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Last Updated: June 20, 2025

Drugs in MeSH Category Endothelium-Dependent Relaxing Factors


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

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:


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].

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].

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].

"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

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