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-four 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:	1,666
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
The Searle Company Limited	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	021366-005	Aug 12, 2003	6,589,959
Astrazeneca	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-002	Aug 12, 2003	6,589,959
Astrazeneca	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-004	Aug 12, 2003	6,589,959
Astrazeneca	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-003	Aug 12, 2003	6,589,959

International Patents for CRESTOR

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

Country	Patent Number	Title	Estimated Expiration
African Regional IP Organization (ARIPO)	1449	Pharmaceutical compositions comprising a HMG reductase inhibitor.
African Regional IP Organization (ARIPO)	1879	Pharmaceutical compositions comprising a HMG CoA reductase inhibitor.
Argentina	023624	COMPOSICIONES FARMACEUTICAS QUE COMPRENDEN UN INHIBIDOR DE HMG COA REDUCTASA
Argentina	025055	COMPOSICIONES FARMACEUTICAS
Argentina	060248	UNA COMPOSICION FARMACEUTICA DE ACIDO (E) -7- [4-(4-FLUORFENIL)-6- ISOPROPIL -2- [METIL (METILSULFONIL) AMINO] PIRIMIDIN -5- IL] - (3R, 5S) -3,5- DIHIDROXIHEPT -6- ENOICO Y USO DE DICHO COMPUESTO

Supplementary Protection Certificates for CRESTOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0720599	CR 2014 00048	Denmark		PRODUCT NAME: KOMBINATION AF ROSUVASTATIN OG EZETIMIBE ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER ROSUVASTATIN SOM ZINK; NAT. REG. NO/DATE: 52921, 52922, 52923 20140820; FIRST REG. NO/DATE: NO 13-9663, 13-9664, 13-9665 20140724
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	300125	Netherlands
0521471	91042	Luxembourg		91042, EXPIRES: 20170630

Crestor (rosuvastatin): Market dynamics and financial trajectory, exclusivity timelines, and key generic/competition risks

Last updated: June 24, 2026

Crestor (rosuvastatin) is an $X+ billion annual statin franchise globally, with revenue that has historically tracked broad statin class pricing pressure, persistent volume share gains in high-acuity cardiovascular segments, and periodic formulary-driven switching. In the US, the competitive threat is largely mature generic supply with limited remaining “blockers” from formulation and label-concordant method-of-use IP rather than from core molecule exclusivity. Outside the US, branded and authorized generics (where present), plus local generic pricing, drive the remaining majority of volatility.

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What is Crestor’s market share and revenue trajectory across the US, EU, and other regions?

How has rosuvastatin pricing evolved vs atorvastatin and simvastatin?

Rosuvastatin sits in the high-prescription, high-maturity end of the statin market. The revenue slope typically reflects three forces:

• Formulary tier placement: rosuvastatin often competes for preferred status against atorvastatin generics and select managed-care preferred statins.
• Wholesale-to-net compression: discounting, rebates, and contracting reduce brand net revenue, even when gross demand remains stable.
• Pack-size and adherence effects: once a payer switches the preferred statin, adherence can lag due to pharmacy fill behavior, but class substitution is usually swift.

US market dynamics: payer contracting and generic penetration

In the US, Crestor lost regulatory brand exclusivity long ago, so the “market dynamics” are not about brand protection of the molecule. They are about:

• Net pricing vs class comps (generics and authorized generics)
• Managed-care formulary changes (step-therapy and preferred drug lists)
• Patient-level persistence (switching friction, lipid monitoring cadence)

Net effect: Crestor revenue has tended to flatten or decline structurally as generic rosuvastatin is widely available, with any remaining branded premium supported by differential patient management programs and contracting rather than by legal exclusivity.

EU and emerging markets: local generic speeds and tender pricing

In Europe and other markets, rosuvastatin revenue trajectories depend on:

• National tender regimes (tend to push rapid price erosion after generic entry)
• Local market access rules
• Pharmacy reimbursement controls

Net effect: outside the US, revenue variability is typically higher due to faster or slower generic uptake depending on country-level procurement and reimbursement design.

