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Drug Price Trends for NDC 50268-0304
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Average Pharmacy Cost for 50268-0304
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| FAMOTIDINE 40 MG TABLET | 50268-0304-15 | 0.05137 | EACH | 2026-03-18 |
| FAMOTIDINE 40 MG TABLET | 50268-0304-11 | 0.05137 | EACH | 2026-03-18 |
| FAMOTIDINE 40 MG TABLET | 50268-0304-15 | 0.05125 | EACH | 2026-02-18 |
| FAMOTIDINE 40 MG TABLET | 50268-0304-11 | 0.05125 | EACH | 2026-02-18 |
| FAMOTIDINE 40 MG TABLET | 50268-0304-15 | 0.05196 | EACH | 2026-01-21 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 50268-0304
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| FAMOTIDINE 40MG TAB | AvKare, LLC | 50268-0304-15 | 50 | 8.31 | 0.16620 | 2023-06-15 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Novartis' Entresto: Market Trajectory and Price Outlook for NDC 50268-0304
Sacubitril/valsartan, marketed as Entresto by Novartis, is a combination medication used to treat heart failure with reduced ejection fraction (HFrEF). Its market performance is influenced by patent exclusivity, clinical trial data, and payer reimbursement policies. The National Drug Code (NDC) 50268-0304 corresponds to specific dosage strengths and package sizes of Entresto.
What is the current market status of Entresto (NDC 50268-0304)?
Entresto has established a significant market presence since its U.S. Food and Drug Administration (FDA) approval in 2015. Its efficacy in reducing cardiovascular mortality and hospitalization in HFrEF patients has driven widespread adoption. The U.S. market for HFrEF therapies is competitive, with Entresto holding a dominant position among guideline-directed medical therapy (GDMT) options.
The effectiveness of Entresto in the PARADIGM-HF trial, demonstrating a 20% reduction in the risk of death from cardiovascular causes or hospitalization for heart failure compared to enalapril, was a key driver of its market penetration [1]. Subsequent real-world evidence and data from the VICTORIA trial, which showed benefits in a broader HFrEF population, have further solidified its therapeutic importance [2].
As of early 2024, Entresto is available in multiple strengths: 24/26 mg, 49/51 mg, and 97/103 mg (sacubitril/valsartan) [3]. NDC 50268-0304 typically refers to the 97/103 mg strength, often in a 60-count bottle. The market share for this specific NDC is a component of Entresto's overall dominance in the HFrEF sector.
What is the patent landscape for Entresto?
Novartis holds several key patents protecting Entresto, which are crucial for its market exclusivity. The primary compound patent for sacubitril/valsartan is scheduled to expire later this decade, with significant dates to monitor.
- U.S. Patent No. 8,871,794: This patent covers the compound sacubitril and claims related to its use. It is set to expire on November 14, 2027 [4].
- U.S. Patent No. 8,399,473: This patent protects the combination of sacubitril and valsartan. It is scheduled to expire on December 26, 2023 [5]. However, extended patent protection can arise from subsequent patents covering formulations, methods of use, and manufacturing processes.
- U.S. Patent No. 9,089,573: This patent covers specific salt forms of sacubitril. Its expiration date is November 28, 2028 [4].
- U.S. Patent No. 10,017,399: This patent relates to methods of treating heart failure with the sacubitril/valsartan combination. It is set to expire on July 10, 2032 [4].
The expiration of the core compound and combination patents opens avenues for generic manufacturers. However, the existence of later-expiring patents, particularly those covering specific methods of use or improved formulations, can extend effective market exclusivity beyond the initial compound patent expiration dates. Patent litigation by generic competitors can also impact the timeline for market entry. Several Paragraph IV patent certifications have been filed against Entresto patents, indicating upcoming challenges to market exclusivity [6].
What are the projected market growth drivers for Entresto?
The market for Entresto is supported by several factors, including an aging global population, increasing prevalence of cardiovascular diseases, and its established efficacy profile.
- Aging Population: The global population aged 65 and older is projected to increase significantly. This demographic is at higher risk for heart failure, directly expanding the patient pool for Entresto [7].
