Atorvastatin calcium - Generic Drug Details

What are the generic sources for atorvastatin calcium and what is the scope of freedom to operate?

Atorvastatin calcium is the generic ingredient in five branded drugs marketed by Cmp Dev Llc, Accord Hlthcare, Agnitio, Alkem Labs Ltd, Apotex Inc, Aurobindo Pharma Ltd, Biocon Pharma, Cadila Pharms Ltd, Dr Reddys, Dr Reddys Labs Ltd, Graviti Pharms, Hetero Labs Ltd V, Invagen Pharms, Lannett Co Inc, Laurus, Lepu Pharm, Lupin Ltd, Macleods Pharms Ltd, Mankind Pharma, Micro Labs Ltd India, MSN, Mylan Pharms Inc, Perrigo R And D, Sandoz Inc, Sciegen Pharms Inc, Shandong Xinhua, Strides Pharma, Sun Pharm Inds Ltd, Teva Pharms, Teva Pharms Usa, Umedica, Zydus Pharms, Upjohn, Organon, and Althera Pharms, and is included in thirty-six NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Atorvastatin calcium has two patent family members in two countries.

There are fifty-five drug master file entries for atorvastatin calcium. Sixty-two suppliers are listed for this compound.

Summary for atorvastatin calcium

International Patents:	2
US Patents:	3
Tradenames:	5
Applicants:	35
NDAs:	36
Drug Master File Entries:	55
Finished Product Suppliers / Packagers:	62
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	71
Patent Applications:	7,534
Drug Sales Revenues:	Drug sales revenues for atorvastatin calcium
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for atorvastatin calcium
What excipients (inactive ingredients) are in atorvastatin calcium?	atorvastatin calcium excipients list
DailyMed Link:	atorvastatin calcium at DailyMed

See drug sales revenues for atorvastatin calcium

Recent Clinical Trials for atorvastatin calcium

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

Sponsor	Phase
NewAmsterdam Pharma	Phase 1
Pharma Medica Research, Inc.	Phase 1
United States Department of Defense	Phase 2

See all atorvastatin calcium clinical trials

Pharmacology for atorvastatin calcium

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

Medical Subject Heading (MeSH) Categories for atorvastatin calcium

Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for atorvastatin calcium

C10AA	HMG CoA reductase inhibitors
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

US Patents and Regulatory Information for atorvastatin calcium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys	ATORVASTATIN CALCIUM	atorvastatin calcium	TABLET;ORAL	214659-003	Jul 14, 2021	AB	RX	No	No
Zydus Pharms	ATORVASTATIN CALCIUM	atorvastatin calcium	TABLET;ORAL	206536-003	Nov 20, 2018	AB	RX	No	No
Macleods Pharms Ltd	ATORVASTATIN CALCIUM	atorvastatin calcium	TABLET;ORAL	208480-004	Jun 3, 2024	AB	RX	No	No
Mylan Pharms Inc	ATORVASTATIN CALCIUM	atorvastatin calcium	TABLET;ORAL	091226-003	May 29, 2012	AB	RX	No	No
Teva Pharms	ATORVASTATIN CALCIUM	atorvastatin calcium	TABLET;ORAL	078773-001	May 29, 2012		DISCN	No	No

Expired US Patents for atorvastatin calcium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-002	Dec 17, 1996	4,681,893*PED
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-002	Dec 17, 1996	5,969,156*PED
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-003	Dec 17, 1996	4,681,893*PED
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-004	Apr 7, 2000	4,681,893*PED
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-002	Dec 17, 1996	5,385,929

International Patents for atorvastatin calcium

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)
World Intellectual Property Organization (WIPO)	2017212409

Supplementary Protection Certificates for atorvastatin calcium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
0247633	62/1997	Austria		PRODUCT NAME: ATORVASTATIN CALCIUM; NAT. REGISTRATION NO/DATE: 1-21926, 1-21927, 1-21928 19970411; FIRST REGISTRATION: GB PL 00018/0240 - PL 00018/0242 19961107
1003503	C01003503/01	Switzerland		PRODUCT NAME: AMLODIPIN + ATORVASTATIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57633 05.07.2006
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