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What financial drivers explain Crestor profitability and cash-flow performance over time?

Key P&L variables

Crestor profitability is shaped by:

• Net revenue compression from rebates and contracting once generics are established
• Low incremental COGS due to long manufacturing scale at multiple suppliers (where branded production continues)
• Marketing and medical spend used to maintain share among initiating prescribers and high-risk cohorts
• Legal and lifecycle costs tied to formulation, label, and Orange Book challenge defenses (typically smaller than early-parity lifecycle IP costs)

Volume vs price mix

In mature statins, the financial “lever” is usually volume share, not unit price. When a brand loses preferred placement, volume falls faster than price adjusts, generating stepwise declines.

Portfolio interactions

Crestor competes within a class that includes:

• atorvastatin (market share leader in many formularies)
• simvastatin and pravastatin (lower-cost but lower utilization in certain risk groups)
• combination products (eg, statin plus other lipid-modifying agents) that can change payer preferences.

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When did Crestor lose exclusivity in the US, and what are the practical remaining IP barriers?

Molecule exclusivity is long expired; what remains is lifecycle IP

For mature brands like Crestor, the decisive timeline is typically:

• Initial New Drug Application exclusivity windows
• Patent terms tied to specific salts, crystalline forms, formulations, or dosing regimens
• Method-of-use patents for label-concordant indications
• Formulation patents (extended-release is not the typical rosuvastatin story; instead it is often about specific film coatings, unit dosage formats, and process claims)

Practical consequence for investors and litigators

Even after core exclusivity expires, remaining IP can affect:

• generic launch timing for specific strengths/dosage forms
• “design-around” feasibility
• settlement leverage in the pre-launch window.

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What patents protect rosuvastatin (Crestor) formulations, methods of use, and specific dosage strengths?

Patent estate structure in mature statins

The rosuvastatin estate generally breaks into:

1. Drug product formulation patents
2. Pharmaceutical compositions and stability/handling claims
3. Crystalline form or solid-state claims
4. Manufacturing process claims
5. Method-of-use patents tied to clinical endpoints or patient populations

How to think about “what is protected” in practice

For a molecule as widely genericized as rosuvastatin, practical protection usually narrows to:

• claims that are specific enough that generics either litigate or delay
• any patents still listed in the US Orange Book that can support litigation under Hatch-Waxman.

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What is the Orange Book status of Crestor, and which strengths have listed patents?

Orange Book is the gating signal for generic entry risk

For each Crestor strength/formulation, the Orange Book provides:

• listed patents (submission type)
• expiration dates
• whether patents are “drug substance” or “drug product”
• any patents associated with specific regulatory exclusivity.

Commercial impact by strength

If some strengths have later-expiring patents or are tied to more active litigation, generic entry may be staggered by strength. The resulting market dynamics show up in:

• pharmacy substitution patterns
• payer tiering by dose strength
• early pipeline entrants targeting the least restricted strengths first.

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Have there been Paragraph IV ANDA challenges for rosuvastatin products, and what settlements affect generic launch timing?

How Paragraph IV filing risk translates into branded revenue

For an established brand, Paragraph IV events influence revenue only during the narrow period between:

• ANDA filing and
• approval or launch.

Once multiple generic entrants exist, post-ANDA litigation rarely reverses the structural revenue decline. It can, however, delay one or more entrants, affecting:

• near-term pricing
• number of competing SKUs
• net unit margins for remaining brand-authorized supply.

Settlement-driven outcomes

Settlements in mature statin cases often produce:

• agreed launch dates
• “carve-outs” for certain strengths
• limits on market entry for specific formulations or manufacturing lines.

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Which companies are key competitors to Crestor in the rosuvastatin market?

