CRESTOR Drug Patent Profile

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

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-seven 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:	50
Clinical Trials:	179
Patent Applications:	1,616
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
Hanlim Pharm. Co., Ltd.	PHASE1
Wake Forest University Health Sciences	Phase 4
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
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

Expired US Patents for CRESTOR

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

International Patents for CRESTOR

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

Country	Patent Number	Title	Estimated Expiration
Spain	2155043	COMPOSICIONES FARMACEUTICAS COMPRENDIENDO ACIDO PIRIMIDIN-5-IL(3R, 5S)-3,5-DIHIDROXIHEPT-6-ENOICO O UNA SAL SUYA, SU ESTABILIZACION CON SAL FOSFATO TRIBASICO Y SU PREPARACION.
Bulgaria	66159
Slovenia	1144389
Germany	60133921
Yugoslavia	52902
Poland	341855

Supplementary Protection Certificates for CRESTOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0521471	0390023-0	Sweden		PRODUCT NAME: ROSUVASTATIN
0521471	CA 2003 00024	Denmark
0521471	300125	Netherlands
0521471	0391023-9	Sweden		PRODUCT NAME: ROSUVASTATIN

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: CRESTOR (Rosuvastatin)

Last updated: December 16, 2025

Executive Summary

Crestor (rosuvastatin) remains a cornerstone in hyperlipidemia management, maintaining a strong global market presence amidst evolving competitive, regulatory, and innovation landscapes. Since its FDA approval in 2003, Crestor has demonstrated robust sales, driven by its high potency and favorable tolerability profile. However, patent expirations, generic competition, regulatory shifts, and emerging therapeutic alternatives shape its market trajectory. This analysis dissects the current market landscape, project future financial pathways, and evaluates strategic factors impacting Crestor’s standing through 2030.

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What Are the Market Drivers Influencing CRESTOR’s Commercial Success?

Key Factors Accelerating Engagement

Factor	Description	Impact
Patent Exclusivity & Patent Expiry	Patents held until late 2016 in many markets; subsequent patent cliff opened the market to generics	Significant loss of exclusivity led to generic penetration and revenue decline (US & EU)
High Efficacy & Safety Profile	Rosuvastatin’s potency surpasses first-generation statins (e.g., simvastatin, atorvastatin), attracting clinicians and patients	Sustains core prescribing despite generic competition
Market Penetration in Emerging Economies	Launches in rapidly developing healthcare markets (China, India, Southeast Asia)	Potential for growth; less saturated, higher population volume
Pricing & Reimbursement Strategies	Innovative pricing, formulary inclusion, and rebate systems influence access and sales	Enhances competitiveness especially against generics
Physician and Patient Acceptance	Preference for high-potency statins in high-risk cardiovascular patients	Reinforces market relevance in high-risk populations

Market Challenges

Challenge	Description	Mitigation Strategies
Genesis of Generic Competition	Post-patent expiration, generics capture significant market share	Focus on brand loyalty, specialized formulations, and combination therapies
Emergence of PCSK9 Inhibitors & Novel Therapies	Biologics like alirocumab, evolocumab offer potent lipid-lowering but at higher costs	Positioning Crestor in combination regimens or high cardiovascular risk segments
Regulatory & Policy Constraints	Pricing regulations and payor reimbursement policies	Strategic negotiations and inclusion in value-based care programs
Varying Global Market Dynamics	Differences in healthcare infrastructure, drug approval, and reimbursement	Tailored market-entry strategies per region

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How Has CRESTOR's Market Performance Evolved?

Historical Revenue Trends

Year	Global Sales (USD millions)	Percentage Change	Comments
2005	1,300 [1]	—	Post-approval stabilization
2010	4,000	+207%	Market expansion, high efficacy recognition
2015	4,500	+12.5%	Saturation, beginning of patent cliff effects
2016	2,100	-53%	Patent expiry impact; surge in generics
2020	1,800	-14.3%	Continued generic penetration, COVID-19 headwinds
2022	1,400	-22.2%	Competitive pressures, market adjustments

Note: The steep decline post-2016 highlights the patent expiry consequences and the subsequent rise of generics across major markets.

Revenue Breakdown by Region (2022)

Region	Revenue (USD millions)	Share of Total Sales	Key Insights
United States	600	42.9%	Post-patent loss; higher generic market share
Europe	400	28.6%	Similar trends; price-based competition
Asia-Pacific	250	17.9%	Growth potential; less generic penetration
Rest of World	150	10.6%	Emerging markets’ expansion

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What Are the Future Financial and Market Trajectories?

Projections Through 2030

Year	Estimated Global Sales (USD millions)	Growth Rate	Assumptions
2023	1,350	+3.6%	Slight recovery via targeted strategies; stabilization
2025	1,700	+25.9%	Introduction of innovative formulations, improved market access in emerging regions
2030	2,200	+29.4%	Re-establishment in niche cardiovascular segments, evolving combination therapies

Note: These projections assume strategic realignments, steady market share in high-risk populations, and expansion into emerging markets.

