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
Hebei General Hospital	PHASE4
Weifang People's Hospital	PHASE4
Chinese PLA General 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

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

International Patents for alirocumab

Country	Patent Number	Estimated Expiration
Eurasian Patent Organization	036042
Morocco	35355
World Intellectual Property Organization (WIPO)	2016011256
Argentina	092098

Supplementary Protection Certificates for alirocumab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
CA 2017 00028	Denmark		PRODUCT NAME: ALIROCUMAB; REG. NO/DATE: EU/1/15/1031/001-012 20150925
C20170021 00219	Estonia		PRODUCT NAME: ALIROKUMAB;REG NO/DATE: EU/1/15/1031 25.09.2015
122017000041	Germany		PRODUCT NAME: PRALUENT (ALIROCUMAB); REGISTRATION NO/DATE: EU/1/15/1031 20150923
PA2017019	Lithuania		PRODUCT NAME: ALIROKUMABAS; REGISTRATION NO/DATE: EU/1/15/1031 20150923

Market Dynamics and Financial Trajectory for the Biologic Drug: Alirocumab

Introduction
Alirocumab, marketed under the brand name Praluent, is a groundbreaking biologic therapy developed by Regeneron Pharmaceuticals in collaboration with Sanofi. This monoclonal antibody targets proprotein convertase subtilisin/kexin type 9 (PCSK9), significantly reducing low-density lipoprotein cholesterol (LDL-C) levels. Approved by the U.S. Food and Drug Administration (FDA) in July 2015, Alirocumab represents a pivotal advancement in lipid management, especially for patients with heterozygous familial hypercholesterolemia (HeFH) and those intolerant to statins. As a biologic with transformative potential, Alirocumab's market and financial outlook are shaped by evolving regulatory landscapes, competitive pressures, and healthcare adoption trends.

Market Dynamics of Alirocumab

Growing Demand for PCSK9 Inhibitors
The escalating prevalence of cardiovascular disease (CVD) globally propels demand for potent lipid-lowering therapies. According to the World Health Organization, CVD remains the leading cause of mortality worldwide, emphasizing the need for effective LDL-C management. Traditional statins, while effective, encounter limitations such as statin intolerance and residual cardiovascular risk, creating a significant niche for novel agents like Alirocumab [1].

Target Patient Population Expansion
Initially approved for familial hypercholesterolemia and clinical atherosclerotic cardiovascular disease (ASCVD), prescriptions for Alirocumab are increasingly expanding to broader populations, including those with high baseline LDL-C levels not adequately managed with statins alone. The chronic nature of hyperlipidemia fosters sustained demand, underpinning predictable revenue streams.

Competitive Landscape
Alirocumab competes principally with Evolocumab (Amgen), another PCSK9 inhibitor approved in 2015. While both drugs demonstrate comparable efficacy, market share battles are influenced by pricing strategies, physician preferences, and formulary inclusion. The emergence of generics is unlikely imminently due to the complexity of biologics manufacturing, ensuring continued exclusivity for branded products [2].

Pricing and Reimbursement Factors
Pricing strategies for Alirocumab have faced scrutiny amidst rising healthcare costs. Originally priced approximately $14,000 annually, payers have negotiated discounts, value-based pricing, and utilization management to optimize cost-effectiveness. The drug's high upfront cost necessitates demonstrable clinical benefits to secure favorable reimbursement, especially in markets with stringent healthcare budgets.

Regulatory and Clinical Developments
Ongoing phase 3 trials, such as ODYSSEY OUTCOMES, solidified Alirocumab's cardiovascular benefits, contributing to expanded indications. Regulatory bodies like the European Medicines Agency (EMA) have approved similar indications, broadening market access. These actions, coupled with real-world evidence, bolster physician confidence and prescribe rates.

Market Penetration Challenges
Despite clinical efficacy, Alirocumab’s adoption faces hurdles:

• Injection route of administration (subcutaneous, typically every two weeks), may impact patient adherence.
• Physician inertia and familiarity with established statin therapies.
• Cost barriers impacting healthcare systems and individual patients.

Over time, strategies such as patient assistance programs and educational initiatives can mitigate these barriers, fostering greater utilization.

Financial Trajectory of Alirocumab

Last updated: July 27, 2025

Revenue Growth Trends
Regeneron’s financial reports indicate Coasted initial slow uptake, but revenue from Alirocumab has been trending upward. In 2021, global sales approximated $1.65 billion, reflecting broader acceptance and expanded indications [3]. The sales trajectory is expected to accelerate with wider adoption, especially as cardiovascular risk management guidelines increasingly recommend PCSK9 inhibitors.