Generic manufacturers and authorized brands

Rosuvastatin generics are supplied by multiple large and mid-sized manufacturers. Competitive dynamics generally follow:

• ability to supply in all strengths at low cost
• payer contracting sophistication
• packaging and distribution reliability

Brand and authorized generics

Where authorized generics exist, they can compress branded pricing quickly and reduce any remaining branded premium.

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How does Crestor compare with atorvastatin brands and generics in US formulary placement and net pricing?

Class competition: why payer behavior matters more than efficacy

Payers usually treat statins as a cost-managed class. Even where clinicians prefer one agent, formulary placement can dominate:

• step therapy rules
• quantity limits and prior authorization thresholds
• preferred drug lists.

Implication for revenue

Crestor’s financial trajectory is most sensitive to:

• shifts in preferred status relative to atorvastatin (the dominant comparator)
• the size of the contracted rebate discounting needed to maintain access.

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What generic entry risks remain for rosuvastatin, and how could they affect Crestor revenue?

Residual risk centers on “strength and formulation” rather than the molecule

As the molecule is widely generic, generic entry risk persists mainly through:

• specific formulation patents still active for certain strengths
• solid-state/crystalline or process claims affecting manufacturing equivalence
• labeling-driven method-of-use arguments.

Timing risk window

The financial effect of any remaining risk is concentrated around:

• patent expiration dates listed in the Orange Book
• key litigation milestones tied to those patents
• generic approval and first commercial shipment dates.

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What biosimilar-style risk applies to Crestor (and what does not)?

No biologic substitution applies

Crestor is a small molecule; biosimilar frameworks do not apply. The substitution pathway is generic ANDA rather than BLA biosimilar entry.

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Key milestones and timeline: what drives Crestor financial inflection points?

Major categories of inflection

1. Regulatory and patent transitions: end of original brand exclusivity, then lifecycle patent expiry and Orange Book clearance.
2. Generic entry waves: first authorized/generic supply, then additional entrants reducing effective pricing.
3. Managed-care contracting: preferred formulary status changes.
4. Litigation settlements: narrow launch-delay windows.

How to map timelines to revenue

Revenue typically shows step changes at:

• first generic effective launch
• tier downgrade or loss of preferred status
• price compression after additional generic entrants.

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Key Takeaways

• Crestor’s financial trajectory is driven by mature generic competition, payer contracting, and formulary positioning, not by remaining core molecule exclusivity.
• In the US, revenue exposure is primarily strength-level and lifecycle-IP-driven timing, with the broader market dominated by generic rosuvastatin supply.
• The commercial battleground remains net pricing and access versus class comparators, especially atorvastatin.
• Remaining IP risk, where present, is concentrated in Orange Book-listed formulation or method-of-use patents that can affect generic launch timing for particular strengths.

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FAQs

1) What drives Crestor net revenue when generic rosuvastatin is already widely available?
Rebate and contracting terms, formulary tier status, and strength-specific switching behavior.

2) Do method-of-use patents still matter for rosuvastatin competition?
They can if any are still Orange Book listed and tied to label coverage that a generic must address to secure carve-outs or avoid litigation.

3) How fast do formularies switch patients from Crestor to generic rosuvastatin or to other statins?
Typically quickly for new prescriptions; persistence for existing patients depends on monitoring cadence and pharmacy substitution rules.

4) What matters more for competition, patent expiry dates or settlement agreements?
Settlement agreements often drive practical launch timing; patent expiry dates determine legal freedom, but settlements control near-term outcomes in many cases.

5) Where does Crestor face the highest pricing pressure?
Markets with aggressive tendering and reimbursement controls, and US plans with strong preferred-drug contracting against low-cost statins.

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References (APA)

No sources were provided in the prompt, and no external market or patent datasets were included in the request.

DrugChatter Q&A for CRESTOR

What is the cost of crestor?
Crestor generic availability date?
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Who makes crestor medication?
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