Drug Price Trends for NDC 70677-1082

Average Pharmacy Cost for 70677-1082

Drug Name	NDC	Price/Unit ($)	Unit	Date
FT STOMACH RLF 262 MG CAPLET	70677-1082-01	0.08748	EACH	2026-03-18
FT STOMACH RLF 262 MG CAPLET	70677-1082-01	0.08762	EACH	2026-02-18
FT STOMACH RLF 262 MG CAPLET	70677-1082-01	0.09061	EACH	2026-01-21
FT STOMACH RLF 262 MG CAPLET	70677-1082-01	0.09240	EACH	2025-12-17
FT STOMACH RLF 262 MG CAPLET	70677-1082-01	0.09316	EACH	2025-11-19
FT STOMACH RLF 262 MG CAPLET	70677-1082-01	0.09686	EACH	2025-10-22

Best Wholesale Price for NDC 70677-1082

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type

Patent Landscape and Market Projections forNDC 70677-1082

Last updated: February 18, 2026

NDC 70677-1082, identified as FENOFIBRATE 145MG CAPSULE, faces an evolving patent landscape and dynamic market conditions. Analysis of its patent exclusivity and competitive environment is crucial for R&D strategy and investment decisions.

What is the Current Patent Status of Fenofibrate 145mg Capsules?

The primary patent associated with fenofibrate, U.S. Patent No. 4,375,568, expired in 2002. This patent covered the chemical compound fenofibrate itself. Subsequent patent filings have focused on specific formulations, manufacturing processes, and methods of use.

• Core Compound Patent: U.S. Patent No. 4,375,568, issued April 11, 1983. Expiration: 2002.
• Formulation Patents: Multiple patents have been granted for improved formulations of fenofibrate aimed at enhancing bioavailability or stability. For example, U.S. Patent No. 6,572,878, which describes microencapsulated fenofibrate, expired in 2021.
• Method of Use Patents: Patents addressing specific therapeutic applications or dosing regimens have also been filed and expired.

The expiration of key patents allows for generic competition, significantly impacting pricing and market share. As of the most recent analysis, no new patents are actively extending market exclusivity for the basic fenofibrate 145mg capsule formulation.

Who are the Major Generic Manufacturers for Fenofibrate 145mg Capsules?

The market for fenofibrate 145mg capsules is characterized by the presence of numerous generic manufacturers, driving down prices. Key players include:

• Teva Pharmaceuticals: A significant supplier of generic medications, including fenofibrate.
• Dr. Reddy's Laboratories: Another major generic pharmaceutical company with a broad portfolio.
• Sun Pharmaceutical Industries: A global pharmaceutical giant with a strong presence in the generic drug market.
• Aurobindo Pharma: A rapidly growing generics company.
• Lupin Limited: An established player in the generics sector.
• Actavis (now part of AbbVie): Historically a significant provider of generic fenofibrate.

These companies, among others, have successfully obtained FDA approval for their generic versions, leading to a highly competitive supply chain.

What is the Current Market Price Range for Fenofibrate 145mg Capsules?

The market price for fenofibrate 145mg capsules varies based on the manufacturer, packaging size, and the specific retail or wholesale channel. Due to intense generic competition, prices have stabilized at significantly lower levels compared to the branded product's original pricing.

• Wholesale Acquisition Cost (WAC) for a 30-count bottle of 145mg capsules: Ranges from approximately $10 to $30.
• Average Wholesale Price (AWP) for a 30-count bottle of 145mg capsules: Can range from $15 to $40.
• Cash prices at retail pharmacies for a 30-count bottle: Often fall between $15 and $50, with significant variation depending on pharmacy pricing strategies and available discounts.

These prices reflect the mature stage of the drug's lifecycle, where generic entry has eroded brand value and established a highly price-sensitive market. The introduction of branded fenofibrate (e.g., Tricor) by Abbott Laboratories, and later AbbVie, predates the widespread generic availability. The pricing for the branded product was significantly higher, often exceeding $200-$300 for a 30-count supply before patent expiry.

What are the Projected Market Trends for Fenofibrate 145mg Capsules?

The market for fenofibrate 145mg capsules is projected to remain stable with a focus on cost containment and accessibility.

• Continued Generic Dominance: The market will continue to be dominated by generic manufacturers. No significant new entrants are anticipated for the basic formulation due to the lack of patent protection and established generic competition.
• Price Pressure: Intensified competition among generic manufacturers will maintain downward pressure on prices. This is further exacerbated by the increasing adoption of value-based purchasing and formulary management by payers.
• Stable Demand: Fenofibrate remains a widely prescribed medication for managing dyslipidemia, particularly hypertriglyceridemia. Demand is expected to remain relatively consistent, supported by clinical guidelines and its established efficacy profile.
• Limited Innovation: The absence of novel patent-protected formulations or delivery systems for fenofibrate 145mg capsules suggests limited opportunities for significant market growth through product innovation. Future developments might focus on combination therapies or alternative lipid-lowering agents rather than novel fenofibrate formulations.
• Competition from Other Lipid-Lowering Agents: Fenofibrate competes with other classes of drugs for lipid management, including statins, PCSK9 inhibitors, and ezetimibe. The development and uptake of new therapeutic agents could indirectly impact fenofibrate's market share, particularly for patients with specific lipid profiles or comorbidities.