Atorvastatin calcium Market Analysis and Financial Projection

Atorvastatin Calcium Market Dynamics and Financial Trajectory

Market Overview

The Atorvastatin Calcium market is poised for significant growth, driven by several key factors. Atorvastatin, a statin medication, is widely prescribed to manage high cholesterol levels and reduce the risk of cardiovascular diseases. Here is a comprehensive look at the market dynamics and financial trajectory of Atorvastatin Calcium.

Market Size and Growth

The global Atorvastatin Calcium market is expected to experience substantial growth over the next decade. By 2033, the market is projected to be worth around USD 571.0 million, up from USD 230.4 million in 2023, growing at a Compound Annual Growth Rate (CAGR) of 9.5% during the forecast period from 2024 to 2033[1][4].

Regional Analysis

North America

North America currently holds a significant market share of 40.1%, with market revenues reaching USD 92.3 million. This dominance is attributed to the region's robust healthcare infrastructure, the presence of major industry players, and an early adoption of advanced medical products[1][4].

Asia Pacific

The Asia Pacific region is expected to witness rapid growth, driven by increased government initiatives, heightened research activity, and growing public awareness of healthcare. This region is poised to become a pivotal area for future market developments[1][3].

Type Analysis

Biocatalysis

Biocatalysis emerges as a dominant force in the Atorvastatin Calcium market, commanding an impressive 39% market share. This preference for biocatalysis reflects a trend towards more eco-friendly and efficient production methods[1][4].

Application Analysis

Capsules

Capsules are the dominant form of administration, accounting for a substantial 51% market share. This preference is due to the ease of use and minimal side effects associated with capsule formulations[1][4].

Drivers of Growth

Rising Cardiovascular Disease Prevalence

The escalating prevalence of cardiovascular diseases (CVDs) worldwide is a primary driver of the Atorvastatin Calcium market. Sedentary lifestyles, poor dietary habits, and an aging population contribute to the increasing incidence of CVDs, making Atorvastatin Calcium a crucial medication for managing and preventing these conditions[1][3].

Growing Health Awareness

Increasing awareness of the importance of cholesterol management and its direct link to heart health is driving the demand for Atorvastatin Calcium. Patients are becoming more proactive in seeking preventive measures, including medication, to reduce their risk of heart-related ailments[1][4].

Restraints

Adverse Effects and Safety Concerns

Despite its efficacy, Atorvastatin Calcium is associated with potential side effects such as muscle pain and liver abnormalities. These safety concerns and adverse reactions can limit patient compliance and may lead to discontinuation of treatment, posing a challenge to the market[1].

Competitive Market Landscape

The Atorvastatin Calcium market is highly competitive, with numerous pharmaceutical companies producing generic versions of the drug. This intense competition can lead to pricing pressures and reduced profit margins, affecting the financial sustainability of market players[1].

Opportunities

Expanding Emerging Markets

There is a significant opportunity for market expansion in emerging economies where the burden of cardiovascular diseases is growing rapidly. Improving access to healthcare and rising disposable incomes in these regions are expected to drive the market growth[1].

Personalized Medicine

The concept of personalized medicine is gaining traction. Tailoring Atorvastatin Calcium dosages and treatment plans based on an individual’s genetic profile and specific risk factors presents an exciting opportunity to enhance treatment outcomes and minimize side effects[1].

Distribution Channels

Online Pharmacies

The online pharmacies segment is projected to be lucrative by 2033, driven by increased adoption of convenience, cost savings, and advancements in technology. As consumer preferences shift towards online purchasing, online pharmacies are set to become a major player in the healthcare and pharmaceutical industries[3].