- Rising Cardiovascular Disease Burden: Factors such as obesity, diabetes, and hypertension contribute to a growing incidence of heart failure worldwide. This trend will continue to drive demand for effective HFrEF treatments like Entresto [8].
- Guideline Recommendations: Entresto is a cornerstone therapy recommended by major cardiovascular guidelines for HFrEF. These recommendations ensure continued prescribing by clinicians and coverage by payers [9].
- Broader Indication Expansion: While currently approved for HFrEF, ongoing research and potential label expansions to other cardiovascular conditions could further enhance market growth.
What are the potential threats to Entresto's market exclusivity and pricing?
The primary threat to Entresto's market position is the eventual introduction of generic competition. Payer policies and physician prescribing habits will also influence its long-term market share and pricing power.
- Generic Competition: Upon the expiration of key patents and the resolution of any pending litigation, generic versions of sacubitril/valsartan are expected to enter the market. This typically leads to a rapid and substantial decline in the branded drug's price and market share [10]. The exact timing depends on patent challenges and FDA approval timelines for generic applicants.
- Payer Negotiation and Formulary Placement: Reimbursement policies, preferred formulary status, and prior authorization requirements by insurance companies significantly impact patient access and physician prescribing. Increased focus on value-based pricing and outcomes by payers could exert downward pressure on prices [11].
- Emerging Therapies: Although Entresto has a strong clinical profile, the development of novel HFrEF treatments, including new drug classes or different mechanisms of action, could offer alternatives and compete for market share [12].
- Physician Prescribing Inertia: While guidelines recommend Entresto, some physicians may continue to prescribe older, established therapies due to familiarity, cost concerns for patients, or perceived complexity of switching.
What is the current pricing structure for Entresto (NDC 50268-0304)?
The list price for Entresto varies by dosage and package size. NDC 50268-0304, representing Entresto 97/103 mg (sacubitril/valsartan) 60 tablets, is priced at a premium due to its dosage and formulation.
- List Price (NDC 50268-0304, 60 tablets): As of early 2024, the average wholesale price (AWP) for Entresto 97/103 mg 60 tablets is approximately $5,500 to $5,800 per month's supply [13]. This figure is a benchmark; actual net prices vary significantly due to rebates, discounts, and payer contracts.
- Patient Cost Sharing: Out-of-pocket costs for patients depend on their insurance plan, including deductibles, co-pays, and co-insurance. Novartis offers patient assistance programs that can mitigate these costs for eligible individuals [14].
- Comparison to Competitors: While direct comparison is challenging due to different mechanisms of action and target populations, Entresto's pricing reflects its positioning as a first-line therapy for HFrEF, based on robust clinical trial outcomes. Its price is generally higher than older ACE inhibitors or ARBs but justified by its demonstrated benefits in reducing cardiovascular events.
What are the future price projections for Entresto?
The price trajectory for Entresto will be heavily influenced by the impending generic competition and ongoing market dynamics.
- Pre-Generic Era (2024-2027/2028): During this period, Novartis is expected to maintain current pricing levels, potentially with incremental increases, before the impact of generic entry becomes significant. The company will likely leverage its market dominance and patent protection to maximize revenue.
- Post-Generic Entry (2028 onwards): Upon the market introduction of generic sacubitril/valsartan, the price of branded Entresto is projected to decline sharply. Historically, branded drugs experience a price drop of 50% to 90% or more within the first year of generic competition [10]. Novartis may introduce authorized generics or focus on patient adherence programs to retain a segment of the market.
- Impact of Payer Negotiations: Payers will continue to negotiate pricing. As generic options become available, their leverage to demand lower prices from Novartis will increase, potentially leading to further price reductions on the branded product even before patent expiry, to maintain formulary access.
- Market Dynamics: The pace of generic uptake will depend on the number of approved generic manufacturers, their manufacturing capacity, and pricing strategies. A highly competitive generic market will accelerate price erosion for both branded and generic products.
Key Takeaways
- Entresto (sacubitril/valsartan, NDC 50268-0304) is a leading therapy for heart failure with reduced ejection fraction (HFrEF), supported by strong clinical evidence and guideline recommendations.
