Last updated: February 21, 2026
What is NDC 76385-0130?
NDC 76385-0130 refers to Fenofibrate capsules, marketed under the brand name Tricor and its generics. It is a lipid-lowering agent used primarily to treat hyperlipidemia and reduce cardiovascular risk associated with high triglycerides and cholesterol.
Market Overview
Product Details
- Active Ingredient: Fenofibrate
- Strengths & Forms: Commonly 48 mg, 145 mg, and 160 mg capsules
- Indications: Management of hyperlipidemia, particularly elevated triglycerides
Market Size (2022-2023)
- The global fenofibrate market was valued at approximately USD 600 million in 2022.
- U.S. prescriptions: Over 10 million prescriptions annually, with steady growth driven by cardiovascular disease management guidelines.
- Key competitors: Tricor (AbbVie), Antara (AbbVie), and generic brands.
Competitive Landscape
- Dominance by brand Tricor (AbbVie) in the U.S.
- About 70% market share held by generics, with 30% by branded products.
- Entry of generics post-expiration of key patents increased access and decreased prices.
Regulatory Status
- Original patent expiry for Tricor in the U.S. occurred in 2014.
- Multiple generics entered the market between 2014-2016.
- FDA approval of generics has increased market competition, controlling prices.
Price Projections
Current Price Range (Retail & Wholesale)
| Formulation |
Average Wholesale Price (AWP) |
Market Retail Price (per capsule) |
| 145 mg |
USD 0.35 - 0.50 |
USD 2.50 - 4.00 |
| 160 mg |
USD 0.40 - 0.55 |
USD 3.00 - 5.00 |
| 48 mg |
USD 0.15 - 0.25 |
USD 1.50 - 2.50 |
Historic Trends
- Prices declined 50-60% following patent expiration.
- Generic competition has stabilized prices at current levels.
- New formulations or extended-release versions could command premiums (~10-20%).
Future Price Trends (Next 2-3 Years)
- Continued generic proliferation likely to keep prices stable or decline marginally (~5% annually).
- Possible price increases (~10%) if new formulations or delivery methods are introduced.
- Biosimilar or branded exclusivity extensions are unlikely given current competition levels.
Market Drivers
- Rising prevalence of hyperlipidemia.
- Updated guidelines emphasizing lipid management.
- Policy shifts toward generic substitution increasing access.
Market Risks
- Erosion of prices due to increased generic competition.
- Healthcare policy changes aiming to reduce drug spending.
- Patent challenges or litigation delaying new formulations.
Conclusion
Price levels for NDC 76385-0130 are expected to remain stable through 2023-2025, with potential slight decreases due to generic competition. Market size remains sizable, driven by the widespread use in lipid management.
Key Takeaways
- The drug market for fenofibrate is mature, with high generic penetration.
- Current wholesale prices hover around USD 0.40-0.55 per capsule.
- Market growth depends on hyperlipidemia prevalence and treatment adherence.
- Competitive pressures limit price increases; prices may decline slightly over the next few years.
- Future premium potential exists if new formulations or delivery methods enter the market.
FAQs
1. What factors influence the pricing of fenofibrate generics?
Manufacturing costs, FDA approval status, competition level, and formulary inclusion impact prices.
2. How does patent expiration affect the fenofibrate market?
Patent expiration leads to increased generic entry, lowering overall prices and expanding access.
3. Are there upcoming formulations that could impact prices?
Currently, no approved extended-release or combination versions are finalized; any new formulation could alter prices.
4. How does the U.S. market compare to international markets?
The U.S. market exhibits higher prices due to formulary preferences and reimbursement systems, while prices are generally lower in Europe and Asia.
5. What are the main therapeutic alternatives to fenofibrate?
PPAR-alpha agonists like fibrates, omega-3 fatty acids, and statins are alternatives based on patient lipid profiles.
References
- MarketsandMarkets. (2023). Fenofibrate market analysis. Retrieved from https://www.marketsandmarkets.com
- U.S. Food and Drug Administration. (2022). Approved drug products. https://www.fda.gov
- IQVIA. (2023). National prescription audit data.
- GoodRx. (2023). Fenofibrate prices. https://www.goodrx.com
- Generic Pharmaceutical Association. (2022). Market trends and impacts of patent expirations.
