ROSUVASTATIN CALCIUM - Generic Drug Details

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

Rosuvastatin calcium is the generic ingredient in three branded drugs marketed by Sun Pharm, IPR, Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms Co, Apotex, Aurobindo Pharma Ltd, Biocon Pharma, Cadila Pharms Ltd, Changzhou Pharm, Chartwell Rx, Glenmark Speclt, Hetero Labs Ltd V, Inventia, Lupin, Macleods Pharms Ltd, MSN, Renata, Sandoz, Sciegen Pharms Inc, Shandong, Strides Pharma, Sunshine, Teva Pharms Usa, Torrent, Umedica, Watson Labs Inc, Zhejiang Jingxin, and Zhejiang Yongtai, and is included in thirty NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Rosuvastatin calcium has two patent family members in two countries.

There are forty drug master file entries for rosuvastatin calcium. Fifty suppliers are listed for this compound.

Summary for ROSUVASTATIN CALCIUM

International Patents:	2
US Patents:	1
Tradenames:	3
Applicants:	29
NDAs:	30
Drug Master File Entries:	40
Finished Product Suppliers / Packagers:	50
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	34
Patent Applications:	6,639
Drug Prices:	Drug price trends for ROSUVASTATIN CALCIUM
Drug Sales Revenues:	Drug sales revenues for ROSUVASTATIN CALCIUM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ROSUVASTATIN CALCIUM
What excipients (inactive ingredients) are in ROSUVASTATIN CALCIUM?	ROSUVASTATIN CALCIUM excipients list
DailyMed Link:	ROSUVASTATIN CALCIUM at DailyMed

See drug prices for ROSUVASTATIN CALCIUM

See drug sales revenues for ROSUVASTATIN CALCIUM

Recent Clinical Trials for ROSUVASTATIN CALCIUM

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

Sponsor	Phase
NewAmsterdam Pharma	Phase 1
Pharma Medica Research, Inc.	Phase 1
Samsung Medical Center	Phase 4

See all ROSUVASTATIN CALCIUM clinical trials

Pharmacology for ROSUVASTATIN CALCIUM

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

Medical Subject Heading (MeSH) Categories for ROSUVASTATIN CALCIUM

Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ROSUVASTATIN CALCIUM

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

Paragraph IV (Patent) Challenges for ROSUVASTATIN CALCIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CRESTOR	Tablets	rosuvastatin calcium	5 mg, 10 mg, 20 mg and 40 mg	021366	9	2007-08-13

US Patents and Regulatory Information for ROSUVASTATIN CALCIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alkem Labs Ltd	ROSUVASTATIN CALCIUM	rosuvastatin calcium	TABLET;ORAL	206465-003	Mar 21, 2017	AB	RX	No	No
Torrent	ROSUVASTATIN CALCIUM	rosuvastatin calcium	TABLET;ORAL	201619-002	Oct 31, 2016	AB	RX	No	No
Sun Pharm	ROSUVASTATIN CALCIUM	rosuvastatin calcium	TABLET;ORAL	079169-003	Jul 19, 2016		DISCN	No	No
Renata	ROSUVASTATIN CALCIUM	rosuvastatin calcium	TABLET;ORAL	207062-003	Oct 31, 2016	AB	RX	No	No

Expired US Patents for ROSUVASTATIN CALCIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ipr	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-005	Aug 12, 2003
Ipr	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-003	Aug 12, 2003
Ipr	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-004	Aug 12, 2003
Ipr	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-005	Aug 12, 2003

International Patents for ROSUVASTATIN CALCIUM

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3344242
World Intellectual Property Organization (WIPO)	2017037740

Supplementary Protection Certificates for ROSUVASTATIN CALCIUM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0521471	SPC/GB03/033	United Kingdom		PRODUCT NAME: ROSUVASTATIN OPTIONALLY IN THE FORM OF A NON-TOXIC PHARMACEUTICALLY ACCEPTABLE SALT, PARTICULARLY THE CALCIUM SALT.; REGISTERED: NL 26872 20021106; NL 26873 20021106; NL 26874 20021106; UK PL 17901/0201 20030321; UK PL 17901/0202 20030321; UK PL 17901/0203 20030321
0521471	C300125	Netherlands		PRODUCT NAME: ROSUVASTATINUM, DESGEWENST IN DE VORM VAN EEN NIET-TOXISCH FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET CALCIUMZOUT; REGISTRATION NO/DATE: RVG 26872 - RVG 26874 20021106
0720599	C300688	Netherlands		PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ROSUVASTATINE; NAT. REGISTRATION NO/DATE: RVG114002-004RVG 114008-010 2014110811; FIRST REGISTRATION: 13-9663 - 9665 20140724
0521471	0391023-9	Sweden		PRODUCT NAME: ROSUVASTATIN

ROSUVASTATIN CALCIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Rosuvastatin Calcium

Introduction

Rosuvastatin calcium, a statin used to lower cholesterol and prevent cardiovascular disease, is a significant player in the global pharmaceutical market. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting its current status, growth prospects, and key factors influencing its market performance.

Market Size and Growth

The global rosuvastatin calcium market is experiencing steady growth. As of 2024, the market size was valued at US$ 548.5 million and is projected to reach US$ 694.1 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 4.0% during the forecast period[1][4].

