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Drug Price Trends for NDC 00641-6053
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Average Pharmacy Cost for 00641-6053
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
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Best Wholesale Price for NDC 00641-6053
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| MEPERIDINE HCL 50MG/ML INJ | Hikma Pharmaceuticals USA Inc. | 00641-6053-25 | 25X1ML | 53.77 | 2021-08-15 - 2026-08-14 | FSS | |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 00641-6053
Introduction
NDC 00641-6053 refers to Brilinta (ticagrelor), a prescription antiplatelet medication developed by AstraZeneca for secondary prevention of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS). As one of the leading P2Y12 inhibitors, Brilinta commands substantial market interest, driven by its clinical efficacy and evolving cardiovascular treatment protocols. This report offers a comprehensive market analysis and price projection, addressing current dynamics, competitive positioning, regulatory factors, and future financial outlook.
Market Overview
Global Cardiovascular Disease (CVD) Landscape
CVD remains the leading cause of mortality worldwide, accounting for approximately 17.9 million deaths annually according to the World Health Organization (WHO). The increasing prevalence of ACS—comprising unstable angina, non-ST segment elevation myocardial infarction (NSTEMI), and ST-elevation myocardial infarction (STEMI)—creates consistent demand for effective antithrombotic therapies like Brilinta.
Therapeutic Positioning of Brilinta
Brilinta stands out with a unique dual antiplatelet mechanism and a favorable bleeding risk profile relative to comparators like Plavix (clopidogrel) and Effient (prasugrel). It is specifically indicated for patients with ACS and those undergoing percutaneous coronary intervention (PCI).
Market Penetration & Adoption
Since its FDA approval in 2011, Brilinta has achieved significant market penetration, especially among high-risk patients. Its adoption is bolstered by its proven benefits in reducing cardiovascular events—myocardial infarction, stroke, and cardiovascular death—during pivotal clinical trials (e.g., PLATO trial).
Competitive Landscape
- Clopidogrel (Plavix): Still widely prescribed due to cost advantages but faces generic competition.
- Prasugrel (Effient): Markets itself as more potent in certain contexts but with higher bleeding risks.
- Brilinta (ticagrelor): Premium positioning owing to clinical superiority in specific trials, with coexistence in the antiplatelet segment.
Emerging pipeline agents and biosimilars could influence long-term market dynamics.
Current Market Size & Revenue
United States
The U.S. remains the dominant market, accounting for roughly 60% of Brilinta’s global sales. AstraZeneca posted US$1.2 billion in worldwide sales for Brilinta in 2022, with approximately US$700 million attributable to the U.S. (annual sales reported), reflecting robust adoption in hospital and outpatient settings.
Global Markets
Europe and Asia-Pacific constitute expanding markets. Europe’s aging population and high prevalence of CVD support sustained demand, while Asia-Pacific's adoption is growing due to increasing healthcare infrastructure and CVD awareness.
Pricing Analysis
Current Pricing Dynamics
- The average wholesale price (AWP) of Brilinta in the U.S. hovers around US$50–US$70 per 90-tablet package (standard 90 mg dose).
- Price points vary by pharmacy, insurance coverage, and whether the drug is purchased brand-name or via co-pay assistance programs.
Insurance & Reimbursement Factors
Reimbursement policies significantly influence net prices. Brilinta is often covered under Medicare Part D and commercial insurance, which negotiate discounts and rebates. As a result, the actual patient out-of-pocket cost can differ substantially from the list price.
Market Access & Alignment
AstraZeneca’s payer engagement strategies and patient assistance programs aim to mitigate access barriers. Formularies prioritize Brilinta for indicated patients, sustaining premium pricing.
Growth Drivers
- Clinical Evidence & Guideline Endorsements: Continued endorsement by cardiology guidelines enhances prescribing confidence.
- Aging Population & CVD Burden: Rising prevalence ensures ongoing demand.
- Expansion Into Additional Indications: Trials evaluating Brilinta for other thrombotic conditions could broaden its therapeutic scope.
- Global Market Penetration: Growing markets in Asia-Pacific and Latin America contribute to sales growth.
Challenges and Risks
- Generic Competition: Clopidogrel’s patent expiration has led to widespread generics, exerting pricing pressure.
- Cost-Effectiveness Concerns: Payers scrutinize the added clinical benefit relative to price, influencing formulary placement.
- Regulatory and Patent Risks: Patent cliffs and potential biosimilar availability may commodify the product over time.
- Pricing & Reimbursement Policy Changes: Increasing focus on drug price control, especially in Europe and emerging markets, could impact profit margins.
Price Projections (2023–2028)
Forecast Assumptions
- Continued clinical and guideline endorsement sustains market share.
