Nicardipine hydrochloride - Generic Drug Details

What are the generic drug sources for nicardipine hydrochloride and what is the scope of patent protection?

Nicardipine hydrochloride is the generic ingredient in ten branded drugs marketed by Chiesi, Ani Pharms, Bionpharma, Epic Pharma Llc, Glenmark Pharms Ltd, Norvium Bioscience, Senores Pharms, Skg Pharma, Am Regent, Amneal, Chengdu Shuode, Eugia Pharma, Hikma, Hikma Intl Pharms, Micro Labs, Navinta Llc, Rk Pharma, Sun Pharm, Wockhardt, Inforlife, and Cipla, and is included in twenty-five NDAs. There are six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Nicardipine hydrochloride has twenty-one patent family members in ten countries.

There are eleven drug master file entries for nicardipine hydrochloride. Twenty-four suppliers are listed for this compound.

Summary for nicardipine hydrochloride

International Patents:	21
US Patents:	6
Tradenames:	10
Applicants:	21
NDAs:	25
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	107
Clinical Trials:	53
Patent Applications:	2,641
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for nicardipine hydrochloride
What excipients (inactive ingredients) are in nicardipine hydrochloride?	nicardipine hydrochloride excipients list
DailyMed Link:	nicardipine hydrochloride at DailyMed

Recent Clinical Trials for nicardipine hydrochloride

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

Sponsor	Phase
Boston Medical Center	Phase 4
University of Illinois at Chicago	Early Phase 1
Nanjing First Hospital, Nanjing Medical University	N/A

See all nicardipine hydrochloride clinical trials

Pharmacology for nicardipine hydrochloride

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

Medical Subject Heading (MeSH) Categories for nicardipine hydrochloride

Antihypertensive Agents

Calcium Channel Blockers

Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for nicardipine hydrochloride

C08CA	Dihydropyridine derivatives
C08C	SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS
C08	CALCIUM CHANNEL BLOCKERS
C	Cardiovascular system

Paragraph IV (Patent) Challenges for NICARDIPINE HYDROCHLORIDE

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 nicardipine hydrochloride

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	7,659,291
Ani Pharms	NICARDIPINE HYDROCHLORIDE	nicardipine hydrochloride	CAPSULE;ORAL	074439-001	Dec 10, 1996		DISCN	No	No
Epic Pharma Llc	NICARDIPINE HYDROCHLORIDE	nicardipine hydrochloride	CAPSULE;ORAL	074928-002	Mar 19, 1998	AB	RX	No	Yes
Glenmark Pharms Ltd	NICARDIPINE HYDROCHLORIDE	nicardipine hydrochloride	CAPSULE;ORAL	216357-001	Dec 16, 2022	AB	RX	No	No
Skg Pharma	NICARDIPINE HYDROCHLORIDE	nicardipine hydrochloride	CAPSULE;ORAL	218202-001	Apr 10, 2024	AB	RX	No	No

Expired US Patents for nicardipine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	CARDENE	nicardipine hydrochloride	INJECTABLE;INJECTION	019734-001	Jan 30, 1992	5,164,405
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-002	Feb 21, 1992	3,985,758
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-002	Feb 21, 1992	5,198,226
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-003	Feb 21, 1992	3,985,758
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-001	Feb 21, 1992	3,985,758

International Patents for nicardipine hydrochloride

Country	Patent Number	Title	Estimated Expiration
Canada	2650922	COMPOSITIONS PHARMACEUTIQUES PREMELANGEES PRETES A L'EMPLOI (PRE-MIXED, READY-TO-USE PHARMACEUTICAL COMPOSITIONS)
Japan	2009534409
Mexico	2008013407	COMPOSICIONES DE BOLO IV PREMEZCLADAS, LISTAS PARA USO Y METODOS DE USO. (PRE-MIXED, READY-TO-USE IV BOLUS COMPOSITIONS AND METHODS OF USE.)
South Korea	20090037388	PRE-MIXED, READY-TO-USE IV BOLUS COMPOSITIONS AND METHODS OF USE
World Intellectual Property Organization (WIPO)	2007121483

Market Dynamics and Financial Trajectory for Nicardipine Hydrochloride

Introduction

Nicardipine hydrochloride, a dihydropyridine calcium channel blocker, is widely used in the treatment of hypertension and subarachnoid hemorrhage. The market for this drug has shown significant growth and is expected to continue on this upward trajectory. Here, we will delve into the market dynamics, financial performance, and future outlook for nicardipine hydrochloride.

