Drugs in MeSH Category Adrenergic beta-Agonists

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-001	Aug 10, 2012	BX	RX	Yes	No			Y
Ars Pharms Operation	NEFFY	epinephrine	SPRAY;NASAL	214697-002	Mar 5, 2025		RX	Yes	No			Y
Bpi Labs	EPINEPHRINE	epinephrine	SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS	205029-001	Jul 29, 2014	AP	RX	Yes	Yes					Y
Ars Pharms Operation	NEFFY	epinephrine	SPRAY;NASAL	214697-002	Mar 5, 2025		RX	Yes	No
Ars Pharms Operation	NEFFY	epinephrine	SPRAY;NASAL	214697-001	Aug 9, 2024		RX	Yes	Yes			Y
Teva Pharms Usa	EPINEPHRINE (AUTOINJECTOR)	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	090589-001	Aug 16, 2018	AB	RX	No	No
Intl Medication Sys	EPINEPHRINE	epinephrine	SOLUTION;INTRAVENOUS	211363-001	Aug 15, 2022		RX	Yes	Yes

Adrenergic beta-Agonists Market Analysis and Financial Projection

The global market for adrenergic beta-agonists is shaped by evolving therapeutic demands, patent expirations, and innovations targeting receptor selectivity and drug efficacy. Here's an analysis of key dynamics:

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Market Dynamics

Growth Drivers

• The global adrenergic agonist market was valued at $45.2 billion in 2024 and is projected to reach $67.8 billion by 2033, growing at a CAGR of 5.8% [6].
• Respiratory conditions (asthma, COPD) and cardiovascular diseases drive demand, with β2-agonists like salbutamol and LABAs (long-acting beta-agonists) dominating respiratory applications[7][8].
• Oral drug formulations are gaining traction due to ease of administration, with capsule/tablet forms accounting for significant market share[2].
• Personalized medicine trends and rising healthcare awareness amplify adoption, particularly in cardiovascular therapies like heart failure and hypertension[11].

Market Segmentation

• By type: β2-agonists lead due to their role in bronchodilation, while β3-agonists are emerging for metabolic disorders[7][11].
• By disease:
  • Asthma/COPD: 70% of β2-agonist use[8].
  • Cardiovascular applications: The THR-β agonists segment is growing at 5.3% CAGR, driven by heart disease prevalence[11].
• Geographically, North America holds the largest share (40%), driven by high respiratory disease rates and aging demographics[6][11].

Innovations & Challenges

• Receptor downregulation (tachyphylaxis) remains a hurdle, but methods to inhibit microRNA-mediated β2-adrenoceptor suppression are in development[12].
• Ultra-long-acting β2-agonists (e.g., vilanterol) and combination therapies (e.g., Trelegy Ellipta) enhance treatment efficacy[8].

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Patent Landscape

Key Patents and Expirations

• WO2019112913A1: Covers β2-selective agonists for respiratory diseases, with claims extending to 2037[1].
• EP4247348A4: Focuses on β-adrenergic agonist formulations for undisclosed therapeutic uses (pending approval)[5].
• Gemtesa (vibegron): Patents on β3-agonists for overactive bladder expire between 2029–2040, opening opportunities for generics[13].

Strategic Opportunities

• Patent cliffs: Expirations of drugs like salmeterol (Serevent) will enable generic entry, lowering costs but increasing competition[6][13].
• New applications: Patents for B-cell disorder treatments (e.g., US-2010009934-A1) and metabolic disease targets highlight diversification beyond traditional uses[9][11].

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Competitive Landscape

• Major players: GSK, Novartis, Teva, and Sanofi lead in production, with 45% market share concentrated among top 10 companies[2][6].
• R&D focus: Investments target receptor selectivity (e.g., β3-agonists for obesity) and combination therapies to improve patient adherence[7][12].

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Future Outlook

• Regulatory support and funding for clinical trials will accelerate novel β-agonist development, particularly for underserved conditions like septic shock and ADHD[2][6].
• Biologics and gene therapies may disrupt the market, but small-molecule β-agonists will remain critical due to their rapid action and cost-effectiveness[6][11].

In summary, the adrenergic beta-agonist market thrives on therapeutic innovation and strategic patent management, with growth anchored in respiratory and cardiovascular care. Expiring patents will reshape competition, while R&D addresses longstanding efficacy challenges.

References

1. https://patents.google.com/patent/WO2019112913A1/en
2. https://www.databridgemarketresearch.com/reports/global-beta-adrenoceptor-agonists-agonists-market
3. https://www.lb7.uscourts.gov/documents/16c651.pdf
4. http://ndl.ethernet.edu.et/bitstream/123456789/91213/1/Medicinal%20Chemistry%20for%20Practitioners-Jie%20Jack%20Li-John%20Wiley%20&%20Sons%20Inc-2020-1.pdf
5. https://patents.google.com/patent/EP4247348A4/ja
6. https://www.verifiedmarketreports.com/product/global-adrenergic-agonist-market-growth-status-and-outlook-2019-2024/
7. https://en.wikipedia.org/wiki/Beta-adrenergic_agonist
8. https://en.wikipedia.org/wiki/Beta2-adrenergic_agonist
9. https://pubchem.ncbi.nlm.nih.gov/patent/US-2010009934-A1
10. https://www.science.gov/topicpages/i/identify+drug+leads
11. https://www.marketstatsville.com/thr-beta-agonists-market
12. https://www.research.usf.edu/dpl/content/data/PDF/18a017.pdf
13. https://pharsight.greyb.com/drug/gemtesa-patent-expiration

Last updated: 2025-03-23