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Last Updated: May 24, 2025

Drugs in MeSH Category Nitric Oxide Donors


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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
Astrazeneca SORBITRATE isosorbide dinitrate TABLET;ORAL 088125-001 Aug 21, 1990 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Hikma Intl Pharms ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;ORAL 088088-001 Nov 2, 1987 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Rubicon ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;ORAL 215723-001 Jul 8, 2022 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Hikma Intl Pharms ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;SUBLINGUAL 086055-001 Nov 2, 1987 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Bausch ISORDIL isosorbide dinitrate TABLET;ORAL 012093-007 Jul 29, 1988 AB RX Yes No ⤷  Try for Free ⤷  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

Nitric Oxide Donors Market Analysis and Financial Projection

The market dynamics and patent landscape for nitric oxide (NO) donor drugs reflect a rapidly evolving field driven by therapeutic demand and technological innovations. Below is a detailed analysis based on current developments:


Market Dynamics

  1. Current Market Size and Growth
    The global inhaled nitric oxide market was valued at USD 954.07 million in 2024, with projections to reach USD 1,971.72 million by 2033, growing at a CAGR of 8.4% [2]. Key drivers include:

    • Rising prevalence of neonatal hypoxic respiratory failure and pulmonary hypertension.
    • Increasing adoption of NO therapy in critical care for conditions like acute respiratory distress syndrome (ARDS) and chronic obstructive pulmonary disease (COPD) [2][6].
    • Expansion into Asia-Pacific markets due to high birth rates and improving healthcare infrastructure [2][6].
  2. Regional Insights

    • North America dominates (largest revenue share) due to established healthcare systems, FDA approvals (e.g., INOMAX® for neonates), and R&D investments [2][16].
    • Europe follows closely, leveraging NO therapy in perioperative and critical care [2].
    • Asia-Pacific is the fastest-growing region, driven by rising neonatal care demands and local suppliers like PUMC Pharmaceuticals in China [2][9].
  3. Key Players and Strategies

    • Major companies (e.g., Mallinckrodt, Bausch + Lomb, Nicox) focus on product launches, partnerships, and geographic expansion [2][10][16].
    • Hybrid drugs like Nicox’s NCX 470 (combining NO donors with prostaglandin analogs) aim to enhance efficacy in glaucoma treatment [10][15].

Patent Landscape

  1. Core Patent Trends

    • Dominant Donor Classes:
      • S-Nitrosothiols (RSNOs) lead in research articles, while nitrates balance patents and publications due to regulatory approval and commercialization [1][6].
      • Metal nitrosyl complexes (e.g., sodium nitroprusside) hold significant patent activity, despite cyanide toxicity concerns [1][6].
    • Novel Delivery Systems:
      • Nanoparticle-based NO donors (e.g., lipidic or polymeric carriers) dominate recent filings, enabling targeted release and reduced cytotoxicity [1][3].
      • Patent WO2020245574A1 covers respiratory delivery of NO via acid-nitrite reaction systems, emphasizing sustained release [13].
  2. Key Patents and Licenses

    • INOMAX® (Mallinckrodt): Patents covering gas delivery systems (expiring 2029–2034) were upheld in the U.S., securing market exclusivity [16].
    • Cellegy Pharmaceuticals: Licensed anal fissure treatment patents in China (expiring 2015), leveraging partnerships with PUMC for market penetration [9].
    • Nicox: Granted formulation patents for NCX 470 in China (extending coverage to 2039), complementing existing composition-of-matter patents [15].
  3. Innovation Challenges

    • Tolerance Development: Drugs like MK-8150 showed diminished efficacy after 28 days despite CYP3A4-mediated NO release, highlighting multifactorial tolerance mechanisms [12].
    • Safety: Sodium nitroprusside’s cyanide release and SNP’s light sensitivity limit clinical utility [6].

Emerging Opportunities

  • Nanomedicine: Over 340,000 articles and 59,600 patents (1970s–2024) emphasize nanoparticle engineering for stabilized NO delivery [1][3].
  • Expanded Indications: Trials explore NO donors for schizophrenia, thyroid dysfunction, and cancer [1][6].
  • Geographic Expansion: Asia-Pacific’s live birth rate (highest globally) and unmet clinical needs position it for growth [2][9].

Competitive Outlook

  • R&D Focus: Hybrid drugs (e.g., NO-conjugated prostaglandins) and gene-activated NO release systems are under development [10][15].
  • Regulatory Hurdles: Costly clinical trials and safety profiles delay new entrants, favoring established players with robust IP portfolios [6][16].

“The development of nitric oxide donors has been revolutionized by nanotechnology, enabling precise control over release kinetics and biodistribution.” [1][3]

In summary, the NO donor market is buoyed by therapeutic demand and nanoparticle-driven innovations, while patent activity underscores strategic expansions into emerging markets and novel delivery platforms. Persistent challenges like donor tolerance and toxicity continue to shape R&D priorities.

References

  1. https://pmc.ncbi.nlm.nih.gov/articles/PMC11591520/
  2. https://straitsresearch.com/report/inhaled-nitric-oxide-market
  3. https://pubs.rsc.org/en/content/articlelanding/2021/nr/d0nr07484e
  4. https://pubmed.ncbi.nlm.nih.gov/11996642/
  5. https://www.nitricoxidelab.com
  6. https://pmc.ncbi.nlm.nih.gov/articles/PMC2013979/
  7. https://www.ncbi.nlm.nih.gov/mesh?Db=mesh&Cmd=DetailsSearch&Term=%22Nitric+Oxide%22%5BMeSH+Terms%5D
  8. https://www.mla.com.au/contentassets/5ed9592c77ad4f3eba721ef88b4db38e/a.bim.0025_mla_bioactives_compendium.pdf
  9. https://www.biospace.com/cellegy-pharmaceuticals-licenses-rights-to-nitric-oxide-donor-patent-in-china-to-new-harbor-corporation
  10. https://www.nicox.com/pipeline-markets-and-science/
  11. https://dokumen.pub/botanical-drug-products-recent-developments-and-market-trends-9781315333236-1315333236-9781315352282-1315352281-9781315369273-1315369273-9781498740067-1498740065.html
  12. https://www.ahajournals.org/doi/10.1161/jaha.116.003493
  13. https://patents.google.com/patent/WO2020245574A1/en
  14. https://meshb-prev.nlm.nih.gov/record/ui?ui=D020030
  15. https://www.nicox.com/wp-content/uploads/EN_NCX-470-New-Formulation-Patent-China-PR_20220221_F.pdf
  16. https://www.mallinckrodt.com/about/news-and-media/news-detail/?id=8241
  17. https://www.govinfo.gov/content/pkg/FR-1997-08-11/html/97-21148.htm
Last updated: 2025-03-23

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