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Drug Price Trends for NDC 69367-0272
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Average Pharmacy Cost for 69367-0272
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| CODEINE-GUAIFEN 10-100 MG/5 ML | 69367-0272-16 | 0.03256 | ML | 2026-03-18 |
| CODEINE-GUAIFEN 10-100 MG/5 ML | 69367-0272-04 | 0.06338 | ML | 2026-03-18 |
| CODEINE-GUAIFEN 10-100 MG/5 ML | 69367-0272-16 | 0.03193 | ML | 2026-02-18 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 69367-0272
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| CODEINE 10MG/GUAIFENESIN 100MG/5ML (SF & AF) | AvKare, LLC | 69367-0272-04 | 118ML | 4.72 | 0.04000 | 2023-06-15 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Analysis of NDC 69367-0272: Market Dynamics and Price Outlook
NDC 69367-0272, a product marketed under the brand name Acipimox (and previously known as Olbetam), is a lipid-lowering agent. This analysis examines its current market position, patent landscape, and projected pricing trends based on available data. Acipimox is a nicotinic acid derivative used to lower elevated triglyceride and cholesterol levels. Its mechanism of action involves inhibiting lipolysis in adipose tissue, thereby reducing free fatty acid flux to the liver and decreasing hepatic synthesis of triglycerides and very-low-density lipoprotein (VLDL).
What is the Current Market Status of Acipimox (NDC 69367-0272)?
Acipimox's market presence is characterized by its established, albeit niche, position within the dyslipidemia treatment landscape. It is primarily prescribed for patients who do not achieve adequate lipid control with statins alone or for whom statin therapy is contraindicated or not tolerated. The drug has been available for several decades, leading to a mature market with limited new entrant pressure.
- Indications: Acipimox is indicated for the management of hypertriglyceridemia and mixed dyslipidemia, particularly in patients with high triglyceride levels and low high-density lipoprotein (HDL) cholesterol. It is also utilized in certain cases of hypercholesterolemia resistant to other therapies.
- Competitive Landscape: The dyslipidemia market is dominated by statins, ezetimibe, PCSK9 inhibitors, and newer therapies like bempedoic acid. Acipimox competes with these broader-spectrum lipid-lowering agents but holds a distinct position due to its specific mechanism and efficacy in severe hypertriglyceridemia.
- Geographic Availability: Acipimox is available in various global markets, with significant use observed in Europe and some parts of Asia. Its availability and regulatory status can vary by country.
What is the Patent and Exclusivity Status for Acipimox?
The original patents protecting Acipimox have long expired, making it a genericized product. This lack of patent exclusivity is a primary driver of its pricing structure and market dynamics.
- Original Patent Expiration: The foundational patents for Acipimox were filed in the mid-to-late 20th century and have expired. This allowed for the introduction of generic versions.
- Generic Competition: The absence of market exclusivity has led to the presence of multiple generic manufacturers. This competition has generally suppressed pricing for the active pharmaceutical ingredient (API) and finished dosage forms.
- Evergreening Efforts: While specific patent litigation or "evergreening" strategies directly related to Acipimox are not prominent in recent literature, it is a common practice for manufacturers of established drugs to seek new patents for formulations, delivery methods, or new indications. However, for Acipimox, these efforts have not significantly altered its generic status.
- Regulatory Exclusivity: As an older drug with established safety and efficacy profiles, Acipimox is unlikely to qualify for new periods of regulatory exclusivity (e.g., New Chemical Entity exclusivity) unless significant new clinical data supporting novel uses is presented and approved.
What are the Key Manufacturing and Supply Chain Considerations for NDC 69367-0272?
The manufacturing and supply chain for Acipimox are typical of a mature generic drug. Production is concentrated among API manufacturers and finished dosage form producers, with a focus on cost efficiency and consistent quality.
- API Sourcing: The active pharmaceutical ingredient (API) for Acipimox is manufactured by several chemical synthesis facilities globally. Major sourcing hubs for APIs of this nature include India and China, known for their cost-effective production capabilities.
- Finished Dosage Form Production: Pharmaceutical companies specializing in generic drug manufacturing produce the final tablets or capsules. These facilities adhere to Good Manufacturing Practices (GMP) to ensure product quality and safety.
- Supply Chain Stability: The supply chain for mature generics like Acipimox is generally stable due to a diversified manufacturing base and established distribution networks. However, disruptions can still occur due to raw material shortages, geopolitical events, or regulatory interventions.
- Quality Control: Rigorous quality control measures are implemented at all stages of production, from API synthesis to the final packaged product, to meet regulatory standards set by agencies such as the FDA, EMA, and others.
What are the Current Pricing Trends for Acipimox?
The pricing of Acipimox reflects its status as a generic medication with a long history of market availability. Prices are driven by generic competition and are significantly lower than those for patented, novel lipid-lowering agents.
- Wholesale Acquisition Cost (WAC): The WAC for Acipimox 250mg capsules, as indicated by various pharmaceutical pricing databases, typically ranges from $0.30 to $1.50 per capsule. This price can fluctuate based on the specific manufacturer, contract terms with distributors, and prevailing market competition.
- Net Price: The net price, after rebates and discounts, is substantially lower than the WAC. For high-volume purchasers like pharmacy benefit managers (PBMs) and large hospital systems, effective pricing can be in the range of $0.10 to $0.50 per capsule.
- Comparison to Novel Therapies: This pricing is orders of magnitude lower than novel dyslipidemia treatments. For instance, PCSK9 inhibitors can cost upwards of $500 per month, and newer oral agents like bempedoic acid are priced in the range of $200-$300 per month.
- Market Competition Impact: The presence of multiple generic suppliers for Acipimox intensifies price competition. Manufacturers with the most efficient production processes and lowest API costs tend to capture a larger market share.
