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-three 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 SUN PHARM INDS LTD on November 30^th, 2011.

Summary for LIPITOR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	228
Patent Applications:	456
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
NYU Langone Health	Phase 4
Gannex Pharma Co., Ltd.	Phase 1
Montefiore Medical Center	N/A

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

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	5,273,995*PED
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-003	Dec 17, 1996	5,969,156*PED
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-002	Dec 17, 1996	RE40667*PED

International Patents for LIPITOR

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

Country	Patent Number	Title	Estimated Expiration
Denmark	1061073
New Zealand	234576	(R-(R * ,R * ))-2-(4-FLUOROPHENYL)-BETA,DELTA-DIHYDROXY-5-(1- METHYLETHYL)-3-PHENYL-4-((PHENYLAMINO)-CARBONYL)-1H-PYRROLE-1-HEPTANOIC ACID AND SALTS THEREOF, AND PHARMACEUTICAL COMPOSITIONS
New Zealand	312907	Crystalline [r-(r*,r*)]-2-(4-fluorophenyl)-beta,delta-dihydroxy-5-(1-methylethyl

Supplementary Protection Certificates for LIPITOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1003503	SZ 30/2006	Austria		PRODUCT NAME: AMLODIPIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SÄUREADDITIONSALZ DESSELBEN IN KOMBINATION MIT ATORVASTATIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DESSELBEN
0720599	122014000088	Germany		PRODUCT NAME: EZETIMIB ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON IN KOMBINATION MIT ATORVASTATIN ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON, INSBESONDERE ATORVASTATIN ALS ATORVASTATINCALCIUMTRIHYDRAT; NAT. REGISTRATION NO/DATE: 90223.00.00 20141113; FIRST REGISTRATION: FRANKREICH CIS: 6 928 917 6 20140912
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 of Lipitor

Introduction

Lipitor, the brand name for atorvastatin, has been a cornerstone in the treatment of high cholesterol and a financial powerhouse for Pfizer, its manufacturer. Since its introduction, Lipitor has navigated through various market dynamics, including patent expirations, generic competition, and shifting global demand. Here, we delve into the market dynamics and financial trajectory of Lipitor.

Historical Context and Peak Sales

Lipitor was launched in 1997 and quickly became the world's best-selling prescription drug. By 2006, it had reached peak sales of nearly $13 billion worldwide, with a significant portion coming from the U.S. market[2].

Patent Expiration and Generic Competition

In 2011, Lipitor lost its patent exclusivity, paving the way for generic atorvastatin to enter the market. This led to a significant decline in U.S. sales, as patients and healthcare providers opted for the cheaper generic alternatives. Despite this, Lipitor's global sales remained substantial, albeit reduced[2][3].

Global Market Performance

After the patent expiration, Lipitor's sales in the U.S. market dwindled to around $100 million annually. However, the drug continued to generate significant revenue from emerging markets, particularly China. Since 2014, Lipitor has maintained annual sales of approximately $2 billion, largely driven by the Chinese market[2].

Pricing Strategies and Market Adaptation

Pfizer's strategic pricing adjustments have been crucial in sustaining Lipitor's sales in China. The company has implemented various tactics, including offering discount cards, to maintain market share. These strategies have helped Lipitor command a premium price in the U.S. market, despite the availability of cheaper generics[2].

Role of Pharmacy Benefit Managers (PBMs)

Pharmacy Benefit Managers (PBMs) play a significant role in the pharmaceutical market, including the pricing and distribution of drugs like Lipitor. PBMs can influence drug prices by designing formularies that may exclude certain drugs or offer preferential treatment to others. This can lead to significant price differences between branded and generic drugs, with branded drugs often being priced lower to maintain market share due to patient inertia and PBM incentives[3].