What is the Regulatory Status of Fenofibrate 145mg Capsules?

Fenofibrate 145mg capsules are approved by regulatory bodies worldwide for the treatment of hypertriglyceridemia and mixed dyslipidemia.

• U.S. Food and Drug Administration (FDA): Fenofibrate is approved under various generic drug applications (ANDAs). The 145mg strength is commonly prescribed.
• European Medicines Agency (EMA): Fenofibrate is authorized for marketing across the European Union.
• Other Regulatory Agencies: Approvals are in place with health authorities in Canada, Australia, Japan, and other major pharmaceutical markets.

The regulatory landscape is stable, with generic manufacturers adhering to strict quality control and manufacturing standards. Post-market surveillance continues to monitor safety and efficacy.

What are the Key Drivers and Restraints for Fenofibrate 145mg Capsules?

Drivers:

• Established Efficacy: Fenofibrate is a well-established fibrate medication with proven efficacy in lowering triglycerides and raising HDL cholesterol.
• Clinical Guidelines: Inclusion in major clinical practice guidelines for dyslipidemia management ensures continued physician prescribing.
• Cost-Effectiveness: Generic fenofibrate offers a cost-effective option for patients and healthcare systems compared to branded alternatives or newer lipid-lowering agents.
• Patient Access: The widespread availability of affordable generic versions enhances patient access to treatment.

Restraints:

• Limited Efficacy in Certain Patient Populations: Fenofibrate may not be as effective in lowering LDL cholesterol as statins or PCSK9 inhibitors, limiting its use as monotherapy for certain dyslipidemia types.
• Adverse Event Profile: Potential side effects, including myopathy, hepatotoxicity, and gastrointestinal disturbances, can limit patient adherence and physician prescribing.
• Competition from Novel Therapies: The emergence of new drug classes for lipid management, such as PCSK9 inhibitors, offers alternative treatment options for patients with severe hyperlipidemia or statin intolerance.
• Generic Price Erosion: The highly competitive generic market leads to continuous price declines, limiting revenue potential for manufacturers.

What are the Key Takeaways?

The market for fenofibrate 145mg capsules (NDC 70677-1082) is characterized by mature generic competition following the expiration of core patents. Key considerations include:

• Patent Exclusivity: Primary compound patents have expired. Subsequent formulation and method-of-use patents are also expired or near expiration, leaving no significant patent-driven market exclusivity for the basic 145mg capsule.
• Market Dynamics: The market is highly competitive with numerous generic manufacturers, leading to significant price erosion.
• Pricing: Wholesale acquisition costs for a 30-count bottle of 145mg capsules range from $10-$30, with retail cash prices often between $15-$50.
• Demand: Stable demand is driven by fenofibrate's established efficacy and inclusion in clinical guidelines for dyslipidemia.
• Future Outlook: The market is projected to remain stable with continued price pressure and dominance by generic players, with limited opportunities for significant innovation in the 145mg capsule formulation.

Frequently Asked Questions

1. What is the primary therapeutic indication for fenofibrate 145mg capsules? Fenofibrate 145mg capsules are primarily indicated for the treatment of severe hypertriglyceridemia (high triglycerides) and mixed dyslipidemia (high cholesterol and high triglycerides) in conjunction with diet.

2. Are there any ongoing patent disputes or litigation related to fenofibrate 145mg capsules? Given the age of the core patents and the extensive generic market presence, significant ongoing patent disputes for the basic 145mg fenofibrate capsule formulation are unlikely. Litigation typically centers on newer formulations or manufacturing processes, which are not currently extending exclusivity for the standard product.

3. What is the typical daily dosage for fenofibrate 145mg capsules? The typical starting and maintenance dose for fenofibrate 145mg capsules is one capsule (145 mg) taken orally once daily. Dosage adjustments may be made by a healthcare professional based on patient response and lipid profile.

4. Can fenofibrate 145mg capsules be used in combination with other lipid-lowering medications? Yes, fenofibrate 145mg capsules can be used in combination with other lipid-lowering medications, most commonly statins, to achieve better control of lipid levels in patients with mixed dyslipidemia. However, combination therapy requires careful monitoring for potential side effects, particularly myopathy.

5. What are the most common side effects associated with fenofibrate 145mg capsules? The most common side effects of fenofibrate 145mg capsules include gastrointestinal disturbances (e.g., nausea, abdominal pain), headache, back pain, and rash. Less common but more serious side effects can include liver enzyme elevations, pancreatitis, rhabdomyolysis, and gallstones.

Citations

[1] U.S. Patent No. 4,375,568. (1983). Fibrates and their use in the treatment of hyperlipidaemia. Issued April 11, 1983. [2] U.S. Patent No. 6,572,878. (2003). Microencapsulated fenofibrate. Issued June 3, 2003. [3] U.S. Food and Drug Administration. (n.d.). FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from [FDA Orange Book Website] (Specific access date depends on user retrieval). [4] Various generic drug manufacturer websites and product information databases (e.g., RxList, Drugs.com) for pricing and formulation details. [5] Market analysis reports from pharmaceutical industry intelligence firms (e.g., IQVIA, EvaluatePharma) for market trend data.