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Last Updated: December 22, 2024

NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE Drug Patent Profile


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When do Nicardipine Hydrochloride In 0.9% Sodium Chloride patents expire, and when can generic versions of Nicardipine Hydrochloride In 0.9% Sodium Chloride launch?

Nicardipine Hydrochloride In 0.9% Sodium Chloride is a drug marketed by Cipla and Hikma Intl Pharms and is included in two NDAs.

The generic ingredient in NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 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 Nicardipine Hydrochloride In 0.9% Sodium Chloride

A generic version of NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE was approved as nicardipine hydrochloride by ANI PHARMS on October 28th, 1996.

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Summary for NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
Drug patent expirations by year for NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
Recent Clinical Trials for NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

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

SponsorPhase
Boston Medical CenterPhase 4
University of Illinois at ChicagoEarly Phase 1
Nanjing First Hospital, Nanjing Medical UniversityN/A

See all NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE clinical trials

US Patents and Regulatory Information for NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cipla NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE nicardipine hydrochloride INJECTABLE;INTRAVENOUS 215592-001 Sep 24, 2024 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hikma Intl Pharms NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE nicardipine hydrochloride INJECTABLE;INTRAVENOUS 022276-003 Apr 7, 2016 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Cipla NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE nicardipine hydrochloride INJECTABLE;INTRAVENOUS 215592-002 Sep 24, 2024 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hikma Intl Pharms NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE nicardipine hydrochloride INJECTABLE;INTRAVENOUS 022276-002 Apr 7, 2016 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Nicardipine Hydrochloride in 0.9% Sodium Chloride Injection

Market Overview

Nicardipine Hydrochloride in 0.9% Sodium Chloride Injection is a critical medication used for the short-term treatment of hypertension, particularly when oral therapy is not feasible or desirable. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Market Size and Growth

The Nicardipine Hydrochloride Injection market has experienced significant growth in recent years. According to market research, the market is expected to continue its upward trend from 2023 to 2031, driven by robust growth rates. The market size is categorized based on type (e.g., 20 mg-20 mL, 25 mg-10 mL, 30 mg-10 mL) and application (hypertension, subarachnoid hemorrhage), as well as geographical regions[1].

Financial Performance

Historically, the financial performance of Nicardipine Hydrochloride Injection has been impressive. For instance, in the second quarter of 2013, Cornerstone Therapeutics reported net sales of $14.2 million for CARDENE I.V. (nicardipine hydrochloride), a substantial increase from $736,000 in the second quarter of 2012. This growth was largely due to the acquisition of product rights for CARDENE I.V. in June 2012[2].

Recent Market Data

As of 2020, US sales of Nicardipine Hydrochloride in 0.9% Sodium Chloride Injection, 200mL, were approximately $82 million for the 12 months ending January 2020, according to IQVIA. This figure highlights the drug's significant market presence and revenue generation[3].

Market Drivers

Several factors drive the growth of the Nicardipine Hydrochloride Injection market:

Increasing Prevalence of Hypertension

The rising prevalence of hypertension globally is a major driver. As the population ages and lifestyle factors contribute to higher blood pressure rates, the demand for effective hypertension treatments like nicardipine hydrochloride increases.

Advancements in Formulation

The introduction of ready-to-use bags, as seen with Hikma's launch in 2020, enhances convenience and reduces preparation time for healthcare professionals. This innovation can increase adoption rates and improve patient outcomes[3].

Expanding Product Portfolios

Companies like Hikma, which is the third largest US supplier of generic injectable medicines, continue to expand their product portfolios. This expansion includes various formulations of nicardipine hydrochloride, such as 10mL vials and ready-to-use bags, broadening the choices available to hospitals[3].

Market Restraints

Despite the growth, there are several restraints to consider:

Safety Concerns

Nicardipine hydrochloride has specific contraindications, such as advanced aortic stenosis, and requires careful dose titration in patients with renal or hepatic impairment. These safety concerns can limit its use in certain patient populations[3].

