Drugs in MeSH Category Endothelium-Dependent Relaxing Factors

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Linde Gas Equip	NOXIVENT	nitric oxide	GAS;INHALATION	207141-002	Oct 2, 2018	AA	RX	No	No
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019		RX	Yes	Yes	11,672,938
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019		RX	Yes	Yes	8,226,916
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	AA	RX	Yes	Yes	8,282,966*PED				Y
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019		RX	Yes	Yes	9,604,028

Endothelium-Dependent Relaxing Factors Market Analysis and Financial Projection

The market dynamics and patent landscape for drugs targeting Endothelium-Dependent Relaxing Factors (EDRFs)—primarily nitric oxide (NO), prostacyclin (PGI₂), and endothelium-derived hyperpolarizing factor (EDHF)—reflect significant growth driven by cardiovascular and pulmonary therapeutic applications. Below is a detailed analysis:

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Market Dynamics

Therapeutic Demand and Growth Projections

• Nitric Oxide Therapies:
  The inhaled NO market is projected to grow from USD 1.31 billion in 2025 to USD 2.21 billion by 2032 (7.7% CAGR), fueled by its use in neonatal pulmonary hypertension and acute respiratory distress syndrome (ARDS)[9][16]. Innovations like GeNO LLC’s portable delivery systems and toxin-scavenging technologies are enhancing adoption[4][16].
• Prostacyclin Analogs:
  The prostacyclin market, valued at USD 990.61 million in 2024, is expected to reach USD 2.06 billion by 2032 (9.58% CAGR)[17][19]. Demand is driven by pulmonary arterial hypertension (PAH) treatments, with novel delivery systems (e.g., subcutaneous treprostinil) improving patient compliance[17].
• Botanical Drugs:
  Plant-based therapies modulating NO pathways are growing at 6.7% CAGR, reaching USD 72.97 billion by 2033[11]. Traditional medicine integration and natural product R&D underpin this expansion.

Regional Trends

• North America dominates due to advanced healthcare infrastructure, with the U.S. leading NO and prostacyclin innovation[9][17].
• Asia-Pacific is the fastest-growing region for inhaled NO, driven by rising respiratory disease prevalence and healthcare investments[16].

Key Drivers

• Increasing PAH cases, particularly in neonates and geriatric populations[16][19].
• Advancements in delivery systems (e.g., nebulizers, transdermal patches)[6][15].
• Shift toward personalized medicine, evidenced by trials targeting patient-specific responses[9][12].

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Patent Landscape

Notable Patents and Innovations

Patent Holder	Key Technology	Expiry	Application
GeNO LLC[4]	NO generation via nitrogen dioxide conversion	2030	Pulmonary hypertension
Loma Linda University[12]	Inhaled sodium nitrite for pulmonary vasodilation	2036	PAH and cerebral vasospasm
Vero Biotech[15]	Silica-based NO delivery	2041	Broad-spectrum NO therapy
Johns Hopkins[18]	Pioglitazone repurposing for muscular dystrophy	2043	Rare disease therapeutics

Challenges and Litigation

• Patent Eligibility: INO Therapeutics’ patent for personalized NO therapy was invalidated as ineligible under Section 101, highlighting regulatory risks in diagnostics-linked treatments[9].
• Generic Competition: Expiring patents for older prostacyclin analogs (e.g., epoprostenol) are opening markets for biosimilars[17][19].

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Future Outlook

• Drug Repurposing: 75% of rare-disease repurposing patents focus on EDRF pathways, including bosentan for muscular dystrophy[18].
• Next-Gen Delivery: Nanoparticle and gene-editing technologies aim to enhance NO bioavailability and target endothelial dysfunction[6][15].
• Unmet Needs: Developing non-invasive monitoring tools and reducing systemic side effects remain priorities[17][19].

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"The future prospects for NO-based therapies are bright and fit in with biotechnology-based approaches to modern drug discovery." – Jain PharmaBiotech Market Analysis[5].

This sector’s growth hinges on balancing innovation with regulatory navigation, ensuring therapies meet both clinical and commercial demands.

References

1. https://pubmed.ncbi.nlm.nih.gov/2545495/
2. https://pmc.ncbi.nlm.nih.gov/articles/PMC4206740/
3. https://pubmed.ncbi.nlm.nih.gov/2827174/
4. https://www.fiercepharma.com/pharma/geno-llc-receives-two-additional-patents-for-inhaled-nitric-oxide-drug-delivery
5. https://www.businesswire.com/news/home/20200514005580/en/Global-Nitric-Oxide-NO-Market-Therapeutics-Drugs-and-Companies-to-2028---ResearchAndMarkets.com
6. https://pmc.ncbi.nlm.nih.gov/articles/PMC11051410/
7. https://www.pnas.org/doi/10.1073/pnas.84.24.9265
8. https://www.pnas.org/doi/10.1073/pnas.97.17.9747
9. https://www.jdsupra.com/legalnews/personalized-therapy-patent-falls-as-38445/
10. https://www.coherentmarketinsights.com/industry-reports/inhaled-nitric-oxide-market
11. https://straitsresearch.com/report/botanical-drugs-market
12. https://news.llu.edu/research/loma-linda-university-receives-patent-for-use-of-nitrite-treat-specific-cardiovascular-conditions
13. https://givingusa.org/building-a-resilient-nonprofit-the-impact-of-recurring-donors-explained/
14. https://meshb-prev.nlm.nih.gov/record/ui?ui=D045462
15. https://pubchem.ncbi.nlm.nih.gov/patent/US-11103669-B2
16. https://www.researchnester.com/reports/inhaled-nitric-oxide-market/7163
17. https://www.databridgemarketresearch.com/reports/global-prostacyclin-market
18. https://drugrepocentral.scienceopen.com/hosted-document?doi=10.58647%2FDRUGREPO.24.1.0012
19. https://industrygrowthinsights.com/report/global-prostacyclin-drug-market/

Last updated: 2025-03-24