PRALUENT Drug Profile

Summary for Tradename: PRALUENT

High Confidence Patents:	8
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for PRALUENT
Recent Clinical Trials:	See clinical trials for PRALUENT

See drug prices for PRALUENT

Recent Clinical Trials for PRALUENT

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Sun U. Kwon	Phase 4
Jonathan Sevransky	Phase 1
Chang Gung University	Phase 2

See all PRALUENT clinical trials

Pharmacology for PRALUENT

Mechanism of Action	PCSK9 Inhibitors
Established Pharmacologic Class	PCSK9 Inhibitor
Chemical Structure	Antibodies, 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

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.

2. DrugPatentWatch analysis and company disclosures

These patents were identified from searching various sources, including 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.

3. Patents from broad patent text search

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 DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Regeneron Pharmaceuticals, Inc.	PRALUENT	alirocumab	Injection	125559		2036-12-13	DrugPatentWatch analysis and company disclosures
Regeneron Pharmaceuticals, Inc.	PRALUENT	alirocumab	Injection	125559		2035-07-16	DrugPatentWatch analysis and company disclosures
Regeneron Pharmaceuticals, Inc.	PRALUENT	alirocumab	Injection	125559		2038-06-04	DrugPatentWatch analysis and company disclosures
Regeneron Pharmaceuticals, Inc.	PRALUENT	alirocumab	Injection	125559		2029-12-15	DrugPatentWatch analysis and company disclosures

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

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Regeneron Pharmaceuticals, Inc.	PRALUENT	alirocumab	Injection	125559		2036-12-13	Patent claims search
Regeneron Pharmaceuticals, Inc.	PRALUENT	alirocumab	Injection	125559		2037-05-22	Patent claims search
Regeneron Pharmaceuticals, Inc.	PRALUENT	alirocumab	Injection	125559		2038-06-21	Patent claims search
Regeneron Pharmaceuticals, Inc.	PRALUENT	alirocumab	Injection	125559		2038-06-13	Patent claims search

International Patents for PRALUENT

Country	Patent Number	Estimated Expiration
Croatia	P20211688
South Korea	20230074283
France	17C1022
Portugal	3169353

Supplementary Protection Certificates for PRALUENT

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
388 50011-2017	Slovakia		PRODUCT NAME: ALIROKUMAB; REGISTRATION NO/DATE: EU/1/15/1031/001 - EU/1/15/1031/012 20150925
PA2017019,C2358756	Lithuania		PRODUCT NAME: ALIROKUMABAS; REGISTRATION NO/DATE: EU/1/15/1031 20150923
17C1022	France		PRODUCT NAME: ALIROCUMAB; REGISTRATION NO/DATE: EU/1/15/1031 20150925
122016000059	Germany		PRODUCT NAME: ALIROCUMAB; REGISTRATION NO/DATE: EU/1/15/1031 20150923

Market Dynamics and Financial Trajectory for the Biologic Drug: PRALUENT

Last updated: September 23, 2025

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Introduction

PRALUENT (alirocumab) is a monoclonal antibody developed by Regeneron Pharmaceuticals and Sanofi, primarily indicated for lowering low-density lipoprotein cholesterol (LDL-C) in patients with hypercholesterolemia. Since its approval by the FDA in 2015, PRALUENT has disrupted traditional lipid-lowering therapy by serving as a novel PCSK9 inhibitor. The drug’s market performance hinges on multiple factors, including evolving cardiovascular treatment paradigms, competitive landscape, regulatory changes, and broader healthcare dynamics.

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Market Landscape and Therapeutic Positioning

The global hypercholesterolemia management market is sizable, driven by increasing prevalence of cardiovascular disease (CVD), statin intolerance issues, and rising awareness of lipid management. Traditional statins continue to be first-line treatment, but the advent of PCSK9 inhibitors, including PRALUENT and Amgen’s Repatha (evolocumab), has expanded therapeutic options for patients inadequately managed with statins or with familial hypercholesterolemia.

PRALUENT’s unique positioning as an injectable, monoclonal antibody targeting PCSK9 has allowed it to carve out a niche among high-risk patients, notably those with familial hypercholesterolemia or statin intolerance. However, its market penetration has been somewhat restrained by high costs, insurance hurdles, and competition.

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Market Dynamics Influencing PRALUENT’s Trajectory

1. Increasing Prevalence of Cardiovascular Disease

CVD remains the leading cause of death worldwide, with an estimated 655 million people affected globally (WHO, 2021). Elevated LDL-C levels are a primary modifiable risk factor. As awareness grows, clinicians are increasingly adopting advanced therapies such as PCSK9 inhibitors for high-risk patients. This demographic expansion propels the potential market size for PRALUENT.

2. Adoption and Prescribing Trends

Despite approval in 2015, PRALUENT’s adoption has been heterogeneous due to factors like:

• Physician familiarity: Endocrinologists and cardiologists initially adopted PCSK9 inhibitors slowly, citing concerns over cost, administration, and uncertain long-term benefits.
• Patient Access: Insurance coverage, high out-of-pocket costs (~$14,000 annually), and prior authorization hurdles limited widespread use.
• Guideline Endorsement: In 2018, the American College of Cardiology expanded PCSK9 inhibitor recommendations for very high-risk patients with uncontrolled LDL-C, catalyzing prescription rates.