Financial Projections

• Market Size in 2023: USD 230.4 million[1][4]
• Market Size in 2033: USD 571.0 million[1][4]
• CAGR: 9.5% from 2024 to 2033[1][4]
• Revenue in North America: USD 92.3 million in 2023[1][4]

Key Segments

Hypercholesterolemia

The hypercholesterolemia segment is particularly lucrative due to the high prevalence of this chronic condition, which requires long-term management. Patients often need to take Atorvastatin Calcium daily, leading to sustained demand and recurring sales[3].

Industry Insights

"As the global aging population becomes more susceptible to hypercholesterolemia and cardiovascular conditions, the demand for statins like Atorvastatin Calcium is expected to rise steadily," notes a report by Allied Market Research. This trend is further boosted by unhealthy diets, sedentary lifestyles, and increasing obesity rates, which contribute to higher cholesterol levels[3].

Generic Dominance

Generic versions of Atorvastatin Calcium have become prominent in the market, leading to cost-effectiveness and increased accessibility for patients. This shift towards generics is a significant factor in the market's growth and expansion[1].

Regulatory Compliance

Ensuring regulatory compliance is crucial for the safe and effective use of Atorvastatin Calcium. Market players must adhere to stringent regulatory standards to maintain market trust and avoid any adverse impacts on patient health[1].

"The global atorvastatin calcium market is experiencing growth due to several factors such as increasing prevalence of cardiovascular diseases, growing health awareness, and the preference for tablets over other forms due to ease of use and minimal side effects." - Allied Market Research[3]

Key Takeaways

• The Atorvastatin Calcium market is expected to grow significantly, reaching USD 571.0 million by 2033.
• North America holds a significant market share, but the Asia Pacific region is poised for rapid growth.
• Biocatalysis and capsule formulations are dominant in the market.
• Rising cardiovascular disease prevalence and growing health awareness are key drivers.
• Adverse effects and a competitive market landscape are significant restraints.
• Emerging markets and personalized medicine offer promising opportunities.

FAQs

What is the projected market size of Atorvastatin Calcium by 2033?

The Atorvastatin Calcium market is expected to be worth around USD 571.0 million by 2033[1][4].

What is the CAGR of the Atorvastatin Calcium market from 2024 to 2033?

The market is growing at a CAGR of 9.5% during the forecast period from 2024 to 2033[1][4].

Which region holds the largest market share in the Atorvastatin Calcium market?

North America currently holds the largest market share, with revenues reaching USD 92.3 million in 2023[1][4].

What are the primary drivers of the Atorvastatin Calcium market?

The primary drivers include the rising prevalence of cardiovascular diseases and growing health awareness among patients regarding cholesterol management[1][3].

What are the potential restraints in the Atorvastatin Calcium market?

Adverse effects and safety concerns, as well as a highly competitive market landscape, are significant restraints[1].

What opportunities are emerging in the Atorvastatin Calcium market?

Expanding emerging markets and the concept of personalized medicine present promising opportunities for market growth[1].

Sources

1. Market.us: Atorvastatin Calcium Market Size, Share | CAGR of 9.5% https://market.us/report/atorvastatin-calcium-market/
2. Market Research Intellect: Global Atorvastatin Calcium Tablets Market Size, Trends and ... https://www.marketresearchintellect.com/product/atorvastatin-calcium-tablets-market/
3. GlobeNewswire: Atorvastatin Calcium Market to Reach $487.8 Million, ... https://www.globenewswire.com/news-release/2024/10/09/2960256/0/en/Atorvastatin-Calcium-Market-to-Reach-487-8-Million-Globally-by-2033-at-5-CAGR-Allied-Market-Research.html
4. PharmiWeb: Maximum Revenue Outlook: Atorvastatin Calcium Market's Upward ... https://www.pharmiweb.com/press-release/2024-03-14/maximum-revenue-outlook-atorvastatin-calcium-market-s-upward-trajectory-to-2033-marketus