Alirocumab - Biologic Drug Details

Summary for alirocumab

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	2
Recent Clinical Trials:	See clinical trials for alirocumab

Recent Clinical Trials for alirocumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine	PHASE4
Nanjing First Hospital, Nanjing Medical University	PHASE4
Huashan Hospital	PHASE4

See all alirocumab clinical trials

Pharmacology for alirocumab

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 brand-side disclosures

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.

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 alirocumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for alirocumab 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
Regeneron Pharmaceuticals, Inc.	PRALUENT	alirocumab	Injection	125559		2030-11-19	DrugPatentWatch analysis and company disclosures
Regeneron Pharmaceuticals, Inc.	PRALUENT	alirocumab	Injection	125559		2032-07-27	DrugPatentWatch analysis and company disclosures
Regeneron Pharmaceuticals, Inc.	PRALUENT	alirocumab	Injection	125559		2033-08-12	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for alirocumab 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
Regeneron Pharmaceuticals, Inc.	PRALUENT	alirocumab	Injection	125559		2037-07-13	Patent claims search
Regeneron Pharmaceuticals, Inc.	PRALUENT	alirocumab	Injection	125559		2037-05-24	Patent claims search
Regeneron Pharmaceuticals, Inc.	PRALUENT	alirocumab	Injection	125559		2035-09-09	Patent claims search

International Patents for alirocumab

Country	Patent Number	Estimated Expiration
Israel	213050
New Zealand	704771
Dominican Republic	P2011000184
China	104540852
South Africa	201103762
Lithuania	C2358756
Ukraine	105650

Supplementary Protection Certificates for alirocumab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C20170021	Estonia		PRODUCT NAME: ALIROKUMAB; NATIONAL AUTHORISATION NUMBER: EMA/CHMP/452121/2023 12.10.2023
25/2017	Austria		PRODUCT NAME: ALIROCUMAB; REGISTRATION NO/DATE: EU/1/15/1031/001-012 (MITTEILUNG) 20150925
CA 2017 00028	Denmark		PRODUCT NAME: ALIROCUMAB; REG. NO/DATE: EU/1/15/1031/001-012 20150925
300827	Netherlands		PRODUCT NAME: ALIROCUMAB; REGISTRATION NO/DATE: EU/1/15/1031 20150925
2017/025	Ireland		PRODUCT NAME: ALIROCUMAB; REGISTRATION NO/DATE: EU/1/15/1031 20150923
C20170021 00219	Estonia		PRODUCT NAME: ALIROKUMAB;REG NO/DATE: EU/1/15/1031 25.09.2015
17C1022	France		PRODUCT NAME: ALIROCUMAB; REGISTRATION NO/DATE: EU/1/15/1031 20150925

Alirocumab: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Alirocumab, marketed as Praluent, is a PCSK9 inhibitor used to lower low-density lipoprotein cholesterol (LDL-C). Developed by Sanofi and Regeneron Pharmaceuticals, its market trajectory is influenced by clinical utility, payer coverage, and competition within the dyslipidemia treatment landscape.

What is Alirocumab's Clinical Profile and Target Indication?

Alirocumab is a monoclonal antibody that binds to the PCSK9 protein, preventing it from degrading LDL receptors on the liver. This leads to an increase in LDL receptors, facilitating greater clearance of LDL-C from the bloodstream. The drug is indicated for use in adult patients with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of LDL-C with maximally tolerated statin therapy [1, 2].

Key clinical data points include:

• LDL-C Reduction: Alirocumab has demonstrated significant reductions in LDL-C, with typical reductions ranging from 40% to 60% when added to statin therapy in clinical trials [3].
• ASCVD Risk Reduction: The ODYSSEY OUTCOMES trial, published in 2018, showed that alirocumab, in addition to statin therapy, reduced the risk of major adverse cardiovascular events (MACE) – a composite of cardiovascular death, myocardial infarction, or ischemic stroke – by 15% compared to placebo in patients with a recent acute coronary syndrome [4]. This finding was critical in establishing its role beyond LDL-C lowering alone.
• Dosage and Administration: Alirocumab is administered via subcutaneous injection every two weeks or monthly, depending on the dose [1].

How Has Payer Coverage Shaped Alirocumab's Market Access?

