Drugs in MeSH Category Potassium Channel Blockers

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys Labs Sa	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	TABLET;ORAL	075389-002	Dec 28, 2017	AB	RX	No	No
Dr Reddys Labs Sa	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	TABLET;ORAL	075389-003	Dec 28, 2017	AB	RX	No	No
Bedford Labs	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	INJECTABLE;INJECTION	076299-001	Oct 24, 2002		DISCN	No	No
Fresenius Kabi Usa	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	INJECTABLE;INJECTION	075761-001	Oct 15, 2002	AP	RX	No	Yes
Upsher Smith Labs	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	TABLET;ORAL	075315-002	Jun 30, 2000		DISCN	No	No
Chartwell Rx	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	TABLET;ORAL	077069-002	Apr 8, 2005	AB	RX	No	No
Wyeth Pharms Inc	CORDARONE	amiodarone hydrochloride	INJECTABLE;INJECTION	020377-001	Aug 3, 1995		DISCN	Yes	No

Potassium Channel Blockers Market Analysis and Financial Projection

The market for potassium channel blockers demonstrates robust growth driven by expanding therapeutic applications and strategic patent developments. These drugs, which modulate cellular potassium flow to treat conditions like cardiac arrhythmias and hypertension, face evolving competitive and intellectual property landscapes.

Market Dynamics

Projected Growth:
The global potassium channel blocker market is anticipated to grow at a 5.3% CAGR from 2023–2031, reaching over $9 billion by 2031[1][9]. Key growth drivers include:

• Rising prevalence of atrial fibrillation and cardiovascular diseases[12][14].
• Increased R&D investment in clinical applications, particularly for multiple sclerosis and hypertension[1][17].
• Expansion of antiarrhythmic drug markets, where potassium channel blockers represent the fastest-growing segment (5.8% CAGR in North America)[12].

Segment Analysis:

• Clinical sub-segments dominate due to use in drug trials and treatment of chronic conditions[1].
• Calcium channel blockers remain market leaders in related vasodilator markets, but potassium-specific inhibitors are gaining traction for their targeted efficacy[6][14].

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Patent Landscape

Key Innovations and IP Strategies:

• Sulphonylurea derivatives (e.g., US5929082A) and peptide-based blockers (e.g., WO2006096911A1) represent major patent classes, covering formulations for diabetes and cardiac applications[2][4].
• Multibinding compounds (AU4426499A) illustrate novel approaches to enhance potassium channel modulation, though few have reached clinical stages[5][17].
• Companies like Metrion Biosciences actively acquire IP portfolios, including 2,000+ small-molecule inhibitors for autoimmune and neurodegenerative diseases[18].

Patent Challenges:

• Entresto (Novartis): Facing generic competition post-2025 patent expiry, with litigation shaping market entry timelines[10].
• Supplementary Protection Certificates (SPCs): Used to extend exclusivity, though secondary patents often face validity disputes[11][19].

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Therapeutic Applications

• Cardiac Arrhythmias: Blockers like amiodarone prolong action potentials, reducing atrial fibrillation inducibility[8][13].
• Hypertension: ROMK inhibitors show diuretic benefits without electrolyte imbalances[17].
• Neuromuscular Disorders: Bioengineered peptibodies (e.g., Fc-TP fusion) demonstrate 300x greater potency in preclinical models[13].

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Competitive Landscape

Leading Players:

• Bristol-Myers Squibb, Sanofi, AstraZeneca dominate clinical segments[1][6].
• Emerging Biotechs: Metrion and Catalyst Pharmaceuticals leverage niche patents (e.g., amifampridine for myasthenic syndromes)[18][19].

Regional Insights:

• North America leads antiarrhythmic sales, driven by aging populations and hypertension rates[12].
• Asia-Pacific emerges as a high-growth region due to healthcare infrastructure improvements[1][9].

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Challenges and Opportunities

• Generic Competition: Patent cliffs for blockbusters like Entresto threaten $7.8 billion in annual revenue[10].
• R&D Hurdles: Despite promising templates (e.g., ROMK inhibitors), few candidates advance beyond in vitro studies[17].
• Biosimilars: Regulatory pathways and patent litigation complexities delay market entry, creating uncertainty[11].

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"Bioengineered anti-ion channel peptibodies can be powerful and highly potent ion channel blockers, with potential to guide antiarrhythmic modalities."[13]

In summary, potassium channel blockers remain a dynamic sector with growth fueled by cardiovascular demand and innovation in biologics. However, patent strategy agility and clinical trial efficiency are critical for sustaining market position.

References

1. https://www.openpr.com/news/2916980/potassium-channel-blocker-market-is-likely-to-experience
2. https://patents.google.com/patent/WO2006096911A1/en
3. https://pubmed.ncbi.nlm.nih.gov/2361173/
4. https://patents.google.com/patent/US5929082A/en
5. https://patents.google.com/patent/AU4426499A/en
6. https://www.transparencymarketresearch.com/peripheral-vasodilator-drugs-market.html
7. https://unitaid.org/uploads/Velpatasvir_Patent_Landscape.pdf
8. https://meshb.nlm.nih.gov/record/ui?ui=D026902
9. https://www.cognitivemarketresearch.com/potassium-channel-blocker-market-report
10. https://www.biospace.com/business/5-pharma-powerhouses-facing-massive-patent-cliffs-and-what-theyre-doing-about-it
11. https://pmc.ncbi.nlm.nih.gov/articles/PMC7188399/
12. https://www.grandviewresearch.com/horizon/outlook/antiarrhythmic-drugs-market/north-america
13. https://www.pnas.org/doi/10.1073/pnas.2212564119
14. https://www.fortunebusinessinsights.com/critical-care-antiarrhythmic-drugs-market-104703
15. https://www.businesswire.com/news/home/20250325654007/en/Dodecyl-Potassium-Phosphate-CAS-33403-10-0-Industry-Research-2025-Global-and-Regional-Market-Trends-2019-2024-and-Forecasts-2025-2029---Patents-Manufacturing-Methods-Prices-SupplyDemand---ResearchAndMarkets.com
16. https://drug-dev.com/scienture-announces-issuance-of-new-patent-covering-its-first-product-losartan-potassium-oral-suspension-through-2041/
17. https://pubmed.ncbi.nlm.nih.gov/26004420/
18. https://www.biospace.com/metrion-biosciences-acquires-rights-to-small-molecule-potassium-channel-inhibitors-from-japan-tobacco
19. https://ir.catalystpharma.com/news-releases/news-release-details/catalyst-pharmaceuticals-announces-issuance-us-patent-11060128