CARDENE Drug Patent Profile

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

Cardene is a drug marketed by Chiesi and is included in three NDAs. There are six patents protecting this drug.

The generic ingredient in CARDENE is nicardipine hydrochloride. There are eleven drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cardene

A generic version of CARDENE was approved as nicardipine hydrochloride by ANI PHARMS on October 28^th, 1996.

Summary for CARDENE

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	173
Clinical Trials:	9
Patent Applications:	3,776
Drug Prices:	Drug price information for CARDENE
What excipients (inactive ingredients) are in CARDENE?	CARDENE excipients list
DailyMed Link:	CARDENE at DailyMed

See drug prices for CARDENE

Recent Clinical Trials for CARDENE

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

Sponsor	Phase
Boston Medical Center	Phase 4
National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2
University of Cincinnati	Phase 2

See all CARDENE clinical trials

Pharmacology for CARDENE

Drug Class	Dihydropyridine Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors

US Patents and Regulatory Information for CARDENE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-003	Feb 21, 1992		DISCN	Yes	No
Chiesi	CARDENE	nicardipine hydrochloride	CAPSULE;ORAL	019488-001	Dec 21, 1988		DISCN	Yes	No
Chiesi	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-002	Jul 31, 2008		RX	Yes	Yes	7,659,291
Chiesi	CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-005	Nov 7, 2008		DISCN	Yes	No	7,612,102		Y
Chiesi	CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-004	Nov 7, 2008	AP	RX	Yes	Yes	10,758,616		Y
Chiesi	CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-004	Nov 7, 2008	AP	RX	Yes	Yes	7,659,291

Expired US Patents for CARDENE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	CARDENE	nicardipine hydrochloride	CAPSULE;ORAL	019488-001	Dec 21, 1988	3,985,758
Chiesi	CARDENE	nicardipine hydrochloride	INJECTABLE;INJECTION	019734-001	Jan 30, 1992	5,164,405
Chiesi	CARDENE	nicardipine hydrochloride	INJECTABLE;INJECTION	019734-001	Jan 30, 1992	4,880,823
Chiesi	CARDENE	nicardipine hydrochloride	INJECTABLE;INJECTION	019734-001	Jan 30, 1992	3,985,758

International Patents for CARDENE

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

Country	Patent Number	Title	Estimated Expiration
Denmark	142869
Australia	2007237903	Pre-mixed, ready-to-use iv bolus compositions and methods of use
Canada	2650922
United Kingdom	9004385
China	101484136	Pre-mixed, ready-to-use pharmaceutical compositions
Brazil	PI0710287

CARDENE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CARDENE

Introduction

CARDENE, also known as nicardipine hydrochloride, is a calcium channel blocker used primarily in the treatment of hypertension and angina. To understand its market dynamics and financial trajectory, we need to delve into various aspects including its pharmacological profile, market competition, regulatory environment, and financial performance of related companies.

Pharmacological Profile of CARDENE

CARDENE is a small molecule drug that targets the Cav2.1 calcium channel, which is involved in the regulation of vascular smooth muscle and cardiac muscle. It produces significant vasodilation, leading to decreased systemic vascular resistance and blood pressure. The drug is effective in treating hypertension and chronic stable angina, with demonstrated improvements in exercise tolerance and reduced frequency of anginal attacks[3][4].

Market Competition

The market for calcium channel blockers, including CARDENE, is competitive and involves several major pharmaceutical companies. Companies like Bayer AG, LTL Pharma Co., Ltd., and CHIESI Farmaceutici SpA are actively involved in the research and development of drugs targeting the Cav2.1 channel. This competition indicates a robust and innovative landscape in the treatment of cardiovascular and nervous system diseases[4].

Indications and Usage

CARDENE is primarily indicated for the treatment of hypertension and angina. Its antihypertensive efficacy has been demonstrated in multiple placebo-controlled studies, showing significant reductions in both systolic and diastolic blood pressure. For angina, it increases exercise tolerance and reduces the frequency of anginal attacks[3].

