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

Summary for ATORVALIQ

International Patents:	2
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	31
Patent Applications:	142
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 four 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	11,369,567		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
World Intellectual Property Organization (WIPO)	2017212409
European Patent Office	3468606	NOUVELLE COMPOSITION PHARMACEUTIQUE DE COMPOSÉ HYPOLIPIDÉMIANT (A NOVEL PHARMACEUTICAL COMPOSITION OF A LIPID LOWERING COMPOUND)

Supplementary Protection Certificates for ATORVALIQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1003503	30/2006	Austria		PRODUCT NAME: AMLODIPIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SAEUREADDITIONSALZ DESSELBEN IN KOMBINATION MIT ATORVASTATIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DESSELBEN; NAT. REGISTRATION NO/DATE: 1-26271, 1-26273 20060330; FIRST REGISTRATION: FR 369300.9;369301.5; 369302.1;369303.8;369304.4;369305.0; 20050707
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	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
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
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	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

ATORVALIQ Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Atorvastatin

Introduction to Atorvastatin

Atorvastatin, a statin medication, is widely used to lower cholesterol and triglyceride levels in the blood, thereby reducing the risk of heart disease, stroke, and other cardiovascular problems. It works by inhibiting the enzyme HMG-CoA reductase, which is crucial for cholesterol production in the liver[4].

Global Market Size and Growth

The global atorvastatin market is experiencing rapid growth, driven by several key factors. As of 2023, the market size was valued at $10.76 billion and is projected to reach $11.86 billion in 2024, growing at a compound annual growth rate (CAGR) of 10.2%. By 2028, the market is expected to expand to $17.73 billion, with a CAGR of 10.6%[1].

Segmentation of the Atorvastatin Market

The atorvastatin market is segmented in several ways:

By Type

• Chemical Synthesis: This method involves the traditional chemical processes to produce atorvastatin.
• Biocatalysis: This method uses biological catalysts, such as enzymes, to synthesize atorvastatin, which is considered more environmentally friendly and efficient[1].

By Therapeutic Treatment

• Cardiovascular Disorders: Atorvastatin is primarily used to treat high cholesterol and reduce the risk of heart attacks and strokes.
• Obesity: It is also used in the management of obesity-related conditions.
• Inflammatory Disorders: Atorvastatin has anti-inflammatory properties, making it useful in treating certain inflammatory conditions.
• Other Therapeutic Treatments: It is used for various other conditions, including hyperlipidemia and hypercholesterolemia[1].

By Application

• Hospital Pharmacy: Atorvastatin is widely prescribed and dispensed through hospital pharmacies.
• Retail Pharmacy: It is also available through retail pharmacies.
• Online Pharmacy: The rise of online pharmacies has made atorvastatin more accessible to patients[1].

Regional Market Outlook

North America

North America was the largest region in the atorvastatin market in 2023, driven by the presence of major pharmaceutical companies, high prevalence of cardiovascular diseases, and a well-established healthcare infrastructure[1][4].

Asia-Pacific

The Asia-Pacific region is expected to be the fastest-growing market during the forecast period. This growth is attributed to the increasing target population, rising awareness about health, and the focus of major players on generic drug availability[1][4].

Key Drivers of Market Growth

Increasing Prevalence of Cardiovascular Diseases

The growing prevalence of cardiovascular diseases is a significant driver of the atorvastatin market. According to the World Heart Federation, deaths from cardiovascular disease increased to 20.5 million in 2021, highlighting the need for effective cholesterol management medications like atorvastatin[1].

Aging Population and Lifestyle Factors

The aging global population is more susceptible to hypercholesterolemia and cardiovascular conditions. Unhealthy diets, sedentary lifestyles, and increasing obesity rates also contribute to higher cholesterol levels, boosting the demand for atorvastatin[1][4].

Availability of Generic Versions

The availability of atorvastatin as a generic drug at competitive prices has significantly contributed to its market growth. Generic versions make the medication more accessible and affordable for a wider population[1].