Market Segmentation

The nicardipine hydrochloride market is segmented based on several key factors:

By Type

• Nicardipine Hydrochloride Injection: Available in various concentrations such as 20 mg-20 mL, 25 mg-10 mL, and 30 mg-10 mL[1].
• Nicardipine Hydrochloride Tablets: Classified into ordinary and sustained-release forms[4].

By Application

• Hypertension: The primary use for managing high blood pressure.
• Subarachnoid Hemorrhage: Used to prevent and treat cerebral vasospasm.
• Other Applications: Includes relief from angina and other cardiovascular conditions[1][4].

By Geography

• North America: A significant market due to high healthcare expenditure and advanced medical infrastructure.
• Europe: Another major market with a strong focus on healthcare.
• Asia-Pacific: Rapidly growing due to increasing healthcare needs and economic development.
• South America and Middle-East & Africa: Emerging markets with potential for future growth[1][4].

Market Dynamics

Drivers

• Increasing Prevalence of Hypertension: The rising global incidence of hypertension drives the demand for antihypertensive medications like nicardipine hydrochloride[1][4].
• Advancements in Healthcare: Improved diagnostic techniques and treatment protocols enhance the use of nicardipine hydrochloride.
• Growing Healthcare Expenditure: Increased spending on healthcare in various regions fuels market growth[1][4].

Restraints

• Competition from Generic Drugs: The presence of generic alternatives can reduce the market share of branded nicardipine hydrochloride products.
• Regulatory Challenges: Stringent regulatory requirements and approval processes can hinder market growth.
• Side Effects and Safety Concerns: Potential side effects and safety issues may limit the use of nicardipine hydrochloride in certain patient populations[1][4].

Opportunities

• Emerging Markets: The Asia-Pacific, South America, and Middle-East & Africa regions offer significant growth opportunities due to their expanding healthcare sectors.
• Research and Development: Continuous R&D can lead to new formulations and applications, expanding the market.
• Partnerships and Collaborations: Strategic partnerships among pharmaceutical companies can enhance market penetration and distribution[1][4].

Challenges

• Economic Factors: Economic downturns can affect healthcare spending and impact the market negatively.
• Patent Expirations: The expiration of patents for branded nicardipine hydrochloride products can lead to increased competition from generics.
• Compliance with Regulations: Adhering to changing regulatory requirements can be challenging and costly[1][4].

Financial Performance

Historical Data

• In 2013, Cornerstone Therapeutics reported significant growth in net sales of CARDENE I.V. (nicardipine hydrochloride), with $14.2 million in the second quarter, a substantial increase from $736,000 in the same quarter of 2012. This growth was largely due to the acquisition of product rights for CARDENE I.V.[2].

Current Market Size and Projections

• The nicardipine hydrochloride injection market is expected to experience robust growth from 2023 to 2031, driven by increasing demand and favorable market dynamics. The market size is projected to grow significantly, with forecasts indicating strong growth rates throughout the forecast period[1].
• Similarly, the nicardipine hydrochloride tablets market has shown rapid growth and is anticipated to continue this trend, with projections suggesting substantial expansion from 2023 to 2031[4].

Revenue and Growth Rates

• The market for nicardipine hydrochloride is valued in billions of USD and is expected to grow at a remarkable CAGR during the forecast period. The revenue growth is driven by increasing market penetration, product pricing strategies, and the dynamics of parent markets and their submarkets[1][4][5].

