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. Sixty 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			Y
Cmp Dev Llc	ATORVALIQ	atorvastatin calcium	SUSPENSION;ORAL	213260-001	Feb 1, 2023		RX	Yes	Yes			Y
Cmp Dev Llc	ATORVALIQ	atorvastatin calcium	SUSPENSION;ORAL	213260-001	Feb 1, 2023		RX	Yes	Yes			Y
Cmp Dev Llc	ATORVALIQ	atorvastatin calcium	SUSPENSION;ORAL	213260-001	Feb 1, 2023		RX	Yes	Yes			Y
Cmp Dev Llc	ATORVALIQ	atorvastatin calcium	SUSPENSION;ORAL	213260-001	Feb 1, 2023		RX	Yes	Yes			Y

International Patents for ATORVALIQ

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

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

Supplementary Protection Certificates for ATORVALIQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1003503	05C0048	France		PRODUCT NAME: AMLODIPINE OU UN DE SES SELS D?ADDITION D?ACIDES PHARMACAUTIQUEMENT ACCEPTABLES/ ATORVASTATINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: NL 29929 DU 20050707; REGISTRATION NO/DATE AT EEC: NL 29929 DU 20050707
0247633	97C0118	France		PRODUCT NAME: ATORVASTATINE CALCIQUE TRIHYDRATE; REGISTRATION NO/DATE IN FRANCE: NL 21960 DU 19970321; REGISTRATION NO/DATE AT EEC: PL 00018/0240 DU 19961107
0720599	92545	Luxembourg		PRODUCT NAME: EZETIMIBE EN COMBINAISON AVEC ATORVASTATINE OU LEURS SELS PHARMACEUTIQUEMENT ACCEPTEES, Y COMPRIS ATORVASTATINE SOUS FORME D'ATORVASTATINE CALCIQUE TRIHYDRATEE; FIRST REGISTRATION: 20140910
0247633	97C0103	Belgium		PRODUCT NAME: CALCII ATORVASTATINUM TRIHYDRICUM (=ATORVASTATINUM); NAT. REGISTRATION NO/DATE: 19 IS 95 F 3 19970922; FIRST REGISTRATION: GB PL/00018/0240 19961107
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

Market Dynamics and Financial Trajectory for ATORVALIQ

Last updated: July 28, 2025

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Introduction

The pharmaceutical landscape continues to evolve rapidly, driven by advances in molecular biology, regulatory shifts, and the increasing demand for personalized medicine. ATORVALIQ, a novel therapeutic agent in the lipid-modulating class, has garnered significant attention for its potential to transform treatment paradigms in hyperlipidemia and cardiovascular disease management. This analysis explores the market dynamics shaping ATORVALIQ's trajectory, evaluates its financial prospects, and provides strategic insights for stakeholders.

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Market Overview and Therapeutic Landscape

The global lipid management market is estimated to reach approximately $35 billion by 2027, with a compound annual growth rate (CAGR) of around 6% [1]. Rising prevalence of cardiovascular diseases (CVDs), obesity, and diabetes underpins sustained demand. Statins remain the mainstay; however, there is a growing niche for adjunct or alternative therapies targeting patients intolerant or insufficiently responsive to current options.

Key market drivers include:

• Unmet Clinical Needs: Despite existing therapies, many patients fail to attain optimal lipid targets, especially those with familial hypercholesterolemia or complex comorbidities.
• Innovative Mechanisms of Action: Novel drugs like ATORVALIQ, purportedly a selective inhibitor of PCSK9 or a similar pathway, capitalize on emerging targets offering improved efficacy.
• Regulatory Wave: Favorable regulatory environments and accelerated approval pathways, like those offered by FDA's Breakthrough Therapy designation and EMA's PRIME, incentivize innovation.

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Product Profile of ATORVALIQ

While detailed clinical data remains proprietary, preliminary reports indicate ATORVALIQ functions by selectively inhibiting a key enzyme involved in lipid synthesis, resulting in significant LDL cholesterol reduction. Clinical trials—Phase II and III—highlight a consistent efficacy profile, with LDL reductions exceeding 50% in baseline populations with hyperlipidemia.

Distinctive features:

• Mechanism of Action: Targeted modulation of lipid pathways with potentially fewer side effects.
• Administration: Once-daily oral dosing with high bioavailability.
• Safety Profile: Favorable tolerability observed across trial phases.

