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Last Updated: January 6, 2025

SACUBITRIL AND VALSARTAN Drug Patent Profile


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Which patents cover Sacubitril And Valsartan, and when can generic versions of Sacubitril And Valsartan launch?

Sacubitril And Valsartan is a drug marketed by Alembic, Alkem Labs Ltd, Biocon Pharma, Crystal, Laurus, Macleods Pharms Ltd, MSN, Torrent, and Zydus Pharms. and is included in nine NDAs.

The generic ingredient in SACUBITRIL AND VALSARTAN is sacubitril; valsartan. There are eleven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the sacubitril; valsartan profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Sacubitril And Valsartan

A generic version of SACUBITRIL AND VALSARTAN was approved as sacubitril; valsartan by ALEMBIC on May 28th, 2024.

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Summary for SACUBITRIL AND VALSARTAN
Drug patent expirations by year for SACUBITRIL AND VALSARTAN
Recent Clinical Trials for SACUBITRIL AND VALSARTAN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Dr. Reddy's Laboratories (Thailand) LimitedPhase 1
Universidade do PortoPhase 4
Unidade de Investigação e Desenvolvimento Cardiovascular (UnIC)Phase 4

See all SACUBITRIL AND VALSARTAN clinical trials

Pharmacology for SACUBITRIL AND VALSARTAN

US Patents and Regulatory Information for SACUBITRIL AND VALSARTAN

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Torrent SACUBITRIL AND VALSARTAN sacubitril; valsartan TABLET;ORAL 213604-003 Aug 22, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Crystal SACUBITRIL AND VALSARTAN sacubitril; valsartan TABLET;ORAL 213605-003 May 28, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Biocon Pharma SACUBITRIL AND VALSARTAN sacubitril; valsartan TABLET;ORAL 213680-001 Aug 30, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Alembic SACUBITRIL AND VALSARTAN sacubitril; valsartan TABLET;ORAL 213682-001 May 28, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Macleods Pharms Ltd SACUBITRIL AND VALSARTAN sacubitril; valsartan TABLET;ORAL 213728-003 Oct 16, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Msn SACUBITRIL AND VALSARTAN sacubitril; valsartan TABLET;ORAL 213748-002 Jul 24, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Alkem Labs Ltd SACUBITRIL AND VALSARTAN sacubitril; valsartan TABLET;ORAL 213764-001 Sep 16, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 7 of 7 entries

SACUBITRIL AND VALSARTAN Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Sacubitril/Valsartan

Introduction

Sacubitril/valsartan, a combination drug used to treat heart failure with reduced ejection fraction (HFrEF), has been a subject of extensive economic and clinical evaluation. This article delves into the market dynamics and financial trajectory of this drug, highlighting its cost-effectiveness, economic benefits, and the impact on healthcare systems.

Clinical Efficacy and Safety

The efficacy and safety of sacubitril/valsartan have been well-established through several clinical trials, including the PARADIGM-HF and PIONEER-HF trials. These studies demonstrated significant reductions in mortality and hospitalization rates among patients with HFrEF, setting a strong foundation for its economic evaluation[1][2][4].

Economic Evaluation

Cost-Effectiveness Analysis

The cost-effectiveness of sacubitril/valsartan has been evaluated in various studies. A key finding is that the drug provides high economic value for patients with ejection fractions (EF) ≤50% and intermediate economic value for those with EF ≤60%. The incremental cost-effectiveness ratio (ICER) ranges from $56,786 to $127,172 per quality-adjusted life-year (QALY) gained, depending on the EF range[2][4].

Lifetime Health Care Costs

Studies have shown that sacubitril/valsartan, compared to renin-angiotensin system (RAS) inhibitors like enalapril, results in higher lifetime costs but also yields more QALYs. For instance, the lifetime cost of sacubitril/valsartan was estimated at $143,317 compared to $102,425 for RAS inhibitors, with an ICER of $76,852 per QALY gained[2].

Hospitalization and Health Care Utilization

Initiating sacubitril/valsartan during hospitalization has been found to be cost-saving compared to initiation after hospitalization or continuing enalapril. This approach reduces lifetime HF-related admissions and results in significant economic benefits, including estimated individual yearly savings of $449 and 5-year savings of $2550 compared to enalapril[1].

Market Dynamics

Increasing Prescription Trends

The use of sacubitril/valsartan has seen a significant increase in recent years. Between 2016 and 2017, the number of Medicare beneficiaries prescribed sacubitril/valsartan increased by 156%, and the number of prescriptions rose by 217%. This trend is attributed to its integration into clinical guidelines and the observed decline in out-of-pocket costs for patients as Medicare formularies added it as a preferred agent[3].

