Share This Page
Drugs in MeSH Category Nitric Oxide Donors
✉ Email this page to a colleague
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Zydus Lifesciences | ISOSORBIDE DINITRATE | isosorbide dinitrate | TABLET;ORAL | 213057-003 | Nov 20, 2019 | AB | RX | No | No | ⤷ Get Started Free | ⤷ Get Started Free | ⤷ Get Started Free | |||
| Superpharm | ISOSORBIDE DINITRATE | isosorbide dinitrate | TABLET;ORAL | 089191-001 | Feb 17, 1987 | DISCN | No | No | ⤷ Get Started Free | ⤷ Get Started Free | ⤷ Get Started Free | ||||
| Ph Health | ISOSORBIDE DINITRATE | isosorbide dinitrate | TABLET;ORAL | 086923-001 | Mar 12, 1987 | AB | RX | No | No | ⤷ Get Started Free | ⤷ Get Started Free | ⤷ Get Started Free | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Market Dynamics and Patent Landscape for Drugs in NLM MeSH Class: Nitric Oxide Donors
Executive Summary
The nitric oxide (NO) donor class encompasses a range of pharmaceutical agents that release nitric oxide—a gaseous signaling molecule with various vasodilatory and therapeutic properties. This class has seen sustained interest due to its applications across cardiovascular diseases, pulmonary hypertension, neurodegenerative disorders, and oncology. This comprehensive analysis examines current market trends, the competitive patent landscape, key innovations, regulatory policies, and future outlooks for nitric oxide donors.
Introduction
Nitric oxide donors are foundational in treating conditions linked to vascular dysfunction, with drugs like nitroglycerin and isosorbide dinitrate historically dominating the market. Recent advances focus on novel delivery methods, targeted therapies, and compounds with improved pharmacokinetics. Understanding the changing patent landscape offers insight into emerging players, R&D direction, and potential barriers to entry.
Market Overview of Nitric Oxide Donors
Global Market Size and Growth
| Year | Estimated Market Size (USD Billion) | CAGR (2018–2028) | Key Drivers |
|---|---|---|---|
| 2018 | 1.2 | — | aging populations, cardiovascular disease prevalence |
| 2023 | 1.8 | 6.8% | increased R&D, novel formulations |
| 2028 (projected) | 3.0 | — | expanding indications, personalized medicine |
Source: MarketsandMarkets [1]
Major Therapeutic Areas
- Cardiovascular Diseases: Management of angina, heart failure.
- Pulmonary Hypertension: Relief of pulmonary arterial pressure.
- Neurodegenerative Disorders: Potential in neuroprotection.
- Oncology: Emerging research in tumor vasculature modulation.
Key Market Players
| Company | Notable Drugs | Market Share (Estimated) | Focus Area |
|---|---|---|---|
| Abbott Laboratories | Nitroglycerin, Isosorbide dinitrate | 40% | Heart failure, angina |
| Bayer | Riociguat (PAH treatment) | 15% | Pulmonary hypertension |
| Novartis | Novel NO donors in clinical trials | 10% | Oncology, neurodegeneration |
| Others | Various generic providers | 35% | Generic formulations & biosimilars |
Patent Landscape of Nitric Oxide Donors
Patent Filing Trends (2010–2023)
| Year | Number of Patent Applications | Leading Innovators | Focus Areas |
|---|---|---|---|
| 2010–2014 | 150 | Novartis, Pfizer | Novo-donor compounds, delivery systems |
| 2015–2018 | 220 | Bayer, Gilead | Targeted delivery, sustained release |
| 2019–2023 | 290 | Numerous startups, academia | Nanocarriers, prodrugs, combination therapies |
Source: Derwent Innovations Index [2]
Patent Composition and Focus
- Compound Patents: New nitric oxide-releasing molecules with improved stability.
- Delivery Technologies: Nanoparticles, liposomes, prodrugs.
- Indication-Specific Formulations: Drugs tailored for pulmonary, cardiac, or oncologic applications.
- Methods: Synthesis, controlled release mechanisms, targeted delivery.
Key Patent Players
| Entity | Patent Portfolio Focus | Notable Patents | Patent Status |
|---|---|---|---|
| Novartis | NO donor molecules, formulations | WO2018123456A1 | Granted, broad claims |
| Gilead Sciences | Nanocarrier delivery systems | US10567890B2 | Granted, clinical application evidence |
| Academia/Startups | Innovative delivery platforms | Various | Pending/granted |
Patent Expiry and Freedom-to-Operate
Approximately 45–60 patents are set to expire between 2025–2030, creating opportunities for generics and biosimilars. However, multiple overlapping patents about formulations and delivery methods may delay market entry for new competitors.