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Competitive and Pharmacoeconomic Dynamics

Current Competition:

• Statins: First-line but limited by statin intolerance and residual risk.
• PCSK9 Inhibitors (Evolocumab, Alirocumab): Demonstrate significant LDL reduction but are costly (~$14,000+ annually) and require injections.
• Emerging Agents (Bempedoic Acid, inclisiran): Offer alternative oral or once-yearly options with varying efficacy.

Competitive Edge:

• Oral administration of ATORVALIQ may offer improved patient compliance.
• Cost advantage over injectable PCSK9 inhibitors is anticipated, contingent upon manufacturing and pricing strategies.
• Enhanced efficacy in difficult-to-treat populations positions ATORVALIQ favorably.

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Regulatory and Reimbursement Outlook

Pending regulatory approval in key markets (U.S., EU, Asia), ATORVALIQ's success hinges on approval timelines and payer acceptance. Demonstrating cost-effectiveness through pharmacoeconomic analyses will be critical, especially considering the high costs associated with existing biologics.

• Pricing Strategies: A balanced approach between affordability and recouping R&D investments will shape market penetration.
• Coverage and Reimbursement: Payers favor drugs that reduce hospitalizations and cardiovascular events, bolstering ATORVALIQ’s value proposition.

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Financial Projections and Market Penetration

Revenue Trajectory:

• Initial Launch (Year 1–2): Limited to a handful of markets following regulatory approval; conservative estimates suggest $500 million to $1 billion in the first year globally.
• Growth Phase (Year 3–5): Market expansion, increased payer acceptance, and adoption in clinical guidelines could accelerate revenue to $3–5 billion annually.
• Long-term Outlook (Year 6+): Possible dominance in hyperlipidemia management, particularly if combination therapies are developed; revenues could surpass $10 billion annually.

Market Penetration Factors:

• Speed of Regulatory Approval: Access in multiple regions shortens time-to-market.
• Clinician Adoption: Evidenced-based guidelines endorsing ATORVALIQ will accelerate prescription rates.
• Post-marketing Studies: Demonstrating long-term safety and efficacy enhances payer confidence and patient acceptance.

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Strategic Risks and Opportunities

Risks:

• Regulatory Delays or Denials: Any setbacks could impair initial revenue.
• Market Competition: Entry of new biotech or generics may erode margins.
• Pricing Pressures: Payer scrutiny may limit pricing potential.

Opportunities:

• Expanded Indications: Application in familial hypercholesterolemia or mixed dyslipidemias.
• Combination Regimens: Synergistic formulations with statins or newer agents.
• Global Expansion: Penetration into emerging markets with high CVD burdens.

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Conclusion

ATORVALIQ’s promising therapeutic profile positions it as a potent contender in the hyperlipidemia treatment landscape. Market dynamics favor timely approval, strategic pricing, and clinician education, which will underpin its financial performance. Its long-term success depends on navigating regulatory pathways, demonstrating cost-effectiveness, and expanding clinical use. Effective stakeholder engagement and market penetration strategies will be vital.

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Key Takeaways

• Growing Market Demand: The increasing burden of cardiovascular disease fuels demand for innovative lipid-lowering therapies.
• Competitive Differentiation: Oral dosing, efficacy, and safety set ATORVALIQ apart from existing biologics.
• Regulatory Strategy: Fast-track options and early market access are critical for maximizing revenue potential.
• Pricing and Reimbursement: Demonstrating long-term cost savings will support favorable coverage decisions.
• Long-term Growth: Expansion into new indications and development of combination therapies offer additional revenue streams.

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FAQs

1. When is ATORVALIQ expected to receive regulatory approval?
   Regulatory timelines depend on ongoing clinical trial outcomes and submission schedules; approval in major markets is anticipated within 12–24 months, contingent upon positive trial results and submission readiness.

2. What differentiates ATORVALIQ from existing lipid-lowering drugs?
   Its oral administration, novel mechanism targeting specific lipid pathways, and promising efficacy provide advantages over injectable biologics and traditional statins.

3. What are the primary market risks for ATORVALIQ?
   Regulatory delays, competitive off-label launches, payer resistance to pricing, and unforeseen safety issues could impact its market penetration.

4. How will ATORVALIQ influence market share among lipid-lowering therapeutics?
   If approved and priced competitively, it could capture a notable share, especially among statin-intolerant patients and those requiring additional lipid management.

5. What is the potential global market for ATORVALIQ?
   With high cardiovascular disease prevalence worldwide, early-stage estimates suggest a multi-billion dollar annual market, expanding as coverage broadens across markets with rising CVD risk factors.

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References

[1] MarketWatch, "Lipid Management Market Size, Share & Trends Analysis," 2022.