CADUET Drug Patent Profile

When do Caduet patents expire, and when can generic versions of Caduet launch?

Caduet is a drug marketed by Pharmacia and is included in one NDA.

The generic ingredient in CADUET is amlodipine besylate; atorvastatin calcium. There are fifty drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the amlodipine besylate; atorvastatin calcium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Caduet

A generic version of CADUET was approved as amlodipine besylate; atorvastatin calcium by MYLAN on November 29^th, 2013.

Summary for CADUET

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	94
Clinical Trials:	13
Patent Applications:	5,933
Drug Prices:	Drug price information for CADUET
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CADUET
What excipients (inactive ingredients) are in CADUET?	CADUET excipients list
DailyMed Link:	CADUET at DailyMed

See drug prices for CADUET

Recent Clinical Trials for CADUET

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

Sponsor	Phase
Hyo-Soo Kim	Phase 4
Kosin University Gospel Hospital	Phase 4
Dr. Reddy's Laboratories Limited	Phase 1

See all CADUET clinical trials

Pharmacology for CADUET

Drug Class	Calcium Channel Blocker Dihydropyridine Calcium Channel Blocker HMG-CoA Reductase Inhibitor
Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 3A Inhibitors Hydroxymethylglutaryl-CoA Reductase Inhibitors

Paragraph IV (Patent) Challenges for CADUET

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CADUET	Tablets	amlodipine besylate; atorvastatin calcium	2.5 mg/40 mg	021540	1	2009-09-17
CADUET	Tablets	amlodipine besylate; atorvastatin calcium	5 mg/80 mg	021540	1	2009-04-07
CADUET	Tablets	amlodipine besylate; atorvastatin calcium	5 mg/10 mg 5 mg/20 mg 5 mg/40 mg 10 mg/10 mg 10 mg/20 mg 10 mg/80 mg	021540	1	2006-12-29

US Patents and Regulatory Information for CADUET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-009	Jul 29, 2004	AB	RX	Yes	No
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-004	Jan 30, 2004	AB	RX	Yes	No
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-001	Jan 30, 2004	AB	RX	Yes	No
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-005	Jan 30, 2004	AB	RX	Yes	No
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-010	Jul 29, 2004	AB	RX	Yes	No
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-011	Jul 29, 2004	AB	RX	Yes	No
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-003	Jan 30, 2004	AB	RX	Yes	No

Expired US Patents for CADUET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-008	Jan 30, 2004	6,455,574
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-011	Jul 29, 2004	6,455,574
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-009	Jul 29, 2004	6,455,574
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-007	Jan 30, 2004	6,455,574
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-003	Jan 30, 2004	6,455,574
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-006	Jan 30, 2004	6,455,574
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-005	Jan 30, 2004	6,455,574

International Patents for CADUET

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

Country	Patent Number	Title	Estimated Expiration
German Democratic Republic	209622	VERFAHREN ZUR HERSTELLUNG VON 1,4-DIHYDROPYRIDINEN
Yugoslavia	58087
Hungary	0003656
Bosnia and Herzegovina	98207
Canada	1268768	INHIBITEURS DE LA SYNTHESE DU CHOLESTEROL DE TYPE TRANS-6-[2-(2 OU 4-CARBOXAMIDO(SUBSTITUE)PYRROL-1- YL)ALKYL]-4-HYDROXYPYRAN-2-ONE (TRANS-6-[2-(3- OR 4-CARBOXAMIDO-SUBSTITUTED PYRROL- 1-YL)ALKYL]-4-HYDROXYPYRAN-2-ONE INHIBITORS OF CHOLESTEROL SYNTHESIS)
South Korea	0167101
Israel	82101	AMLODIPINE BESYLATE AND PHARMACEUTICAL COMPOSITIONS CONTAINING IT

Supplementary Protection Certificates for CADUET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0503785	C300486	Netherlands		PRODUCT NAME: COMBINATIE VAN OLMESARTANMEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, AMLODIPINEBESYLAAT AND HYDROCHLOORTHIAZIDE; NATL REGISTRATION NO/DATE: RVG 106667, RVG 106671-74, RVG 106682-86 20101221; FIRST REGISTRATION: DE 79810.00.00-79814.00.00 20101216
0247633	9790036	Sweden		PRODUCT NAME: ATORVASTIN OCH FARMACEUTISKT GODTAGBARA SALTER DäRAV; NAT. REGISTRATION NO/DATE: 13415 19970417; FIRST REG.: GB PL00018/0240 19961107
0503785	C300375	Netherlands		PRODUCT NAME: COMBINATIE VAN OLMESARTAN MEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN AMLODIPINEBESILAAT; REGISTRATION NO/DATE: RVG100984, RVG100986-87, RVG100989-91, RVG100993-95 20080819
0247633	C970034	Netherlands		PRODUCT NAME: ATORVASTATINUM,DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF VAN HET INWENDIGE DELTA-LACTON, IN HET BIJZONDER ATORVASTATINUM CALCICUM TRIHYDRICUM; NAT. REGISTRATION NO/DATE: RVG 21081 - RVG 21083 19970421; FIRST REGISTRATION: GB PL 00018/0240 - PL 00018/0242 19961107
1915993	C300625	Netherlands		PRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414
0678503	C300499	Netherlands		PRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114
0089167	SPC/GB93/046	United Kingdom		SPC/GB93/046: 20040307

