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Last Updated: June 14, 2025

Drugs in MeSH Category Muscarinic Antagonists


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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
Jubilant Generics SOLIFENACIN SUCCINATE solifenacin succinate TABLET;ORAL 205484-001 Oct 2, 2024 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Austarpharma SOLIFENACIN SUCCINATE solifenacin succinate TABLET;ORAL 210281-002 May 20, 2019 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Unichem TOLTERODINE TARTRATE tolterodine tartrate TABLET;ORAL 205399-001 Aug 5, 2020 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Aurobindo Pharma GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 202675-001 Apr 15, 2013 AA RX No 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

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].

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].

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].

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

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