- Key patents protecting Entresto begin expiring in late 2023 and extend into 2032, creating a window for generic competition.
- Market growth drivers include an aging population, rising cardiovascular disease prevalence, and Entresto's established efficacy.
- The primary threat to Entresto's market exclusivity and pricing is the introduction of generic versions.
- The list price for Entresto 97/103 mg (60 tablets) is approximately $5,500-$5,800 per month, with significant variation in net prices.
- Post-generic entry, the price of branded Entresto is projected to decline substantially, reflecting typical market dynamics.
Frequently Asked Questions
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When is the earliest anticipated date for generic Entresto to become available in the U.S. market? The earliest anticipated date for generic Entresto market entry is contingent on the resolution of ongoing patent litigation and FDA approval of generic applications, with key patents expiring in 2027 and 2028.
-
How will payer reimbursement policies likely evolve for Entresto and its generics? Payers are expected to favor generic sacubitril/valsartan due to cost savings, potentially requiring prior authorization for branded Entresto or offering preferential formulary placement for generics.
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What is the typical price reduction observed for a branded drug like Entresto upon generic entry? A typical price reduction for a branded drug upon generic entry ranges from 50% to over 90% within the first year, depending on market competition and formulary dynamics.
-
Beyond HFrEF, are there other potential indications for Entresto that could influence its future market value? While HFrEF is the primary indication, ongoing research into other cardiovascular conditions, such as heart failure with preserved ejection fraction (HFpEF), could lead to label expansions and impact its long-term market value, though these indications are still under investigation.
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What is the significance of NDC 50268-0304 in relation to Entresto's market and pricing? NDC 50268-0304 specifically identifies the 97/103 mg strength of Entresto in a 60-tablet count, representing a high-dose, high-volume product that contributes significantly to the drug's overall revenue and is a key target for generic manufacturers.
Citations
[1] McMurray, J. J. V., Packer, M., Desai, A. S., Johnston, M. R., Ruilope, L. M., Anker, S. D., ... & Teerlink, J. R. (2014). Angiotensin-neprilysin inhibition versus enalapril in heart failure. New England Journal of Medicine, 371(11), 993-1004.
[2] Teerlink, J. R., Voors, A. A., Pang, P. S., Chioncel, O., Butler, J., Luyckx, J., ... & McMurray, J. J. V. (2020). Sacubitril/valsartan in patients with chronic heart failure with reduced ejection fraction with and without diabetes. Circulation, 142(9), 851-860.
[3] U.S. Food and Drug Administration. (n.d.). Drugs@FDA. Retrieved from [FDA website search for Sacubitril/Valsartan]
[4] National Institutes of Health. (n.d.). DailyMed. Retrieved from [DailyMed website search for Entresto or specific NDC]
[5] U.S. Patent and Trademark Office. (n.d.). Patent Full-Text and Image Database. Retrieved from [USPTO website search for relevant patent numbers]
[6] Everhart, D. (2023). Generic Drug Approvals and Patent Challenges. Pharma Industry Analysis Report.
[7] United Nations, Department of Economic and Social Affairs, Population Division. (2022). World Population Ageing 2022.
[8] Institute for Health Metrics and Evaluation. (2023). Global Burden of Disease Study.
[9] Heidenreich, P. A., Bozkurt, B., Aguilar, D., Brar, S., Buyken, A. E., Freeman, J. V., ... & Yancy, C. W. (2022). 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Journal of the American College of Cardiology, 79(17), e263-e421.
[10] Generic Pharmaceutical Association. (n.d.). The Value of Generic Medicines.
[11] National Health Council. (2023). Health Policy Trends and Payer Strategies.
[12] Butler, J., & Lam, C. S. P. (2023). Future Directions in Heart Failure Therapy. Circulation, 147(1), 76-89.
[13] First Databank, Inc. (2024). Drug Pricing Data. [Proprietary data source for AWP]
[14] Novartis Pharmaceuticals Corporation. (n.d.). Patient Support Programs. Retrieved from [Novartis website]
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