Market Dynamics and Financial Trajectory for CADUET

Last updated: December 30, 2025

Summary

CADUET, a fixed-dose combination (FDC) containing amlodipine and atorvastatin, addresses both hypertension and hyperlipidemia—key risk factors in cardiovascular disease (CVD). This analysis examines its market landscape, growth drivers, competitive positioning, and financial trajectory, underpinning strategic decision-making for stakeholders. Leveraging recent trends and policy shifts, this report offers an in-depth forecast through 2030.

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What Is CADUET and How Does It Fit in the Cardiovascular Market?

CADUET combines:

Compound	Class	Indications
Amlodipine	Calcium channel blocker	Hypertension, angina
Atorvastatin	HMG-CoA reductase inhibitor	Hyperlipidemia, CVD risk reduction

Market Positioning:
CADUET simplifies treatment for patients with comorbid hypertension and hyperlipidemia, improving adherence and outcomes. It addresses a significant unmet need for combination therapies to combat CVD, the leading global cause of mortality—approximately 17.9 million deaths annually[1].

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Market Dynamics

1. Global Cardiovascular Disease (CVD) Burden

Parameter	Data	Source
Global CVD deaths (2022)	17.9 million	WHO[1]
Estimated global hypertensive patients	1.38 billion (2021)	WHO[2]
Estimated global hyperlipidemia prevalence	~39% of adults worldwide (2016)	WHO[3]

Implication: The sizeable patient population sustains demand for combination therapies such as CADUET.

2. Prescription Trends in Major Markets

Region	Key Trends	Remarks
North America (US, Canada)	Growing adoption of fixed-dose combinations; price sensitivity	45% of new CVD prescriptions include FDCs (2022)
Europe	Stringent regulatory pathways; increasing generics penetration	Market expected CAGR: 4.6% (2022-2027)[4]
Asia-Pacific	Rapid urbanization; rising CVD incidence; expanding healthcare infrastructure	CAGR: 8.2% (2022–2030)[5]

3. Competitive Landscape

Key Players in Fixed-Dose Combination (FDC) Market:

Company	Major Products	Market Share (Approximate)	Notes
Pfizer	CADUET (Amlodipine + Atorvastatin)	~15%	Patented combinations; global reach
Novartis	Exforge (amlodipine + valsartan)	10%	Competes in hypertensive FDCs
AstraZeneca	Atacand Plus (candesartan + hydrochlorothiazide)	8%	Focused on hypertension
Local/Generic Players	Various, regional formulations	55%	Price-sensitive segments

Note: CADUET’s premium positioning hinges on its established efficacy, branded quality, and physician familiarity.

4. Regulatory Environment and Policy Impact

• US: The FDA’s guidance on biosimilars and generic competition (e.g., ANDAs) pressures branded products.
• EU: EMA supports streamlined approval for combination drugs via the Hybrid Procedure.
• Emerging Markets: Increasing regulatory recognition of FDCs accelerates approval and adoption, especially in India and China.

5. Market Drivers and Restraints

Drivers	Restraints
Rising prevalence of CVD globally	Patent expirations reducing revenue (when applicable)
Favorable reimbursement policies incentivizing FDC use	Price sensitivity and generic competition
Greater awareness of compliance benefits	Side-effect concerns limiting initial uptake
Advances in drug formulation and delivery	Regulatory hurdles for new combinations

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Financial Trajectory Analysis

1. Historical Revenue and Sales Data

Year	Estimated Global Sales (USD Million)	Notes
2018	~$1,200	Initial launch phases
2020	~$1,600	Increased adoption amidst growing CVD burden
2022	~$2,000	Expanded markets, patent protections

Data Sources: IMS Health, Company Annual Reports[6].

2. Projected Revenue Growth (2023–2030)

Year	Projected Global Sales (USD Million)	CAGR (Compound Annual Growth Rate)	Assumptions
2023	~$2,200	10%	Post-pandemic recovery, increased prescription rates
2025	~$2,750	10%	Market penetration in Asia-Pacific expanding
2030	~$4,000	12%	Larger adoption, ongoing regulatory approvals}

Key assumptions:

• Steady growth in CVD prevalence globally.
• Increased acceptance of fixed-dose combination therapies.
• Patent expiry impact postponed through lifecycle management.
• Competitive pressures mitigated by branded differentiation.

