cardene in 0.83% sodium chloride in plastic container Drug Patent Profile

Which patents cover Cardene In 0.83% Sodium Chloride In Plastic Container, and what generic alternatives are available?

Cardene In 0.83% Sodium Chloride In Plastic Container is a drug marketed by Chiesi and is included in one NDA. There are six patents protecting this drug.

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

The generic ingredient in CARDENE IN 0.83% SODIUM CHLORIDE 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 0.83% Sodium Chloride In Plastic Container

A generic version of cardene in 0.83% sodium chloride in plastic container was approved as nicardipine hydrochloride by ANI PHARMS on October 28^th, 1996.

Summary for cardene in 0.83% sodium chloride in plastic container

International Patents:	21
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	55
Clinical Trials:	9
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cardene in 0.83% sodium chloride in plastic container
DailyMed Link:	cardene in 0.83% sodium chloride in plastic container at DailyMed

Recent Clinical Trials for cardene in 0.83% sodium chloride in plastic container

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

Sponsor	Phase
Boston Medical Center	Phase 4
University of Cincinnati	Phase 2
Vanderbilt University Medical Center	Phase 2

See all cardene in 0.83% sodium chloride in plastic container clinical trials

Pharmacology for cardene in 0.83% sodium chloride 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

US Patents and Regulatory Information for cardene in 0.83% sodium chloride in plastic container

cardene in 0.83% sodium chloride in plastic container is protected by six 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 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-004	Nov 7, 2008	AP	RX	Yes	Yes	7,659,291
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	11,547,758
Chiesi	CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-004	Nov 7, 2008	AP	RX	Yes	Yes	8,455,524
Chiesi	CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-004	Nov 7, 2008	AP	RX	Yes	Yes	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	9,364,564		Y

International Patents for cardene in 0.83% sodium chloride in plastic container

See the table below for patents covering cardene in 0.83% sodium chloride in plastic container 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 in 0.83% sodium chloride in plastic container Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CARDENE I.V. (Nicardipine Hydrochloride)

Introduction to CARDENE I.V.

CARDENE I.V. (nicardipine hydrochloride) is a calcium channel blocker used for the short-term treatment of hypertension when oral therapy is not feasible or desirable. It is particularly effective in treating acute severe hypertension or acute postoperative hypertension[3].

Pharmaceutical Industry Overview

The pharmaceutical industry is experiencing significant changes driven by various factors, including regulatory pressures, patent expirations, and increasing competition from biosimilars and generics.

• Revenue Growth and Challenges: Despite headwinds such as product exclusivity losses and biosimilar competition, the global branded pharmaceutical industry is expected to see healthy revenue growth through 2027. Companies like Eli Lilly & Co. and Novo Nordisk are leading this growth, particularly with their obesity and diabetes treatments[2].
• Regulatory Environment: The Inflation Reduction Act (IRA) of 2022 has introduced price caps and Medicare negotiation on certain products, which will impact revenue and margins for pharmaceutical companies. However, these companies are expected to adapt by prioritizing R&D and M&A to support revenue growth[2].

Market Position of CARDENE I.V.

CARDENE I.V. operates within the broader cardiovascular therapeutic area, which is a significant segment of the pharmaceutical market.

• Competitive Landscape: The treatment of hypertension involves a range of drugs, with nicardipine hydrochloride being one of the options. Companies like Bayer AG, LTL Pharma Co., Ltd., and CHIESI Farmaceutici SpA are actively involved in the development of drugs targeting similar mechanisms, indicating a competitive landscape[4].
• Indications and Usage: CARDENE I.V. is specifically indicated for short-term hypertension management, which positions it as a niche product within the cardiovascular market. Its efficacy in different clinical settings, such as acute severe hypertension and postoperative hypertension, makes it a valuable option for healthcare providers[3].

Financial Trajectory

The financial performance of CARDENE I.V. is influenced by several factors, including market demand, competition, and regulatory changes.

• Revenue Potential: Given the stable demand for hypertension treatments, CARDENE I.V. is likely to maintain a steady revenue stream. However, its growth may be modest compared to newer therapies in other therapeutic areas like oncology or rare diseases[1][2].
• Cost and Pricing Dynamics: The pharmaceutical industry is under scrutiny for drug pricing, and regulations like the IRA are designed to cap price increases. This could impact the pricing strategy for CARDENE I.V. and potentially reduce its revenue if prices are capped or rebates are required[2].

