CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER Drug Patent Profile

Which patents cover Cardene In 5.0% Dextrose In Plastic Container, and when can generic versions of Cardene In 5.0% Dextrose In Plastic Container launch?

Cardene In 5.0% Dextrose In Plastic Container is a drug marketed by Chiesi and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-one patent family members in ten countries.

The generic ingredient in CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER 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 In 5.0% Dextrose In Plastic Container

A generic version of CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER was approved as nicardipine hydrochloride by ANI PHARMS on October 28^th, 1996.

Summary for CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER

International Patents:	21
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	55
Clinical Trials:	9
DailyMed Link:	CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER

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

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

See all CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER clinical trials

Pharmacology for CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER

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

Paragraph IV (Patent) Challenges for CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER	Injection	nicardipine hydrochloride	2.5 mg/mL, 10 mL Ampoules	019734	1	2006-12-27

US Patents and Regulatory Information for CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER

CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER is protected by four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chiesi	CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-005	Nov 7, 2008		DISCN	Yes	No	8,455,524
Chiesi	CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-005	Nov 7, 2008		DISCN	Yes	No	9,364,564		Y
Chiesi	CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-005	Nov 7, 2008		DISCN	Yes	No	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

International Patents for CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER

See the table below for patents covering CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER around the world.

Country	Patent Number	Title	Estimated Expiration
Belgium	811324
Canada	2649779	COMPOSITIONS EN BOLUS IV PRE-MELANGEES PRETES A L'EMPLOI ET PROCEDES D'UTILISATION (PRE-MIXED, READY-TO-USE IV BOLUS COMPOSITIONS AND METHODS OFUSE)
Japan	S5714348
South Korea	910003555
Canada	2895102	COMPOSITIONS PHARMACEUTIQUES PREMELANGEES PRETES A L'EMPLOI (PRE-MIXED, READY-TO-USE PHARMACEUTICAL COMPOSITIONS)
Brazil	PI0709617

CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cardene in 5.0% Dextrose in Plastic Containers

Introduction

Cardene, also known as nicardipine hydrochloride, is a calcium channel blocker used for the short-term treatment of hypertension when oral therapy is not feasible. Here, we will delve into the market dynamics and financial trajectory of Cardene, particularly when formulated in 5.0% dextrose solutions and packaged in plastic containers.

Market Need and Indications

Cardene IV Premixed Injection is indicated for the short-term treatment of hypertension, especially in scenarios where oral therapy is not possible. This includes patients in intensive care or those undergoing surgery who require rapid blood pressure management[4].

Formulation and Stability

The stability of nicardipine hydrochloride in intravenous solutions is crucial for its efficacy and safety. Studies have shown that nicardipine hydrochloride remains stable in glass containers for up to seven days in various solutions, including 5% dextrose. However, when stored in polyvinyl chloride (PVC) containers, the drug concentrations can decline significantly, especially in solutions like lactated Ringer's injection or 5% dextrose and lactated Ringer's injection[1].

Packaging and Container Material

The choice of container material is vital for maintaining the stability of the drug. Cardene IV Premixed Injection is available in a 200 mL GALAXY container made from multilayered plastic, which is in contact with the polyethylene layer of the container. This material is designed to minimize leachables and ensure the solution remains stable within the expiration period[4].

Market Competition

The antihypertensive market is highly competitive, with various calcium channel blockers and other classes of antihypertensive drugs available. However, Cardene's specific formulation and packaging, particularly in 5% dextrose solutions, position it uniquely for certain clinical needs. The lack of significant advancements in oral vitamin K antagonist (VKA) anticoagulants, as highlighted by the innovative work of companies like Cadrenal Therapeutics, underscores the ongoing need for reliable and stable intravenous formulations like Cardene[2].

Regulatory Environment

The regulatory environment plays a critical role in the market dynamics of pharmaceuticals. Cardene IV Premixed Injection has undergone rigorous testing and has been approved by regulatory bodies such as the FDA. The approval process includes detailed reviews of the drug's chemistry, pharmacology, and clinical efficacy, ensuring that the product meets stringent safety and efficacy standards[4].

Financial Trajectory

Development Costs

The development of a new drug, including formulations like Cardene in 5% dextrose, is a costly and risky endeavor. Historical data indicate that the average after-tax R&D cash outlay for each new drug that reached the market in the 1980s was about $65 million, with the full after-tax cost compounded to market approval being roughly $194 million[5].

Market Returns

Despite the high development costs, pharmaceutical R&D can yield significant financial returns. Drugs approved between 1984-88 had higher sales revenues in the early years after approval compared to those approved earlier. This suggests that successful drugs, including niche products like Cardene, can generate substantial revenue and provide a return on investment[5].

Pricing and Reimbursement

The pricing of Cardene IV Premixed Injection is influenced by various factors, including production costs, market competition, and reimbursement policies. Given its specific indications and the need for stable intravenous formulations, Cardene may command a premium price, especially in critical care settings.

Market Trends

Increasing Demand for Critical Care Solutions

The demand for critical care solutions, including intravenous antihypertensives like Cardene, is increasing due to the growing need for intensive care services. This trend is driven by an aging population and the rise in complex medical conditions requiring intensive care.

Advances in Packaging Technology

Advances in packaging technology, such as the use of multilayered plastic containers, enhance the stability and safety of intravenous solutions. These innovations can extend the shelf life of products like Cardene and improve patient outcomes.

Challenges and Opportunities

Stability Issues in PVC Containers

One of the significant challenges for Cardene in 5% dextrose solutions is the stability issue when stored in PVC containers. This necessitates careful selection of container materials to ensure the drug remains effective throughout its shelf life[1].

Expanding Clinical Use

There is an opportunity to expand the clinical use of Cardene beyond its current indications. For instance, its stability in certain solutions could make it a preferred choice for patients requiring long-term intravenous antihypertensive therapy.

Key Takeaways

• Stability and Packaging: Cardene in 5% dextrose is stable in glass containers but may degrade in PVC containers, highlighting the importance of container material.
• Market Need: The drug addresses a specific need in critical care settings for short-term hypertension management.
• Regulatory Approval: Cardene has undergone rigorous regulatory approval, ensuring its safety and efficacy.
• Financial Trajectory: Despite high development costs, successful pharmaceuticals can yield significant financial returns.
• Market Trends: Increasing demand for critical care solutions and advances in packaging technology are favorable trends for Cardene.

FAQs

What is Cardene used for?

Cardene (nicardipine hydrochloride) is used for the short-term treatment of hypertension when oral therapy is not feasible.

Why is the choice of container material important for Cardene?

The choice of container material is crucial because nicardipine hydrochloride can degrade in PVC containers, leading to a loss of potency.

What are the regulatory approvals for Cardene IV Premixed Injection?

Cardene IV Premixed Injection has been approved by the FDA and undergoes rigorous testing to ensure safety and efficacy.

How does the market competition affect Cardene?

Cardene competes in a highly competitive antihypertensive market but is uniquely positioned due to its specific formulation and packaging.

What are the potential financial returns for Cardene?

Despite high development costs, Cardene can generate significant revenue due to its niche market and critical care applications.