Last updated: February 16, 2026
What is the Drug Associated with NDC 62332-0679?
NDC 62332-0679 corresponds to Ranolazine, marketed primarily under the brand name Ranexa. Approved by the FDA in 2006, Ranolazine is used to treat chronic angina. It functions as an anti-anginal agent, reducing the frequency of angina episodes.
Current Market Landscape
Market Size and Demand
- The global angina market valued approximately $7 billion USD in 2022 (source: IQVIA).
- Ranolazine's market share in the anti-anginal segment has grown steadily since approval, driven by its unique mechanism and safety profile.
- In the US, adult prescription volume exceeds 2 million annually, with a year-over-year growth rate of roughly 3-4%.
Competitive Environment
Ranolazine faces competition from both first-line therapies and newer agents:
| Drug Name |
Class |
Market Share (2022) |
FDA Approval Year |
Notes |
| Amiodarone |
Antiarrhythmic |
25% |
1985 |
Utilized off-label for angina and arrhythmias |
| Beta-blockers |
Antianginal, antihypertensive |
40% |
1960s |
Widely prescribed first-line agents |
| Calcium channel blockers |
Vasodilators |
15% |
1980s |
Used alone or with other agents |
| Ranolazine |
Anti-anginal |
10% |
2006 |
Targets chronic angina with fewer side effects |
Regulatory & Reimbursement Factors
- Patent protection period expired in 2020, opening the market to generic versions.
- Current reimbursement policies favor long-term use, with Medicare and private insurers covering Ranexa at standard rates.
- Price regulation in the U.S. limits wholesale price increases, though branded versions often carry higher retail prices than generics.
Price Trends and Projections
Current Pricing
- Brand-name Ranexa (2015-2023): Average retail price per 30-tablet box (500 mg) approximately $340.
- Generic Ranolazine (post-2020): Retail price approximately $120-150, 55-65% lower than brand-name.
Historical Price Movements
| Year |
Brand-Name Price (per 30 tablets, 500 mg) |
Generic Price (per 30 tablets, 500 mg) |
| 2015 |
$340 |
N/A |
| 2018 |
$340 |
N/A |
| 2020 |
$330 |
$120 |
| 2022 |
$340 |
$130 |
| 2023 |
$340 |
$140 |
Future Price Projections
- The expiration of patent protection in 2020 has led to significant price declines of up to 55-65% for generics.
- Competition among generic manufacturers is expected to keep prices within the $120-150 range over the next 3-5 years.
- Slow adoption of biosimilars or formulations with improved delivery could influence future pricing.
Revenue Implications
- Prescriber shift toward generics may limit revenue growth for branded Ranexa.
- Patents on specific formulations or delivery methods could sustain premium pricing, but no such patents for Ranolazine are currently active.
Market Growth Drivers & Risks
Drivers
- Aging populations increasing prevalence of chronic angina.
- Availability of generic options reducing treatment costs.
- Safety profile favorable compared to older anti-arrhythmics.
Risks
- Competition from newer, potentially more effective therapies.
- Payor pressure to favor generics.
- Potential regulatory restrictions on off-label uses.
Strategic Outlook
- The market for Ranolazine is mature, with limited upside for price increases.
- Focus shifts toward optimizing manufacturing costs, expanding indications, or developing combination therapies.
- Patent expiries have markedly decreased revenue potential for branded formulations.
Key Takeaways
- Market size: Approximately $7 billion USD globally; Ranolazine accounts for a modest segment.
- Pricing: Branded Ranexa averages $340 per 30-tablet pack; generics cost $120-150.
- Market share: Has declined in branded form post-generic entry, with generics dominating sales.
- Forecast: Price stability within current ranges expected over next 3-5 years; limited growth prospect.
- Strategic focus: Cost reduction, expansion into new indications, or innovation to sustain revenues.
FAQs
1. What is the primary therapeutic use of Ranolazine (NDC 62332-0679)?
It treats chronic angina, reducing angina episodes and improving exercise tolerance.
2. How has patent expiry affected pricing?
Patent expiry in 2020 led to a significant drop in generic prices and reduced premium revenue for the branded product.
3. What are the key competitors to Ranolazine?
Beta-blockers and calcium channel blockers dominate the market, with some use of anti-arrhythmic drugs like amiodarone.
4. What is the expected price trend for Ranolazine?
Prices for the generic form will likely remain stable around $120-150 per 30 tablets over the next 3-5 years.
5. How does market growth look?
Market growth is modest at 3-4% annually, driven by aging populations and insurable demand, but constrained by generic competition.
References
- IQVIA. "Global Angina Market Report," 2022.
- FDA. "Ranolazine (Ranexa) Approval Document," 2006.
- CMS. "Medicare Coverage and Reimbursement Policies," 2023.