Impact of Macro Trends

Several macro trends are shaping the financial trajectory of CARDENE I.V.

• Aging Population: An aging population increases the demand for cardiovascular treatments, including hypertension management. This demographic trend is expected to support the sales of CARDENE I.V.[1].
• Healthcare Access and Expenditures: Growing access to healthcare and increasing prescription expenditures are positive drivers for the pharmaceutical industry, including niche products like CARDENE I.V.[1].

R&D and Innovation

The development of new drugs and therapies is crucial for the long-term financial health of pharmaceutical companies.

• Target Cav2.1: Nicardipine hydrochloride targets Cav2.1, a mechanism with promising potential in treating cardiovascular disorders. Ongoing R&D in this area could lead to new indications or improved formulations, potentially boosting the product's financial performance[4].
• Digital and Personalized Medicine: The pharmaceutical industry is increasingly adopting digital technologies and personalized medicine approaches. While CARDENE I.V. is a traditional small molecule drug, its manufacturer could benefit from integrating these trends into their broader product portfolio[5].

Distribution and Supply Chain

The distribution of pharmaceuticals is a critical aspect of their financial trajectory.

• Drug Distribution Industry: The big three drug distributors in the US—Cardinal Health, Cencora, and McKesson—control a significant portion of the market. These distributors play a crucial role in ensuring the safe and efficient delivery of products like CARDENE I.V. to healthcare providers[1].

Challenges and Headwinds

Despite the positive trends, there are several challenges that CARDENE I.V. and its manufacturer must navigate.

• Patent Expirations and Biosimilars: The pharmaceutical industry is facing a wave of patent expirations and increasing biosimilar competition. While CARDENE I.V. is not directly impacted by these trends, the overall market dynamics could affect its sales and pricing[2].
• Regulatory Pressures: The IRA and other regulatory measures aimed at controlling drug prices will continue to pose challenges for pharmaceutical companies. Manufacturers must adapt to these changes to maintain profitability[2].

Key Takeaways

• Stable Revenue Stream: CARDENE I.V. is expected to maintain a stable revenue stream due to its niche position in hypertension management.
• Regulatory Impact: The product's pricing and revenue could be affected by regulatory measures aimed at controlling drug prices.
• R&D Potential: Ongoing R&D targeting Cav2.1 could lead to new opportunities for the product.
• Macro Trends: An aging population and increasing healthcare access are positive drivers for the product's sales.

Frequently Asked Questions (FAQs)

Q: What is CARDENE I.V. used for? A: CARDENE I.V. (nicardipine hydrochloride) is used for the short-term treatment of hypertension when oral therapy is not feasible or desirable.

Q: How does the competitive landscape affect CARDENE I.V.? A: The competitive landscape for hypertension treatments is robust, with several companies developing drugs targeting similar mechanisms. However, CARDENE I.V.'s specific indications and efficacy make it a valuable option.

Q: What are the key regulatory challenges for CARDENE I.V.? A: The Inflation Reduction Act (IRA) and other regulatory measures aimed at controlling drug prices are significant challenges for CARDENE I.V. and its manufacturer.

Q: How does the aging population impact CARDENE I.V.'s sales? A: An aging population increases the demand for cardiovascular treatments, including hypertension management, which supports the sales of CARDENE I.V.

Q: What role do drug distributors play in the financial trajectory of CARDENE I.V.? A: Drug distributors like Cardinal Health, Cencora, and McKesson ensure the safe and efficient delivery of CARDENE I.V. to healthcare providers, which is crucial for its financial performance.

Cited Sources:

1. Morningstar - "3 Stocks to Watch in the Drug Distribution Industry"
2. S&P Global Ratings - "Pharmaceutical Industry 2024 Credit Outlook Is Stable As Revenue Growth Mitigates Pressures"
3. Baxter - "CARDENE I.V. (nicardipine hydrochloride) Injection"
4. Patsnap Synapse - "Unleashing the Power of nicardipine hydrochloride - A Comprehensive Review on R&D Breakthroughs"
5. PwC - "Next in pharma: How can pharmaceutical companies drive growth?"