Drugs in MeSH Category Nitric Oxide Donors

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
Hikma Intl Pharms	ISOSORBIDE DINITRATE	isosorbide dinitrate	TABLET;ORAL	088088-001	Nov 2, 1987	AB	RX	No	No
Rubicon	ISOSORBIDE DINITRATE	isosorbide dinitrate	TABLET;ORAL	215723-001	Jul 8, 2022	AB	RX	No	No
Hikma Intl Pharms	ISOSORBIDE DINITRATE	isosorbide dinitrate	TABLET;SUBLINGUAL	086055-001	Nov 2, 1987		DISCN	No	No
Bausch	ISORDIL	isosorbide dinitrate	TABLET;ORAL	012093-007	Jul 29, 1988	AB	RX	Yes	No

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:

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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].

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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].

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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].

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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].

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“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