CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER Drug Patent Profile

Which patents cover Cardene In 4.8% Dextrose In Plastic Container, and when can generic versions of Cardene In 4.8% Dextrose In Plastic Container launch?

Cardene In 4.8% Dextrose 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 4.8% 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 4.8% Dextrose In Plastic Container

A generic version of CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER was approved as nicardipine hydrochloride by ANI PHARMS on October 28^th, 1996.

Summary for CARDENE IN 4.8% DEXTROSE 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
DailyMed Link:	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for CARDENE IN 4.8% 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 4.8% DEXTROSE IN PLASTIC CONTAINER clinical trials

Pharmacology for CARDENE IN 4.8% 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

US Patents and Regulatory Information for CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER

CARDENE IN 4.8% DEXTROSE 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 4.8% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-002	Jul 31, 2008		RX	Yes	Yes
Chiesi	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-002	Jul 31, 2008		RX	Yes	Yes			Y
Chiesi	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-002	Jul 31, 2008		RX	Yes	Yes
Chiesi	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-002	Jul 31, 2008		RX	Yes	Yes
Chiesi	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-002	Jul 31, 2008		RX	Yes	Yes			Y

International Patents for CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER

See the table below for patents covering CARDENE IN 4.8% DEXTROSE 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

CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CARDENE in 4.8% Dextrose

Introduction to CARDENE

CARDENE, also known as Nicardipine Hydrochloride, is a small molecule drug used in the treatment of various nervous system and cardiovascular diseases, particularly hypertension and certain types of angina[4].

Current Market Landscape

Pharmaceutical Industry Trends

The pharmaceutical industry is experiencing significant changes driven by various factors, including the expiration of patents, increasing biosimilar competition, and regulatory pressures such as the Inflation Reduction Act (IRA) of 2022. Despite these challenges, the industry is expected to see healthy revenue growth through 2027, driven by new drug approvals and robust pipeline assets[2].

Drug Distribution and Sales

The US drug distribution market, dominated by Cardinal Health, Cencora, and McKesson, is seeing growth driven by factors such as the popularity of GLP-1s (diabetes and weight-loss drugs) and an increase in specialty asset investments. These distributors play a crucial role in the supply chain, purchasing pharmaceuticals from biopharma firms and delivering them to healthcare providers, which allows manufacturers to focus on their core competencies[1].

CARDENE's Position in the Market

Therapeutic Indications

Nicardipine Hydrochloride, the active ingredient in CARDENE, targets Cav2.1 and is primarily used for treating hypertension and other cardiovascular disorders. This indicates a strong potential in the cardiovascular therapeutic area, which is a significant segment within the pharmaceutical market[4].

Competitive Landscape

The competitive landscape for drugs targeting Cav2.1 is intense, with companies like Bayer AG, LTL Pharma Co., Ltd., and CHIESI Farmaceutici SpA leading in the approved phase. This competition suggests that while CARDENE has a established presence, it must continue to innovate to remain competitive[4].

Financial Trajectory

Revenue Growth and Challenges

The financial trajectory of CARDENE is influenced by broader industry trends. While the pharmaceutical industry is expected to experience healthy revenue growth, there are challenges such as patent expirations and biosimilar competition that could impact specific drugs. For instance, the loss of exclusivity for major products and the rise of biosimilars can reduce revenue for branded drugs[2].

Pricing Dynamics

Drug pricing dynamics, particularly under the Inflation Reduction Act, will cap price increases across Medicare channels or require manufacturers to pay rebates for price increases above the rate of inflation. This regulation could impact the pricing strategy and margins for CARDENE and similar drugs[1][2].

Market Projections

Given the robust wave of new drug approvals and the strong pipeline assets in the pharmaceutical industry, companies with drugs like CARDENE are likely to see continued growth. However, this growth will be tempered by the need to adapt to changing regulatory environments and increasing competition.

Impact of Regulatory Changes

Inflation Reduction Act

The Inflation Reduction Act of 2022 introduces significant changes to drug pricing, including Medicare price negotiation and caps on price increases. This could affect the revenue and profitability of CARDENE, especially if it falls under the categories subject to these regulations[1][2].

Patent Expirations

As patents expire, generic or biosimilar alternatives become more prevalent, which can erode the market share of branded drugs like CARDENE. However, manufacturers can offset these losses through the growth of other approved therapies and pipeline assets[1][2].

Innovation and R&D

R&D Investments

Pharmaceutical companies, including those involved in the development of CARDENE, are prioritizing investments in research and development (R&D) to support revenue growth. This includes focusing on innovative treatments and expanding into new therapeutic areas[5].

Digital Transformation

The pharmaceutical industry is also embracing digital transformation, which can enhance customer engagement, streamline clinical trials, and improve overall efficiency. Companies that adapt these technologies are likely to have a competitive edge in the market[5].

Key Takeaways

• Market Trends: The pharmaceutical industry is experiencing growth driven by new drug approvals and robust pipeline assets, despite challenges from patent expirations and regulatory pressures.
• CARDENE's Position: Nicardipine Hydrochloride has a strong presence in the cardiovascular therapeutic area but faces intense competition.
• Financial Trajectory: Revenue growth for CARDENE will be influenced by industry trends, regulatory changes, and the need for continuous innovation.
• Regulatory Impact: The Inflation Reduction Act and patent expirations will require strategic adaptations to maintain market share and profitability.
• Innovation: Prioritizing R&D and embracing digital transformation are crucial for long-term success in the pharmaceutical industry.

FAQs

Q: What are the primary therapeutic indications for CARDENE? A: CARDENE, or Nicardipine Hydrochloride, is primarily used for treating hypertension and other cardiovascular disorders.

Q: How does the Inflation Reduction Act impact drug pricing? A: The Inflation Reduction Act caps price increases across Medicare channels or requires manufacturers to pay rebates for price increases above the rate of inflation.

Q: What are the major challenges facing the pharmaceutical industry in 2024? A: The industry faces challenges such as patent expirations, biosimilar competition, and regulatory pressures, including the Inflation Reduction Act.

Q: How are pharmaceutical companies adapting to changing market conditions? A: Companies are prioritizing R&D investments, focusing on innovative treatments, and embracing digital transformation to enhance customer engagement and streamline operations.

Q: What is the expected revenue growth for the pharmaceutical industry through 2027? A: The industry is expected to experience healthy revenue growth through 2027, driven by new drug approvals and robust pipeline assets.

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. FDA: "Controlled Correspondence: NICARDIPINE HYDROCHLORIDE-NDA"
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 and innovation?"