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. Eight 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:	2
Raw Ingredient (Bulk) Api Vendors:	133
Clinical Trials:	13
Patent Applications:	3,166
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	021540-001	Jan 30, 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	021540-005	Jan 30, 2004	AB	RX	Yes	No
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	021540-010	Jul 29, 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
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-004	Jan 30, 2004
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-010	Jul 29, 2004
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-011	Jul 29, 2004
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-008	Jan 30, 2004

International Patents for CADUET

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

Country	Patent Number	Title	Estimated Expiration
Germany	3761485
Ireland	902659
Israel	177376
New Zealand	537880	Therapeutic combinations comprising amlodipin and atorvastatin
Spain	2233526

Supplementary Protection Certificates for CADUET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0247633	9790036	Sweden		PRODUCT NAME: ATORVASTIN OCH FARMACEUTISKT GODTAGBARA SALTER DäRAV; NAT. REGISTRATION NO/DATE: 13415 19970417; FIRST REG.: GB PL00018/0240 19961107
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
1507558	C300528	Netherlands		PRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
0502314	SPC/GB11/010	United Kingdom		PRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK
0247633	SPC/GB97/011	United Kingdom		SPC/GB97/011: 20070529, EXPIRES: 20111106

Market Dynamics and Financial Trajectory for the Drug: Caduet

Introduction

Caduet, a combination drug consisting of amlodipine besylate and atorvastatin calcium, is widely used to treat high blood pressure and high cholesterol. This article delves into the market dynamics and financial trajectory of Caduet, highlighting its growth prospects, key players, and the impact of various market factors.

Market Size and Growth

The global market for amlodipine besylate, a key component of Caduet, is projected to grow significantly. By 2032, the amlodipine besylate market is estimated to reach USD 0.56 billion, with a Compound Annual Growth Rate (CAGR) of 5.00% during the forecast period from 2024 to 2032[1].

Key Market Drivers

Several factors drive the growth of the Caduet market:

Increasing Prevalence of Cardiovascular Diseases

The rising incidence of hypertension and heart diseases, particularly among the aging population, is a significant driver. High blood pressure and high cholesterol often co-occur, affecting a substantial portion of the population. For instance, an estimated 55% of people with high blood pressure also have high cholesterol, and 43% of those with high cholesterol have high blood pressure[4].

Lifestyle Factors

Heightened alcohol and tobacco consumption, along with a sedentary lifestyle and inadequate dietary habits, contribute to the increasing demand for cardiovascular medications like Caduet[1].

Awareness and Healthcare Investments

Increased awareness programs addressing cardiovascular diseases and investments in cardiovascular departments further fuel the market growth[1].

Regional Analysis

North America

North America holds the largest market share for amlodipine besylate due to the high rate of high blood pressure linked to lifestyle factors and an aging population. The number of Americans aged 65 and older is expected to increase significantly, from 47 million in 2022 to 82 million by 2050, driving the demand for Caduet[1].

Europe

Europe is also experiencing a high aging rate, leading to an increased occurrence of chronic illnesses like high blood pressure. The EU-27 region is projected to see a significant rise in the number of individuals aged 65 and above, from 90.5 million in 2019 to 129.8 million by 2050[1].

Asia-Pacific

The Asia-Pacific region is the fastest-growing market due to the increasing incidence of hypertension and other cardiovascular diseases[1].

Key Players

The market for Caduet is dominated by several key players:

• Pfizer: As the manufacturer of Caduet, Pfizer plays a crucial role in the market.
• Mylan: Known for its generic versions of various drugs.
• Reddy’s Laboratories: A major player in the generic and branded pharmaceutical market.
• Apotex: Another significant player in the generic pharmaceutical sector.
• Teva Pharmaceutical: A global leader in generic and specialty medicines.
• Cipla: An Indian multinational pharmaceutical company.
• Hikma Pharmaceuticals: A multinational pharmaceutical company with a strong presence in the Middle East and North Africa.
• Strides Pharma: A global pharmaceutical company with a focus on generics and biosimilars.
• Upsher-Smith Laboratories: A U.S.-based pharmaceutical company specializing in generics and branded products.
• InvaGen Pharmaceuticals: A subsidiary of Cipla, focusing on generics and biosimilars[1].

