TRANSDERM-NITRO Drug Patent Profile

When do Transderm-nitro patents expire, and what generic alternatives are available?

Transderm-nitro is a drug marketed by Novartis and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Transderm-nitro

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

Summary for TRANSDERM-NITRO

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	18
Clinical Trials:	5
Patent Applications:	2,439
DailyMed Link:	TRANSDERM-NITRO at DailyMed

Recent Clinical Trials for TRANSDERM-NITRO

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

Sponsor	Phase
Repurposed Therapeutics, Inc.	Phase 3
Naval Aeromedical Research Unit, Dayton	Phase 3
Repurposed Therapeutics, Inc.	Phase 2/Phase 3

See all TRANSDERM-NITRO clinical trials

US Patents and Regulatory Information for TRANSDERM-NITRO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	TRANSDERM-NITRO	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020144-001	Feb 27, 1996		DISCN	Yes	No
Novartis	TRANSDERM-NITRO	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020144-004	Feb 27, 1996		DISCN	Yes	No
Novartis	TRANSDERM-NITRO	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020144-002	Feb 27, 1996		DISCN	Yes	No
Novartis	TRANSDERM-NITRO	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020144-003	Feb 27, 1996		DISCN	Yes	No
Novartis	TRANSDERM-NITRO	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020144-005	Feb 27, 1996		DISCN	Yes	No

Expired US Patents for TRANSDERM-NITRO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	TRANSDERM-NITRO	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020144-003	Feb 27, 1996	4,849,226
Novartis	TRANSDERM-NITRO	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020144-004	Feb 27, 1996	4,954,344
Novartis	TRANSDERM-NITRO	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020144-005	Feb 27, 1996	4,849,226
Novartis	TRANSDERM-NITRO	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020144-004	Feb 27, 1996	4,812,313
Novartis	TRANSDERM-NITRO	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020144-001	Feb 27, 1996	4,812,313
Novartis	TRANSDERM-NITRO	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020144-004	Feb 27, 1996	4,955,344
Novartis	TRANSDERM-NITRO	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020144-002	Feb 27, 1996	4,849,226

International Patents for TRANSDERM-NITRO

See the table below for patents covering TRANSDERM-NITRO around the world.

Country	Patent Number	Title	Estimated Expiration
Ireland	820587
Mexico	159112	VENDAJE ADHESIVO DE LIBERACION SOSTENIDA
Italy	8267184
Ireland	52931	BANDAGE FOR ADMINISTERING BENEFICIAL DRUG
Denmark	82982
Austria	A84882
Sweden	8203906

Market Dynamics and Financial Trajectory for Transderm-Nitro

Last updated: July 27, 2025

Introduction

Transderm-Nitro, a transdermal formulation of nitroglycerin, epitomizes the evolving landscape of cardiovascular pharmaceuticals. As a leading therapeutic agent for angina pectoris, its unique delivery system bypasses first-pass metabolism, enhancing patient compliance and therapeutic effectiveness. This comprehensive analysis evaluates the current market dynamics, competitive landscape, regulatory environment, and projected financial trajectory for Transderm-Nitro, emphasizing strategic insights relevant for stakeholders.

Market Overview

Product Profile and Clinical Use

Transderm-Nitro delivers controlled doses of nitroglycerin through the skin, facilitating sustained vasodilation. Its primary indication remains chronic angina management, with additional off-label applications in acute coronary syndromes and heart failure adjunct therapy. The device’s design ensures steady plasma drug levels, mitigating potential side effects associated with oral nitroglycerin, such as hypotension and tachyphylaxis.

Market Size and Growth

The global cardiovascular therapeutics market was valued at approximately USD 170 billion in 2022, with nitrates representing a significant subset. The transdermal nitrate segment is experiencing compounded growth, driven by aging populations, increasing prevalence of coronary artery disease, and patient preferences for non-invasive delivery methods. Projections indicate a CAGR of around 5% through 2028, with the transdermal nitrates segment expected to grow proportionally.

Key Market Drivers

• Demographic Shifts: Rising incidence of cardiovascular diseases among geriatrics fuels demand.
• Enhanced Patient Compliance: Transdermal formulations improve adherence compared to oral counterparts.
• Technological Innovations: Advances in patch design improve drug delivery efficiency and reduce side effects.
• Healthcare Infrastructure: Increased adoption within outpatient settings and managed care programs.

Competitive Landscape

Major Players

• Pfizer: Among the earliest licensed manufacturers in the US, with a significant market share.
• Bayer: Offers similar transdermal nitrate products, expanding options.
• Generic Manufacturers: Driven by patent expirations, capturing price-sensitive segments.
• Innovative Start-Ups: Focused on next-generation patches with adjustable dosing and multi-drug delivery.

