Anticholinergic Drug Class List

Drugs in Drug Class: Anticholinergic

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cipla	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	albuterol sulfate; ipratropium bromide	SOLUTION;INHALATION	077559-001	Dec 31, 2007	AN	RX	No	No
Luoxin Aurovitas	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	albuterol sulfate; ipratropium bromide	SOLUTION;INHALATION	206532-001	Jul 8, 2020		DISCN	No	No
Nephron	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	albuterol sulfate; ipratropium bromide	SOLUTION;INHALATION	076749-001	Dec 31, 2007	AN	RX	No	Yes
Ritedose Corp	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	albuterol sulfate; ipratropium bromide	SOLUTION;INHALATION	202496-001	Oct 1, 2012	AN	RX	No	No
Sun Pharm	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	albuterol sulfate; ipratropium bromide	SOLUTION;INHALATION	207875-001	Aug 7, 2017	AN	RX	No	No

Anticholinergic Market Analysis and Financial Projection

The anticholinergic drugs market is experiencing robust growth driven by aging populations, chronic disease prevalence, and drug innovations, while patent expirations and strategic acquisitions reshape competitive dynamics. Below is a detailed analysis:

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Market Dynamics

Growth Projections and Drivers

• The global anticholinergic drugs market is projected to grow from $5.09 billion in 2024 to $10.94 billion by 2030 at a 13.58% CAGR[1]. Alternative forecasts estimate growth to $8.57 billion by 2029 (8% CAGR)[2] and $7.94 billion by 2028 (8.1% CAGR)[3].
• Key drivers:
  • Rising geriatric populations susceptible to neurological and respiratory disorders (e.g., Parkinson’s, COPD)[7][9].
  • Increased prevalence of chronic conditions, with 142.66 million people aged 50+ expected to have ≥1 chronic disease by 2050[2][3].
  • Advancements in drug delivery (e.g., extended-release formulations, transdermal patches)[16] and personalized medicine[13].

Market Segmentation

• By type: Synthetic compounds dominate due to broad therapeutic applications[9].
• By application:
  • Overactive bladder, Parkinson’s disease, and COPD account for major shares[2][7].
  • Pre-operative anticholinergics (e.g., glycopyrrolate injections) are emerging growth areas[2].
• By region:
  • North America leads with high healthcare spending[1][7].
  • Asia-Pacific sees rapid growth due to urbanization and improved healthcare access[1][13].

Challenges and Opportunities

• Restraints: Adverse effects (e.g., cognitive impairment in the elderly) and product recalls[9].
• Opportunities: Expansion into online pharmacies[13], R&D for safer formulations (e.g., soft anticholinergics with reduced toxicity)[15], and strategic collaborations[1].

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Patent Landscape

Innovations and Key Patents

• Soft Anticholinergics:
  • Bodor Laboratories’ patents (e.g., US8,147,809) cover esters with reduced systemic toxicity for overactive bladder and hyperhidrosis[8][11]. Their licensee Brickell BioTech advanced Sofpironium Bromide Gel to Phase 3 trials for hyperhidrosis[11].
  • WO2016144727A1 combines peripheral anticholinergics with CNS-targeted agonists to treat Alzheimer’s and Parkinson’s with fewer side effects[10].
• Continuous Manufacturing: Hovione’s WO2020254791 streamlines production of inhaled anticholinergics like umeclidinium bromide for COPD[12].

Patent Expirations and Generics

• Notable expirations in February 2025 include Covis Pharma’s Tudorza Pressair (COPD) and Duaklir Pressair, potentially enabling generic competition[6].
• Expired patents (e.g., US4,258,049) have paved the way for cost-effective alternatives like alembic’s glycopyrrolate injection[2][15].

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Competitive Strategies

• Product Launches: Companies like Alembic Pharmaceuticals introduced FDA-approved generics to capture market share[2].
• Acquisitions: Halozyme’s $960 million acquisition of Antares Pharma (2022) expanded its portfolio in self-injection technologies[2].
• Focus on Inhalation Therapies: GlaxoSmithKline and Boehringer Ingelheim dominate COPD treatments, leveraging patented delivery systems[12].

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Regional Insights

• North America: Accounts for ~30% of the market, driven by high R&D investment and aging demographics[7][13].
• Europe: Strategic collaborations and regulatory support boost innovation[1].
• Asia-Pacific: Expected to grow at 7.1% CAGR (2020–2027) due to rising healthcare expenditure[5][16].

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Highlight: "The market is reshaped by scientific advancements and strategic mergers, balancing efficacy and safety in drug development."[1]

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Future Outlook

1. Technological Integration: AI and IoT will optimize manufacturing and patient compliance[9].
2. Biosimilars and Generics: Patent expirations post-2025 will intensify competition, lowering prices[6][13].
3. Neurological Applications: Focus on Alzheimer’s and dementia treatments using targeted anticholinergic combinations[10].

This interplay of innovation, demographic trends, and strategic moves positions anticholinergic drugs as a critical sector in global healthcare.

References

1. https://www.360iresearch.com/library/intelligence/anticholinergic-drugs
2. https://www.thebusinessresearchcompany.com/report/anticholinergic-drugs-global-market-report
3. https://www.researchandmarkets.com/reports/5991134/anticholinergic-drugs-global-market-report
4. https://patents.google.com/patent/US4465834A/en
5. https://www.businesswire.com/news/home/20210312005415/en/Global-Anticholinergic-Drugs-Industry-2020-to-2027---Market-Trajectory-and-Analytics---ResearchAndMarkets.com
6. https://www.pharmamanufacturing.com/home/article/55249347/key-drugs-losing-patent-protection-in-2025
7. https://www.sphericalinsights.com/reports/united-states-anticholinergic-drug-market
8. https://www.drugpatentwatch.com/p/patent/8147809
9. https://www.fortunebusinessinsights.com/anticholinergic-drug-market-110469
10. https://patents.google.com/patent/WO2016144727A1
11. https://bodorlaboratories.com/news/
12. https://www.hovione.com/knowledge-center/patent/continuous-process-preparation-anticholinergic-drugs-0
13. https://www.researchandmarkets.com/report/anticholinergic
14. https://pubchem.ncbi.nlm.nih.gov/patent/CN-1625556-A
15. https://patents.google.com/patent/US5258388A/en
16. https://www.promarketreports.com/reports/anticholinergic-drugs-market-6461
17. https://patents.google.com/patent/EP0238982A1/en