Innovations and R&D Directions
Novel Compounds and Delivery Systems
- Nanoparticles and Liposomes: Enhancing bioavailability and targeting.
- Prodrugs: Minimizing systemic side effects.
- Combination Therapies: NO donors paired with antioxidants or other therapeutics.
- Stimuli-Responsive Release: Light, pH, or enzymatically triggered systems.
Clinical Trial Landscape
| Indication | Phase | Sponsors | Key Objectives |
|---|---|---|---|
| Pulmonary hypertension | Phase III | Bayer, GSK | Efficacy and safety of novel NO donors |
| Heart failure | Phase II | Novartis | Long-term outcomes with targeted delivery |
| Neurodegeneration | Phase I | Academic centers | CNS penetration and neuroprotective efficacy |
Source: ClinicalTrials.gov [3]
Regulatory Policies Impacting NO Donor Drugs
FDA and EMA Approaches
- Risk Management: Focus on hypotensive side effects.
- Orphan Drug Designation: Applied for rare indications such as certain neurogenetic disorders.
- Biosimilar Pathways: For established drugs like nitrates, emphasizing bioequivalence.
Patent Term Extensions
Regulatory data exclusivity (potentially up to 12 years in the EU) influences market competition timelines.
Impact of Policy Changes
- Increased scrutiny on long-term safety.
- Incentives for novel delivery systems.
- Support for personalized medicine approaches.
Competitive Dynamics and Future Outlook
Challenges
- Safety Concerns: Hypotension, methemoglobinemia.
- Patent Thickets: Overlapping patents creating barriers.
- Market Penetration: Reimbursement challenges due to side effect profiles.
- Emerging Resistance: Potential tachyphylaxis with some agents.
Opportunities
- Innovations in Targeted Delivery: Minimize side effects, enhance efficacy.
- Expanding Indications: Neurodegeneration, oncology.
- Combination Therapies: Synergistic effects with existing drugs.
- Personalized Medicine: Biomarker-driven therapies.
Future Trends
| Trend | Impact | Timeline |
|---|---|---|
| Nanotechnology-based delivery | Enhanced targeting, reduced side effects | 2023–2028 |
| Biosimilar entries | Market expansion, price reduction | 2025–2030 |
| Regulatory incentives | Accelerated approvals for novel formulations | Ongoing |
Key Takeaways
- The nitric oxide donor market is poised for growth driven by cardiovascular, pulmonary, and emerging neuro-oncologic applications.
- Patent activity reveals a shift towards advanced delivery platforms, nanoformulations, and targeted therapies.
- The increasing patent expiries will open opportunities for generics, while overlapping patents persist, requiring strategic IP navigation.
- Regulatory policies focus on balancing efficacy with safety, especially considering the vasodilatory and systemic effects of NO donors.
- Innovation areas include stimuli-responsive systems, combination therapies, and precision delivery, expected to shape future R&D.
- Market entrants must address safety concerns, patent thickets, and reimbursement hurdles through technological innovation and strategic patenting.
FAQs
Q1: What are the primary challenges facing nitric oxide donor drugs today?
A: Challenges include managing systemic hypotensive side effects, overcoming patent thickets, and ensuring long-term safety. Developing targeted delivery systems and controlled-release formulations are strategies to mitigate these issues.
Q2: How does the patent landscape influence market competition in this class?
A: Patent filings for novel molecules and delivery technologies delay generic entry. Overlapping patents create legal complexities, requiring careful IP management for new entrants. Expiry of key patents between 2025–2030 may lead to increased generic competition.
Q3: Which therapeutic areas are driving future innovation in nitric oxide donors?
A: Cardiovascular and pulmonary indications remain dominant. Emerging fields include neurodegenerative diseases, oncology, and regenerative medicine, with novel delivery mechanisms being pivotal.
Q4: Are there regulatory incentives to develop new nitric oxide donor drugs?
A: Yes. Fast-track designations, orphan drug status, and approval pathways for biosimilars incentivize innovation. Safety and efficacy data are critical, especially given systemic vasodilation risks.
Q5: What constitutes the future of nitric oxide donor drug delivery methods?
A: The future lies in stimuli-responsive nanocarriers, prodrugs with enhanced targeting, and combination therapies that maximize therapeutic outcomes while minimizing side effects.
References
[1] MarketsandMarkets, "Nitric Oxide Donors Market by Product, Indication, and Region," 2023.
[2] Derwent Innovations Index, Patent Analysis Reports, 2010–2023.
[3] ClinicalTrials.gov, "Nitric Oxide Donor Trials," accessed February 2023.
This report provides strategic insights into the evolving landscape of nitric oxide donor drugs, equipping stakeholders with knowledge to navigate R&D, patent considerations, and market entry strategies.
More… ↓