Regulatory Challenges

The regulatory environment can pose challenges. For example, compounds like nicardipine hydrochloride may face stringent approval processes or be denied for certain uses if medical evidence is insufficient[5].

Market Opportunities

Growing Demand in Emerging Markets

Emerging markets in regions like Asia-Pacific, South America, and the Middle-East and Africa present significant opportunities for growth. Increasing healthcare spending and improving healthcare infrastructure in these regions can drive demand for nicardipine hydrochloride injections[1].

Generic Market Expansion

The entry of generic versions, such as Hikma's launch, can increase market competition and reduce costs, making the drug more accessible to a wider patient base[3].

Market Challenges

Competition from Alternative Treatments

The market faces competition from other hypertension treatments, including oral medications and other injectable drugs. This competition can impact market share and pricing strategies.

Economic Factors

Economic fluctuations and changes in healthcare policies can affect the market. For instance, changes in reimbursement policies or economic downturns can reduce healthcare spending and impact drug sales.

Financial Projections

The financial trajectory of nicardipine hydrochloride injections is positive, with forecasts indicating continued growth. The market is expected to expand significantly from 2023 to 2031, driven by increasing demand and the introduction of new formulations.

Revenue Projections

The market size is projected to grow substantially, with revenue expected to increase across various segments, including different types and applications, as well as geographical regions[1].

Gross Margin and Profitability

Companies like Cornerstone Therapeutics have reported high gross margins, up to 75%, due to the addition of products like CARDENE I.V. and growth in net product sales. This trend is expected to continue, contributing to the overall profitability of the market[2].

Key Takeaways

  • Market Growth: The Nicardipine Hydrochloride Injection market is expected to grow significantly from 2023 to 2031.
  • Financial Performance: Historical data shows substantial revenue growth, with recent sales figures indicating a strong market presence.
  • Drivers: Increasing prevalence of hypertension, advancements in formulation, and expanding product portfolios drive market growth.
  • Restraints: Safety concerns, regulatory challenges, and competition from alternative treatments are key restraints.
  • Opportunities: Growing demand in emerging markets and the expansion of the generic market present significant opportunities.
  • Challenges: Economic factors and competition from other treatments are challenges to consider.

FAQs

What is the primary use of Nicardipine Hydrochloride Injection?

Nicardipine Hydrochloride Injection is primarily used for the short-term treatment of hypertension when oral therapy is not feasible or desirable.

How has the market for Nicardipine Hydrochloride Injection performed historically?

Historically, the market has shown significant growth, with notable increases in sales revenue. For example, Cornerstone Therapeutics reported a substantial increase in sales from $736,000 to $14.2 million in the second quarter of 2013 compared to the same period in 2012[2].

What are the key drivers of the Nicardipine Hydrochloride Injection market?

Key drivers include the increasing prevalence of hypertension, advancements in formulation, and the expansion of product portfolios by companies like Hikma[1][3].

What are the main restraints on the Nicardipine Hydrochloride Injection market?

Main restraints include safety concerns, regulatory challenges, and competition from alternative treatments[3][5].

What are the financial projections for the Nicardipine Hydrochloride Injection market?

The market is projected to grow significantly from 2023 to 2031, with substantial increases in revenue expected across various segments[1].

Who are the major players in the Nicardipine Hydrochloride Injection market?

Major players include companies like Hikma and Cornerstone Therapeutics, which have significant market presence and are expanding their product portfolios[2][3].

Sources

  1. Market Research Intellect: "Global Nicardipine Hydrochloride Injection Sales Market Size, Scope And Forecast 2021-2031"[1]
  2. GlobeNewswire: "Cornerstone Therapeutics Reports Second Quarter 2013 Financial Results"[2]
  3. Hikma: "Hikma launches Nicardipine Hydrochloride premixed injection in ready-to-use bags"[3]
  4. Market Research Intellect: "Global Nicardipine Hydrochloride Tablets Market Size, Scope And Forecast 2021-2031"[4]
  5. JSTOR: "Finance Committee Unveils Details Of Monumental Drug Pricing Bill"[5]

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