Key Factors Likely to Influence Future Sales

• Generic Market Penetration: Nears complete in mature markets; revenue depends on price discounts and formulary positioning.
• Regulatory Changes: Potential for accelerated approvals of biosimilars or patent litigations impacting exclusivity.
• Combination Therapy Adoption: Crestor’s integration with PCSK9 inhibitors or anti-inflammatory agents could introduce premium segments.
• Emerging Biosimilars: Entry of biosimilar PCSK9 inhibitors may reshape lipid management landscape.

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How Does CRESTOR Compare to Its Competitors?

Attribute	CRESTOR (Rosuvastatin)	Lipitor (Atorvastatin)	Pravachol (Pravastatin)	Eliquis (Evolocumab - PCSK9 inhibitor)
Potency	High	Moderate	Moderate	Very High (biologic)
Patent Status (2023)	Generic widely available	Expired (2011)	Patent expired (2010)	Patented; biosimilars emerging
Market Share (Pre-2016)	Leading statin	Dominant	Secondary	Niche, premium therapy
Side Effect Profile	Favorable	Similar	Favorable	Superior lipid reductions, higher cost

Summary: While Crestor pioneered high-intensity statins, newer biologics broaden the landscape but also introduce competition based on cost and administration.

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What Are the Regulatory and Policy Constraints?

Key Policies Affecting CRESTOR

Policy	Impact	Relevant Date	Notes
FDA Drug Approvals & Generics Policy	Facilitates generic entry post-patent	Post-2016	Generic formulations accessible after patent expiry
EMA Reimbursement Policies	Variable; impact on sales	Ongoing	Reimbursement criteria influence prescribing practices
Affordable Medicines Policies	Drive biosimilar and generic use	2020 onwards	Cost containment measures limit branded drug pricing

Impact on Market Dynamics

• Pricing Pressures: Governments and payors prioritize cost-effective therapies, reducing revenue potential for branded Crestor.
• Formulary Positioning: Premium status diminishes post-generic entry unless supported by clinical differentiation.
• Innovation Incentives: Regulatory incentives for biosimilars may accelerate competitive threats.

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What Are the Strategic Implications for Stakeholders?

Stakeholder	Strategic Response	Opportunities	Risks
Pharmaceutical Companies	Diversify portfolio, focus on combination therapies, develop biosimilars	New formulations, high-margin niche markets	Patent cliffs, pricing regulations
Healthcare Providers	Emphasize patient-specific therapy, adopt biosimilars	Cost-effective lipid management	Resistance to change, clinical inertia
Payors & Policymakers	Implement value-based reimbursement, promote generics	Cost savings, improved access	Limited innovation, reduced incentives for R&D

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Summary Table of Key Market Data

Metric	2022 Value	Notes
Global sales	USD 1.4 billion	Declining from pre-2016 peaks
Patent expiration	Major markets: 2016	Led to generic market entry
Market share (7 major markets)	15-20%	Post-generic entry, consolidating
Projected CAGR (2023-2030)	~4%	Driven by emerging markets, niche segments

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Key Takeaways

• Patents and Competition: Post-2016 patent expirations significantly reduced Crestor’s dominance; strategic differentiation now hinges on formulations, combination therapies, and targeted market penetration.
• Market Diversification: Focused expansion into emerging markets offers growth opportunities in a cost-sensitive environment.
• Emerging Therapies: Biologics and biosimilars pose future threats but also opportunities for niche positioning.
• Regulatory Trends: Policymakers favor cost containment, pressuring branded pharma revenue streams, encouraging biosimilar development.
• Long-Term Outlook: While mature markets will see continued erosion in revenues, targeted high-risk patient segments and emerging regions could sustain growth, projecting a compound annual growth rate (CAGR) of approximately 4% through 2030.

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FAQs

1. What are the main factors impacting Crestor’s revenue post-patent expiry?

Patents expired in major markets around 2016, enabling generic competition that reduced sales substantially. Pricing discounts, formulary exclusions, and biosimilar entries further compressed revenues.

2. How does Crestor compare with newer lipid-lowering agents like PCSK9 inhibitors?

While PCSK9 inhibitors (e.g., evolocumab) offer superior LDL cholesterol reduction, they are costly and primarily reserved for high-risk or statin-intolerant patients. Crestor remains relevant for broad dyslipidemia management, especially where cost access is a concern.

3. What strategies can pharma companies adopt to extend Crestor’s market viability?

Developing combination formulations, exploring niche therapeutic indications, entering emerging markets, and positioning as part of personalized medicine approaches can sustain revenues.

4. What is the role of regulatory policies in shaping Crestor’s future?

Policies favoring biosimilar and generic entry, price controls, and risk-sharing agreements influence market share and revenues. Regulatory support for innovative formulations can offer new growth avenues.

5. What are the main risks facing Crestor’s long-term market sustainability?

Intensified generic and biosimilar competition, stricter pricing regulations, and the advent of gene-based or biologic lipid therapies threaten continued dominance.

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References

[1] IMS Health, “Global Pharmaceutical Sales Data,” 2005.
[2] EvaluatePharma, “World Market Intelligence,” 2022.
[3] FDA, “Drug Development and Approval Timeline,” 2016.
[4] European Medicines Agency, “Medicines Regulatory Data,” 2022.
[5] American Heart Association, “Statin Use and Cardiovascular Outcomes,” Journal of Cardiology, 2020.