CRESTOR Drug Patent Profile

Which patents cover Crestor, and when can generic versions of Crestor launch?

Crestor is a drug marketed by IPR and is included in one NDA.

The generic ingredient in CRESTOR is rosuvastatin calcium. There are forty-two drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the rosuvastatin calcium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Crestor

A generic version of CRESTOR was approved as rosuvastatin calcium by WATSON LABS INC on April 29^th, 2016.

Summary for CRESTOR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	178
Patent Applications:	1,466
Drug Prices:	Drug price information for CRESTOR
Drug Sales Revenues:	Drug sales revenues for CRESTOR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CRESTOR
What excipients (inactive ingredients) are in CRESTOR?	CRESTOR excipients list
DailyMed Link:	CRESTOR at DailyMed

See drug prices for CRESTOR

See drug sales revenues for CRESTOR

Recent Clinical Trials for CRESTOR

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

Sponsor	Phase
Wake Forest University Health Sciences	Phase 4
The Searle Company Limited	N/A
University of Karachi	N/A

See all CRESTOR clinical trials

Pharmacology for CRESTOR

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

Paragraph IV (Patent) Challenges for CRESTOR

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 CRESTOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ipr	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-002	Aug 12, 2003	AB	RX	Yes	No
Ipr	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-005	Aug 12, 2003	AB	RX	Yes	Yes
Ipr	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-003	Aug 12, 2003	AB	RX	Yes	No
Ipr	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-004	Aug 12, 2003	AB	RX	Yes	No

Expired US Patents for CRESTOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ipr	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-005	Aug 12, 2003	RE37314*PED
Ipr	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-003	Aug 12, 2003	7,030,152*PED
Ipr	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-004	Aug 12, 2003	7,964,614*PED
Ipr	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-005	Aug 12, 2003	7,030,152*PED
Ipr	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-004	Aug 12, 2003	6,589,959
Ipr	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-002	Aug 12, 2003	7,964,614*PED

International Patents for CRESTOR

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

Country	Patent Number	Title	Estimated Expiration
Israel	143977
Japan	2001206847	PHARMACEUTICAL COMPOSITION
Luxembourg	91042
Canada	2381926
Slovenia	1223918
Japan	2001525058

Supplementary Protection Certificates for CRESTOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0521471	300125	Netherlands
0720599	300688	Netherlands		PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ROSUVASTATINE; NATIONAL REGISTRATION NO/DATE: RVG114002-004 20140811; FIRST REGISTRATION: NO 13-9663 - 9665 20140724
0521471	91042	Luxembourg		91042, EXPIRES: 20170630
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	CA 2003 00024	Denmark
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

CRESTOR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Crestor (Rosuvastatin)

Introduction

Crestor, known generically as rosuvastatin, is a potent statin developed by AstraZeneca, used to lower cholesterol levels and reduce the risk of cardiovascular diseases. The drug's market dynamics and financial trajectory have been significantly influenced by various factors, including patent expirations, generic competition, and changing healthcare landscapes.

Market Exclusivity and Patent Impact

The market exclusivity period for Crestor ended in 2016, marking a pivotal point in its financial trajectory. Prior to this, Crestor was one of the top-selling statins globally, with annual sales reaching as high as $3.5 billion in 2008[4].

Pre-Patent Expiry

Before the patent expiry, Crestor experienced significant growth. In 2005, it recorded $1.2 billion in global sales, which increased to $2.1 billion in 2006 and $2.8 billion in 2007. By 2008, sales had estimated to reach $3.5 billion[4].

Post-Patent Expiry

The expiration of Crestor's patent in 2016 led to a dramatic decline in sales. The introduction of generic rosuvastatin resulted in a nearly 52% fall in U.S. Crestor sales, with a $392 million drop in revenue compared to the previous year. This decline represented 61% of the overall drop in AstraZeneca's total revenue during the second quarter of 2016[2].

Financial Performance

Revenue Decline

Following the patent expiry, Crestor's revenue plummeted. For instance, in 2015, Crestor's annual prescriptions peaked at 24.8 million, with national spending reaching $8.79 billion. However, by 2018, the number of Crestor purchases dropped to 1.63 million, with annual expenditures falling to $0.61 billion[1].

Impact on AstraZeneca

The decline in Crestor sales had a substantial impact on AstraZeneca's financials. Despite this, the company's other portfolios, such as cardiovascular drug Brilinta and diabetes drug Farxiga, saw increased sales, helping to mitigate the loss. Additionally, AstraZeneca's oncology portfolio, particularly the drug Tagrisso, showed significant growth, contributing to the company's overall revenue[2].

