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Last Updated: February 20, 2025

PRALUENT Drug Profile


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Summary for Tradename: PRALUENT
Recent Clinical Trials for PRALUENT

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Sun U. KwonPhase 4
Jonathan SevranskyPhase 1
Chang Gung Memorial HospitalPhase 2

See all PRALUENT clinical trials

Pharmacology for PRALUENT
Mechanism of ActionPCSK9 Inhibitors
Established Pharmacologic ClassPCSK9 Inhibitor
Chemical StructureAntibodies, Monoclonal
Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

  1. Brand-side disclosures in response to biosimilar applications
  2. These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

  3. General brand-side disclosures
  4. These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

  5. Patents from broad patent text search
  6. For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for PRALUENT Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for PRALUENT Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for PRALUENT Derived from Patent Text Search

These patents were obtained by searching patent claims
Showing 1 to 4 of 4 entries

Market Dynamics and Financial Trajectory for the Biologic Drug: Praluent

Introduction

Praluent, a biologic drug developed by Sanofi and Regeneron, is a PCSK9 inhibitor designed to lower LDL cholesterol levels. Despite its clinical efficacy, the drug has faced significant challenges in the market. Here, we delve into the market dynamics and financial trajectory of Praluent.

Clinical Efficacy and Market Position

Praluent (alirocumab) is part of a class of drugs known as PCSK9 inhibitors, which have been shown to be highly effective in reducing LDL cholesterol. However, its market performance has been hampered by several factors, including high list prices and competition from other PCSK9 inhibitors like Amgen's Repatha[1].

Pricing Strategy and Impact

Initially, Praluent was launched with a high wholesale acquisition cost (WAC) of $14,625 per year. However, due to poor payer reimbursement and low sales, Sanofi and Regeneron reduced the list price by 60% to $5,850 per year. This move was aimed at securing better insurance coverage and reducing out-of-pocket costs for patients, particularly those on Medicare[1].

Sales Performance

Despite the price reduction, Praluent's sales have not met expectations. In the first quarter of 2019, Sanofi reported €56 million in Praluent sales, a 10% increase year-over-year, largely driven by growth in European markets. However, U.S. sales declined by 27% due to increased rebates[1].

In more recent quarters, Praluent has shown some improvement. For the first quarter of 2024, Sanofi reported a 25.5% increase in Praluent sales, driven by growth in Europe and China[4].

Competition and Market Share

Praluent faces stiff competition from Repatha, which has maintained a lead in the PCSK9 inhibitor market. According to Iqvia data, Repatha prescriptions were nearly double those of Praluent in 2019. The competitive landscape is further complicated by the emergence of new therapies, such as inclisiran from The Medicines Co., which offers a less frequent dosing regimen and potential manufacturing advantages[1].

Payer Reimbursement and Coverage

One of the significant challenges for Praluent has been securing adequate payer reimbursement. Both Sanofi and Regeneron, as well as Amgen, have struggled to convince payers to cover these high-cost drugs. The recent price reductions have helped in securing greater Medicare coverage, but the impact on overall sales is still being assessed[1].

Financial Performance

Sanofi's financial reports indicate that while Praluent sales have shown some growth, they are still a small fraction of the company's overall revenue. In the first quarter of 2024, Sanofi's total sales grew by 6.7%, driven largely by the strong performance of other drugs like Dupixent. Praluent's contribution, though increasing, remains modest compared to other products in Sanofi's portfolio[4].

Regional Performance

The performance of Praluent varies significantly across different regions. In Europe, Praluent has seen growth, offsetting the decline in U.S. sales. In China, the drug has also shown an increase in sales, contributing to the overall growth in the Rest of World segment[4].

Future Outlook

The future trajectory of Praluent depends on several factors, including continued efforts to secure better payer reimbursement, competition from new therapies, and the ability to expand its market share. Sanofi and Regeneron are optimistic about the drug's potential, especially with the new price strategy and increased Medicare coverage. However, it will take more time to assess whether these strategies will lead to sustained growth[1].

Impact of Generic Competition

The broader pharmaceutical landscape is also influenced by generic competition, which affects other Sanofi products. For instance, the loss of exclusivity for Aubagio and the introduction of generics have negatively impacted sales, highlighting the need for continuous innovation and strategic pricing[4].

Research and Development

Sanofi and Regeneron continue to invest in research and development, which is crucial for maintaining a competitive edge. The companies are exploring new indications and therapies, which could potentially offset the challenges faced by Praluent[3].

Key Takeaways

  • Pricing Strategy: The significant price reduction of Praluent aimed to improve payer reimbursement and patient access.
  • Sales Performance: Despite price cuts, Praluent's sales have been below expectations, though recent quarters show some improvement.
  • Competition: Praluent faces strong competition from Repatha and emerging therapies like inclisiran.
  • Payer Reimbursement: Securing adequate payer coverage remains a significant challenge.
  • Regional Performance: Growth in Europe and China has offset declines in the U.S.
  • Future Outlook: The drug's future depends on securing better reimbursement, expanding market share, and navigating competition.

FAQs

What is Praluent, and how does it work?

Praluent (alirocumab) is a biologic drug that inhibits the PCSK9 protein, which is involved in the regulation of LDL cholesterol levels. By blocking PCSK9, Praluent reduces the amount of LDL cholesterol in the blood.

Why did Sanofi and Regeneron reduce the price of Praluent?

The price reduction was aimed at improving payer reimbursement and reducing out-of-pocket costs for patients, particularly those on Medicare, to increase access and sales.

How does Praluent compare to its main competitor, Repatha?

Praluent faces significant competition from Repatha (evolocumab), with Repatha maintaining a lead in the PCSK9 inhibitor market. However, Praluent has shown growth in certain regions and with the new pricing strategy.

What are the challenges faced by Praluent in terms of payer reimbursement?

Praluent has struggled to secure adequate payer reimbursement due to its high list price, despite recent reductions. This has been a major barrier to its market success.

How has the emergence of new therapies impacted Praluent?

The emergence of new therapies like inclisiran, which offers a less frequent dosing regimen and potential manufacturing advantages, poses a significant competitive threat to Praluent.

Sources

  1. Biopharma Dive: "Praluent's lower list price isn't yielding better sales yet"
  2. Regeneron Investor Relations: "Regeneron Reports Fourth Quarter and Full Year 2023 Financial"
  3. Sanofi Press Release: "Sanofi Q2: strong performance with 10% sales growth; 2024 guidance upgraded"
  4. Sanofi Press Release: "Sanofi Q1: robust 7% sales growth driven by Dupixent and new launches"

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