Market Share and Revenue Drivers
Efficacy data, labeling expansions, and payer negotiations are pivotal. The ODYSSEY OUTCOMES trial demonstrated that Alirocumab significantly reduced major adverse cardiovascular events (MACE), reinforcing its position and potentially stimulating market penetration. As the patient pool grows, revenue gains are projected to follow suit, bolstered by more aggressive formulary inclusion and evolving clinical guidelines.

Impact of Biosimilar Development
While initial barriers to biosimilar entry exist for biologics like Alirocumab, the eventual introduction of biosimilars could impose downward pressure on prices, affecting revenues. Nonetheless, given the complexities of biologic manufacturing and evolving patent landscapes, a robust period of market exclusivity is anticipated, safeguarding revenue streams over the medium term.

Emerging Market Opportunities
Developing economies, where cardiovascular disease burdens are rising, present significant growth potential. Regulatory approvals and localized pricing strategies could unlock new revenue streams. However, affordability and healthcare infrastructure constraints remain challenges to widespread adoption in these regions.

Future Outlook
Projections indicate that Alirocumab’s global sales could cross the $3 billion mark by 2026, driven by increased indications, favorable clinical data, and rising cardiovascular disease burden. Furthermore, pipeline enhancements—such as route-of-administration improvements or combination therapies—may extend its lifecycle and revenue potential.

Key Factors Influencing Future Market and Financial Performance

• Clinical Evidence and Guidelines: Updated lipid management guidelines increasingly recommend PCSK9 inhibitors, directly influencing prescription volumes.
• Pricing Strategies: Innovative payment models, including outcomes-based agreements, could improve payer acceptance and patient access.
• Regulatory Approvals: Approvals for additional indications (e.g., heterozygous familial hypercholesterolemia in pediatric populations) will expand market potential.
• Patents and Legal Protections: Patents extending into the late 2020s will ensure market exclusivity, supporting sustained revenue.
• Competitive Innovations: New therapies in development, such as gene editing or oral PCSK9 inhibitors, could eventually challenge Alirocumab’s dominance, but are unlikely to impact short-term revenues.

Conclusion
Alirocumab’s market dynamics are shaped by its clinical efficacy, evolving payer policies, and competitive landscape. Its financial trajectory reflects increased adoption driven by compelling evidence of cardiovascular benefits and expanding indications. Although challenges such as pricing pressures and emerging competitors exist, the persistent global burden of hypercholesterolemia and CVD ensures a favorable outlook for Alirocumab in the near and long term.

Key Takeaways

• The increasing global burden of CVD remains a critical driver for Alirocumab’s market demand.
• Clinical trial success and guideline endorsements are pivotal in expanding its indication slate and patient access.
• Pricing and reimbursement negotiations significantly influence sales growth, while innovations may sustain market position.
• Regulatory exclusivities and patent protections are crucial for financial predictability amid potential biosimilar entries.
• Developing markets offer growth opportunities, contingent on affordability and healthcare infrastructure improvements.

FAQs

1. What is the primary mechanism of action of Alirocumab?
Alirocumab is a monoclonal antibody that inhibits PCSK9, leading to increased LDL receptor recycling on hepatocytes and a subsequent reduction in plasma LDL cholesterol levels.

2. How does Alirocumab compare to other PCSK9 inhibitors?
The primary competitor is Evolocumab (Repatha). Both demonstrate similar efficacy and safety profiles. Market differentiation hinges on pricing, administration frequency, and approved indications.

3. What are the main challenges facing Alirocumab’s market expansion?
Key challenges include high drug costs, limited patient awareness, physician inertia, administration via injection, and payer restrictions. Emerging biosimilars may also exert downward pricing pressure.

4. How has recent clinical trial data impacted Alirocumab’s commercial prospects?
The ODYSSEY OUTCOMES trial confirmed cardiovascular risk reduction benefits, reinforcing its value proposition and prompting guideline updates that favor its use, thus driving sales.

5. What future developments could influence Alirocumab’s financial trajectory?
Expansion of indications, improved formulations, integration into combination therapies, and broader payer coverage are vital. Market entry of biosimilars could, however, temper long-term revenues.

References

1. World Health Organization. Cardiovascular Diseases Fact Sheet. 2021.
2. FDA Label. Praluent (Alirocumab) Prescribing Information. 2015.
3. Regeneron Pharmaceuticals. Annual and Quarterly Reports. 2021.