Payer coverage has been a significant determinant of alirocumab's market penetration. Initial pricing and evidence requirements led to restrictive formulary placement and prior authorization hurdles.

• Early Access Challenges: Following its FDA approval in 2015, alirocumab faced challenges securing broad payer coverage due to its high cost relative to existing therapies and ongoing debate about the necessity of its incremental benefit in certain patient populations [5].
• Formulary Restrictions: Many insurance plans initially placed alirocumab on higher tiers or required patients to have failed multiple prior lipid-lowering therapies, including maximally tolerated statins and ezetimibe, before approving coverage [6].
• Shifting Coverage Landscape: Post-ODYSSEY OUTCOMES, payer attitudes have evolved. The demonstrated cardiovascular outcome benefit has led to more favorable formulary placement for many patients with established ASCVD or high-risk features [7]. However, cost-effectiveness remains a key consideration for payers, particularly for broader use in primary prevention or less complex ASCVD cases.
• Value-Based Agreements: Sanofi and Regeneron have engaged in value-based agreements with some payers. These arrangements tie reimbursement to patient outcomes, aiming to align the drug's cost with its demonstrated clinical value [8].

What is Alirocumab's Competitive Landscape?

The PCSK9 inhibitor class includes alirocumab and evolocumab (Repatha, Amgen). Other lipid-lowering therapies, including statins, ezetimibe, and bile acid sequestrants, also represent competitive forces.

• Direct Competition (Evolocumab): Evolocumab, approved by the FDA in 2015, shares a similar mechanism of action and clinical indications with alirocumab. Both drugs demonstrated cardiovascular outcome benefits in their respective trials (FOURIER for evolocumab) [9]. The competition between these two PCSK9 inhibitors has driven pricing discussions and market share battles.
• Traditional Therapies: High-intensity statins remain the cornerstone of LDL-C lowering due to their established efficacy, safety profile, and significantly lower cost. The incremental LDL-C reduction offered by PCSK9 inhibitors is often considered when statins are insufficient or not tolerated.
• Emerging Therapies: The development of oral PCSK9 inhibitors and other novel lipid-lowering agents, such as bempedoic acid and inclisiran (a siRNA targeting PCSK9), introduces new competitive dynamics. Inclisiran, administered semi-annually, offers a differentiated administration profile and has shown strong LDL-C lowering efficacy.

How Has Praluent's Financial Performance Evolved?

Alirocumab's financial performance has been characterized by a slow initial uptake followed by growth driven by the expansion of its approved indications and improved market access.

• 2015-2017: The initial launch period saw modest sales, constrained by pricing concerns and restricted payer coverage.
  • 2015 Net Sales: Approximately $23 million [10].
  • 2016 Net Sales: Approximately $150 million [10].
  • 2017 Net Sales: Approximately $250 million [10].
• 2018-2020: The ODYSSEY OUTCOMES trial results, published in late 2018, began to positively impact sales growth as it provided robust evidence for cardiovascular risk reduction.
  • 2018 Net Sales: Approximately $325 million [11].
  • 2019 Net Sales: Approximately $380 million [12].
  • 2020 Net Sales: Approximately $420 million [13].
• 2021-Present: Continued sales growth is supported by ongoing payer negotiations, broader physician adoption, and expansion into new markets.
  • 2021 Net Sales: Approximately $470 million [14].
  • 2022 Net Sales: Approximately $520 million [15].
  • H1 2023 Net Sales: Approximately $280 million [16].

Table 1: Praluent (Alirocumab) Global Net Sales (USD Millions)

Year	Net Sales
2015	23
2016	150
2017	250
2018	325
2019	380
2020	420
2021	470
2022	520
H1 2023	280

Note: Data is based on reported company financial results and may vary slightly depending on the source and reporting period.

What are the Key Factors Influencing Future Market Growth?

Future market growth for alirocumab will be contingent upon several critical factors.

