapy requirements for the branded product.

What is the Projected Price Trajectory for Eliquis NDC 00597-0435?

The price trajectory for Eliquis is shaped by its market maturity, patent expiration timelines, and the anticipated impact of generic competition.

• Current Pricing Power: Until significant generic entry occurs, Eliquis is expected to maintain its current pricing levels, supported by its strong market position and continued demand. The WAC price is high, but net realized prices are reduced by significant rebates.
• Pre-Generic Pricing: The period leading up to authorized generic entry will likely see stable pricing for the branded product, with ongoing rebate negotiations to secure market share against competitors.
• Post-Generic Impact: The introduction of generic apixaban will lead to a substantial decrease in the realized price of the drug.
  • Authorized Generics: The presence of an authorized generic, typically launched by the brand manufacturer or a licensee, will lead to a significant price erosion, though usually less severe than a full multi-player generic launch.
  • Multi-Player Generics: Once multiple generic manufacturers enter the market, price competition will intensify, driving down prices rapidly. The average selling price for apixaban is projected to decrease by 50-70% within two years of broad generic availability.
• Price Erosion Curve:
  • Year 1 Post-Generic Entry: Branded Eliquis price may decline by 20-30% due to competitive pressure and shifts to generics.
  • Year 2 Post-Generic Entry: Branded Eliquis may see further price declines of 10-15% as generic penetration reaches over 70%.
  • Long-Term: The branded product will likely continue to lose market share and its price will be further depressed, serving a niche segment of the market or specific payer contracts.

Projected Net Price Index (Post-Generic Entry):

Timeframe	Projected Net Price Change (vs. Pre-Generic WAC)
0-6 Months Post-Generic Entry	-40% to -55%
6-18 Months Post-Generic Entry	-60% to -75%
18+ Months Post-Generic Entry	-70% to -85%

Note: "Net Price" refers to the realized price after accounting for rebates, discounts, and chargebacks. These projections assume typical market dynamics for a major branded drug facing generic competition. Actual prices may vary based on specific contract terms and market events.

What is the Competitive Landscape for Apixaban?

The competitive landscape for apixaban is characterized by established branded competitors and an impending wave of generic entrants.

• Direct Oral Anticoagulants (DOACs):
  • Xarelto (rivaroxaban): Marketed by Bayer and Janssen, Xarelto is Eliquis's primary branded competitor. Both drugs target similar indications.
  • Pradaxa (dabigatran etexilate): Boehringer Ingelheim's DOAC, Pradaxa, also competes in this space.
  • Savaysa/Lixiana (edoxaban): Daiichi Sankyo's edoxaban is another DOAC.
• Warfarin: While an older anticoagulant, warfarin remains a significant competitor due to its low cost and established use, particularly in certain patient populations or where cost is a primary driver.
• Emerging Competition: The most significant competitive threat is the upcoming generic entry of apixaban itself. Once generics become widely available, they will exert substantial downward pricing pressure.
• Market Share Dynamics: Eliquis has consistently gained market share from warfarin and has maintained a strong position against Xarelto and Pradaxa. However, this trend is expected to reverse with the introduction of generic apixaban.
• Manufacturer Strategies: Bristol Myers Squibb and Pfizer are expected to employ strategies such as:
  • Negotiating favorable launch terms for authorized generics.
  • Potentially exploring new indications or formulations to extend market exclusivity or differentiate the branded product.
  • Focusing on patient support programs and physician relationships.

What are the Key Takeaways?

• Eliquis (apixaban, NDC 00597-0435) holds a dominant position in the anticoagulant market, driven by its efficacy and broad indications.
• U.S. patent protections are expected to expire around late 2026 to early 2027, opening the door for authorized and subsequent generic apixaban entry.
• Payer utilization management tools, such as step therapy and prior authorization, are influencing Eliquis's market access and growth rate.
• The introduction of generic apixaban will lead to a significant decrease in the net realized price of the drug, with projections indicating a 60-85% reduction within 18 months of broad generic availability.
• The competitive landscape will fundamentally shift from branded DOAC competition to price-driven generic competition upon patent expiry.

Frequently Asked Questions

1. When is the earliest date authorized generic apixaban is expected to launch in the U.S.? Authorized generic apixaban is anticipated to launch in the U.S. around late 2026 to early 2027, contingent on ongoing legal proceedings and settlement agreements.

2. What is the primary driver of Eliquis's current market share? Eliquis's market share is driven by its approved indications for stroke prevention in nonvalvular atrial fibrillation and treatment of venous thromboembolism, supported by strong clinical trial data demonstrating efficacy and a favorable safety profile, particularly regarding bleeding risk.

3. How will payer policies impact the net price of branded Eliquis after generic entry? Payer policies will accelerate the price decline of branded Eliquis post-generic entry. Payers will likely favor generics on formularies, increase step-therapy requirements for the branded product, and negotiate steeper rebates for any remaining market share held by Eliquis.

4. Will Bristol Myers Squibb and Pfizer continue to market branded Eliquis after generic entry? Yes, Bristol Myers Squibb and Pfizer are expected to continue marketing branded Eliquis, potentially focusing on specific patient segments or securing limited market access contracts. However, its market share and pricing power will be severely diminished.

5. What is the projected percentage decrease in apixaban prices within two years of broad generic availability? The average selling price for apixaban is projected to decrease by 50-70% within two years of broad generic availability due to intensified price competition among multiple generic manufacturers.

Citations

[1] IQVIA. (Various Years). Pharmaceutical market data and analysis reports. [2] U.S. Food and Drug Administration. (n.d.). Drug Approvals & Databases. Retrieved from [FDA website] (Specific drug approval data for Apixaban). [3] EvaluatePharma. (Various Years). Pharmaceutical market intelligence reports. [4] Bristol Myers Squibb. (2024, February 2). Bristol Myers Squibb Announces Fourth Quarter and Full Year 2023 Results. Retrieved from [Bristol Myers Squibb Investor Relations website]. [5] Generic Pharmaceutical Association (GPhA). (Various Years). Industry reports and patent litigation updates.