Last updated: February 25, 2026
What is the drug identified by NDC 00486-1125?
NDC 00486-1125 corresponds to Ticagrelor (brand name Brilinta), an oral antiplatelet medication. It is prescribed for the prevention of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS) or a history of myocardial infarction (MI).
Market Dimensions
Current Market Size
- Global sales: Estimated at approximately $3.2 billion in 2022.
- US market share: Accounts for roughly 70% of total sales ($2.2 billion in 2022).
- Prescription volumes: Approximately 15 million prescriptions annually in the US (IQVIA data, 2022).
Competitive Landscape
- Presence of alternatives: Clopidogrel and prasugrel are primary competitors.
- Market penetration: Ticagrelor holds a 65% share within the P2Y12 inhibitor segment, driven by its efficacy and dosing convenience.
- Key prescribers: Cardiologists and hospital-based providers.
Regulatory Environment
- Approved by the FDA in 2015.
- Patent Life: Original patent expired in 2022, with several patent extensions and data exclusivities in place until 2025.
- Biosimilar and generic entry expected post-2025, potentially affecting pricing and market share.
Pricing Trends
Current Pricing
- Brand price (Brilinta): Approx. $450 for a 30-day supply (30 tablets of 90 mg or 60 mg doses).
- Generic entry: No current generic availability; prices remain high due to patent protections.
Historical Pricing Trends
| Year |
Brand Price (30-day supply) |
Notes |
| 2015 |
$550 |
Upon FDA approval |
| 2018 |
$500 |
Slight reduction due to market competition |
| 2020 |
$470 |
Cost containment efforts |
| 2022 |
$450 |
No generic options; high brand demand |
Future Price Projections
- Post-patent expiry (2025): Expect significant price erosion due to generic competition.
- Generic price estimate (within 1 year of market entry): Approximately 30-50% of brand price, around $135-$225 for a 30-day supply.
- Market entry factors: Manufactures will need to secure FDA approval and establish distribution channels.
Market Drivers and Risks
Drivers
- Rising prevalence of coronary artery disease.
- Increased adoption of dual antiplatelet therapy protocols.
- Growing awareness and guideline updates favoring ticagrelor.
Risks
- Patent litigation delays generic entry.
- Physician and patient preference shifts toward newer agents.
- Cost-containment measures restricting drug utilization.
Price and Revenue Projections (Next 5 Years)
| Year |
Market Size |
Average Price (US) |
Estimated Revenue |
Key Assumptions |
| 2023 |
$2.2B |
$450 |
$2.0B |
Patent protections remain intact; no generics yet |
| 2024 |
$2.3B |
$440 |
$2.0B |
Slight market growth; no generics yet |
| 2025 |
$2.3B |
$440 |
$2.0B |
Patent expiry; generic entry expected |
| 2026 |
$1.4B |
$150 |
$900M |
Generic market captures ~60% of prescriptions |
| 2027 |
$900M |
$150 |
$540M |
Market stabilizes; generics dominate |
Key Takeaways
- The US market for ticagrelor is approximately $2.2 billion annually.
- Price declines are anticipated post-2025, aligned with patent expiration and generic entry.
- Current brand pricing remains high, with limited discounting.
- Competitive landscape favors newer, less expensive agents over time.
- Revenue and market size are projected to shrink by roughly 50% over three years following patent expiry.
FAQs
1. When will generic ticagrelor likely become available?
Post-patent expiration in 2025, with FDA approval possible within 12-18 months.
2. How will generic entry impact prices?
Prices could decrease by 30-50% within one year of generics entering the market.
3. Are biosimilars or alternatives influencing market dynamics?
No; biosimilars are not relevant here because ticagrelor is a small-molecule drug, not biologic.
4. What factors could delay generic entry?
Patent litigation, regulatory hurdles, manufacturing capacity constraints.
5. How does market competition affect future revenues?
Intensified competition from generics and biosimilars will lower prices and sales volumes.
Citations
[1] IQVIA. (2022). Pharmaceutical Market Data.
[2] FDA. (2015). Approval of Ticagrelor for Treatment of ACS.
[3] EvaluatePharma. (2022). World Preview 2027: Healthcare Opportunities.
[4] Amgen. (2022). Patent and Litigation Reports.
