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, Encube, Tp Anda Holdings, Abbvie, Fougera Pharms Inc, Padagis Israel, Actavis Labs Fl Inc, Aurobindo Pharma, Dr Reddys, Glenmark Speclt, Mankind Pharma, Natco, Rubicon Research, Sigmapharm Labs Llc, Viwit Pharm, and Viatris, and is included in fifty-five 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-seven 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:	36
NDAs:	55
Drug Master File Entries:	36
Finished Product Suppliers / Packagers:	37
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	209
Patent Applications:	6,626
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
National Cheng-Kung University Hospital	PHASE4
Boston Scientific Corporation	PHASE4
Vivek Reddy	PHASE4

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
Pohl Boskamp	NITRONAL	nitroglycerin	INJECTABLE;INJECTION	018672-001	Aug 30, 1983		DISCN	No	No
Zydus Pharms	NITROGLYCERIN	nitroglycerin	TABLET;SUBLINGUAL	210153-002	Mar 8, 2022		DISCN	No	No
Valeant Pharms North	MINITRAN	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	089772-001	Aug 30, 1996		DISCN	No	No
Zydus Pharms	NITROGLYCERIN	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	089885-002	Oct 30, 2017	AB2	RX	No	No

Expired US Patents for NITROGLYCERIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	TRANSDERM-NITRO	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020144-004	Feb 27, 1996
Novartis	TRANSDERM-NITRO	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020144-004	Feb 27, 1996
Uspharma	NITRO-DUR	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020145-006	Apr 4, 1995
Novartis	TRANSDERM-NITRO	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020144-005	Feb 27, 1996

International Patents for NITROGLYCERIN

Country	Patent Number	Title	Estimated Expiration
Germany	202008007318
Spain	2565632
World Intellectual Property Organization (WIPO)	2012113564
Russian Federation	2010142023	ДЛИТЕЛЬНО СТАБИЛЬНАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ С АКТИВНЫМ ВЕЩЕСТВОМ ГЛИЦЕРОЛ ТРИНИТРАТОМ

Market Dynamics and Financial Trajectory for Nitroglycerin

Last updated: July 27, 2025

Introduction

Nitroglycerin, a critical pharmaceutical agent primarily utilized for treating angina pectoris and other cardiovascular conditions, has a storied history rooted in both medicinal applications and industrial origins. Its dual role as a vasodilator and an industrial explosive underscores its complex market dynamics. As regulatory landscapes evolve, alongside technological and clinical advancements, understanding nitroglycerin’s market trajectory offers valuable insights for stakeholders across pharma, healthcare, and manufacturing sectors.

Historical Context and Clinical Significance

Developed in the late 19th century, nitroglycerin's pharmacological utility revolutionized cardiovascular therapy. Its efficacy in rapid symptom relief for angina has established it as a standard treatment, supplemented by various formulations such as sublingual tablets, transdermal patches, and intravenous solutions [1]. Despite its age, nitroglycerin remains indispensable, owing to its rapid onset and reliable vasodilatory effects.

Market Size and Global Demand

The global demand for nitroglycerin persists driven by the endemic prevalence of cardiovascular diseases (CVDs). According to the World Health Organization, CVDs account for approximately 17.9 million deaths annually, underpinning a continued need for effective therapies like nitroglycerin [2].

The pharmaceutical segment for angina management globally is projected to grow at a compound annual growth rate (CAGR) of around 3-4% over the next five years, driven by aging populations and increased healthcare infrastructure in emerging markets [3]. The nitroglycerin market comprises both branded and generic formulations, with the latter dominating due to cost-effectiveness and widespread clinical adoption.

Key Market Players and Competitive Landscape

Major pharmaceutical players operating in licensed or generic manufacturing include Pfizer, Novartis, Teva Pharmaceutical Industries, and Hikma Pharmaceuticals. Observations indicate a trend towards consolidations and licensing agreements aimed at optimizing supply chains and expanding geographic reach [4].

Generic manufacturers benefit from lower production costs, helping to sustain stable pricing despite patent expirations. For example, the expiration of several patents in the 2000s in North America and Europe led to a surge in generic production, significantly impacting market prices and profitability [5].

Regulatory Environment and Patent Dynamics

While original patents generally expired decades ago, regulatory oversight remains stringent. The FDA and EMA require comprehensive quality controls, especially considering nitroglycerin's sensitive nature due to its explosive properties. The regulatory landscape influences market entry barriers, with generic manufacturers investing heavily in compliance infrastructure.

Importantly, patents on certain formulations or delivery mechanisms can extend market exclusivity. Novel transdermal systems or combination therapies incorporating nitroglycerin have recently gained regulatory approval, potentially affecting market trajectories [6].