Market Preferences and Patient Behavior

The preference for brand-name drugs over generics is a complex issue. Patients often exhibit inertia, sticking to the brand they know rather than switching to generics. This behavior is particularly pronounced in the anti-cholesterol drug market, where patients are less likely to adopt a generic drug containing a different molecule, even if it is cheaper[3].

Financial Performance and Profitability

Despite the challenges posed by generic competition, Lipitor remains a lucrative product for Pfizer. The drug continues to generate billions of dollars annually, contributing significantly to Pfizer's revenue. The financial performance of Lipitor highlights the enduring profitability of successful pharmaceutical products, even after patent expiration[2].

Global Atorvastatin Market Outlook

The global atorvastatin market, which includes both branded and generic versions, is projected to grow. According to Cognitive Market Research, the global atorvastatin market size is expected to reach USD 4624.2 million in 2024 and expand at a compound annual growth rate (CAGR) of 3.80% from 2024 to 2031. This growth is driven by increasing prevalence of cardiovascular diseases, rising healthcare spending, and better access to healthcare in emerging markets[4].

Regional Market Dynamics

The atorvastatin market varies significantly across different regions. North America, particularly the U.S., has a mature market with slower growth rates compared to emerging markets like China and other parts of Asia-Pacific. These regions are expected to drive the future growth of the atorvastatin market due to increasing healthcare investments and rising awareness of cholesterol treatment[4].

Industry Insights and Expert Opinions

Industry experts highlight the complexities of the pharmaceutical market, especially in the context of branded vs. generic drugs. As noted by Josh Feng in his study on prescription drug pricing dynamics, "PBMs reduce expenditures by over 20% through their ability to exclude drugs from insurance, but capture a significant fraction of the savings"[3].

Regulatory and Ethical Considerations

The pricing and marketing tactics of pharmaceutical companies, including Pfizer, have raised regulatory and ethical questions. For instance, the use of discount cards for Lipitor has been scrutinized, especially in government healthcare programs like Medicare and Medicaid[2].

Key Takeaways

• Enduring Profitability: Despite losing patent exclusivity, Lipitor continues to generate significant revenue globally.
• Global Market Shifts: Emerging markets, particularly China, have become crucial for Lipitor's sales.
• Pricing Strategies: Strategic pricing and discount programs have helped maintain Lipitor's market share.
• Patient Behavior: Patient inertia and preference for brand-name drugs influence market dynamics.
• Regulatory Scrutiny: Pricing and marketing tactics are under regulatory and ethical scrutiny.

FAQs

What happened to Lipitor's sales after its patent expiration?

After losing its patent exclusivity in 2011, Lipitor's sales in the U.S. market significantly declined due to the entry of generic atorvastatin. However, the drug continued to generate substantial revenue from emerging markets like China.

How does Pfizer maintain Lipitor's sales in the face of generic competition?

Pfizer uses strategic pricing adjustments and offers discount cards to maintain Lipitor's market share, especially in emerging markets.

What role do Pharmacy Benefit Managers (PBMs) play in the pharmaceutical market?

PBMs influence drug prices by designing formularies that can exclude certain drugs or offer preferential treatment to others, affecting the pricing and market share of drugs like Lipitor.

Why do patients prefer brand-name drugs over generics?

Patients often exhibit inertia, preferring to stick with the brand they know rather than switching to generics, especially in the anti-cholesterol drug market.

What is the projected growth of the global atorvastatin market?

The global atorvastatin market is expected to grow at a CAGR of 3.80% from 2024 to 2031, driven by increasing prevalence of cardiovascular diseases and better access to healthcare in emerging markets.

Sources

1. Journal of Ethics: "Authenticity, Uniqueness, and the Lessons of Lipitor"[1]
2. Axios: "Cholesterol drug Lipitor is still generating billions for Pfizer"[2]
3. Harvard Scholar: "Explaining Prescription Drug Pricing Dynamics"[3]
4. Cognitive Market Research: "Global Atorvastatin Market Report 2024"[4]

Last updated: 2024-12-16