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Last Updated: December 26, 2024

NICARDIPINE Drug Patent Profile


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Which patents cover Nicardipine, and when can generic versions of Nicardipine launch?

Nicardipine is a drug marketed by Ani Pharms, Bionpharma, Epic Pharma Llc, Glenmark Pharms Ltd, Norvium Bioscience, Senores Pharms, Skg Pharma, Am Regent, Amneal, Chengdu Shuode, Eugia Pharma, Hikma Intl Pharms, Micro Labs, Navinta Llc, Rk Pharma, Sun Pharm, West-ward Pharms Int, Wockhardt, Inforlife, and Cipla. and is included in twenty-two NDAs.

The generic ingredient in NICARDIPINE 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

A generic version of NICARDIPINE was approved as nicardipine hydrochloride by ANI PHARMS on October 28th, 1996.

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Summary for NICARDIPINE
US Patents:0
Applicants:20
NDAs:22
Drug Prices: Drug price information for NICARDIPINE
DailyMed Link:NICARDIPINE at DailyMed
Drug patent expirations by year for NICARDIPINE
Drug Prices for NICARDIPINE

See drug prices for NICARDIPINE

US Patents and Regulatory Information for NICARDIPINE

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
West-ward Pharms Int NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride INJECTABLE;INJECTION 078714-001 Dec 28, 2009 DISCN No No ⤷  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
Wockhardt NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride INJECTABLE;INJECTION 090671-001 Nov 17, 2009 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ani Pharms NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride CAPSULE;ORAL 074439-001 Dec 10, 1996 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Skg Pharma NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride CAPSULE;ORAL 218202-002 Apr 10, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Micro Labs NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride INJECTABLE;INJECTION 216420-001 Jul 7, 2023 AP RX No No ⤷  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 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Nicardipine Hydrochloride

Introduction to Nicardipine Hydrochloride

Nicardipine hydrochloride is a calcium channel blocker widely used to treat high blood pressure and relieve angina. The market for this drug is experiencing significant growth, driven by several key factors.

Market Size and Growth Projections

The nicardipine hydrochloride market has demonstrated robust growth in recent years and is expected to continue this trend. Here are some key projections:

  • Nicardipine Hydrochloride Tablets Market: This market is anticipated to grow substantially from 2023 to 2031, with the global market size expected to reach USD billions by the end of the forecast period[1].
  • Nicardipine Hydrochloride API Market: The global API market was valued at approximately USD 450 million in 2023 and is projected to reach around USD 750 million by 2032[2].
  • Nicardipine Hydrochloride Injection Market: This market is also poised for significant growth, driven by increasing incidences of hypertension and related cardiovascular diseases. The demand is expected to soar as healthcare systems prioritize effective blood pressure management[3].

Market Segmentation

The nicardipine hydrochloride market is segmented in various ways to understand its dynamics better:

  • By Type:

    • Tablets: Ordinary and sustained-release tablets are key segments, with sustained-release formulations gaining attention for their prolonged therapeutic effects[1].
    • API: Segmented by purity levels (≥99% and <99%)[4].
    • Injection: Traditional intravenous administration and novel formulations like sustained-release injections are prominent segments[3].
  • By Application:

    • High Blood Pressure: The primary application, with a growing demand due to the increasing prevalence of hypertension.
    • Angina: Another significant application, particularly in hospital settings where rapid blood pressure control is crucial.
    • Others: Includes various other therapeutic uses[1][3].
  • By Geography:

    • North America: A significant market due to advanced healthcare infrastructure and high demand.
    • Europe: Characterized by stringent regulations and a diversified approach, with countries like Germany and France leading in consumption.
    • Asia-Pacific: Rapidly evolving market driven by increasing cardiovascular diseases and an aging population.
    • South America and Middle-East & Africa: Emerging markets with growing demand due to improving healthcare access and awareness[1][3][4].

Drivers of Market Growth

Several factors are driving the growth of the nicardipine hydrochloride market:

  • Increasing Incidences of Hypertension: The global prevalence of hypertension, affecting nearly 1.13 billion people, is a major driver[3].
  • Advancements in Pharmaceutical Technology: Novel formulations and delivery methods, such as sustained-release formulations, are enhancing patient compliance and therapeutic outcomes[3].
  • Regulatory Environment: Stringent regulations in regions like Europe ensure high-quality formulations, while the introduction of biosimilars is making treatments more accessible and affordable[3].
  • Economic and Social Factors: Growing healthcare budgets, increasing awareness about cardiovascular health, and government initiatives to improve healthcare access are contributing to market growth[3][4].

