Drugs in MeSH Category Gasotransmitters

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999		DISCN	Yes	No	8,282,966*PED				Y
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	8,293,284*PED				Y
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	AA	RX	Yes	Yes	9,265,911*PED				Y
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	AA	RX	Yes	Yes	8,846,112*PED				Y
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-004	Jan 17, 2023		RX	Yes	Yes	11,931,377		Y	Y
Airgas Therap	ULSPIRA	nitric oxide	GAS;INHALATION	203144-001	Jul 27, 2023	AA	RX	No	No

Gasotransmitters Market Analysis and Financial Projection

Last updated: March 24, 2025

The market dynamics and patent landscape for gasotransmitter-related drugs reflect a rapidly evolving field driven by therapeutic potential and technological innovation. Below is a structured analysis:

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Market Dynamics

Therapeutic Potential:
Nitric oxide (NO), carbon monoxide (CO), and hydrogen sulfide (H₂S) are central to cardiovascular, neurological, and immune regulation. Their roles in treating chronic wounds, ischemia, and bacterial infections[7][15] have spurred R&D investment. For example, NO’s vasodilatory properties and H₂S’s angiogenic effects[7][17] are being leveraged for organ transplantation and regenerative medicine.

Key Growth Drivers:

1. Delivery System Innovation:

   • Hydrogels[7], polymers[12][15], and electrochemical generators[2] address challenges like short half-life and systemic toxicity.
   • Gas-powered injectors (e.g., Kaléo’s Aerio, CrossJect’s ZENEO) enable high-volume delivery of viscous biologics[9].

2. Drug Repurposing:

   • Statins and resveratrol exhibit secondary gasotransmitter-mediated effects, expanding their therapeutic applications[17].

3. Biomedical Applications:

   • Focus areas include tissue engineering[11], antimicrobial therapies[7], and cardiovascular interventions[17].

Challenges:

• Toxicity risks at high concentrations[1][15].
• Need for localized delivery to minimize off-target effects[7][12].

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Patent Landscape

Key Innovation Areas:	Category	Examples	Patent Trends
Synthesis	Electrochemical in situ generation[2], hybrid molecules combining NO/H₂S donors[3]	Rising filings for enzyme-stable intermediates[10].
Delivery Systems	PLGA/polymer-controlled release[12][15], hydrogels[7], microneedle arrays[9]	Dominated by formulations targeting burst reduction[15].
Combination Therapies	Hybrid drugs integrating gasotransmitters with anti-inflammatories or antioxidants[3][11]	Growing interest in synergistic effects[3].

Leading Players:

• Device Developers: Kaléo, CrossJect, and Altaviz (gas-powered injectors)[9].
• Pharmaceutical Firms: Pfizer (combination therapies)[13], Novo Nordisk (delivery partnerships)[9].
• Academic Institutions: Research on polymer-based delivery systems[12][15].

Geographical Trends:

• US and Europe lead in electrochemical/hydrogel patents[2][7].
• Asia-Pacific emerging in polymer-based delivery[12].

Licensing and Accessibility:

• Voluntary licenses (e.g., Medicines Patent Pool agreement for Paxlovid[13]) may influence generic production in low-income regions.

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Future Directions

1. Targeted Delivery: Nanoparticles and stimuli-responsive hydrogels to minimize off-target effects[7][12].
2. Clinical Translation: Dose optimization studies to balance efficacy and toxicity[11][15].
3. Regulatory Frameworks: Harmonizing approval processes for novel delivery platforms[9][13].

"Advances in injection technologies... can reduce injection-site pain and improve patient adherence." – *ONdrugDelivery, 2025*[9]

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Key Takeaways:

• Gasotransmitter therapeutics are transitioning from experimental to clinical stages, fueled by delivery innovations.
• Patent activity underscores a race to protect synthesis methods and localized delivery technologies.
• Market growth hinges on overcoming pharmacokinetic challenges and expanding therapeutic indications.

References

1. https://en.wikipedia.org/wiki/Gasotransmitter
2. https://patents.google.com/patent/US20180221210A1/en
3. https://pubmed.ncbi.nlm.nih.gov/32224139/
4. https://mdpi-res.com/bookfiles/book/4220/Advanced_Materials_in_Drug_Release_and_Drug_Delivery_Systems.pdf?v=1738980240
5. https://pmc.ncbi.nlm.nih.gov/articles/PMC5061972/
6. https://openagriculturejournal.com/VOLUME/16/ELOCATOR/e187433152207050/FULLTEXT/
7. https://pmc.ncbi.nlm.nih.gov/articles/PMC11180494/
8. https://dergi.fabad.org.tr/wp-content/uploads/2023/10/48-03-00-Tamami.pdf
9. https://www.ondrugdelivery.com/drug-delivery-trends-for-2025/
10. https://www.wipo.int/edocs/pubdocs/en/patents/946/wipo_pub_946.pdf
11. https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2017.00659/full
12. https://cris.maastrichtuniversity.nl/files/241149367/s8627.pdf
13. https://www.citizen.org/wp-content/uploads/Paxlovid-Patent-Landscape-Feb-16-final-website.pdf
14. https://law.resource.org/pub/us/works/Phase1Searches/Data/WebOfScience/NIHSearch01.WOS.0065.4.19.ris
15. https://pmc.ncbi.nlm.nih.gov/articles/PMC4113624/
16. https://pubmed.ncbi.nlm.nih.gov/20865561/
17. https://pmc.ncbi.nlm.nih.gov/articles/PMC3038605/