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Last Updated: December 22, 2024

NITROGLYCERIN Drug Patent Profile


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Which patents cover Nitroglycerin, and what generic alternatives are available?

Nitroglycerin is a drug marketed by Lannett Co Inc, Mylan Technologies, Zydus Pharms, Abraxis Pharm, Am Regent, Hospira, Intl Medication, Luitpold, Smith And Nephew, Cosette, Fougera Pharms Inc, Padagis Israel, Actavis Labs Fl Inc, Aurobindo Pharma, Dr Reddys, Glenmark Speclt, Mankind Pharma, Natco, Rubicon, Sigmapharm Labs Llc, Viwit Pharm, and Baxter Hlthcare. and is included in thirty-two NDAs.

The generic ingredient in NITROGLYCERIN 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 Nitroglycerin

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

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Summary for NITROGLYCERIN
Drug patent expirations by year for NITROGLYCERIN
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Recent Clinical Trials for NITROGLYCERIN

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

SponsorPhase
Alexandria UniversityPhase 2/Phase 3
The First Affiliated Hospital with Nanjing Medical UniversityN/A
Huizhou Municipal Central HospitalN/A

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Pharmacology for NITROGLYCERIN
Drug ClassNitrate Vasodilator
Physiological EffectVasodilation
Medical Subject Heading (MeSH) Categories for NITROGLYCERIN
Paragraph IV (Patent) Challenges for NITROGLYCERIN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
NITROLINGUAL PUMPSPRAY Sublingual Spray nitroglycerin 400 mcg/spray, 4.9 g and 12 g bottles 018705 1 2012-04-17
NITROSTAT Sublingual Tablets nitroglycerin 0.3 mg, 0.4 mg, and 0.6 mg 021134 1 2005-10-19

US Patents and Regulatory Information for NITROGLYCERIN

NITROGLYCERIN is protected by zero US patents and one FDA Regulatory Exclusivity.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Natco NITROGLYCERIN nitroglycerin TABLET;SUBLINGUAL 211604-001 Apr 30, 2019 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dr Reddys NITROGLYCERIN nitroglycerin TABLET;SUBLINGUAL 208191-001 Aug 26, 2016 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sigmapharm Labs Llc NITROGLYCERIN nitroglycerin TABLET;SUBLINGUAL 207745-003 May 7, 2018 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hospira NITROGLYCERIN IN DEXTROSE 5% nitroglycerin INJECTABLE;INJECTION 071846-001 Aug 31, 1990 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Rubicon NITROGLYCERIN nitroglycerin TABLET;SUBLINGUAL 209779-002 May 3, 2021 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Viwit Pharm NITROGLYCERIN nitroglycerin TABLET;SUBLINGUAL 218583-001 Oct 15, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Zydus Pharms NITROGLYCERIN nitroglycerin TABLET;SUBLINGUAL 210153-003 Mar 8, 2022 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

NITROGLYCERIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Nitroglycerin

Introduction

Nitroglycerin, a crucial medication for treating cardiovascular conditions such as angina and heart failure, is experiencing significant market dynamics driven by various factors. This article delves into the current market situation, growth prospects, challenges, and financial trajectory of nitroglycerin.

Market Size and Growth Prospects

The global nitroglycerin market is poised for substantial growth. Here are some key statistics:

  • Nitroglycerin API Market: The global nitroglycerin API market was valued at USD 22.9 million in 2024 and is expected to grow at a compound annual growth rate (CAGR) of 6.00% from 2024 to 2031[1].
  • Medical Nitroglycerin Sprays Market: This segment was valued at USD 815.45 million in 2023 and is projected to reach USD 1685.24 million by 2032, with a CAGR of 8.4% during the forecast period[3].

Regional Market Analysis

The market is segmented across various regions, each with its own growth trajectory:

  • North America: This region holds a significant market share, with the nitroglycerin API market expected to grow at a CAGR of 4.2% from 2024 to 2031. The medical nitroglycerin sprays market in North America is also robust, driven by FDA approvals and strong distribution networks[1][3].
  • Europe: Europe is the second most profitable region, with a steady CAGR. Nitroglycerin is widely used in Europe for treating cardiovascular ailments, including angina pectoris[3].
  • Asia Pacific: This region is expected to grow at a CAGR of 8% from 2024 to 2031 for the nitroglycerin API market, driven by economic development and urbanization[1].
  • Latin America and Middle East & Africa: These regions also show growth potential, with CAGRs of 5.4% and 5.7%, respectively, from 2024 to 2031[1].

Drivers of Market Growth

Several factors are driving the growth of the nitroglycerin market:

  • Increasing Prevalence of Cardiovascular Diseases: The rise in sedentary lifestyles, stress, and poor dietary habits has led to an increase in cardiovascular diseases, thereby boosting the demand for nitroglycerin[1].
  • Aging Population: The global aging population is a significant driver, as older individuals are more prone to cardiovascular conditions[3].
  • Advancements in Healthcare Infrastructure: Improvements in healthcare infrastructure and increasing awareness about cardiovascular health are also driving market growth[1].
  • Regulatory Approvals: Recent FDA approvals, such as the approval of Cosette Pharmaceuticals' generic nitroglycerin ointment, are diversifying the market and enhancing accessibility[2].