Recent Key Strategies and Developments

Investments in Research and Development

Companies are investing heavily in the research and development of innovative atorvastatin formulations. This includes the adoption of green chemistry in manufacturing and the integration of digital health technologies[1].

Acquisitions and Expansions

Strategic acquisitions, such as Aspen Pharmacare Holdings Limited's acquisition of Viatris Inc.'s drug products portfolio, are expanding the market reach and capabilities of pharmaceutical companies[1].

Shift Towards Personalized Medicine

There is a growing trend towards personalized medicine and pharmacogenomics-based therapy, which could further enhance the efficacy and adoption of atorvastatin[1].

Competitive Landscape

The atorvastatin market is highly competitive, with major players including Mylan Pharmaceuticals Inc., Novartis AG, GlaxoSmithKline plc, Amgen Inc., Sanofi SA, Teva Pharmaceuticals Industries Ltd., Merck and Co., Bristol-Myers Squibb Company, AstraZeneca PLC, and Pfizer Inc.[4].

Financial Performance of Key Players

Companies like Shilpa Medicare Limited, which specializes in complex Active Pharmaceutical Ingredients (APIs) and formulation development, have shown resilient performance despite macroeconomic challenges. Shilpa Medicare Limited reported a significant increase in revenue and EBITDA in the fiscal year 2024, driven by their strategic focus on niche growth areas such as biologics, transdermal, and oral dissolving films[2][5].

Challenges and Opportunities

Pricing Pressure and Regulatory Challenges

Pharmaceutical companies face pricing pressure and regulatory challenges, such as those experienced by Shilpa Medicare Limited during the fiscal year 2023. However, these companies are adapting by optimizing manufacturing processes, expanding into international markets, and developing value-added products[2][5].

Emerging Markets and New Formulations

Entering emerging markets and developing new formulations, such as transdermal and oral dissolving films, present significant opportunities for growth. For instance, Shilpa Medicare Limited's entry into the US market with their first NDA product and expansion into other emerging markets through marketing partners are key strategic moves[2][5].

Key Takeaways

• The global atorvastatin market is expected to grow significantly, driven by the increasing prevalence of cardiovascular diseases and the aging population.
• The market is segmented by type, therapeutic treatment, and application, with North America being the largest region and Asia-Pacific expected to be the fastest-growing.
• Key drivers include the availability of generic versions, investments in R&D, and the integration of digital health technologies.
• Major players are focusing on personalized medicine and expanding their product portfolios through strategic acquisitions and new formulations.

Frequently Asked Questions

Q: What is the primary use of atorvastatin? A: Atorvastatin is primarily used to lower cholesterol and triglyceride levels in the blood, reducing the risk of heart disease, stroke, and other cardiovascular problems.

Q: Which region is expected to be the fastest-growing in the atorvastatin market? A: The Asia-Pacific region is expected to be the fastest-growing market during the forecast period.

Q: What are the key drivers of the atorvastatin market growth? A: The key drivers include the increasing prevalence of cardiovascular diseases, the aging population, lifestyle factors, and the availability of generic versions.

Q: Who are the major players in the atorvastatin market? A: Major players include Mylan Pharmaceuticals Inc., Novartis AG, GlaxoSmithKline plc, Amgen Inc., Sanofi SA, Teva Pharmaceuticals Industries Ltd., Merck and Co., Bristol-Myers Squibb Company, AstraZeneca PLC, and Pfizer Inc.

Q: What are the recent trends in the atorvastatin market? A: Recent trends include investments in R&D, the adoption of green chemistry, the shift towards personalized medicine, and the integration of digital health technologies.

Cited Sources

1. The Business Research Company: Global Atorvastatin Market Report 2024.
2. Shilpa Medicare Limited: Integrating | Innovating | Expanding - Shilpa Medicare Limited.
3. Value in Health: Pricing Anomalies in the “Age of Cure.
4. Allied Market Research: Atorvastatin Calcium Market Size, Share | Forecast - 2033.
5. Shilpa Medicare Limited: Shilpa Medicare Limited - AWS.