Regulatory Environment

The regulatory environment for drugs like CARDENE is stringent and involves rigorous clinical trials to ensure safety and efficacy. The FDA approval process is a critical milestone, and any changes in regulatory policies, such as those related to drug pricing and reimbursement, can significantly impact the market dynamics. For example, the Inflation Reduction Act, which caps price increases for certain drugs, could influence the pricing strategies of pharmaceutical companies[1].

Financial Performance of Related Companies

While CARDENE itself is not a standalone financial entity, the financial performance of companies involved in its distribution and related pharmaceuticals can provide insights into its market trajectory.

Drug Distribution Industry

The US drug distribution market, dominated by companies like Cardinal Health, Cencora, and McKesson, has seen significant growth. These companies have benefited from macro trends such as an aging population, growth in prescription expenditures, and increasing access to healthcare. The rise of GLP-1s (diabetes and weight-loss drugs) has been a particular driver of growth, contributing to double-digit year-over-year sales increases for these distributors[1].

Pharmaceutical Companies

Pharmaceutical companies developing and marketing drugs like CARDENE also play a crucial role. These companies invest heavily in R&D to maintain their competitive edge. For instance, Bayer AG, one of the key players in the development of Cav2.1 targeting drugs, would reflect the financial health and R&D investments in their financial reports[4].

Financial Trajectory

Revenue and Growth

The revenue generated by drugs like CARDENE is influenced by several factors, including prescription rates, pricing dynamics, and competition. Given the competitive landscape, companies must continuously innovate and expand their product portfolios to maintain market share. The financial trajectory for CARDENE would likely follow the broader trends in the pharmaceutical industry, with growth driven by increasing demand for cardiovascular and hypertension treatments[1].

Challenges and Opportunities

One of the significant challenges facing drugs like CARDENE is the expiring patents of blockbuster drugs, which can lead to generic competition and reduced margins. However, the growth in other therapeutic areas such as oncology, rare diseases, and neurology provides opportunities for expansion and innovation. The increasing focus on personalized medicine and AI-driven healthcare solutions could also open new avenues for CARDENE and similar drugs[1][5].

Key Takeaways

• Pharmacological Profile: CARDENE is a calcium channel blocker effective in treating hypertension and angina.
• Market Competition: The market is competitive with several major pharmaceutical companies involved in R&D.
• Regulatory Environment: Stringent FDA regulations and policies like the Inflation Reduction Act impact the market.
• Financial Performance: Growth is driven by macro trends and innovation in the pharmaceutical industry.
• Challenges and Opportunities: Expiring patents pose challenges, while new therapeutic areas offer opportunities.

FAQs

What is CARDENE used for?

CARDENE, or nicardipine hydrochloride, is used primarily for the treatment of hypertension and chronic stable angina.

How does CARDENE work?

CARDENE works by targeting the Cav2.1 calcium channel, leading to vasodilation and a decrease in systemic vascular resistance and blood pressure.

What companies are involved in the development of drugs like CARDENE?

Companies like Bayer AG, LTL Pharma Co., Ltd., and CHIESI Farmaceutici SpA are actively involved in the development of drugs targeting the Cav2.1 channel.

How does the regulatory environment impact CARDENE?

The regulatory environment, including FDA approvals and policies like the Inflation Reduction Act, can significantly impact the pricing and market dynamics of CARDENE.

What are the financial prospects for CARDENE?

The financial prospects for CARDENE are tied to the broader trends in the pharmaceutical industry, with growth potential in areas like oncology, rare diseases, and neurology.

Sources

1. Morningstar: "3 Stocks to Watch in the Drug Distribution Industry"
2. Cardlytics: "Cardlytics Announces Fourth Quarter and Full Year 2023 Financial Results"
3. FDA: "CARDENE - accessdata.fda.gov"
4. Patsnap Synapse: "Unleashing the Power of nicardipine hydrochloride - A Comprehensive Review on R&D Breakthroughs"
5. Cardea: "Cardea Acquires Select Assets and Secures $25 Million Capital Commitment from Leading Global Investors"