Recent data indicate a gradual uptick in prescriptions, supported by better insurance coverage and updated guidelines. The 2022 guideline update emphasizes the role of PCSK9 inhibitors, including PRALUENT, in secondary prevention, broadening its market appeal.

3. Competitive Landscape

PRALUENT faces direct competition from Amgen’s Repatha, which has similar efficacy and dosing frequency. The two products are largely interchangeable, but Repatha has a broader indication label and varied dosing options, potentially affecting PRALUENT's market share.

Emerging therapies targeting lipid pathways, such as inclisiran (a small interfering RNA therapy), threaten to disrupt the market further. Inclisiran’s biannual dosing may provide a competitive advantage in patient adherence and convenience, challenging PRALUENT's market stance.

4. Pricing, Medicaid, and Reimbursement Factors

Price leadership is crucial. PRALUENT’s list price has remained high, but value-based pricing negotiations and rebates influence real-world access. Notably, recent price reductions in the U.S. aim to improve affordability and reimbursement.

Moreover, value-based contracting, where insurers link reimbursement to patient outcomes, could play a role in optimizing access and expanding the patient base.

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Financial Trajectory: Revenue and Market Potential

Historical Revenue Performance

Since its launch, PRALUENT’s revenues have demonstrated moderate growth, reflecting modest uptake due to reimbursement hurdles. In 2022, Sanofi reported global sales of approximately $1.4 billion for PRALUENT, representing a YoY increase of roughly 9% (source: company filings).

Growth Drivers

• Market Expansion: Greater adoption in high-risk populations and expanded indications.
• Pricing Strategies: Price adjustments and discounts to improve market access.
• Patient Demographics: Rising prevalence of familial hypercholesterolemia and statin intolerance.

Revenue Forecasts

Analysts project PRALUENT’s global revenues could reach $2.5 billion by 2025, driven by:

• Broader guideline endorsement
• Policy shifts favoring value-based care
• Expansion into emerging markets

However, the emergence of alternative therapies and market saturation in developed regions may temper these estimates.

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Regulatory and Healthcare Policy Impact

Regulatory agencies’ evolving stance influences PRALUENT’s market dynamics. Positive reimbursement decisions, inclusion in national formularies, and expanded approved indications bolster sales. Conversely, payor pushback on high drug costs remains a challenge.

Furthermore, healthcare systems’ shift toward cost-effective, long-term prevention strategies complements the high-cost nature of biologics like PRALUENT, prompting negotiations for value-based reimbursement models.

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Future Outlook and Strategic Considerations

1. Innovation and Formulation Improvements

Bio-similar or biosimilar development remains distant due to the complex nature of monoclonal antibodies. Nonetheless, formulation improvements, such as extended dosing intervals or subcutaneous devices, could improve patient adherence and reduce costs.

2. Market Expansion

Expanding indications, including potential use in broader cardiovascular population subsets, will be pivotal. Clinical trials assessing long-term outcomes (e.g., ODYSSEY OUTCOMES trial) support these efforts, potentially increasing the drug’s value proposition.

3. Competitive Positioning

PRALUENT must contend with:

• Biotech entrants (inclisiran) offering less frequent dosing
• Pricing pressures from payors
• Patient preference shifts toward oral therapies

Strategic collaborations, real-world evidence demonstration, and cost-reduction initiatives remain essential.

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Key Takeaways

• Growing Market Opportunity: The global hypercholesterolemia burden and guideline updates favor increased adoption of PCSK9 inhibitors like PRALUENT.
• Pricing and Access Challenges: High costs and reimbursement barriers restrict market penetration, though ongoing price negotiations and value-based models aim to improve access.
• Competitive and Innovation Risks: The emergence of alternative therapies such as inclisiran and biosimilars could threaten PRALUENT’s market share.
• Revenue Potential: With expanded indications and guideline support, PRALUENT’s revenues are projected to grow steadily, potentially reaching $2.5 billion globally by 2025.
• Strategic Focus: Market expansion, formulation innovation, and strong payer negotiations are critical for sustaining its financial trajectory.

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FAQs

1. How does PRALUENT compare to its main competitors?
PRALUENT and Repatha are similar in efficacy and administration; choice often depends on formulary preferences, dosing options, and patient-specific factors. Repatha’s broader indications and slightly more flexible dosing schedule can influence prescribing decisions.

2. What are the key barriers to PRALUENT’s wider adoption?
High list prices, insurance approval processes, and patient adherence concerns hinder broader adoption. Additionally, the advent of less frequent dosing therapies like inclisiran may impact future uptake.

3. How are regulatory agencies influencing PRALUENT’s market?
Regulatory agencies’ decisions on expanded labels, reimbursement policies, and value assessments directly impact market access. Positive guidance and inclusion in treatment guidelines foster growth.

4. What role does reimbursement play in PRALUENT’s revenue?
It is critical: better insurance coverage and lower patient copays drive higher utilization, whereas reimbursement restrictions limit access and sales potential.

5. What are the prospects of biosimilar development affecting PRALUENT?
Currently, biosimilar development for monoclonal antibodies like PRALUENT faces scientific and regulatory hurdles. While biosimilars may eventually emerge, their market entry remains speculative within the near term.

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References

[1] WHO. Cardiovascular diseases (2021). World Health Organization.
[2] Sanofi and Regeneron Pharmaceuticals. PRALUENT product data sheets (2022).
[3] Company financial reports (2022).
[4] American College of Cardiology. Lipid management guidelines (2018, 2022).
[5] Market research firm estimates (2023).