NITROGLYCERIN - Generic Drug Details

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

Nitroglycerin is the generic ingredient in sixteen branded drugs marketed by Evus, Pohl Boskamp, Bausch, Valeant Pharms, Valeant Pharms North, Uspharma, Lannett Co Inc, Mylan Technologies, Zydus Pharms, Novartis, Sanofi Aventis Us, Abraxis Pharm, Am Regent, Hospira, Intl Medication, Luitpold, Smith And Nephew, Baxter Hlthcare, Rorer, Parke Davis, Cosette, Abbvie, 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 Viatris, and is included in fifty-two NDAs. There are two patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Nitroglycerin has twenty patent family members in nine countries.

There are thirty-six drug master file entries for nitroglycerin. Thirty-five suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for NITROGLYCERIN

International Patents:	20
US Patents:	2
Tradenames:	16
Applicants:	34
NDAs:	52
Drug Master File Entries:	36
Finished Product Suppliers / Packagers:	35
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	188
Patent Applications:	6,692
Drug Prices:	Drug price trends for NITROGLYCERIN
What excipients (inactive ingredients) are in NITROGLYCERIN?	NITROGLYCERIN excipients list
DailyMed Link:	NITROGLYCERIN at DailyMed

See drug prices for NITROGLYCERIN

See drug sales revenues for NITROGLYCERIN

Recent Clinical Trials for NITROGLYCERIN

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

Sponsor	Phase
Alexandria University	Phase 2/Phase 3
Nanjing Jiangbei Hospital	N/A
The First Affiliated Hospital with Nanjing Medical University	N/A

See all NITROGLYCERIN clinical trials

Generic filers with tentative approvals for NITROGLYCERIN

Applicant	Application No.	Strength	Dosage Form
		0.2MG/HR	Film, Extended Release; Transdermal
		0.4MG/HR	Film, Extended Release; Transdermal
		0.6MG/HR	Film, Extended Release; Transdermal

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for NITROGLYCERIN

Drug Class	Nitrate Vasodilator
Physiological Effect	Vasodilation

Medical Subject Heading (MeSH) Categories for NITROGLYCERIN

Explosive Agents

Vasodilator Agents

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Technologies	NITROGLYCERIN	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	074559-004	Feb 6, 1998	AB2	RX	No	Yes
Viwit Pharm	NITROGLYCERIN	nitroglycerin	TABLET;SUBLINGUAL	218583-003	Oct 15, 2024	AB	RX	No	No
Dr Reddys	NITROGLYCERIN	nitroglycerin	TABLET;SUBLINGUAL	208191-001	Aug 26, 2016	AB	RX	No	No
Actavis Labs Fl Inc	NITROGLYCERIN	nitroglycerin	TABLET;SUBLINGUAL	203693-001	Oct 16, 2017		DISCN	No	No
Aurobindo Pharma	NITROGLYCERIN	nitroglycerin	TABLET;SUBLINGUAL	217879-002	Oct 26, 2023	AB	RX	No	No
Lannett Co Inc	NITROGLYCERIN	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	075115-002	Aug 10, 2004		DISCN	No	No
Valeant Pharms	MINITRAN	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	089771-001	Aug 30, 1996		DISCN	No	No

Expired US Patents for NITROGLYCERIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	RECTIV	nitroglycerin	OINTMENT;INTRA-ANAL	021359-001	Jun 21, 2011
Novartis	TRANSDERM-NITRO	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020144-001	Feb 27, 1996
Novartis	TRANSDERM-NITRO	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020144-004	Feb 27, 1996
Novartis	TRANSDERM-NITRO	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020144-005	Feb 27, 1996
Pohl Boskamp	NITROLINGUAL PUMPSPRAY	nitroglycerin	SPRAY, METERED;SUBLINGUAL	018705-002	Jan 10, 1997
Novartis	TRANSDERM-NITRO	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020144-003	Feb 27, 1996
Uspharma	NITRO-DUR	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020145-004	Apr 4, 1995

International Patents for NITROGLYCERIN

Country	Patent Number	Title	Estimated Expiration
Canada	2827714	CONDITIONNEMENT DE PREPARATIONS PHARMACEUTIQUES SOLIDES CONTENANT LA SUBSTANCE ACTIVE TRINITRATE DE GLYCERYLE (PACKAGING OF SOLID PHARMACEUTICAL PREPARATIONS CONTAINING THE ACTIVE SUBSTANCE GLYCERYL TRINITRATE)
Canada	2718345	PREPARATION PHARMACEUTIQUE A GRANDE STABILITE, CONTENANT LE PRINCIPE ACTIF TRINITRATE DE GLYCEROL (LONG-TERM STABLE PHARMACEUTICAL PREPARATION HAVING THE ACTIVE INGREDIENT GLYCEROL TRINITRATE)
Australia	2012219926	Stabilized granules containing glyceryl trinitrate
Poland	2678006
European Patent Office	2678000	GRANULES STABILISÉS CONTENANT DU TRINITRATE DE GLYCÉRYLE (STABILIZED GRANULES CONTAINING GLYCERYL TRINITRATE)
Australia	2009224968	Long-term stable pharmaceutical preparation having the active ingredient glycerol trinitrate
European Patent Office	2254552	PRÉPARATION PHARMACEUTIQUE À GRANDE STABILITÉ, CONTENANT LE PRINCIPE ACTIF TRINITRATE DE GLYCÉROL (LONG-TERM STABLE PHARMACEUTICAL PREPARATION HAVING THE ACTIVE INGREDIENT GLYCEROL TRINITRATE)

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.