CRESTOR Drug Patent Profile

When do Crestor patents expire, and what generic alternatives are available?

Crestor is a drug marketed by Astrazeneca 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. Forty-five 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CRESTOR

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
Astrazeneca	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-002	Aug 12, 2003	AB	RX	Yes	No
Astrazeneca	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-005	Aug 12, 2003	AB	RX	Yes	Yes
Astrazeneca	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-003	Aug 12, 2003	AB	RX	Yes	No
Astrazeneca	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-004	Aug 12, 2003	AB	RX	Yes	No

International Patents for CRESTOR

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

Country	Patent Number	Title	Estimated Expiration
New Zealand	519774	Pharmaceutical compositions comprising the HMG CoA reductase inhibitorHMG CoA reductase inhibitor (E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl]-(3R,5S)-3,5-dihydroxyhept-6-enoic acid with an inorganic salt
United Kingdom	9900339
Germany	60001371
Norway	20003967
Bulgaria	66009
Australia	6580000
Montenegro	P33808

Supplementary Protection Certificates for CRESTOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0521471	0391023-9	Sweden		PRODUCT NAME: ROSUVASTATIN
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	300125	Netherlands
0521471	C00521471/01	Switzerland		FORMER REPRESENTANTIVE: BOVARD AG PATENTANWAELTE, CH
0720599	92544	Luxembourg		PRODUCT NAME: EZETIMIBE EN COMBINAISON AVEC ROSUVASTATINE OU LEURS SELS PHARMACEUTIQUEMENT ACCEPTEES, Y COMPRIS ROSUVASTATINE SOUD FORME DE SEL DE ZINC; FIRST REGISTRATION DATE: 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

CRESTOR (Rosuvastatin Calcium): Investment Fundamentals Analysis

Last updated: February 19, 2026

Crestor, the brand name for rosuvastatin calcium, is a statin medication used to lower cholesterol and reduce the risk of cardiovascular events. Developed by AstraZeneca, it has been a significant product in the cardiovascular therapeutics market. Analysis of its patent landscape, market performance, and competitive positioning provides a basis for evaluating its investment potential.

What is the Core Patent Protection for Crestor?

The foundational patent for rosuvastatin calcium is U.S. Patent No. 5,262,535, filed on September 25, 1992, and granted on November 16, 1993. This patent covers the composition of matter for rosuvastatin. The expiration of this core patent in the United States was in November 2010, marking the beginning of generic competition [1].

Additional patents extended the exclusivity period for Crestor through various formulations and methods of use. For example, U.S. Patent No. 7,320,990, related to a specific crystalline form of rosuvastatin calcium, was granted in 2008 and was set to expire in 2024. However, patent litigation often leads to earlier invalidation or non-infringement findings for such secondary patents. In the case of rosuvastatin, significant legal challenges by generic manufacturers aimed at overcoming these later patents. For instance, challenges to patent extensions under the Hatch-Waxman Act were common, and their success or failure directly impacted the market entry timeline for generics [2].

What Has Been Crestor's Market Performance and Sales Trajectory?

Crestor achieved blockbuster status, generating substantial revenue for AstraZeneca. In its peak years, global annual sales exceeded $6 billion. For example, in 2011, Crestor reported sales of $6.3 billion [3]. By 2015, sales had declined to approximately $5.2 billion as generic competition intensified in major markets [4].

The sales trajectory is characterized by a sharp increase during its patent-protected period, followed by a precipitous decline post-patent expiry due to the introduction of lower-cost generic alternatives. The market entry of generics in the United States occurred around 2011, and in Europe, it followed shortly thereafter. This dynamic is typical for branded pharmaceuticals once their primary intellectual property protection lapses.

Who are the Key Generic Competitors for Crestor?

Following the expiration of Crestor's primary patents, numerous pharmaceutical companies launched generic versions of rosuvastatin calcium. Major generic manufacturers that entered the market include:

• Teva Pharmaceuticals
• Sun Pharmaceutical Industries
• Mylan N.V. (now Viatris)
• Aurobindo Pharma
• Dr. Reddy's Laboratories
• Torrent Pharmaceuticals

These companies competed on price and market share, significantly eroding Crestor's revenue. The availability of multiple generic suppliers created a highly competitive pricing environment.

What is the Current Status of Crestor's Patent Exclusivity and Market Position?

As of late 2023, Crestor's primary composition of matter patents have long expired in all major global markets. Secondary patents related to specific formulations or manufacturing processes may still exist, but their effectiveness in preventing generic competition has been largely diminished through legal challenges and market realities.

Crestor, as a branded product, now holds a diminished market share compared to its peak. Its market position is primarily as a legacy product with established brand recognition, but it faces intense price competition from a multitude of generic rosuvastatin products. The brand faces pressure from both branded and generic statins, as well as newer non-statin lipid-lowering therapies.

What are the Therapeutic and Market Considerations for Rosuvastatin?

