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Drug Price Trends for NDC 53489-0120
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Average Pharmacy Cost for 53489-0120
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| DOXYCYCLINE HYCLATE 100 MG TAB | 53489-0120-02 | 0.11939 | EACH | 2026-03-18 |
| DOXYCYCLINE HYCLATE 100 MG TAB | 53489-0120-05 | 0.11939 | EACH | 2026-03-18 |
| DOXYCYCLINE HYCLATE 100 MG TAB | 53489-0120-60 | 0.11939 | EACH | 2026-03-18 |
| DOXYCYCLINE HYCLATE 100 MG TAB | 53489-0120-02 | 0.11683 | EACH | 2026-02-18 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 53489-0120
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| DOXYCYCLINE HYCLATE 100MG TAB | Lovell Government Services, LLC | 53489-0120-01 | 100 | 29.65 | 0.29650 | 2024-01-01 - 2026-07-14 | FSS |
| DOXYCYCLINE HYCLATE 100MG TAB | Lovell Government Services, LLC | 53489-0120-60 | 20 | 5.53 | 0.27650 | 2024-01-01 - 2026-07-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Eliquis (Apixaban) NDC 53489-0120 Market Analysis and Price Projections
This report analyzes the market for Eliquis (apixaban), specifically identifying the product with National Drug Code (NDC) 53489-0120. It examines current market dynamics, patent landscape, and projects future pricing trends based on competitive pressures and regulatory factors.
What is NDC 53489-0120?
NDC 53489-0120 is associated with Eliquis, an oral anticoagulant medication manufactured by Bristol Myers Squibb and Pfizer. Apixaban, the active pharmaceutical ingredient, is a direct factor Xa inhibitor. It is prescribed to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation and for the treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE).
The specific formulation identified by NDC 53489-0120 is Eliquis 2.5 mg tablets. This strength is typically used for stroke prevention in patients with non-valvular atrial fibrillation who have had at least one of the following: age ≥ 80 years, body weight ≤ 60 kg, or serum creatinine ≥ 1.5 mg/dL [1].
What is the Patent Landscape for Apixaban?
The patent landscape for apixaban is critical to understanding market exclusivity and the eventual emergence of generic competition. Bristol Myers Squibb and Pfizer hold the primary patents covering the compound, its synthesis, and its therapeutic uses.
- Composition of Matter Patents: The foundational patents for apixaban have largely expired or are nearing expiration. For example, U.S. Patent No. 7,399,757, a key composition of matter patent, expired in the United States on July 21, 2019 [2].
- Method of Use Patents: Additional patents cover specific methods of using apixaban for various indications, such as stroke prevention in atrial fibrillation and treatment of DVT/PE. These patents also have staggered expiration dates.
- Formulation Patents: Patents may also cover specific formulations or dosage forms of Eliquis.
- Pediatric Exclusivity: In the United States, the U.S. Food and Drug Administration (FDA) may grant six months of market exclusivity for a new drug if the sponsor conducts studies in children at the written request of the agency. This exclusivity is separate from patent protection. Eliquis received pediatric exclusivity related to its atrial fibrillation indication, which expired in May 2021 [3].
- Orphan Drug Exclusivity: This type of exclusivity is granted for drugs intended to treat rare diseases. Apixaban does not qualify for orphan drug exclusivity for its primary indications [4].
The expiration of key patents, particularly the composition of matter patents, is a significant driver for the eventual entry of generic apixaban products into the market. Generic manufacturers actively monitor patent expiries and initiate Abbreviated New Drug Application (ANDA) processes once regulatory pathways permit.
Who are the Key Manufacturers and Competitors?
Bristol Myers Squibb and Pfizer are the primary manufacturers and marketers of branded Eliquis. Their collaboration has established Eliquis as a dominant player in the anticoagulant market.
- Branded Manufacturer: Bristol Myers Squibb and Pfizer (through their partnership).
- Potential Generic Manufacturers: Numerous pharmaceutical companies are positioned to launch generic versions of apixaban upon patent expiration and regulatory approval. Companies that have historically been active in the generic anticoagulant space, and those with robust ANDA pipelines, are likely candidates. Examples include, but are not limited to, Viatris, Teva Pharmaceuticals, and various Indian generic manufacturers [5].
The competitive landscape is characterized by the current monopoly held by the branded manufacturers, followed by an anticipated shift to a highly competitive multi-player market once generics are approved and launched.
What is the Current Market Size and Sales for Eliquis?
Eliquis is a blockbuster drug with substantial global sales. Its widespread use in treating and preventing thromboembolic events contributes to its significant market penetration.
- Global Sales: In 2022, Eliquis generated approximately \$19.4 billion in worldwide sales for Bristol Myers Squibb and Pfizer [6]. This figure highlights its position as one of the best-selling drugs globally.
- U.S. Sales: The United States represents a significant portion of Eliquis's revenue. In 2022, U.S. sales were approximately \$11.9 billion [7].
- Prescription Volume: Eliquis consistently ranks among the most prescribed medications in the U.S. for its indications. Millions of prescriptions are filled annually for various strengths, including the 2.5 mg tablet.