Manufacturing Challenges and Supply Chain Considerations

Manufacturing nitroglycerin poses unique challenges due to its explosive nature. Facilities must adhere to rigorous safety standards, increasing operational costs. Additionally, maintaining consistent quality and bioavailability across different formulations influences manufacturing investments.

Supply chain dynamics are also affected by raw material availability, geopolitical factors, and global health emergencies. Recent disruptions, like those caused by the COVID-19 pandemic, have highlighted vulnerabilities, prompting manufacturers to diversify sourcing and inventory management strategies [7].

Technological Innovations and Future Outlook

Innovations focusing on improved delivery systems—such as sustained-release transdermal patches and novel sublingual formulations—are expanding therapeutic options, potentially extending market longevity for nitroglycerin. Research into combination therapies aims to enhance efficacy and patient compliance.

Furthermore, advances in manufacturing automation and process optimization are reducing costs and improving safety. These innovations can facilitate greater availability, especially in emerging markets, thus expanding the overall market size.

Financial Trajectory and Investment Opportunities

The stable demand profile combined with growth driven by demographic shifts suggests a steady financial underpinning for nitroglycerin. Established players witnessing patent expirations have experienced revenue declines initially, but growth potential exists through formulation innovations and market expansion.

Emerging markets present lucrative avenues, particularly where healthcare infrastructure upgrades boost cardiovascular treatment adoption. Conversely, increasing competition from alternative therapies—like calcium channel blockers and nitrates with longer duration—may pressure prices.

Investment opportunities revolve around generic manufacturers with scalable production capacities and innovative formulation developers. Additionally, companies engaged in manufacturing safer, non-explosive formulations could command premium valuations as safety regulations tighten [8].

Market Risks and Challenges

Key risks include regulatory hurdles related to safety protocols, particularly concerning handling and storage, which can stifle new entrants. Patent litigations and disputes over formulation claims could also impact market dynamics.

Substitutes and alternative therapies pose challenges, especially if new medications offer comparable efficacy with improved convenience or fewer side effects. Additionally, global supply chain disruptions and raw material shortages may impact production capacities and profitability.

Conclusion

The market for nitroglycerin remains resilient, underpinned by its essential role in cardiovascular therapy. While patent expiries and manufacturing challenges introduce volatility, technological advancements and expanding global healthcare access present opportunities for sustained growth. Stakeholders must navigate regulatory complexities and competitive pressures, leveraging innovations to optimize financial trajectories.

Key Takeaways

• The global demand for nitroglycerin is driven by the high prevalence of cardiovascular conditions, ensuring steady market relevance.

• Patent expirations have fostered a competitive generic landscape, stabilizing prices but encouraging innovation in formulations.

• Manufacturing safety and quality standards significantly influence market dynamics and entry barriers.

• Technological innovations in delivery systems and manufacturing processes can extend nitroglycerin’s market lifespan and profitability.

• Emerging markets offer growth prospects, contingent upon improving healthcare infrastructure and regulatory environments.

FAQs

1. How does patent expiration affect nitroglycerin's market landscape?
Patent expiration allows generic manufacturers to produce cost-effective versions, increasing competition and reducing prices. While this drives accessibility, it pressures branded formulations' profitability, shifting focus toward formulation innovation and new delivery systems.

2. What are the main regulatory challenges for nitroglycerin manufacturers?
Regulations focus on safety standards due to its explosive nature, quality control for consistent dosing, and approval processes for new formulations. Stringent compliance can raise operational costs and pose barriers for new entrants.

3. Are there emerging alternatives to nitroglycerin in angina treatment?
Yes. Alternatives include calcium channel blockers, long-acting nitrates, and novel agents like ranolazine. These options may offer longer-lasting relief or fewer side effects, influencing nitroglycerin's market share.

4. How do technological innovations impact nitroglycerin’s global market?
Innovations in drug delivery, such as transdermal patches and sublingual formulations, improve efficacy and patient compliance. Manufacturing process improvements can lower costs and increase supply stability.

5. What is the outlook for investments in nitroglycerin manufacturing and formulations?
Stable demand and expansion in emerging markets suggest positive prospects. Investing in formulation innovation and scalable manufacturing capabilities offers growth opportunities, despite competitive and regulatory challenges.

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References

[1] WHO. Cardiovascular Diseases (CVDs). World Health Organization.
[2] WHO. Cardiovascular Diseases Fact Sheet. 2021.
[3] MarketsandMarkets. Cardiovascular Therapeutics Market Forecast. 2022.
[4] Global Data. Pharmaceutical Market Reports. 2022.
[5] U.S. Patent and Trademark Office. Patent Expirations in Cardiology. 2015–2020.
[6] EMA. Regulatory Approvals for Transdermal Cardiovascular Drugs. 2021.
[7] World Economic Forum. Supply Chain Disruptions in Pharmaceuticals. 2022.
[8] Fitch Ratings. Pharmaceutical Manufacturing Safety Standards. 2022.