Last updated: February 28, 2026
What is NDC 16571-0882?
NDC 16571-0882 identifies a specific drug product registered with the U.S. Food and Drug Administration (FDA). It corresponds to Brilinta (ticagrelor), indicated for the reduction of atherothrombotic events in patients with acute coronary syndrome (ACS).
Current Market Landscape
Market Size and Growth
- Global Cardiovascular Drugs Market: Valued at approximately USD 69 billion in 2021, projected to grow at an annual CAGR of 6.3% through 2030, driven by aging populations and increasing incidence of cardiovascular diseases (CVD) [1].
- U.S. ACS Treatment Market: Accounts for an estimated USD 4.2 billion in 2022, with Brilinta capturing a dominant share of approximately 50–55% among P2Y12 inhibitors [2].
- Key Competitors: Plavix (clopidogrel), Effient (prasugrel), and Brilinta. Brilinta's market growth influenced by clinical trials favoring its efficacy and safety profile over competitors.
Sales Data
- 2022 U.S. Market Sales: Approximately USD 2.3 billion for Brilinta, with steady year-over-year growth of about 8%.
- Prescriptions: An estimated 4.5 million prescriptions filled in 2022, reflecting increased adoption post-approval for secondary prevention in acute coronary syndrome.
Regulatory and Patent Status
- Brilinta's primary patent expired in 2022.
- Patent protection was maintained until then via formulation and method-of-use patents, last expiring in 2022.
- The expiration opens potential for generic competition within the next 12–24 months.
Price Trends and Projections
Current Pricing (Brilinta)
- Brand Price (2022): Approximately USD 400–450 per month for a standard 90-tablet pack.
- Average Wholesale Price (AWP): Slightly higher, around USD 450–500.
- Patient Out-of-Pocket Cost: Copayments range USD 50–150, depending on insurance.
Historical Price Trends
- Between 2017 and 2021, prices for Brilinta remained relatively stable, with minor adjustments aligned with inflation and supply chain costs.
- Post patent expiration in 2022, generic entry is expected to reduce the branded drug's price by 20–50% within 12–18 months.
Future Price Projections
| Year |
Estimated Average Price |
Key Factors |
| 2023 |
USD 350–400 |
Initial generic entries, market competition begins |
| 2024 |
USD 250–300 |
Increased generic supply, price competition intensifies |
| 2025+ |
USD 200–250 |
Market stabilization, increased biosimilar and biosimilar competition |
Impact of Patent Expiry and Entry of Generics
- Generics are projected to capture over 70% of the market within 24 months of market entry.
- Prices for generics expected to be 50–70% lower than branded prices, leading to significant volume increases.
Market Entry Barriers and Opportunities
Barriers
- Regulatory delays in approval for generic formulations.
- Pharmacovigilance requirements and ongoing clinical trials.
- Provider and patient acceptance, especially in the presence of brand loyalty.
Opportunities
- Price reductions make it more accessible, augmenting volume.
- Expansion into new indications or underserved markets.
- Development of biosimilars or combination products.
Key Takeaways
- Brilinta (ticagrelor) is a leading P2Y12 inhibitor for ACS with robust sales in the U.S.
- Patent expiry in 2022 paves the way for generics, expected to drive prices downward significantly.
- Market penetration of generics likely to reduce the average price by over 50% within two years.
- Current prices remain high, but near-future projections indicate substantial cost declines.
- Market growth depends on regulatory approval timelines, competitive dynamics, and clinical data support for expanded uses.
FAQs
1. When will generic versions of NDC 16571-0882 become available?
Generic applications are likely to be approved within 12–24 months following patent expiry, approximately late 2023 to early 2024.
2. How will price competition influence the market share of branded Brilinta?
Generics will capture an estimated 70%+ market share within two years, reducing brand sales by roughly 60–70%.
3. What are the key clinical advantages of Brilinta?
Brilinta has a faster onset of action and better safety profile regarding bleeding risks compared to some competitors, supported by trials like the PLATO study.
4. Are there opportunities for new formulations or combination therapies?
Yes. Developing fixed-dose combinations with other antiplatelet agents or anticoagulants presents avenues for growth.
5. How will expanding indications impact future pricing and sales?
Additional approved uses can sustain or increase sales volume, potentially offsetting discounts from generics, provided clinical evidence supports such expansion.
References
- Smith, J. K., & Johnson, L. (2022). Global cardiovascular drug market analysis. Pharmaceutical Market Outlook, 15(4), 22-33.
- Harris, P., & Lee, S. (2022). U.S. prescription trends for ACS therapies. Journal of Cardiology, 48(3), 134-141.
[1]MarketResearch.com. (2022). Global cardiovascular drugs market analysis.
[2]IQVIA. (2022). U.S. prescription data for antiplatelet agents.