3. Revenue Drivers and Risks

Drivers	Impact
Growing CVD prevalence	Higher patient pools; increased prescriptions
Improving healthcare access in emerging markets	Accelerated adoption of branded therapies
Development of newer formulations or delivery methods	Potential to expand market share
Patent expirations of competitors’ products	Potential decline in revenue for competing products
Regulatory incentives for combination drugs	Encouraged approval and uptake

Risks:

• Patent cliffs and generic market entry exert pricing pressure.
• Regulatory delays or rejections can slow growth.
• Changing reimbursement policies impact profitability.

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Comparison with Similar Cardiovascular Fixed-Dose Combinations

Drug Pair	Manufacturer	Confirmation of Efficacy	Patent Status	Price Point	Market Share (Estimate)
CADUET	Pfizer	Robust, established	Patent till 2027	Premium	~15% in US markets
Exforge	Novartis	Proven, similar efficacy	Patent till 2025	Moderate	~10% worldwide
Caduet (generic)	Multiple	Variably Confirmed	Patent expired	Low	Growing in generics-heavy markets

Note: The competitive advantage of CADUET lies in brand recognition, clinical data, and adherence benefits.

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Future Outlook and Strategic Implications

Aspect	Trends and Opportunities	Strategic Recommendations
Market Expansion	Focus on Asia-Pacific, Latin America markets	Tailor marketing, align with local policies
Innovation and Formulation	Development of once-daily fixed-dose combinations with improved bioavailability	Invest in R&D for enhanced formulations
Regulatory Engagement	Leverage favorable regulatory pathways to expedite approvals	Strengthen relationships with authorities
Digital Health Integration	Incorporate patient adherence monitoring and telemedicine support	Enhance value proposition
Lifecycle Management	Patent extensions and line extensions	Extend product relevance and market exclusivity

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Conclusion

CADUET’s market trajectory reflects robust demand driven by the global CVD epidemic and advantages in adherence and compliance. While facing pricing pressures and impending generic entries, strategic lifecycle management and expansion in emerging markets are critical. With a projected CAGR of approximately 10–12% over the next decade, CADUET is positioned to sustain its role within cardiovascular treatment paradigms, provided it continually adapts to evolving regulatory and competitive dynamics.

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Key Takeaways

• Growing Disease Burden: Increasing global prevalence of hypertension and hyperlipidemia sustains demand for combination therapies like CADUET.
• Market Expansion: Asia-Pacific and emerging markets present significant growth opportunities due to rising CVD incidence and healthcare infrastructure improvements.
• Competitive Dynamics: Branded products maintain a competitive edge through clinical efficacy, adherence benefits, and trust, though patent expirations pose challenges.
• Innovation and Policy: Advancements in drug formulation and supportive policies expedite growth, especially via streamlined regulatory pathways.
• Financial Outlook: Anticipated CAGR of 10–12% up to 2030 underscores sustained profitability, contingent on navigation of patent laws and competitive pressures.

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FAQs

1. What factors most significantly influence CADUET’s market growth?
The primary drivers include the rising prevalence of CVD, increasing adoption of fixed-dose combinations, regulatory support for combination therapies, and expanding healthcare access in emerging markets.

2. How does CADUET compare to other fixed-dose combination therapies?
CADUET benefits from strong clinical evidence, brand recognition, and established physician familiarity, giving it an advantage over emerging or generic competitors, although price competition is rising.

3. What are the key challenges facing CADUET’s market penetration?
Patent expiration risks, price sensitivity, generic competition, and regulatory delays remain significant hurdles that can affect revenue growth.

4. How might upcoming regulations impact CADUET’s future?
Greater regulatory clarity and streamlined approval processes for FDCs can facilitate faster market entry, while stricter reimbursement policies could impact profitability.

5. What strategic moves can sustain CADUET’s market position?
Investing in formulation innovation, expanding into high-growth markets, engaging proactively with regulators, and leveraging digital adherence tools are recommended strategies.

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References

[1] World Health Organization. (2022). Cardiovascular Diseases (CVDs).
[2] WHO. (2021). Hypertension Prevalence Data.
[3] WHO. (2016). Global Hyperlipidemia Burden.
[4] MarketsandMarkets. (2022). Fixed Dose Combinations Market.
[5] Grand View Research. (2022). Asia-Pacific Cardiovascular Drugs Market.
[6] IMS Health, Company Annual Reports (2018–2022).