Challenges and Limitations

Despite the growth prospects, the nitroglycerin market faces several challenges:

  • High Production Costs: The high cost of nitroglycerin API is a significant barrier, limiting its accessibility and affordability for patients and healthcare providers. This high cost constrains market expansion and adoption rates[1].
  • Stringent Regulations and Safety Concerns: Strict regulatory requirements and safety concerns further limit the sales of nitroglycerin API. Addressing these challenges through technological advancements and strategic partnerships is crucial[1].
  • Side Effects and Resistance: Nitroglycerin formulations can have side effects such as prolonged migraines and resistance in tiny blood arteries, which may hinder growth prospects[4].

Financial Implications and Revenue Streams

The financial trajectory of the nitroglycerin market is influenced by several factors:

  • Revenue Potential: The approval of generic versions, such as Cosette Pharmaceuticals' generic nitroglycerin ointment, can significantly enhance revenue streams. For instance, the U.S. annual sales of nitroglycerin ointment 0.4% are estimated at $21.2 million[2].
  • Competitive Generic Therapy (CGT) Exclusivity: The 180-day exclusivity period granted under CGT provisions can provide a temporary boost in sales, allowing companies to establish a strong market presence and capture significant market share[2].
  • Cost Structures and Profitability: The cost structures associated with manufacturing and distribution will influence the profitability margins of nitroglycerin products. Companies must optimize processes and explore strategic partnerships to reduce costs[2].

Impact of COVID-19

The COVID-19 pandemic had a mixed impact on the nitroglycerin market:

  • Initial Disruptions: The pandemic caused disruptions in global supply chains and manufacturing processes, leading to a decrease in production and availability of nitroglycerin API[1].
  • Increased Demand: However, as the pandemic progressed, the demand for nitroglycerin API surged, especially in the healthcare sector for treating cardiovascular conditions. This increased demand contributed to the market's gradual recovery[1].

Market Segmentation and Distribution Channels

The market is segmented based on various distribution channels:

  • Conventional Retail Pharmacies: These pharmacies are expected to gain approximately half of the overall revenue share over the forecast period, supported by strong distribution networks[3].
  • Online Pharmacies: Online pharmacies are gaining momentum, with a market share nearly equal to that of conventional pharmacies. The digital purchase volumes, especially during the pandemic, have driven this growth[3].

Key Players and Strategic Developments

Major players in the market are focusing on research and development, product expansion, and strategic partnerships:

  • Cosette Pharmaceuticals: The company's recent FDA approval for a generic nitroglycerin ointment and its commitment to R&D and innovation highlight its strategic focus on expanding its product portfolio[2].
  • Other Players: Companies like Evus Health Solutions, Perrigo Company plc, and Arimax Pharmaceuticals are also significant players in the medical nitroglycerin sprays market, with a focus on product development and market expansion[3].

Future Prospects and Growth Opportunities

The nitroglycerin market is expected to continue its growth trajectory driven by:

  • Increasing Demand for Cardiovascular Treatments: The rising prevalence of angina pectoris and other cardiovascular conditions will drive the demand for nitroglycerin sprays and other formulations[4].
  • Advancements in Healthcare: Continued advancements in healthcare infrastructure and increasing awareness about cardiovascular health will further boost market growth[1].

Key Takeaways

  • The nitroglycerin market is growing due to increasing cardiovascular diseases, an aging population, and advancements in healthcare.
  • High production costs and stringent regulations are significant challenges.
  • Recent FDA approvals and strategic developments by key players are driving market growth.
  • The market is expected to stabilize and continue growing, driven by ongoing R&D and increasing investments in healthcare infrastructure.

Frequently Asked Questions (FAQs)

Q: What is the current market size of the nitroglycerin API market? A: The global nitroglycerin API market size was estimated at USD 22.9 million in 2024[1].

Q: What is the expected CAGR for the medical nitroglycerin sprays market from 2024 to 2032? A: The medical nitroglycerin sprays market is projected to grow at a CAGR of 8.4% from 2024 to 2032[3].

Q: How does the COVID-19 pandemic impact the nitroglycerin market? A: The pandemic initially caused disruptions but later led to increased demand for nitroglycerin API, contributing to the market's recovery[1].

Q: What are the primary distribution channels for medical nitroglycerin sprays? A: Conventional retail pharmacies and online pharmacies are the primary distribution channels, with conventional pharmacies expected to gain a significant revenue share[3].

Q: Which regions are expected to be the most profitable for the nitroglycerin market? A: North America and Europe are expected to be the most profitable regions, driven by strong distribution networks and regulatory approvals[1][3].

Cited Sources:

  1. Cognitive Market Research - Nitroglycerin API market report.
  2. Stock Titan - Cosette Pharmaceuticals Announces the Approval and Launch of First Generic Version of RECTIV® (nitroglycerin) ointment.
  3. Zion Market Research - Medical Nitroglycerin Sprays Market report.
  4. Future Market Insights - Medical Nitroglycerin Sprays Market report.

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