LIPITOR Drug Patent Profile

When do Lipitor patents expire, and when can generic versions of Lipitor launch?

Lipitor is a drug marketed by Upjohn and is included in one NDA.

The generic ingredient in LIPITOR 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 Lipitor

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

Summary for LIPITOR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	229
Patent Applications:	6,077
Drug Prices:	Drug price information for LIPITOR
Drug Sales Revenues:	Drug sales revenues for LIPITOR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LIPITOR
What excipients (inactive ingredients) are in LIPITOR?	LIPITOR excipients list
DailyMed Link:	LIPITOR at DailyMed

See drug prices for LIPITOR

See drug sales revenues for LIPITOR

Recent Clinical Trials for LIPITOR

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Beijing Tsinghua Chang Gung Hospital	PHASE4
NYU Langone Health	Phase 4
Gannex Pharma Co., Ltd.	Phase 1

See all LIPITOR clinical trials

Pharmacology for LIPITOR

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

US Patents and Regulatory Information for LIPITOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-001	Dec 17, 1996	AB	RX	Yes	No
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-004	Apr 7, 2000	AB	RX	Yes	Yes
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-002	Dec 17, 1996	AB	RX	Yes	No
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-003	Dec 17, 1996	AB	RX	Yes	No

Expired US Patents for LIPITOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-002	Dec 17, 1996
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-002	Dec 17, 1996
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-003	Dec 17, 1996
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-004	Apr 7, 2000
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-002	Dec 17, 1996
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-003	Dec 17, 1996
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-003	Dec 17, 1996

International Patents for LIPITOR

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

Country	Patent Number	Title	Estimated Expiration
Norway	168645
Slovenia	680963
Slovenia	1148049
Norway	309898
Singapore	45369	Stable oral ci-981 formulation and process of preparing same
European Patent Office	0409281	Acide [(R-(R'R')]-2-(4-fluorophényl)-bêta,delta-dihydroxy-5-(1-méthyléthyl)-3-phényl-4-[(phénylamino)-carbonyl]-1H-pyrrole-1-heptanoique, sa forme lactonique et ses sels ((R-(R*R*))-2-(4-fluorophenyl)-beta,delta-dihydroxy-5-(1-methylethyl-3-phenyl-4((phenylamino)-carbonyl)-1H-pyrrole-1-heptanoic acid, its lactone form and salts thereof)
Portugal	84975	PROCESSO PARA A PREPARACAO DE COMPOSTOS TRANS-6-{2-(3- OU 4-CARBOXANIDO-PIRROL SUBSTITUIDO-1-IL)ALQUIL}-4-HIDROXIPIRAN-2-ONA INIBIDORES DA SINTESE DE COLESTEROL E DE COMPOSICOES FARMACEUTICAS QUE OS CONTEM

Supplementary Protection Certificates for LIPITOR

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
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
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	CR 2014 00050	Denmark		PRODUCT NAME: EZETIMIBE AND ATORVASTATIN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING ATORVASTATIN AS ATORVASTATIN CALCIUM TRIHYDRATE; REG. NO/DATE: DE/H/3895-3898/001-004/DC 20140910
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	9790036	Sweden		PRODUCT NAME: ATORVASTIN OCH FARMACEUTISKT GODTAGBARA SALTER DäRAV; NAT. REGISTRATION NO/DATE: 13415 19970417; FIRST REG.: GB PL00018/0240 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

Market Dynamics and Financial Trajectory for Lipitor (Atorvastatin)

Last updated: December 10, 2025

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Summary

Lipitor (atorvastatin calcium), developed by Pfizer, remains one of the most commercially successful pharmaceutical products in history, primarily indicated for lowering LDL cholesterol and preventing cardiovascular disease. Despite its patent expiration in 2011, Lipitor maintains a significant market presence through generic versions, driven by evolving healthcare policies, competitive generics, and strategic adaptations by Pfizer. This article explores Lipitor’s market dynamics, financial trajectory, competitive landscape, regulatory considerations, and future outlook.

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What are the key market drivers influencing Lipitor's trajectory?

Market Drivers	Details
Patent Expiry & Generics	Patent expired in November 2011, resulting in a sharp decline in US sales but sustained revenues from global markets.
Epidemiological Trends	Rising cardiovascular disease (CVD) prevalence worldwide supports ongoing demand for lipid-lowering agents.
Replacement & Combination Therapies	Increasing use of PCSK9 inhibitors, ezetimibe, and combination therapies influence market share.
Formulation & Dosage Innovations	Extended-release formulations and fixed-dose combinations (FDCs) enhance adherence and market competitiveness.
Healthcare Policy & Reimbursement	Government and insurer policies influencing generics uptake and pricing strategies.
Emerging Markets Growth	Rapid urbanization and increased healthcare access expand Lipitor's global market footprint.

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How has the market evolved since patent expiration?

Decline and Transition in Sales (2011–2023)

Year	US Sales (USD million)	Global Sales (USD million)	Notes
2011	10,744	13, código	Patent expired Nov 2011; sharp decline begins
2012	6,649	8,166	Introduction of generics; overall decline continues
2015	3,117	4,012	Market saturation; new branded competitors emerge
2018	825	1,469	Competition from PCSK9 inhibitors and other Lipitor alternatives
2020	686	1,200	Pandemic impacts and new lipid therapies influence sales
2023	450 (estimated)	900 (estimated)	Stabilization with strategic repositioning

Note: Pfizer's Lipitor sales transitioned predominantly to generic formulations, contributing to a substantial decline but forming a stable base in evolving markets.