Spending and Utilization

Medicare and Medicaid spending on sacubitril/valsartan has increased substantially. In 2017, Medicare Part D spent $227 million on sacubitril/valsartan, a 241% increase from 2016. Medicaid spending also saw a 251% increase, totaling $29 million for 1.7 million prescription fills[3].

Financial Trajectory

Annual Costs and Savings

The annual cost of sacubitril/valsartan is approximately $10,242, which places it in the category of intermediate economic value. However, sensitivity analyses indicate that reducing the drug's cost could make it cost-saving or highly cost-effective. For example, at a cost of $338 annually, sacubitril/valsartan would be cost-saving, and at $3,673 annually, it would meet the threshold for high economic value[2].

Impact on Healthcare Systems

The economic benefits of sacubitril/valsartan extend beyond individual patient costs. By reducing hospitalizations and improving quality of life, the drug can lead to significant savings for healthcare systems. A study found that initiating sacubitril/valsartan during hospitalization could result in 44% fewer admissions over a lifetime compared to enalapril, leading to substantial cost savings[1].

Quality of Life and Productivity Gains

Quality-Adjusted Life-Years (QALYs)

Sacubitril/valsartan not only extends life but also improves its quality. Studies have used the Euro-QoL EQ-5D score to measure quality of life, showing that patients treated with sacubitril/valsartan experience better health outcomes compared to those on enalapril[1].

Productivity Gains

From a societal perspective, the increased life expectancy and improved health status due to sacubitril/valsartan translate into productivity gains. These gains, along with reduced healthcare costs, contribute to the overall economic benefit of the drug[1].

Challenges and Considerations

Cost and Affordability

Despite its economic value, the adoption of sacubitril/valsartan has been slower due to its higher cost compared to traditional therapies like enalapril. The wholesale acquisition cost of sacubitril/valsartan is significantly higher than that of ACE inhibitors, making it a challenge for healthcare providers and patients to adhere to the treatment[5].

Policy and Coverage

Efforts to improve affordability and access are crucial. Proposals such as redesigning Medicare Part D payment structures and permitting Medicare to negotiate drug prices could help reduce the financial burden on patients and healthcare systems[3].

Key Takeaways

  • Economic Value: Sacubitril/valsartan provides high economic value for patients with EF ≤50% and intermediate economic value for those with EF ≤60%.
  • Cost Savings: Initiating the drug during hospitalization can lead to significant cost savings and reduced hospital admissions.
  • Quality of Life: The drug improves quality-adjusted life-years and overall health outcomes.
  • Market Trends: The use of sacubitril/valsartan is increasing, driven by its clinical efficacy and integration into guidelines.
  • Challenges: High costs remain a barrier to widespread adoption, necessitating policy changes to improve affordability.

FAQs

What is the cost-effectiveness of sacubitril/valsartan compared to RAS inhibitors?

Sacubitril/valsartan is cost-effective compared to RAS inhibitors, with an ICER ranging from $56,786 to $127,172 per QALY gained, depending on the ejection fraction range[2].

How does the cost of sacubitril/valsartan impact its economic value?

The cost of sacubitril/valsartan is a strong driver of its cost-effectiveness. At lower costs (e.g., $338 annually), it can be cost-saving, while at higher costs (e.g., $10,242 annually), it provides intermediate economic value[2].

What are the economic benefits of initiating sacubitril/valsartan during hospitalization?

Initiating sacubitril/valsartan during hospitalization can result in significant economic benefits, including reduced hospital admissions and cost savings of $449 per year and $2550 over five years compared to enalapril[1].

How has the use of sacubitril/valsartan changed in recent years?

The use of sacubitril/valsartan has increased significantly, with a 156% increase in Medicare beneficiaries prescribed the drug between 2016 and 2017, and a corresponding increase in spending by Medicare and Medicaid[3].

What are the challenges in adopting sacubitril/valsartan widely?

The high cost of sacubitril/valsartan compared to traditional therapies is a significant barrier to its widespread adoption, necessitating policy changes to improve affordability and access[5].

Sources

  1. Gaziano TA, Fonarow GC, Velazquez EJ, et al. Cost-effectiveness of sacubitril-valsartan in hospitalized patients who have heart failure with reduced ejection fraction. JAMA Cardiol. Published online August 12, 2020. doi:10.1001/jamacardio.2020.2822
  2. Economic Evaluation of Sacubitril/Valsartan for HF. American College of Cardiology. Published November 17, 2023.
  3. Medicare and Medicaid Utilization and Associated Spending on Sacubitril/Valsartan. JAMA Network. Published November 18, 2019.
  4. Health and Economic Evaluation of Sacubitril-Valsartan for Heart Failure. JAMA Network. Published September 27, 2023.
  5. Cost-Effectiveness of Sacubitril-Valsartan in Heart Failure. American College of Cardiology. Published April 27, 2016.

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