Rosuvastatin is classified as a high-intensity statin, effective in reducing low-density lipoprotein cholesterol (LDL-C) levels. Clinical trials, such as the JUPITER study, demonstrated its efficacy in reducing cardiovascular events in individuals with elevated C-reactive protein but normal LDL-C levels [5].

The market for statins is mature and highly competitive. While Crestor was a leading brand, the overall statin market is now dominated by generics due to cost-effectiveness. The advent of novel lipid-lowering agents, such as PCSK9 inhibitors (e.g., evolocumab, alirocumab) and bempedoic acid, offers alternative treatment options for patients who are statin-intolerant or require additional LDL-C reduction. These newer therapies, however, are typically priced at a premium and often used in specific patient populations.

What are the Regulatory and Pricing Dynamics Affecting Rosuvastatin Products?

Regulatory bodies worldwide have approved multiple generic versions of rosuvastatin. The pricing of these generics is driven by the highly competitive generic pharmaceutical market, influenced by manufacturing costs, market volume, and reimbursement policies of national health systems and private insurers.

In the United States, the Food and Drug Administration (FDA) oversees the generic drug approval process, ensuring bioequivalence to the reference listed drug (Crestor). In Europe, the European Medicines Agency (EMA) and national regulatory authorities manage approvals. Pricing negotiations with payers, including government bodies and private insurance companies, are critical for market access and profitability for both branded Crestor and its generic equivalents.

What is the Future Outlook for Rosuvastatin in the Pharmaceutical Market?

The future outlook for rosuvastatin, as both the branded Crestor and its generic forms, is one of continued market presence but with limited growth potential. The branded Crestor will likely continue to see declining sales as generic penetration remains high. Generic rosuvastatin will remain a widely prescribed, cost-effective treatment for hypercholesterolemia and cardiovascular risk reduction.

However, the market is shifting towards personalized medicine and novel therapeutics. While statins, including rosuvastatin, will remain foundational in many treatment protocols, their dominance may be challenged by therapies that offer different mechanisms of action or improved tolerability for specific patient groups. The overall market for lipid-lowering agents is expected to evolve, with a blend of generic statins, branded generics, and newer, higher-priced specialty medications.

Key Takeaways

• Crestor's (rosuvastatin calcium) foundational patent expired in November 2010 in the U.S., paving the way for generic entry.
• Secondary patents extended exclusivity for a period but were subject to legal challenges and ultimately did not prevent broad generic competition.
• Crestor achieved peak global sales exceeding $6 billion annually before generic erosion.
• Major generic manufacturers, including Teva, Sun Pharma, and Mylan, dominate the rosuvastatin market post-patent expiry.
• The rosuvastatin market is mature and highly competitive, with generics offering significant cost advantages.
• While statins remain a cornerstone of cardiovascular prevention, newer lipid-lowering therapies are emerging, potentially impacting the long-term growth trajectory of rosuvastatin.

FAQs

1. When did generic rosuvastatin become available in the United States? Generic rosuvastatin became available in the United States around 2011, following the expiration of Crestor's primary patents.

2. What is the mechanism of action for rosuvastatin? Rosuvastatin is a statin that inhibits HMG-CoA reductase, an enzyme involved in cholesterol synthesis in the liver, thereby reducing LDL cholesterol levels.

3. Are there any remaining patents that protect Crestor as a brand? While primary composition of matter patents have expired, secondary patents related to specific formulations or manufacturing processes may exist. However, their ability to prevent generic competition is significantly limited due to prior litigation and market dynamics.

4. What are the main side effects associated with rosuvastatin? Common side effects of rosuvastatin include muscle pain, headache, nausea, and abdominal pain. More serious, though rare, side effects can include muscle damage (rhabdomyolysis) and liver problems.

5. How does rosuvastatin compare to other statins in terms of efficacy? Rosuvastatin is considered one of the most potent statins, particularly in its ability to lower LDL cholesterol. It is often prescribed at higher doses for patients requiring significant LDL reduction.

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Citations

[1] U.S. Patent No. 5,262,535. (1993). Substituted pyrimidine compounds. Retrieved from USPTO Patent Database.

[2] U.S. Food & Drug Administration. (n.d.). Hatch-Waxman Act and Drug Price Competition. Retrieved from FDA website.

[3] AstraZeneca. (2012). Annual Report 2011. Retrieved from AstraZeneca Investor Relations.

[4] AstraZeneca. (2016). Annual Report 2015. Retrieved from AstraZeneca Investor Relations.

[5] Ridker, P. M., Buring, J. E., Rifai, N., Manning, W. J., Cook, N. R., & for the JUPITER Study Group. (2008). Rosuvastatin in the primary prevention of cardiovascular disease among men and women with elevated C-reactive protein. New England Journal of Medicine, 359(21), 2206-2217. https://doi.org/10.1056/NEJMoa0803455