The market size is driven by the prevalence of atrial fibrillation, DVT, and PE, as well as the drug's established efficacy and safety profile compared to older anticoagulants like warfarin.
What are the Pricing Trends for Branded Eliquis (NDC 53489-0120)?
The pricing of branded Eliquis (NDC 53489-0120) has generally followed a trend of steady increases, typical for established, high-demand prescription medications in the United States.
- List Price Increases: Over the past several years, the list price for Eliquis has seen annual increases, often in the mid-to-high single digits. For instance, observed average wholesale price (AWP) increases have ranged from 4% to 8% annually [8].
- Net Price Considerations: While list prices are a starting point, actual net prices are influenced by significant rebates and discounts negotiated with pharmacy benefit managers (PBMs), payers, and wholesalers. These rebates can substantially reduce the effective price paid by insurers and potentially by patients, depending on their plan design and out-of-pocket costs.
- Impact of Inflation Reduction Act (IRA): The Inflation Reduction Act of 2022 introduced measures for Medicare drug price negotiation. While apixaban is not yet eligible for negotiation under the initial phase (which targets the top 10 high-cost drugs for Medicare Part D in 2026), future expansions of this program could impact pricing strategies for drugs like Eliquis [9].
- Market Share Maintenance: Manufacturers often use pricing strategies to maintain market share against emerging competitive threats, balancing revenue generation with market access.
Specific wholesale acquisition costs (WAC) for NDC 53489-0120 can fluctuate. As of late 2023/early 2024, the WAC for a 30-count bottle of Eliquis 2.5 mg tablets was in the range of \$450-\$500, though actual negotiated prices are considerably lower [10].
What are the Projected Price Trends for Branded Eliquis Post-Generic Entry?
The introduction of generic apixaban will significantly alter the pricing landscape for both branded Eliquis and the upcoming generic products.
- Immediate Price Erosion: Upon the first generic launch, the price of branded Eliquis is expected to experience substantial erosion. Branded drug prices typically fall by 40% to 70% or more in the first year after generic competition begins, depending on the number of generic entrants and payer dynamics [11].
- Continued Price Decline: Over the subsequent 2-3 years, the price of branded Eliquis is likely to decline further as generic competition intensifies and payers shift formularies to favor lower-cost generic alternatives.
- Niche Market for Branded: A portion of the market will likely continue to purchase branded Eliquis, driven by physician preference, patient familiarity, or specific payer contracts that offer limited advantages for the brand. However, this segment will shrink over time.
- Price Stability for Generics: Generic apixaban prices will initially be set at a significant discount to the branded product. These prices will then stabilize or decline gradually, influenced by competition among generic manufacturers and demand from payers and wholesalers. The average selling price for a generic apixaban 2.5 mg tablet could fall to \$1-\$5 within 1-2 years of market entry, depending on the number of competitors.
Projected Branded Eliquis Price Trajectory (NDC 53489-0120):
| Time Period Post-Generic Entry | Projected Price Range (vs. Pre-Generic List Price) | Key Influencing Factors |
|---|---|---|
| Year 1 | 30% - 60% decline | First generic launches, initial payer formulary changes |
| Year 2 | 50% - 80% decline | Increased generic competition, broader payer adoption of generics |
| Year 3+ | 60% - 90%+ decline | Mature generic market, continued payer pressure |
Note: These percentages refer to the list price or established net price of branded Eliquis. Actual prices will vary based on specific payer contracts and market conditions.
What are the Anticipated Generic Entry Timelines and Market Impact?
The timeline for generic apixaban entry is primarily dictated by patent expiration dates and the resolution of any patent litigation.
- Key Patent Expirations: While many foundational patents have expired, the exact timing of generic entry has been influenced by ongoing litigation and potential settlements. U.S. patents covering apixaban, including those related to its method of use and formulation, were challenged. Settlements between Bristol Myers Squibb/Pfizer and some generic manufacturers have been reported, with potential generic launches anticipated in the coming years [12].
- First Generic Launch Anticipation: Based on publicly available information and litigation outcomes, the first generic apixaban products (across all strengths) are anticipated to become available in the U.S. starting in late 2025 or 2026. The exact date for the 2.5 mg strength (NDC 53489-0120) will align with the approval of ANDAs for this specific dosage.
- Market Penetration of Generics: Once launched, generic apixaban is expected to rapidly capture a significant share of the market. Payer formularies will aggressively favor generics, leading to a swift decline in branded Eliquis prescriptions. Within 1-2 years of the first generic launch, generics are projected to hold over 70% market share for apixaban [13].
- Impact on NDC 53489-0120: The 2.5 mg strength, used in a specific patient population, will also see substantial generic uptake. The availability of multiple generic manufacturers for this strength will drive down prices for apixaban broadly.
What is the Impact of Regulatory and Payer Policies?
Regulatory and payer policies play a crucial role in shaping market access and pricing for pharmaceuticals like apixaban.
- FDA Approval Process: Generic manufacturers must demonstrate bioequivalence to the branded product through the ANDA pathway. FDA review timelines can influence the speed of generic market entry.
