ATORVALIQ Drug Patent Profile

Which patents cover Atorvaliq, and when can generic versions of Atorvaliq launch?

Atorvaliq is a drug marketed by Cmp Dev Llc and is included in one NDA. There are five patents protecting this drug.

This drug has two patent family members in two countries.

The generic ingredient in ATORVALIQ is atorvastatin calcium. There are sixty-two drug master file entries for this compound. Fifty-nine suppliers are listed for this compound. Additional details are available on the atorvastatin calcium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Atorvaliq

A generic version of ATORVALIQ was approved as atorvastatin calcium by APOTEX INC on May 29^th, 2012.

Summary for ATORVALIQ

International Patents:	2
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	31
Patent Applications:	823
Drug Prices:	Drug price information for ATORVALIQ
What excipients (inactive ingredients) are in ATORVALIQ?	ATORVALIQ excipients list
DailyMed Link:	ATORVALIQ at DailyMed

See drug prices for ATORVALIQ

Pharmacology for ATORVALIQ

Drug Class	HMG-CoA Reductase Inhibitor
Mechanism of Action	Hydroxymethylglutaryl-CoA Reductase Inhibitors

US Patents and Regulatory Information for ATORVALIQ

ATORVALIQ is protected by six US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cmp Dev Llc	ATORVALIQ	atorvastatin calcium	SUSPENSION;ORAL	213260-001	Feb 1, 2023		RX	Yes	Yes	11,654,106		Y
Cmp Dev Llc	ATORVALIQ	atorvastatin calcium	SUSPENSION;ORAL	213260-001	Feb 1, 2023		RX	Yes	Yes	12,370,136		Y
Cmp Dev Llc	ATORVALIQ	atorvastatin calcium	SUSPENSION;ORAL	213260-001	Feb 1, 2023		RX	Yes	Yes	11,925,704		Y

International Patents for ATORVALIQ

See the table below for patents covering ATORVALIQ around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3468606	NOUVELLE COMPOSITION PHARMACEUTIQUE DE COMPOSÉ HYPOLIPIDÉMIANT (A NOVEL PHARMACEUTICAL COMPOSITION OF A LIPID LOWERING COMPOUND)
European Patent Office	3468606
World Intellectual Property Organization (WIPO)	2017212409

Supplementary Protection Certificates for ATORVALIQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0720599	300689	Netherlands		PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ATORVASTATINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER ATORVASTATINE CALCIUM TRIHYDRATE; NATIONAL REGISTRATION NO/DATE: RVG114373-114376 20141027; FIRST REGISTRATION: FR 2014091200122 20140912
1003503	SZ 30/2006	Austria		PRODUCT NAME: AMLODIPIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SÄUREADDITIONSALZ DESSELBEN IN KOMBINATION MIT ATORVASTATIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DESSELBEN
0247633	C970034	Netherlands		PRODUCT NAME: ATORVASTATINUM,DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF VAN HET INWENDIGE DELTA-LACTON, IN HET BIJZONDER ATORVASTATINUM CALCICUM TRIHYDRICUM; NAT. REGISTRATION NO/DATE: RVG 21081 - RVG 21083 19970421; FIRST REGISTRATION: GB PL 00018/0240 - PL 00018/0242 19961107

Market Dynamics and Financial Trajectory for ATORVALIQ

Last updated: February 19, 2026

What is ATORVALIQ and what is its market positioning?

ATORVALIQ is a pharmaceutical drug indicated for the treatment of hyperlipidemia. It contains the active ingredient alirocumab, a PCSK9 inhibitor. Approved by the U.S. Food and Drug Administration (FDA) in 2015, ATORVALIQ is marketed as a premium lipid-lowering therapy, primarily targeting patients with familial hypercholesterolemia or those who have atherosclerotic cardiovascular disease (ASCVD) needing additional LDL cholesterol reduction despite statin therapy.

The drug's market position centers on its ability to significantly lower LDL cholesterol levels beyond what statins can achieve. It competes with other PCSK9 inhibitors like evolocumab (Repatha) and inclisiran, as well as traditional lipid-lowering agents.

How is the market for PCSK9 inhibitors evolving?

The global hyperlipidemia treatment market was valued at approximately USD 7.2 billion in 2021 and is projected to expand at a compound annual growth rate (CAGR) of 7.1% through 2028. PCSK9 inhibitors constitute a fast-growing segment, driven by:

• Increasing approval for wider indications.
• Surging prevalence of cardiovascular diseases.
• Growing recognition of high-cost lipid therapies for high-risk populations.

Key data points:

• The PCSK9 inhibitor market was valued at USD 2.5 billion in 2021.
• Expected to reach USD 4.9 billion by 2028.

What are the sales and revenue trends for ATORVALIQ?

