Drugs in MeSH Category Muscarinic Antagonists

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Jubilant Generics	SOLIFENACIN SUCCINATE	solifenacin succinate	TABLET;ORAL	205484-001	Oct 2, 2024	AB	RX	No	No
Austarpharma	SOLIFENACIN SUCCINATE	solifenacin succinate	TABLET;ORAL	210281-002	May 20, 2019	AB	RX	No	No
Unichem	TOLTERODINE TARTRATE	tolterodine tartrate	TABLET;ORAL	205399-001	Aug 5, 2020	AB	RX	No	No
Aurobindo Pharma	GLYCOPYRROLATE	glycopyrrolate	TABLET;ORAL	202675-001	Apr 15, 2013	AA	RX	No	No

Muscarinic Antagonists Market Analysis and Financial Projection

The market for muscarinic antagonists is experiencing steady growth driven by therapeutic demand and innovation, while the patent landscape reflects intense R&D activity targeting receptor specificity and combination therapies.

Market Dynamics

• Growth Projections:

  • The global muscarinic antagonist market is expected to grow at a 4.1–4.2% CAGR, reaching $1.89 billion by 2026 for receptor-targeting therapies[5][9]. Broader estimates suggest expansion to $10 billion by 2026 for antagonist-specific segments, driven by respiratory diseases and aging populations[9].
  • North America dominates with 35% market share, followed by Europe (30%) and Asia-Pacific (25%), where rising healthcare investments in countries like China are accelerating adoption[9].

• Therapeutic Drivers:

  • Chronic Obstructive Pulmonary Disease (COPD) accounts for the largest application segment due to the efficacy of long-acting muscarinic antagonists (LAMAs) like tiotropium and glycopyrrolate[5][10].
  • Emerging applications include cognitive disorders, overactive bladder, and gastrointestinal conditions, with R&D focusing on subtype-selective antagonists (e.g., M1, M4) to reduce off-target effects[1][14].

• Innovation Trends:

  • Combination therapies: Muscarinic antagonist/β2-agonist (MABA) hybrids and inhaled corticosteroid (ICS) combinations are under clinical evaluation to enhance efficacy in asthma and COPD[7][10].
  • Next-gen LAMAs: While newer LAMAs (e.g., umeclidinium) show comparable efficacy to tiotropium, pipeline stagnation has shifted focus to dual-target drugs and improved delivery systems[3][7].

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Patent Landscape

• Key Players and Strategies:

  • Major assignees include Theravance Biopharma, GlaxoSmithKline, and Bristol-Myers Squibb, with patents covering biphenyl compounds, azabicyclo derivatives, and formulation technologies[2][8][12][15].
  • Collaborations and licensing dominate pipeline development, exemplified by Theravance’s YUPELRI® (revefenacin), protected under patent US11,247,969 until 2037[2].

• Technological Focus:

  • Subtype selectivity: Patents like US11,149,022B2 highlight M4 receptor antagonists for neurological disorders, while others target M1 for cognitive dysfunction[13][14].
  • Combination formulations: EP2130830A1 and WO2004/056811 disclose compositions pairing muscarinic antagonists with corticosteroids or PDE-4 inhibitors to broaden therapeutic scope[12].

• Geographic Hotspots:

  • The U.S. and Europe lead in patent filings, but Asia-Pacific is emerging as a hub for manufacturing and novel drug discovery[9].

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Challenges and Future Directions

1. Safety and Selectivity: Despite advances, achieving subtype-specific targeting remains challenging, with off-target effects limiting broader use[1][14].
2. Pipeline Innovation: While few novel LAMAs are in development, MABAs and allosteric modulators represent untapped potential[6][7].
3. Market Competition: Strategic alliances (e.g., Allergan’s acquisition of Heptares’ M1 agonists) are critical to sustain growth in a crowded respiratory market[14].

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Highlight: "Advances in genetic and molecular biology techniques are aiding in the identification of new drug targets... potentially leading to novel treatments with improved specificity."[1]

This dynamic landscape underscores a shift toward precision medicine in muscarinic therapies, balancing patent-driven innovation with evolving clinical demands.

References

1. https://www.globenewswire.com/news-release/2024/11/21/2984969/28124/en/Muscarinic-Acetylcholine-Receptor-M1-Antagonists-Pipeline-Research-Report-2024-Comprehensive-Insights-on-8-Drugs-Featuring-Tonix-Pharmaceuticals-BMS-WinSanTor-and-Apnimed.html
2. https://www.drugpatentwatch.com/p/patent/11247969
3. https://pmc.ncbi.nlm.nih.gov/articles/PMC4655912/
4. https://patents.google.com/patent/US7488827B2/en
5. https://www.industryarc.com/Research/Muscarinic-Acetylcholine-Receptor-Market-Research-507041
6. https://pmc.ncbi.nlm.nih.gov/articles/PMC8779880/
7. https://www.dovepress.com/long-acting-muscarinic-antagonists-under-investigational-to-treat-chro-peer-reviewed-fulltext-article-JEP
8. https://pubchem.ncbi.nlm.nih.gov/patent/US-7498440-B2
9. https://github.com/amramcocosxa/Market-Research-Report-List-1/blob/main/muscarinic-antagonist-market.md
10. https://pmc.ncbi.nlm.nih.gov/articles/PMC8666145/
11. https://www.researchandmarkets.com/reports/4382695/muscarinic-acetylcholine-receptor-machr
12. https://patents.google.com/patent/EP2130830A1/en
13. https://patents.google.com/patent/US11149022B2/en
14. https://pmc.ncbi.nlm.nih.gov/articles/PMC8962391/
15. https://pubchem.ncbi.nlm.nih.gov/patent/US-8183257-B2
16. https://pmc.ncbi.nlm.nih.gov/articles/PMC3523197/
17. https://pmc.ncbi.nlm.nih.gov/articles/PMC6236374/

Last updated: 2025-03-23