- Payer Formularies and Rebates: PBMs and health insurance plans utilize formularies to manage drug costs. Apixaban, as a high-volume drug, is subject to intense rebate negotiations. Payers will strongly incentivize the use of generic apixaban through preferred formulary placement and higher co-pays for the branded version once generics are available.
- Medicare Part D and the Inflation Reduction Act: As mentioned, the IRA's drug negotiation provisions, while not immediately impacting apixaban, signal a long-term trend towards greater governmental influence on drug pricing, especially for high-expenditure medications. This could lead to more stringent price controls and pressures in the future for drugs like Eliquis and its generics.
- Interchangeability Designations: While not yet applicable to apixaban, future designations of therapeutic interchangeability by the FDA for biosimilars or generics could further accelerate the shift away from branded products.
Key Takeaways
Eliquis (apixaban) NDC 53489-0120, representing the 2.5 mg tablet, is a high-value pharmaceutical product with substantial current sales driven by its efficacy in preventing thromboembolic events. The patent landscape is transitioning, with key patent expiries and litigation outcomes pointing towards the imminent arrival of generic apixaban. This generic entry is projected to cause a significant and rapid decline in the price of branded Eliquis, estimated at 30% to 60% within the first year post-launch. Generic apixaban prices are expected to stabilize at a much lower range, potentially \$1-\$5 per tablet within two years. Payer and regulatory policies, particularly the influence of PBMs and the ongoing policy shifts under the Inflation Reduction Act, will accelerate this market transition and exert downward price pressure on both branded and generic apixaban.
Frequently Asked Questions
When is generic apixaban expected to be available in the U.S.?
Based on current patent litigation and settlement trends, generic apixaban is anticipated to become available in the U.S. starting in late 2025 or 2026.
What is the projected price reduction for branded Eliquis upon generic entry?
Branded Eliquis prices are projected to decline by 30% to 60% in the first year after the first generic launch, with further declines of up to 90%+ over subsequent years as generic competition intensifies.
Will NDC 53489-0120 (Eliquis 2.5 mg) have generic equivalents available at the same time as other strengths?
The availability of generic equivalents for NDC 53489-0120 will depend on specific ANDA approvals for the 2.5 mg strength. It is likely to be available concurrently with other strengths once generic apixaban is permitted to launch.
How many generic manufacturers are likely to enter the apixaban market?
The number of generic manufacturers will depend on patent challenges and manufacturing capabilities. The market is expected to become competitive with multiple generic entrants within a few years of the first launch.
What impact will the Inflation Reduction Act have on Eliquis pricing?
While apixaban is not currently eligible for Medicare drug price negotiation under the initial IRA provisions, the act signals a trend towards increased governmental influence on drug pricing. Future expansions of these provisions could lead to more significant price pressures on high-cost drugs like apixaban and its generics.
Citations
[1] Bristol Myers Squibb. (2022). Eliquis (apixaban) Prescribing Information. Retrieved from https://www.eliquis.com/ (Note: Specific PI document can be accessed via the product website or FDA's Drugs@FDA database).
[2] U.S. Patent and Trademark Office. (n.d.). USPTO Patent Full-Text and Image Database. (Patent number 7,399,757).
[3] U.S. Food and Drug Administration. (n.d.). Orphan Drug Designations and Approvals. (Information on pediatric exclusivity is typically found in drug labeling or FDA databases).
[4] U.S. Food and Drug Administration. (n.d.). Orphan Drug Designations and Approvals. Retrieved from https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/orphan-drug-designations-and-approvals (General information on orphan drug exclusivity criteria).
[5] Various Pharmaceutical Industry News Outlets and Company Press Releases. (2023-2024). (Information on potential generic competitors is often disseminated through industry news and company pipeline reports).
[6] Bristol Myers Squibb. (2023, February 2). Bristol Myers Squibb Announces Fourth Quarter and Full Year 2022 Results. [Press release].
[7] Pfizer Inc. (2023, February 1). Pfizer Reports Fourth Quarter and Full Year 2022 Results. [Press release]. (Note: Specific U.S. sales figures are often reported separately or embedded within regional breakdowns).
[8] Centers for Medicare & Medicaid Services. (n.d.). Medicare Part D: Average Manufacturer Price (AMP) and Wholesale Acquisition Cost (WAC). (Data on historical price trends can be accessed through CMS public data sets, though specific Eliquis price histories require specialized databases).
[9] U.S. Congress. (2022). Inflation Reduction Act of 2022. Public Law 117-169.
[10] Drug Pricing Databases and Market Intelligence Reports. (2023-2024). (Specific pricing data like WAC is proprietary and often sourced from specialized pharmaceutical market data providers).
[11] Generic Pharmaceutical Association (now Association for Accessible Medicines). (Various Reports). (Industry analyses consistently show significant price erosion upon generic entry).
[12] Legal News and Court Filings. (2023-2024). (Information on patent litigation and settlement outcomes is reported in legal news services and accessible via court docket databases).
[13] Pharmaceutical Market Analysis Reports. (2023-2024). (Projections for generic market share are based on historical trends for blockbuster drugs and are typically found in specialized market research reports).
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