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Last Updated: December 22, 2024

NITRO IV Drug Patent Profile


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When do Nitro Iv patents expire, and when can generic versions of Nitro Iv launch?

Nitro Iv is a drug marketed by Pohl Boskamp and is included in one NDA.

The generic ingredient in NITRO IV is nitroglycerin. There are thirty-six drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Nitro Iv

A generic version of NITRO IV was approved as nitroglycerin by AM REGENT on May 24th, 1988.

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Summary for NITRO IV
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 36
Patent Applications: 3,146
DailyMed Link:NITRO IV at DailyMed
Drug patent expirations by year for NITRO IV

US Patents and Regulatory Information for NITRO IV

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pohl Boskamp NITRO IV nitroglycerin INJECTABLE;INJECTION 018672-002 Aug 30, 1983 DISCN 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

NITRO IV Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Nitroglycerin API (NITRO IV)

Introduction

Nitroglycerin, commonly known as NITRO IV when administered intravenously, is a crucial medication for treating cardiovascular conditions such as angina and heart failure. The market for nitroglycerin API is experiencing significant growth, driven by various factors including changing lifestyles, increasing healthcare expenditure, and advancements in healthcare infrastructure.

Global Market Size and Growth

The global nitroglycerin API market size was estimated at USD 22.9 million in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 6.00% from 2024 to 2031[1].

Regional Market Dynamics

North America

North America dominated the nitroglycerin API market in 2024, accounting for around 40% of the global revenue with a market size of USD 9.16 million. The region's robust healthcare infrastructure, high prevalence of cardiovascular diseases, favorable government policies, and advanced research and development facilities contribute to its dominance. The North American market is expected to grow at a CAGR of 4.2% from 2024 to 2031[1].

Europe

Europe held a significant share of the global nitroglycerin API market, with a market size of USD 6.87 million in 2024. The European market is anticipated to grow at a CAGR of 4.5% from 2024 to 2031, driven by increasing healthcare expenditure and growing awareness about cardiovascular diseases[1].

Asia Pacific

The Asia Pacific region is experiencing rapid expansion in the nitroglycerin API market, with a market size of USD 5.27 million in 2024. This region is expected to grow at a CAGR of 8% from 2024 to 2031, fueled by increasing healthcare expenditure, growing awareness about cardiovascular diseases, and a large patient population, particularly in countries like India and China[1].

Latin America and Middle East & Africa

Latin America and the Middle East & Africa also contribute to the global nitroglycerin API market, albeit with smaller market shares. Latin America accounted for more than 5% of the global revenue with a market size of USD 1.15 million in 2024, expected to grow at a CAGR of 5.4%. The Middle East and Africa held around 2% of the global revenue with a market size of USD 0.46 million in 2024, expected to grow at a CAGR of 5.7% from 2024 to 2031[1].

Drivers of Market Growth

Changing Lifestyles and Increasing Prevalence of Cardiovascular Diseases

The rise in sedentary lifestyles, stress, and poor dietary habits has led to an increase in cardiovascular diseases globally. This heightened demand for pharmaceuticals, including nitroglycerin, is a significant driver of the market growth[1].

Aging Population

The aging population worldwide further amplifies the demand for nitroglycerin API, as older individuals are more prone to cardiovascular conditions[1].

Economic Development and Urbanization

Countries experiencing economic development and urbanization are contributing to the market's expansion. These regions often see an increase in healthcare expenditure and a greater need for effective treatments for cardiovascular diseases[1].

Advancements in Healthcare Infrastructure

Improvements in healthcare infrastructure and increasing awareness about cardiovascular health are driving the market growth. Pharmaceutical companies are strategically focusing on expanding their nitroglycerin API production capacities to meet the escalating global demand[1].

Impact of COVID-19

The COVID-19 pandemic initially disrupted the global supply chain and manufacturing processes, leading to a decrease in nitroglycerin API production and availability. However, as the pandemic progressed, the demand for nitroglycerin API surged, especially in the healthcare sector for treating cardiovascular conditions. The growing awareness about nitroglycerin's therapeutic benefits and its inclusion in several COVID-19 treatment protocols further boosted market growth. The market is expected to stabilize and continue its growth trajectory post-pandemic[1].

Key Players in the Market

Top companies operating in the nitroglycerin API market include Novasep, Copperhead Chemical, Dipharma, Cambrex, Bharat Pharma, SD Sinepharm, and Dorsa Pharmaceutical. These companies are investing in research and development and expanding their production capacities to meet the growing demand[4].

Financial Trajectory

Revenue Projections

The global nitroglycerin API market is projected to grow significantly over the next several years. With a CAGR of 6.00%, the market is expected to expand substantially from its current size of USD 22.9 million in 2024[1].

Regional Revenue Contributions

North America, Europe, and the Asia Pacific will continue to be major contributors to the global revenue. The Asia Pacific region, in particular, is expected to show the highest growth rate due to its large patient population and increasing healthcare expenditure[1].

Regulatory Environment

The regulatory environment plays a crucial role in the nitroglycerin API market. Laws and regulations such as those outlined in the Federal Food, Drug, and Cosmetic Act, which include provisions for user-fee programs for prescription drugs and medical devices, influence the market dynamics. These regulations ensure the safety and efficacy of nitroglycerin API and other pharmaceuticals, thereby impacting market growth[3].

Future Outlook

Research and Development

Ongoing research and development activities are expected to drive the market growth. Pharmaceutical companies are focusing on improving the production processes and therapeutic benefits of nitroglycerin API, which will further boost its demand[1].

Increasing Investments in Healthcare Infrastructure

Investments in healthcare infrastructure worldwide are anticipated to continue, supporting the growth of the nitroglycerin API market. This includes advancements in manufacturing processes, distribution networks, and healthcare facilities[1].

Key Takeaways

  • The global nitroglycerin API market is growing at a CAGR of 6.00% from 2024 to 2031.
  • North America, Europe, and the Asia Pacific are the key regions driving market growth.
  • Changing lifestyles, an aging population, economic development, and advancements in healthcare infrastructure are major drivers of the market.
  • The COVID-19 pandemic initially disrupted but ultimately boosted the market due to increased demand.
  • Top companies are investing in research and development to meet the growing demand.

FAQs

What is the current global market size of the nitroglycerin API market?

The global nitroglycerin API market size was estimated at USD 22.9 million in 2024[1].

What is the expected CAGR of the nitroglycerin API market from 2024 to 2031?

The nitroglycerin API market is expected to grow at a CAGR of 6.00% from 2024 to 2031[1].

Which region dominates the nitroglycerin API market?

North America dominated the nitroglycerin API market in 2024, accounting for around 40% of the global revenue[1].

How did the COVID-19 pandemic impact the nitroglycerin API market?

The COVID-19 pandemic initially disrupted the supply chain but later boosted the market due to increased demand for treating cardiovascular conditions[1].

Who are the top companies operating in the nitroglycerin API market?

Top companies include Novasep, Copperhead Chemical, Dipharma, Cambrex, Bharat Pharma, SD Sinepharm, and Dorsa Pharmaceutical[4].

Sources

  1. Cognitive Market Research: Nitroglycerin API market report.
  2. U.S. Department of Energy: DOE National Clean Hydrogen Strategy and Roadmap (Draft).
  3. Public Law 112–144: An Act to amend the Federal Food, Drug, and Cosmetic Act.
  4. Business Research Insights: Nitroglycerin API Market Size, Share | Analysis Report, 2032.

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