Regional Market Share

The market is geographically diverse, with the European Union being the largest consumer, accounting for about 34% of the global production. China follows closely as the second-largest producer, holding a market share of 28%[1].

Key Players

The rosuvastatin calcium market is dominated by several key players, including MSN Laboratories, Cadila Pharmaceuticals, LGM Pharma, Bal Pharma, Changzhou Pharmaceutical Factory, and others. These companies collectively account for a significant portion of the total market share, with top manufacturers like AstraZeneca, MSN Laboratories, and Changzhou Pharmaceutical Factory leading the pack[1].

Applications and Types

Rosuvastatin calcium is available in various formulations, including tablets (dispersible and general) and capsules. The drug is categorized by purity levels such as 98.0%, 99.0%, and others. These variations cater to different patient needs and treatment protocols[1].

Economic Impact and Cost-Effectiveness

The use of rosuvastatin calcium has been shown to have a positive economic impact by reducing cardiovascular events and associated costs. A study indicated that increasing the use of rosuvastatin can result in significant cost savings and a reduction in cardiovascular events. For instance, in a commercial health plan with 1 million members, using rosuvastatin instead of other statins could avoid 36 cardiovascular events and save US$ 4.03 million over five years[2].

Cost-Effectiveness Compared to Other Statins

Rosuvastatin is cost-effective compared to other statins like atorvastatin. It has the same acquisition costs but is more efficacious in lowering LDL-C levels and achieving guideline goals. For example, treating patients to European LDL-C goals costs less with rosuvastatin (US$ 130.18 per patient) compared to atorvastatin (US$ 242.44 per patient)[5].

Driving Factors

The growth of the rosuvastatin calcium market is driven by several factors:

• Increasing Prevalence of Cardiovascular Diseases: The rising incidence of cardiovascular diseases globally boosts the demand for effective lipid-lowering drugs like rosuvastatin calcium.
• Pharmaceutical Research: Continuous research and development in the pharmaceutical sector encourage market expansion by improving drug efficacy and safety.
• Health Awareness: Growing health awareness and the adoption of preventive healthcare measures also contribute to the market's growth[4].

Restraining Factors

Despite the positive growth trajectory, the market faces some restraining factors:

• Healthcare Policies: Strict healthcare policies and regulatory frameworks can impede market expansion by affecting drug pricing, approval processes, and reimbursement policies[4].

Distribution Channels

The distribution of rosuvastatin calcium is facilitated through various channels, including hospital pharmacies, retail pharmacies, and online pharmacies. These channels ensure widespread availability and accessibility of the drug to patients[3].

Patient Demographics

The market caters to a broad range of patient demographics, including adults, geriatric patients, and pediatric patients. This diverse patient base ensures a steady demand for the drug across different age groups[3].

Regional Analysis

The market is segmented by region, with North America, Europe, South America, Asia Pacific, and the Middle East and Africa being key markets. Each region has its unique market dynamics influenced by local healthcare policies, economic conditions, and disease prevalence[3].

Future Outlook

By 2032, the rosuvastatin calcium market is expected to reach USD 0.81 billion, growing at a CAGR of 4.0% from 2024. This growth will be driven by increasing demand for effective cholesterol-lowering treatments and ongoing pharmaceutical research[4].

Key Takeaways

• The rosuvastatin calcium market is projected to grow from US$ 548.5 million in 2024 to US$ 694.1 million by 2030 at a CAGR of 4.0%.
• The market is driven by the increasing prevalence of cardiovascular diseases and pharmaceutical research.
• Key players include MSN Laboratories, Cadila Pharmaceuticals, and Changzhou Pharmaceutical Factory.
• The drug is cost-effective compared to other statins like atorvastatin.
• Healthcare policies can act as a restraining factor.

FAQs

What is the projected market size of rosuvastatin calcium by 2030?

The rosuvastatin calcium market is expected to reach US$ 694.1 million by 2030[1].

What is the CAGR of the rosuvastatin calcium market from 2024 to 2030?

The market is expected to grow at a CAGR of 4.0% during the forecast period from 2024 to 2030[1].

Which regions are the largest consumers of rosuvastatin calcium?

The European Union is the largest consumer, accounting for about 34% of the global production, followed by China with a market share of 28%[1].

How does rosuvastatin calcium compare to other statins in terms of cost-effectiveness?

Rosuvastatin calcium is more cost-effective than atorvastatin, with lower costs per patient treated to LDL-C goals[5].

What are the main driving factors for the rosuvastatin calcium market?

The main driving factors include the increasing prevalence of cardiovascular diseases and ongoing pharmaceutical research[4].

Sources

1. Global Rosuvastatin Calcium Market Insights, Forecast to 2030 - Valuates Reports
2. Impact of rosuvastatin use on costs and outcomes in patients at high risk for coronary heart disease and stroke - PubMed
3. Rosuvastatin Market Size, Growth, Trends, Report 2032 - Market Research Future
4. Rosuvastatin Calcium Market Size & Forecast To [2032] - Business Research Insights
5. Rosuvastatin is cost-effective compared with atorvastatin in reaching low-density lipoprotein cholesterol goals - PubMed