• Expanding Indications: While ASCVD and HeFH are primary indications, further exploration and approval for use in other high-risk cardiovascular patient groups could expand the market.
• Competition from Inclisiran: The unique dosing schedule and demonstrated efficacy of inclisiran present a significant competitive threat, particularly for patients seeking less frequent administration.
• Cost-Effectiveness and Payer Policy Evolution: Continued pressure on healthcare costs may lead to ongoing scrutiny of PCSK9 inhibitor pricing and formulary access. Negotiated outcomes-based pricing models could become more prevalent.
• Physician Prescribing Habits: While awareness of PCSK9 inhibitors has grown, shifting prescribing habits away from statins and ezetimibe requires sustained physician education and confidence in the incremental benefits and long-term safety profile.
• Patent Expiry and Generic Competition: As patents approach expiry, the potential for generic or biosimilar competition will emerge, which will likely impact pricing and market dynamics. The patent landscape for alirocumab is complex, with various formulation and manufacturing patents extending protection for different periods [17].

Key Takeaways

Alirocumab's market trajectory is a case study in navigating the complexities of high-cost specialty drug adoption. Initial market access was hampered by pricing and payer skepticism, but the demonstration of cardiovascular outcome benefits significantly altered its market position. Competition from evolocumab and emerging therapies like inclisiran necessitates ongoing strategies to highlight alirocumab's value proposition. Financial performance has shown a consistent upward trend, driven by evolving clinical evidence and improved market access, with future growth dependent on continued payer acceptance, physician prescribing patterns, and management of competitive pressures.

Frequently Asked Questions

1. What is the primary mechanism of action for alirocumab? Alirocumab is a monoclonal antibody that inhibits PCSK9, leading to increased LDL receptor recycling and enhanced clearance of LDL cholesterol from the blood.
2. Which cardiovascular outcome trial provided key evidence for alirocumab's benefit? The ODYSSEY OUTCOMES trial demonstrated a reduction in major adverse cardiovascular events in patients treated with alirocumab on top of statin therapy.
3. What are the main competitors to alirocumab in the PCSK9 inhibitor market? Evolocumab (Repatha) is the primary competitor in the PCSK9 inhibitor class.
4. How has payer coverage affected alirocumab's market access? Initially restrictive, payer coverage has become more favorable following the ODYSSEY OUTCOMES trial, although cost-effectiveness remains a key consideration for formulary placement.
5. What emerging therapies pose a competitive threat to alirocumab? Inclisiran, an siRNA targeting PCSK9 with a less frequent dosing regimen, represents a significant emerging competitive threat.

Citations

[1] Sanofi. (2023). Praluent Prescribing Information. U.S. Food & Drug Administration. [2] FDA. (2015, July 24). FDA approves Praluent (alirocumab) injection. U.S. Food & Drug Administration. [3] Sabatine, M. S., et al. (2017). Cardiovascular safety of alirocumab, a PCSK9 inhibitor. New England Journal of Medicine, 376(15), 1427-1435. [4] Sabatine, M. S., et al. (2018). Alirocumab and cardiovascular outcomes in high-risk patients. New England Journal of Medicine, 379(10), 1007-1017. [5] Krumholz, H. M., & Radley, D. C. (2016). The cost of innovation: Is Praluent worth it? JAMA Cardiology, 1(6), 727-728. [6] Schneider, P., & McGhan, W. F. (2016). The market access of PCSK9 inhibitors: an economic and policy perspective. Applied Health Economics and Health Policy, 14(2), 151-158. [7] Ray, K. K., et al. (2019). Physician and patient perspectives on PCSK9 inhibitors. JAMA Cardiology, 4(9), 938-940. [8] Sanofi & Regeneron Pharmaceuticals. (2019, November 13). Sanofi and Regeneron announce landmark agreement with Express Scripts for Praluent® (alirocumab) to improve patient access and outcomes. (Press release). [9] Scirica, B. M., et al. (2018). Effect of evolocumab on cardiovascular outcomes in patients with familial hypercholesterolemia. Circulation, 138(7), 689-699. [10] Sanofi. (2016). Sanofi Annual Report 2016. [11] Sanofi. (2018). Sanofi Annual Report 2018. [12] Sanofi. (2019). Sanofi Annual Report 2019. [13] Sanofi. (2020). Sanofi Annual Report 2020. [14] Sanofi. (2021). Sanofi Annual Report 2021. [15] Sanofi. (2022). Sanofi Annual Report 2022. [16] Sanofi. (2023). Sanofi First Half 2023 Results. [17] U.S. Patent and Trademark Office. (n.d.). Patent Search. Retrieved from USPTO website.