Pricing and Cost Considerations

The cost of Caduet can vary significantly based on the dosage and the pharmacy. For example, a supply of 30 tablets of Caduet (5 mg-80 mg) can cost around $801 for cash-paying customers. Generic versions of amlodipine/atorvastatin are available at lower prices, starting from $229.44 for 30 tablets[2].

Clinical Efficacy and Impact

Caduet has been shown to significantly reduce the calculated 10-year risk of coronary heart disease (CHD) and fatal cardiovascular disease (CVD). The CRUCIAL trial demonstrated a relative risk reduction of 27% in CHD and 23% in fatal CVD after 12 months of treatment compared to usual care[4].

Financial Trajectory

Revenue Projections

The financial trajectory of Caduet is closely tied to the overall market for amlodipine besylate and atorvastatin. With the market expected to reach USD 0.56 billion by 2032, Caduet is likely to contribute significantly to this revenue, given its widespread use and clinical efficacy.

Patent and Generic Impact

The expiration of patents for key drugs, including Caduet, can impact revenue. However, the availability of generic versions helps maintain market presence. For instance, the generic version of amlodipine/atorvastatin is available at a lower cost, which can help sustain market share despite patent expirations[2].

Mergers and Acquisitions

Pfizer's strategic mergers, such as the acquisition of Wyeth, have helped the company diversify its portfolio and mitigate the impact of patent expirations. These mergers have enabled Pfizer to generate more earnings from its combined portfolio, including drugs like Caduet[3].

Market Challenges

Patent Cliff

The pharmaceutical industry faces significant challenges due to the patent cliff, where blockbuster drugs lose their exclusivity. Caduet, being a combination of two drugs, faces this challenge as both amlodipine besylate and atorvastatin have generic versions available. This can lead to a decline in revenue from branded sales[3].

Competitive Landscape

The market for cardiovascular medications is highly competitive, with numerous generic and branded options available. This competition can affect the pricing and market share of Caduet.

Key Takeaways

• The global amlodipine besylate market, which includes Caduet, is projected to reach USD 0.56 billion by 2032 with a CAGR of 5.00%.
• North America and Europe are significant markets due to the high prevalence of cardiovascular diseases and an aging population.
• Caduet has been clinically proven to reduce the risk of CHD and fatal CVD.
• Key players like Pfizer, Mylan, and Reddy’s Laboratories dominate the market.
• The financial trajectory is influenced by patent expirations, generic availability, and strategic mergers.

FAQs

What is Caduet used for?

Caduet is used to treat high blood pressure and high cholesterol by combining amlodipine besylate, a calcium channel blocker, and atorvastatin calcium, a statin[5].

How effective is Caduet in reducing cardiovascular risk?

Caduet has been shown to reduce the calculated 10-year risk of coronary heart disease by 27% and fatal cardiovascular disease by 23% after 12 months of treatment[4].

What are the key drivers of the Caduet market?

The key drivers include the increasing prevalence of cardiovascular diseases, lifestyle factors, and investments in cardiovascular healthcare[1].

Who are the major players in the Caduet market?

Major players include Pfizer, Mylan, Reddy’s Laboratories, Apotex, Teva Pharmaceutical, Cipla, Hikma Pharmaceuticals, Strides Pharma, Upsher-Smith Laboratories, and InvaGen Pharmaceuticals[1].

How does the patent cliff affect Caduet’s financial trajectory?

The patent cliff can lead to a decline in revenue from branded sales as generic versions of amlodipine besylate and atorvastatin become available. However, strategic mergers and diversification can help mitigate this impact[3].

Sources

1. Market Research Future, "Amlodipine Besylate Market Trends, Growth, Forecast 2032 | MRFR"
2. Drugs.com, "Caduet Prices, Coupons, Copay Cards & Patient Assistance"
3. Pharmaceutical Executive, "Attack of the Monster Merger"
4. Pfizer, "Caduet Reduces 10-Year Calculated Risk Of Coronary Heart Disease Fatal Cardiovascular Disease"
5. Drugs.com, "Caduet: Package Insert / Prescribing Information"