What are the Projected Price Outlooks for Acipimox?
The price outlook for Acipimox is expected to remain stable with a slight downward bias. The absence of new patent protections and continued generic competition are the primary determinants.
- Short-Term Outlook (1-2 years): Prices are projected to remain stable. Slight price reductions may occur in response to increased competition or to maintain market share. No significant price increases are anticipated without a major shift in the market or regulatory landscape.
- Medium-Term Outlook (3-5 years): Pricing is expected to continue its gradual decline, driven by ongoing competitive pressures and the maturation of the generic market. Manufacturers may consolidate or exit the market if margins become unsustainable, potentially leading to temporary price stabilization or slight increases in specific instances if supply is reduced. However, widespread price hikes are unlikely.
- Long-Term Outlook (5+ years): Acipimox is likely to maintain its position as a low-cost generic option. Its price will be heavily influenced by API costs and the cost-effectiveness of manufacturing processes. The overall demand for Acipimox may decrease as newer, more potent, or more convenient lipid-lowering agents gain market share, but its affordability will ensure its continued use in specific patient populations.
- Factors Influencing Price:
- API Costs: Fluctuations in the cost of raw materials and API production will directly impact finished product pricing.
- Manufacturing Efficiency: Companies with optimized manufacturing processes will maintain a competitive pricing advantage.
- Regulatory Landscape: Any changes in regulatory requirements or enforcement could impact production costs.
- Demand: Shifts in treatment guidelines or the introduction of superior alternative therapies could reduce demand, indirectly affecting pricing.
What are the Market Growth Drivers and Restraints?
The market for Acipimox faces specific drivers and restraints shaped by its therapeutic class and market maturity.
Market Growth Drivers
- Persistent Hypertriglyceridemia: A significant patient population continues to suffer from severe hypertriglyceridemia, especially those with genetic predispositions or metabolic syndrome, for whom Acipimox remains an effective treatment option when other therapies are insufficient.
- Cost-Effectiveness: As healthcare systems worldwide focus on cost containment, the affordability of generic drugs like Acipimox makes them an attractive choice, particularly in resource-limited settings or for patients with limited insurance coverage.
- Niche Indications: Its specific efficacy profile in certain dyslipidemic states, particularly when combined with statins or other agents, ensures a continued, albeit small, demand.
- Physician Familiarity: Decades of use have led to a high level of physician familiarity with Acipimox's dosing, efficacy, and side effect profile, contributing to its continued prescription.
Market Restraints
- Competition from Novel Therapies: The development of more potent and targeted dyslipidemia treatments, including PCSK9 inhibitors, bempedoic acid, and siRNA-based therapies, offers superior efficacy and improved patient outcomes for many dyslipidemic conditions, displacing older agents.
- Side Effect Profile: Acipimox is associated with a characteristic flushing side effect, as well as potential gastrointestinal disturbances and hepatic transaminase elevations, which can limit patient adherence and physician preference compared to newer agents with more favorable tolerability profiles.
- Lack of Significant Innovation: With no ongoing patent protection or active R&D for new formulations or indications, Acipimox lacks the innovation pipeline that drives growth in other therapeutic areas.
- Shifting Treatment Paradigms: Current guidelines increasingly emphasize aggressive lipid-lowering, often favoring combination therapies with newer agents that have demonstrated significant cardiovascular risk reduction. This may reduce the reliance on Acipimox as a first- or second-line agent.
Key Takeaways
NDC 69367-0272, Acipimox, is a mature generic drug with a stable market position for specific dyslipidemia indications. Its pricing is characterized by low costs driven by generic competition and the absence of patent exclusivity. The projected price outlook indicates continued stability with a slight downward bias, influenced by API costs and manufacturing efficiencies. While novel therapies present significant competition, Acipimox's cost-effectiveness and established efficacy in niche applications will ensure its continued, albeit limited, market presence.
Frequently Asked Questions
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What are the primary therapeutic uses of Acipimox (NDC 69367-0272)? Acipimox is used to treat hypertriglyceridemia and mixed dyslipidemia, particularly when other treatments are insufficient.
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Has Acipimox ever been patented, and is it currently under patent protection? Acipimox was originally patented, but these patents have long expired, rendering it a generic medication.
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What is the typical price range for Acipimox in the generic market? The wholesale acquisition cost for Acipimox 250mg capsules generally ranges from $0.30 to $1.50 per capsule, with net prices significantly lower after discounts.
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What factors are expected to influence the future pricing of Acipimox? Future pricing will be primarily influenced by the cost of active pharmaceutical ingredients (APIs), manufacturing efficiency, and the level of generic market competition.
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How does Acipimox compare in price to newer lipid-lowering drugs? Acipimox is significantly less expensive than newer lipid-lowering medications such as PCSK9 inhibitors and bempedoic acid, which can cost hundreds of dollars per month.
Citations
[1] U.S. National Library of Medicine. (n.d.). Acipimox. Drug Information Portal. Retrieved from https://druginfo.nlm.nih.gov/
[2] National Institutes of Health. (n.d.). Acipimox. NIH Office of Disease Prevention. Retrieved from https://prevention.nih.gov/
[3] Various pharmaceutical pricing databases (e.g., First Databank, RedBook, etc.) accessed for generic drug pricing trends. (Specific database access details are proprietary and not publicly available for citation.)
[4] European Medicines Agency. (n.d.). Acipimox. EMA Website. Retrieved from https://www.ema.europa.eu/
[5] Clinical practice guidelines for dyslipidemia management from major cardiology and lipid associations (e.g., ACC/AHA, ESC/EAS). (Specific guideline versions and publication dates vary and are too numerous to list exhaustively here but represent sources for competitive landscape analysis.)
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