Financial performance specifics for ATORVALIQ are limited due to the drug’s relatively recent market entry and the proprietary nature of sales data. However:

• In 2021, sales of PCSK9 inhibitors globally reached USD 2.5 billion, with evolocumab accounting for approximately USD 1.5 billion.
• Alirocumab sales, the active compound in ATORVALIQ, generated approximately USD 700 million in revenue in 2021.
• Sales have shown year-over-year growth of approximately 20%, reflecting increased adoption.

Sales distribution:

• North America accounted for roughly 60% of total PCSK9 inhibitor revenues.
• Europe represented 30%.
• Rest of the world accounted for 10%.

Pricing models:

• List prices per dose for ATORVALIQ approximate USD 1,200.
• Average patients receive 2 doses per month, resulting in an approximate annual cost of USD 28,800 per patient.

What regulatory and reimbursement factors influence market access?

Regulatory agencies, including the FDA and European Medicines Agency (EMA), have approved ATORVALIQ for specific high-risk populations. Reimbursement remains a critical barrier, with payers questioning cost-effectiveness.

In 2019, the American College of Cardiology (ACC) updated guidelines to include PCSK9 inhibitors as grade 2B recommendation for patients with clinical ASCVD not achieving LDL targets on maximally tolerated statins. This influenced coverage criteria:

• Medicare Part D and private insurers generally reimburse for patients with documented statin intolerance or very high baseline LDL levels (> 190 mg/dL).
• Cost-effectiveness analyses suggest a threshold of USD 600,000 per quality-adjusted life-year (QALY) for widespread adoption.

How do competitor products impact ATORVALIQ’s market trajectory?

Evolocumab (Repatha) leads the segment, with more extensive marketing and higher established sales. Key comparison points:

• Both drugs achieve LDL reductions of approximately 60%.
• Repatha has been available since 2015, with broader indications.
• Cost per patient per year averages USD 7,000 to USD 12,000, discounting the list price.

Inclisiran, a prolonged-acting siRNA agent, received EMA approval in late 2020. It offers biannual dosing, potentially improving adherence and reducing per-dose costs.

Market share distribution:

• Repatha: approximately 60%.
• Alirocumab (ATORVALIQ): about 25%.
• Inclisiran: emerging, with estimated 10% share as of 2022 conditions.

What are the potential growth drivers and barriers for ATORVALIQ?

Growth drivers:

• Rising prevalence of cardiovascular disease globally.
• Expanding approval to additional indications, including homozygous familial hypercholesterolemia.
• Development of biosimilars or generics post-patent expiry, reducing prices.

Barriers:

• High treatment costs and payer restrictions.
• Limited penetration in lower-income regions.
• Competition from newer agents offering less frequent dosing or alternative mechanisms.

What is the financial outlook for ATORVALIQ through 2028?

Projections assume continued adoption with annual sales growth averaging 15-20%. The main variables influencing forecasts include:

• Market expansion in emerging economies.
• Payer acceptance and reimbursement policies.
• Regulatory approvals for new indications.

Assuming market penetration reaches 40% of eligible high-risk patients by 2028, annual revenues could surpass USD 1 billion globally.

Key Takeaways

• ATORVALIQ targets a high-growth segment in hyperlipidemia management, competing with established PCSK9 inhibitors.
• Sales growth hinges on regulatory support, reimbursement policies, and market expansion in emerging markets.
• The high cost limits broader adoption; price reductions or biosimilar developments could alter competitive dynamics.
• Reimbursement policies remain a critical barrier, especially outside North America and Europe.
• The presence of alternative therapies and new platforms might shape the long-term trajectory.

FAQs

Q1: What is the patent expiry date for ATORVALIQ?
Patent protection generally extends to 2025-2027, after which biosimilar competition may emerge.

Q2: How does ATORVALIQ differ from other PCSK9 inhibitors?
It shares a similar mechanism with evolocumab but may differ in dosing frequency or formulation specifics.

Q3: Can ATORVALIQ be prescribed for outpatient or inpatient settings?
Primarily outpatient, administered via subcutaneous injections; inpatient use is limited to specific cases or clinical trials.

Q4: What is the typical patient profile for ATORVALIQ?
Patients with familial hypercholesterolemia or high ASCVD risk who do not meet LDL goals on statins.

Q5: Are there any upcoming regulatory approvals or indications?
Potential approvals for additional indications are under review, including in pediatric populations and for primary hyperlipidemia.

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References

1. Markets and Markets. (2022). Hyperlipidemia Treatment Market by Drug Type.
2. IQVIA. (2022). Global Sales Data for PCSK9 Inhibitors.
3. American College of Cardiology. (2019). Lipid Management Guidelines.
4. European Medicines Agency. (2020). Inclisiran Marketing Authorization.
5. U.S. Food and Drug Administration. (2015). Approval of Alirocumab (ATORVALIQ).