NITROLINGUAL Drug Patent Profile

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

Nitrolingual is a drug marketed by Pohl Boskamp and is included in one NDA. There is one patent protecting this drug.

The generic ingredient in NITROLINGUAL 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 Nitrolingual

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

Summary for NITROLINGUAL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	2
Patent Applications:	3,038
Drug Prices:	Drug price information for NITROLINGUAL
What excipients (inactive ingredients) are in NITROLINGUAL?	NITROLINGUAL excipients list
DailyMed Link:	NITROLINGUAL at DailyMed

See drug prices for NITROLINGUAL

See drug sales revenues for NITROLINGUAL

Recent Clinical Trials for NITROLINGUAL

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

Sponsor	Phase
United States Naval Medical Center, San Diego	Phase 2
University of Zurich	Phase 4

See all NITROLINGUAL clinical trials

Pharmacology for NITROLINGUAL

Drug Class	Nitrate Vasodilator
Physiological Effect	Vasodilation

US Patents and Regulatory Information for NITROLINGUAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pohl Boskamp	NITROLINGUAL	nitroglycerin	AEROSOL;SUBLINGUAL	018705-001	Oct 31, 1985		DISCN	No	No
Pohl Boskamp	NITROLINGUAL PUMPSPRAY	nitroglycerin	SPRAY, METERED;SUBLINGUAL	018705-002	Jan 10, 1997	AB	RX	Yes	Yes	7,872,049		Y

International Patents for NITROLINGUAL

See the table below for patents covering NITROLINGUAL around the world.

Country	Patent Number	Title	Estimated Expiration
Ireland	910772
Ireland	68451	Nitroglycerin pump spray
Germany	59106106

NITROLINGUAL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Nitroglycerin API and Related Products

Introduction to Nitroglycerin API

Nitroglycerin, commonly known by its brand name Nitrolingual among others, is a crucial pharmaceutical compound used primarily in the treatment of cardiovascular conditions such as angina and heart failure. The market for nitroglycerin API (Active Pharmaceutical Ingredient) is experiencing significant growth, driven by several key factors.

Global Market Size and Growth Rate

The global nitroglycerin API market is estimated to be valued 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 dominates the nitroglycerin API market, accounting for around 40% of the global revenue in 2024. This dominance is attributed to the region's robust healthcare infrastructure, high prevalence of cardiovascular diseases, favorable government policies, and advanced research and development facilities. The North American market is expected to grow at a CAGR of 4.2% from 2024 to 2031[1].

Europe

Europe is another significant market for nitroglycerin API, with a market size of USD 6.87 million in 2024. The region is expected to grow at a CAGR of 4.5% from 2024 to 2031. The growth is driven by increasing healthcare expenditure and a rising awareness about cardiovascular health[1].

Asia Pacific

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

Latin America and Middle East & Africa

Latin America and the Middle East & Africa also contribute to the global 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, growing 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, growing at a CAGR of 5.7% from 2024 to 2031[1].

Drivers of Market Growth

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 nitroglycerin API is a significant driver of 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].

Advancements in Healthcare Infrastructure

Improvements in healthcare infrastructure and increasing awareness about cardiovascular health are driving the market growth. Countries experiencing economic development and urbanization are particularly contributing to the market's expansion[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. However, as the pandemic progressed, the demand for nitroglycerin API surged, especially in the healthcare sector. This increased demand, coupled with the resumption of manufacturing activities, resulted in a gradual recovery of the market[1].

Market Segmentation and Distribution Channels

Medical Nitroglycerin Sprays Market

The global medical nitroglycerin sprays market, which includes products like Nitrolingual, was valued at USD 815.45 million in 2023 and is projected to reach USD 1685.24 million by 2032, growing at a CAGR of 8.4% during the forecast period. Conventional retail pharmacies dominate this market, but online pharmacies are gaining momentum due to increased digital literacy and the impact of the pandemic[4].

Financial Performance and Investments

Pharmaceutical companies are strategically focusing on expanding their nitroglycerin API production capacities to meet the escalating global demand. This trend is expected to persist, fostering substantial market growth in the foreseeable future.

Investments in Healthcare Infrastructure

Increasing investments in healthcare infrastructure worldwide are driving the growth of the nitroglycerin API market. This includes advancements in research and development, as well as strong collaborations between pharmaceutical companies[1].

Challenges and Opportunities

Supply Chain Disruptions

The COVID-19 pandemic highlighted the vulnerability of global supply chains. Ensuring stable and resilient supply chains will be crucial for the sustained growth of the nitroglycerin API market[1].

Regulatory Environment

Favorable government policies and regulatory frameworks play a significant role in the market's growth. Pharmaceutical companies must navigate these regulations to expand their market presence[1].

Research and Development

Ongoing research and development activities are expected to stabilize and continue the growth trajectory of the nitroglycerin API market. New therapeutic applications and improved formulations could further boost market growth[1].

Key Takeaways

• The global nitroglycerin API market is valued at USD 22.9 million in 2024 and is expected to grow at a CAGR of 6.00% from 2024 to 2031.
• North America dominates the market, followed by Europe and the Asia Pacific region.
• The market is driven by increasing prevalence of cardiovascular diseases, an aging population, and advancements in healthcare infrastructure.
• The COVID-19 pandemic initially disrupted but eventually boosted the market due to increased demand.
• Pharmaceutical companies are expanding their production capacities to meet the growing demand.

FAQs

1. What is the current market size of the nitroglycerin API market?

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

2. What is the projected growth rate of the nitroglycerin API market from 2024 to 2031?

The market is expected to grow at a compound annual growth rate (CAGR) of 6.00% from 2024 to 2031[1].

3. Which region dominates the nitroglycerin API market?

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

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

The pandemic initially disrupted the global supply chain and manufacturing processes but later boosted the market due to increased demand for nitroglycerin API in the healthcare sector[1].

5. What are the key drivers of the nitroglycerin API market growth?

The key drivers include the increasing prevalence of cardiovascular diseases, an aging population, advancements in healthcare infrastructure, and favorable government policies[1].

Cited Sources:

1. Cognitive Market Research - Nitroglycerin API market report[1].
2. Annual Reports - Nitro 2021 Annual Report[2].
3. Market Research Intellect - Global 2 Nitro Biphenyl Market Size Forecast[3].
4. Zion Market Research - Medical Nitroglycerin Sprays Market report[4].
5. Annual Reports - Nitro 2020 Annual Report[5].