Market Trends and Drivers

Growing Prevalence of Cardiovascular Diseases

The escalating incidence of cardiovascular diseases (CVD) globally has been a significant driver for the rosuvastatin market. Factors such as unhealthy lifestyles, poor dietary habits, smoking, and lack of physical activity have contributed to a steep increase in CVD prevalence, thereby increasing the demand for effective treatments like rosuvastatin[3].

Aging Population and Co-Morbid Conditions

The aging population, coupled with the prevalence of co-morbid conditions such as hypertension and diabetes, further compounds the burden of CVD. This demographic shift continues to bolster the market for rosuvastatin[3].

Generic Availability and Affordability

The availability of generic rosuvastatin has increased accessibility and affordability, driving up the volume of prescriptions. By 2018, the number of generic rosuvastatin purchases exceeded those of Crestor, reaching 22.5 million purchases[1].

Regulatory Approvals and Formulation Innovations

New approvals and patent extensions, as well as advances in drug formulations and delivery methods, have enhanced patient adherence and expanded market opportunities for rosuvastatin[3].

Healthcare Infrastructure and Market Segments

Institutional and Retail Markets

Hospitals and clinics represent significant market sub-segments due to the high volume of inpatients and outpatients requiring cholesterol management. Retail pharmacies also play a crucial role in facilitating widespread patient access to rosuvastatin[3].

Emerging Markets

The increased availability of rosuvastatin in emerging markets, driven by improving healthcare infrastructure and the expansion of global pharmaceutical companies, has further driven market growth[3].

Competitive Landscape

Generic Competition

The entry of generic rosuvastatin into the market has significantly altered the competitive landscape. Generic versions have captured a substantial share of the market, leading to a decline in branded statin sales. For example, after the patent expiry, private insurance spending on generic rosuvastatin surged to $1.61 billion by the end of 2018, while spending on Crestor dropped significantly[1].

Differentiation Strategies

AstraZeneca's efforts to differentiate Crestor through postmarketing trials and additional indications, such as treating atherosclerosis, helped maintain some market share. However, the availability of generic alternatives has made it challenging to sustain high sales levels[4].

Future Outlook

Market Growth Projections

Despite the challenges posed by generic competition, the rosuvastatin market is projected to grow. The market size was valued at USD 6.4 billion in 2023 and is expected to reach USD 22.9 billion by 2031, growing at a CAGR of 4.7% during the forecast period[3].

Continued Demand for Statins

The ongoing demand for effective cholesterol management due to the rising incidence of CVD and the aging population will continue to drive the market for rosuvastatin. However, the market will remain competitive, with generic versions playing a significant role[3].

Key Takeaways

• Crestor's sales peaked before its patent expiry in 2016, with significant declines thereafter due to generic competition.
• The drug's market dynamics are influenced by the growing prevalence of CVD, aging population, and co-morbid conditions.
• Generic availability has increased accessibility and affordability, driving up prescription volumes.
• AstraZeneca has diversified its portfolio to mitigate the impact of declining Crestor sales.
• The rosuvastatin market is projected to grow, driven by ongoing demand for cholesterol management.

FAQs

What was the impact of Crestor's patent expiry on its sales?

The patent expiry of Crestor in 2016 led to a nearly 52% fall in U.S. sales, resulting in a significant decline in revenue.

How has the availability of generic rosuvastatin affected the market?

The availability of generic rosuvastatin has increased accessibility and affordability, driving up the volume of prescriptions and capturing a substantial share of the market.

What are the key drivers of the rosuvastatin market?

The key drivers include the growing prevalence of cardiovascular diseases, an aging population, and the presence of co-morbid conditions such as hypertension and diabetes.

How has AstraZeneca responded to the decline in Crestor sales?

AstraZeneca has diversified its portfolio, investing heavily in its pipeline and seeing growth in other drug categories such as cardiovascular and oncology.

What is the projected growth of the rosuvastatin market?

The rosuvastatin market is projected to grow from USD 6.4 billion in 2023 to USD 22.9 billion by 2031, at a CAGR of 4.7%.

Sources

1. JAMA Network Open: "Use and Expenditures for Brand-name Statins After Introduction of Generic Versions"
2. BioPharma Dive: "AstraZeneca's revenues plummet as Crestor faces US competition"
3. Verified Market Research: "Rosuvastatin Market Size, Scope, Trends, Analysis & Forecast"
4. Pharmaceutical Executive: "Brand of the Year: Crestor"
5. Transparency Market Research: "Rosuvastatin Market Trends and Forecast to 2026"