Challenges and Restraints

Despite the positive outlook, the market faces several challenges:

  • Competition: The market is highly competitive, with both branded and generic manufacturers vying for market share. The expiration of patents for branded products is intensifying competition from generic manufacturers[3][4].
  • Regulatory Challenges: Strict regulatory environments, particularly in Europe, can pose barriers to entry for new manufacturers[3].
  • Economic Constraints: Healthcare budget constraints, especially in regions like Eastern Europe, can affect the affordability and accessibility of nicardipine hydrochloride[3].

Opportunities and Future Projections

The market presents several opportunities for growth and expansion:

  • Emerging Markets: Countries in Asia-Pacific and Latin America offer lucrative opportunities due to rising awareness about cardiovascular health and government initiatives to improve healthcare access[3].
  • Innovative Delivery Systems: Advances in delivery systems, such as telemedicine and digital health platforms, are expected to increase the demand for injectable formulations that can be easily administered in outpatient settings[3].
  • Generic Formulations: The rise of generic formulations is making nicardipine hydrochloride more accessible and affordable, opening up new market segments[3].

Competitive Dynamics

The competitive landscape of the nicardipine hydrochloride market is dynamic and intense:

  • Key Players: Companies like CR Double Crane, Sunflower, Conba, Xiuzheng, Sancess (tablets market), and Msn Laboratories Private Ltd, Gland Pharma Ltd, Hikma Pharmaceuticals (API market) are prominent players. These companies are focusing on research and development to enhance the efficacy and safety profiles of their formulations[1][4].
  • Innovation and Adaptation: Companies that adapt to trends such as patient-centric delivery methods, advanced manufacturing processes, and cost-effective production techniques are likely to capture a larger market share[3].

Financial Trajectory

The financial trajectory of the nicardipine hydrochloride market is positive, with significant growth projected over the next several years:

  • Revenue Growth: The market is expected to see substantial revenue growth, with the API market projected to reach USD 750 million by 2032 and the tablets market anticipated to reach USD billions by 2031[1][2].
  • Investment Opportunities: The market offers various investment opportunities, particularly in emerging markets and innovative delivery systems. Companies that invest in research and development and adapt to market trends are likely to see strong financial returns[3][4].

Key Takeaways

  • The nicardipine hydrochloride market is experiencing robust growth driven by increasing incidences of hypertension and advancements in pharmaceutical technology.
  • The market is segmented by type, application, and geography, with emerging markets in Asia-Pacific and Latin America offering significant growth opportunities.
  • Despite challenges such as competition and regulatory constraints, the market presents numerous opportunities for innovation and expansion.
  • The financial trajectory is positive, with substantial revenue growth projected over the next several years.

FAQs

What are the primary applications of nicardipine hydrochloride?

The primary applications of nicardipine hydrochloride are treating high blood pressure and relieving angina.

Which regions are driving the growth of the nicardipine hydrochloride market?

The Asia-Pacific region, particularly countries like India and China, and emerging markets in Latin America are driving the growth of the nicardipine hydrochloride market.

How is the competitive landscape of the nicardipine hydrochloride market?

The competitive landscape is intense, with both branded and generic manufacturers competing for market share. Key players are focusing on research and development to enhance their formulations.

What are the key drivers of the nicardipine hydrochloride market growth?

The key drivers include increasing incidences of hypertension, advancements in pharmaceutical technology, and favorable regulatory environments.

What are the future projections for the nicardipine hydrochloride market?

The market is projected to see significant growth, driven by emerging trends such as patient-centric delivery methods, innovative delivery systems, and the rise of generic formulations.

Cited Sources

  1. Market Research Intellect: "Nicardipine Hydrochloride Tablets Market Size, Scope And Forecast"
  2. DataIntelo: "Nicardipine Hydrochloride API Market Research Report 2032"
  3. PMarketResearch: "Worldwide Nicardipine Hydrochloride Injection Market Research 2024"
  4. Market Research Intellect: "Global Nicardipine Hydrochloride API Market Size, Trends and Forecast"

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