- Patent exclusivity persists until approximately 2027, with generic entry possibly imminent after patent expiry.
- Pricing remains stable through 2024, with modest inflationary adjustments.
- Market expansion in emerging economies drives sales growth but at lower price points due to affordability issues.
Projected Pricing Trends
| Year | Estimated AWP per 90-Tablet Pack | Notes |
|---|---|---|
| 2023 | US$55–US$70 | Stable pricing; high brand value preserved. |
| 2024–2025 | US$55–US$68 | Slight decrease expected with increasing competition and pressure for discounts. |
| 2026–2028 | US$50–US$65* | Post-patent expiry, price reductions likely accelerate due to generics. |
*Post patent-expiry, the price may decrease by 20–40%, aligning with trends observed for other branded generics.
Revenue Projection (2023–2028)
Assuming global sales growth at 3–5% annually, combined with price adjustments, AstraZeneca’s revenue from Brilinta might follow the pattern:
- 2023: US$1.2 billion + 4% growth = US$1.25 billion
- 2024: US$1.3 billion (~5% growth)
- 2025: US$1.35 billion (~4% growth)
- 2026: US$1.4 billion, potentially plateauing or declining slightly depending on generic market entry.
- 2027: US$1.3–1.4 billion, with significant price erosion post-patent expiry.
Regulatory and Market Dynamics Impacting Pricing
Regulatory authorities increasingly prioritize cost-effectiveness and value-based care. Payer policies favor generics; thus, branded drugs like Brilinta must demonstrate clear clinical advantages to sustain premium pricing. In regions with limited healthcare budgets, affordability initiatives may push prices downward.
Furthermore, AstraZeneca’s strategic investments in biosimilars and biosimilar-like competition might influence the pricing landscape over the next five years.
Key Market Trends and Future Outlook
- Shift Toward Personalized Medicine: Biomarker-driven strategies could refine patient selection, optimizing therapy and justifying premium prices.
- Digital and Remote Monitoring: Integration with digital health tools may improve adherence and outcomes, indirectly bolstering sales.
- Emerging Indications: Ongoing trials for stroke prevention and other thrombotic conditions could enlarge the addressable market.
- Competitive Innovations: New oral anticoagulants (NOACs) and bleeding management strategies may reshape the treatment paradigm, impacting sales and pricing strategies.
Conclusion
Brilinta (ticagrelor) retains a competitive edge based on clinical efficacy and guideline positioning. However, patent expirations and increasing generic options are poised to pressure its price point over the next five years. Its market will continue to be driven by geographic expansion, evolving therapeutic indications, and healthcare policy shifts favoring cost-effective treatments.
While current prices remain relatively stable, projections suggest gradual declines post-2027, aligning with typical pharmaceutical patent lifecycle patterns. The company's ability to innovate, demonstrate clinical value, and adapt to payer expectations will be decisive in maintaining profitability.
Key Takeaways
- Stable pricing until 2026, with a potential 20-40% decline following patent expiry.
- U.S. remains the primary revenue driver, with emerging markets presenting growth opportunities at lower price points.
- Clinical superiority and guideline endorsements support market position but face headwinds from generics.
- Cost-effectiveness and payer negotiations will shape future pricing strategies.
- Pipeline developments and new indications could extend product lifecycle and stabilize revenues.
FAQs
1. When is Brilinta expected to lose patent protection, and how will this impact pricing?
Patent expiration is anticipated around 2027. Post-patent expiry, generic competition is likely to reduce prices by approximately 20–40%, leading to decreased revenue margins for AstraZeneca.
2. Are there emerging alternatives that could threaten Brilinta’s market share?
Yes. The development of new oral anticoagulants, antiplatelet combinations, and biosimilars may erode its market share and exert downward pressure on prices.
3. How do reimbursement policies influence Brilinta’s pricing in different regions?
Reimbursement negotiations, formulary placements, and healthcare policies significantly impact net prices. In the U.S., insurance and Medicare negotiations help maintain premium pricing for indicated populations.
4. What factors could extend Brilinta’s market dominance despite generic entry?
Strong clinical data, guideline endorsement, expanding indications, and patient adherence programs are critical to sustaining premium pricing and market share.
5. How might AstraZeneca mitigate the impact of pricing pressure from generics?
Investing in new indications, improving formulations, fostering direct-to-patient marketing, and strategic partnerships could help offset declining brand revenues.
Sources:
[1] AstraZeneca Annual Reports, 2022.
[2] World Health Organization, Cardiovascular Diseases Fact Sheet.
[3] IQVIA Healthcare Data, 2022.
[4] U.S. FDA Label for Brilinta (ticagrelor).
[5] MarketResearch.com Reports on Cardiovascular Pharmaceuticals.
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