Competitive Landscape

Key Players

• Baxter International Inc.
• Hospira (Pfizer Inc.)
• Fresenius SE & Co. KGaA
• Novartis AG
• Sagent Pharmaceuticals Inc.
• Pfizer Inc.
• Luitpold Pharmaceuticals Inc. (American Regent Inc.)
• Mylan N.V.
• Bausch Health Companies Inc.
• Hikma Pharmaceuticals PLC[1].

Market Strategies

• Companies are focusing on expanding their product portfolios, enhancing sales and marketing efforts, and engaging in strategic partnerships to strengthen their market positions.
• The competitive landscape is also influenced by recent activities such as mergers and acquisitions, new product introductions, and collaborations among key players[1][4].

Clinical and Therapeutic Impact

Hemodynamic Effects

• Nicardipine hydrochloride has been shown to enhance myocardial performance in patients with severe chronic heart failure. It reduces arterial blood pressure, systemic vascular resistance, and pulmonary capillary wedge pressure while increasing cardiac index, stroke volume index, and left ventricular stroke work index[3].

Therapeutic Applications

• The drug is effective in treating hypertension and subarachnoid hemorrhage, and its sustained-release form helps in managing angina and other cardiovascular conditions[1][4].

Future Outlook

Market Growth

• The market for nicardipine hydrochloride is poised for significant growth, driven by increasing demand, favorable market dynamics, and the expanding healthcare sector in emerging markets[1][4][5].

Emerging Trends

• The integration of new technologies and innovative formulations is expected to shape the future of the nicardipine hydrochloride market.
• Growing awareness about cardiovascular health and the importance of early diagnosis and treatment will further drive market growth[1][4].

Key Takeaways

• The nicardipine hydrochloride market is segmented by type, application, and geography, with a strong presence in North America, Europe, and the Asia-Pacific region.
• The market is driven by the increasing prevalence of hypertension, advancements in healthcare, and growing healthcare expenditure.
• Key players are focusing on expanding their product portfolios and engaging in strategic partnerships to maintain market competitiveness.
• The drug has significant clinical and therapeutic benefits, particularly in enhancing myocardial performance and managing cardiovascular conditions.
• The future outlook is positive, with projections indicating robust growth rates and emerging trends shaping the market.

FAQs

What are the primary applications of nicardipine hydrochloride?

• The primary applications of nicardipine hydrochloride include the treatment of hypertension and subarachnoid hemorrhage, as well as relieving angina and other cardiovascular conditions[1][4].

Which regions are expected to drive the growth of the nicardipine hydrochloride market?

• The Asia-Pacific, North America, and Europe regions are expected to drive the growth of the nicardipine hydrochloride market due to their expanding healthcare sectors and increasing demand for antihypertensive medications[1][4].

What are the key factors driving the growth of the nicardipine hydrochloride market?

• The growth of the nicardipine hydrochloride market is driven by the increasing prevalence of hypertension, advancements in healthcare, growing healthcare expenditure, and the expanding healthcare sector in emerging markets[1][4].

Who are the key players in the nicardipine hydrochloride market?

• Key players in the nicardipine hydrochloride market include Baxter International Inc., Hospira (Pfizer Inc.), Fresenius SE & Co. KGaA, Novartis AG, and others[1].

What is the expected growth rate of the nicardipine hydrochloride market from 2023 to 2031?

• The nicardipine hydrochloride market is expected to grow at a remarkable CAGR from 2023 to 2031, driven by favorable market dynamics and increasing demand[1][4][5].

Sources

1. Market Research Intellect - Global Nicardipine Hydrochloride Injection Sales Market Size, Scope And Forecast[1].
2. GlobeNewswire - Cornerstone Therapeutics Reports Second Quarter 2013 Financial Results[2].
3. PubMed - Acute and Chronic Hemodynamic Effects of Nicardipine[3].
4. Market Research Intellect - Global Nicardipine Hydrochloride Tablets Market Size, Scope And Forecast[4].
5. Market Research Intellect - Global Nicardipine Hydrochloride API Market Size, Trends and Forecast[5].