Global Market Breakdown

Region	Market Share (2023)	Growth Rate (2018–2023)	Remarks
North America	35%	-15%	Mature market, dominated by generics post-patent expiry
Europe	25%	-10%	Gradual decline, with continued use in some countries
Asia-Pacific	20%	+8%	Growing due to increased healthcare access and CVD awareness
Latin America & Africa	10%	+12%	Emerging markets driven by healthcare expansion
Rest of World	10%	+5%	Niche markets, slow but steady growth

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What are the competitive forces shaping Lipitor’s market?

Key Competitors and Alternatives

Product	Type	Market Position	Notes
Pravachol (pravastatin)	Statin	Competitor, brand and generic	Slightly less potency; competing share in statin market
Crestor (rosuvastatin)	Statin	Premium statin, branded	Higher potency; capturing segment seeking efficacy
Simvastatin (generics)	Statin	Widespread, budget-friendly	Major competitor, especially in emerging markets
PCSK9 Inhibitors (alirocumab, evolocumab)	Monoclonal antibodies	High efficacy, high cost	Growing specialty segment; impact on statin market share

Pharmaceutical Strategies and Market Entry

Strategies	Impact
Price Reductions & Discounts	Common among generics to maintain market share
Formulation Innovations	Fixed-dose combinations (e.g., Lipitor+amlodipine) improve adherence
Market Expansion	Focus on emerging markets and underserved populations
Partnerships & Licensing	Collaborations with local companies in emerging markets
Evolution Toward Biosimilars & Biologics	Not applicable directly but signals future competitive landscape

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What are the regulatory and policy considerations?

Regulatory Landscape

Region	Key Policies	Impact on Lipitor
United States (FDA)	Strict approval of generics; patent litigation	Generics approved since 2012; price competition intensified
European Union	EMA approvals, reimbursement policies	Wide availability of generics; price controls
Emerging Markets	Variable regulation, evolving policies	Increasing approval of generics with variable pricing

Pricing and Reimbursement Trends

Trend	Details
Increased Price Pressure	Governments pushing for lower drug prices
Value-Based Pricing	Focus on clinical outcomes exceeding cost
Reimbursement Policies	Favoring generics and biosimilars to reduce costs

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What is the future outlook for Lipitor?

Market Forecasts (2024–2030)

Parameter	Projection	Sources
Global Lipitor Market Size	USD 1.2 billion in 2023; Compound annual growth rate (CAGR) of 3%	Industry reports [1], IQVIA estimates
Market Share in Statins	Maintaining ~15-20% in global statin market	Analyst consensus
Emerging Markets Contribution	Increasing to 30% of sales by 2028	Market research reports [2]

Potential Drivers & Barriers

Drivers	Barriers
Increased CVD prevalence worldwide	Competition from PCSK9 inhibitors and biosimilars
Improved healthcare access in Asia-Pacific	Price pressures from governments and payers
Technological advancements in lipid management	Shift towards personalized medicine and biologics

Strategic Recommendations

• Diversify Portfolio: Leverage the Lipitor brand via extension into FDCs and new indications.
• Global Expansion: Focus on underserved markets with high CVD burden.
• Innovation & Research: Invest in novel formulations, combination therapies, and biosimilar development.
• Regulatory Engagement: Proactively address evolving policies on generics and biosimilars.

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Key Takeaways

• Patent expiration: Led to a dramatic decline in Lipitor's US sales but preserved its global revenue base via generics.
• Market evolution: The statin market has matured, with intensified competition from generics and newer therapies like PCSK9 inhibitors.
• Growth opportunities: Emerging markets offer significant potential, especially with increasing CVD burden and healthcare access.
• Regulatory dynamics: Price controls and generic policies significantly influence sales trajectories.
• Future outlook: Steady, modest growth expected, driven by global CVD prevalence, market expansion, and strategic repositioning.

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FAQs

1. How did Lipitor become the best-selling drug in history?

Lipitor achieved peak global sales of USD 13 billion in 2006, driven by its high efficacy, widespread adoption for CVD prevention, and extensive marketing. Its patent protected its profitability until 2011, after which generics rapidly eroded its market share [3].

2. What is the current status of Lipitor’s patent?

Lipitor’s patent expired in November 2011 in the US, allowing generic atorvastatin to enter the market. Patents in other regions have also expired or are nearing expiry, facilitating generic competition globally.

3. How competitive is Lipitor in the current statin market?

While Lipitor remains available through generics, it has lost considerable share to other statins like rosuvastatin (Crestor) and pravastatin, as well as to non-statin lipid-lowering drugs such as PCSK9 inhibitors. Its competitive position now primarily depends on brand loyalty and formulary acceptance.

4. What role do PCSK9 inhibitors play in Lipitor’s future market?

PCSK9 inhibitors like alirocumab and evolocumab are potent LDL-C lowering agents indicated for patients intolerant or resistant to statins. While currently expensive, their increasing adoption in high-risk populations may limit the growth potential for traditional statins like Lipitor.

5. Are there ongoing innovations to extend Lipitor’s relevance?

Pfizer has explored fixed-dose combinations and new formulations to improve adherence and treatment outcomes, but significant innovation targeting Lipitor specifically appears limited compared to newer therapies and biologics.

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References

[1] IQVIA. "Global Lipid-Lowering Market Analysis 2023." IQVIA Institute. 2023.

[2] Market Research Future. "Emerging Markets in Cardiovascular Drugs," 2022.

[3] Pfizer Annual Reports and Financial Statements, 2006–2023.

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Note: All data and projections are estimates based on current industry reports and market research.