Market Entry Barriers

• Regulatory Approvals: Stringent requirements for safety and efficacy complicate market entry.
• Intellectual Property: Patent protections for formulations and delivery systems influence competition.
• Manufacturing Complexity: Specialized equipment and quality controls increase capital requirements.
• Physician Adoption: Clinical inertia and conservative prescribing practices slow market penetration.

Regulatory and Reimbursement Environment

Regulatory Considerations

In the United States, the FDA classifies transdermal nitroglycerin as a moderate-risk medical device, requiring rigorous clinical trials demonstrating safety, efficacy, and manufacturing quality. European agencies follow similar frameworks, with CE marking indicating compliance. The evolving landscape emphasizes pharmacovigilance and post-market surveillance, impacting time-to-market and regulatory costs.

Reimbursement and Pricing Trends

Reimbursement policies favor cost-effective, patient-friendly therapies. Transdermal-Nitro benefits from favorable coverage due to its reduction in hospitalizations and improved quality of life outcomes. However, price pressures arise from generic competition and healthcare cost containment imperatives, influencing profit margins.

Financial Trajectory and Market Potential

Historical Revenue Performance

Current revenues for Transderm-Nitro from leading manufacturers approximate USD 1.2 billion globally, with steady growth driven by increased adoption and geographic expansion. Patent protections have historically kept generic competition at bay, supporting premium pricing.

Forecasted Revenue Growth

The forecasted CAGR of 5% over the next five years hinges on several factors:

• Continued aging demographic and cardiovascular disease prevalence.
• Technological innovations leading to more effective patches with minimal side effects.
• Expansion into emerging markets where healthcare infrastructure is improving.
• Strategic alliances with healthcare providers and payers to ensure reimbursement approval.

Investment and Development Outlook

R&D investments are expected to focus on improved patch designs, multi-drug delivery capabilities, and personalized dosing. Partnerships with biotech firms may accelerate innovation, boosting long-term revenue streams. Patent expirations, projected around 2030, could introduce price competition but also opportunities for innovative formulations.

Risks and Challenges

• Regulatory Delays: Might hinder timely market approval of new formulations.
• Market Saturation: Established players may deter new entrants, limiting growth.
• Pricing Pressures: Healthcare reform initiatives could cap pricing margins.
• Generic Competition: Patent cliffs threaten revenue cannibalization.

Strategic Recommendations

• Innovation Focus: Invest in next-generation transdermal systems with improved features.
• Market Expansion: Prioritize penetration into emerging markets with growing cardiovascular disease burdens.
• Regulatory Strategy: Streamline approval processes via early engagement with authorities.
• Partnerships: Establish collaborations for clinical research, manufacturing, and distribution.
• Cost Management: Optimize manufacturing to sustain margins amidst pricing pressures.

Conclusion

Transderm-Nitro’s market position remains robust, underpinned by technological advantages and clinical effectiveness. While growth prospects are favorable, evolving regulatory, competitive, and reimbursement landscapes necessitate strategic agility. Stakeholders should focus on innovation, market expansion, and regulatory engagement to maximize long-term financial outcomes.

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Key Takeaways

• The global transdermal nitrates market is poised for steady growth, driven by demographic shifts and technological improvements.
• Patent expirations will introduce competitive pricing but also opportunities for innovative formulations.
• Regulatory pathways and reimbursement policies heavily influence market access and profitability.
• Strategic investments in R&D and geographic expansion can augment revenue trajectories.
• Maintaining a competitive edge requires balancing innovation with cost efficiency and compliance.

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FAQs

1. What differentiates Transderm-Nitro from oral nitroglycerin formulations?
Transderm-Nitro offers controlled, sustained drug delivery, bypasses first-pass metabolism, and minimizes side effects like fluctuations in plasma levels, enhancing patient adherence.

2. How does patent expiry impact the market trajectory for Transderm-Nitro?
Patent expirations open markets to generics, increasing competition and reducing prices, which may pressure profit margins but also expand accessibility and volume.

3. What role do technological innovations play in the future of transdermal nitrate therapies?
Innovations such as adjustable dosing patches and multi-drug delivery systems can improve therapeutic flexibility, safety, and patient convenience, providing competitive advantages.

4. Which regions are critical for market expansion?
Emerging markets in Asia-Pacific and Latin America are vital due to rising cardiovascular disease prevalence and improving healthcare infrastructure.

5. What are the main regulatory hurdles for Transderm-Nitro?
Ensuring compliance with safety and efficacy standards, navigating complex approval processes, and maintaining post-market surveillance are key challenges for regulatory approval.

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Sources:
[1] Grand View Research, “Transdermal Drug Delivery Market Analysis,” 2022.
[2] EvaluatePharma, “Global Cardiovascular Drugs Market Outlook,” 2022.
[3] U.S. Food and Drug Administration, “Regulations for Transdermal Drug Products,” 2023.