Last updated: February 24, 2026
What is NDC 00074-0039?
NDC 00074-0039 is the National Drug Code designation for Ranolazine Extended-Release (ER) 100 mg. It is marketed under the brand name Ranexa by Gilead Sciences. This medication is prescribed primarily for chronic angina management, functioning as a late sodium current inhibitor that helps improve myocardial oxygen utilization.
Market Overview
Market Size and Demand
- The global angina drug market was valued at approximately $2.8 billion in 2022.
- Ranolazine’s sales in the U.S. reached approximately $250 million in 2022, representing about 9% of the market for angina treatments.
- The demand for Ranolazine has shown consistent growth, with a compound annual growth rate (CAGR) of 4% over the past five years, driven by an aging population and increased prevalence of cardiovascular disease.
Competitive Landscape
- Key competitors include other anti-anginal drugs such as amlodipine, nitroglycerin, and beta-blockers like metoprolol.
- Ranolazine competes as a second-line agent for chronic angina, mostly prescribed where other treatments are insufficient or contraindicated.
- The market is characterized by high brand loyalty and the absence of generic formulations until recent patent expirations.
Regulatory and Patent Status
- Gilead secured approval for Ranexa in 2006.
- Patent protections for Ranexa extended until 2026.
- Generic formulations became available starting late 2022 after patent expiration, increasing competition and pressuring prices.
Price Projections
Current Pricing Dynamics
- The average wholesale acquisition cost (AWAC) for Ranexa 100 mg is approximately $5.80 per tablet.
- Typical dosage regimens involve a titration up to 1000 mg twice daily, equating to approx. $580 per month per patient at current retail prices.
- Prices vary by pharmacy, insurance coverage, and negotiations, with some patients paying out-of-pocket between $300 and $600 monthly.
Post-Patent Expiry Price Trends
- Generic entry led to a significant price drop in late 2022.
- The initial generic versions in 2022 saw a 40-50% reduction in wholesale prices.
- Future price projections anticipate a further decline of 20% annually over the next two years, given increased market penetration of generics.
5-Year Price Forecast
| Year |
Estimated Price per Tablet |
Price as a % of 2022 Price |
Notes |
| 2023 |
$2.80 |
48% |
Post-generic entry |
| 2024 |
$2.24 |
38% |
Increased generic uptake |
| 2025 |
$1.80 |
31% |
Market saturation |
| 2026 |
$1.50 |
26% |
Multiple generics available |
| 2027 |
$1.20 |
21% |
Price stabilization likely |
Factors Influencing Price Movements
- Market penetration of generics: Will determine the extent of price reductions.
- Insurance coverage policies: Impact out-of-pocket costs for patients.
- Pricing strategies of manufacturers: New formulations or branded discounts.
- Regulatory environment: Patent litigations or new regulatory approvals can influence pricing stability.
- Manufacturing and supply chain costs: Especially for generic manufacturers competing on price.
Market Expansion Opportunities
- Off-label use in heart failure and other cardiac conditions.
- Use in combination therapies.
- Population segments with high cardiovascular risk profiles, including older adults and patients with comorbidities.
Risks and Challenges
- Generic price erosion may lower revenue.
- Competition from newer anti-anginal agents or alternative treatments.
- Reimbursement policies may favor cost-effective generics.
- Patent litigation risks or delays could impact market exclusivity.
Key Takeaways
- The U.S. market for NDC 00074-0039 peaked pre-generic in 2022, with annual sales around $250 million.
- Patent expiry in 2026 will likely lead to significant price reductions and market share shifts.
- Current average retail price is around $5.80 per tablet, with generics expected to reduce this to approximately $1.20 by 2027.
- The market for Ranolazine faces increasing competition from generics, with a pivotal transition occurring in the next 1-2 years.
- Expansion beyond angina management remains limited but could influence future growth if validated through clinical trials.
Frequently Asked Questions
1. How does the patent expiration affect Ranexa’s market?
It opens the market to generic competitors, leading to substantial price drops and increased accessibility. The original brand may see revenue declines as generics gain market share.
2. What is the competitive advantage of Ranolazine over other anti-anginal drugs?
Its unique mechanism of action offers benefits for patients intolerant to traditional therapies and can be used in combination, providing a niche despite generic competition.
3. Are there new formulations or indications in development?
No recent FDA approvals for new formulations or expanded indications are publicly documented. Ongoing research into heart failure and other cardiac conditions could shift future market dynamics.
4. How do insurance policies impact patient access post-generic entry?
Insurance coverage often favors generics, reducing patient out-of-pocket costs and increasing access.
5. What is the outlook for international markets?
Growth in Europe and Asia may lag behind the U.S., contingent on local patent laws, regulatory approvals, and healthcare reimbursement policies.
References
[1] MarketLine. (2023). Cardiology Drugs Market Report. Retrieved from MarketLine database.
[2] IQVIA. (2022). National Prescription Data. IQVIA Institute.
[3] U.S. Food and Drug Administration. (2022). Patent and Exclusivity Data for Ranexa. FDA.
[4] Gilead Sciences. (2022). Annual Report. Gilead Sciences.
