Drugs in MeSH Category Anti-Arrhythmia Agents

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms	ACEBUTOLOL HYDROCHLORIDE	acebutolol hydrochloride	CAPSULE;ORAL	074007-002	Oct 18, 1995	AB	RX	No	No
Apothecon	ATENOLOL	atenolol	TABLET;ORAL	073317-001	Mar 20, 1992		DISCN	No	No
Caplin	PROCAINAMIDE HYDROCHLORIDE	procainamide hydrochloride	INJECTABLE;INJECTION	218674-001	Feb 4, 2025	AP	RX	No	No
Eugia Pharma	ADENOSINE	adenosine	SOLUTION;INTRAVENOUS	205331-001	Nov 2, 2017	AP	RX	No	No
Fresenius Kabi Usa	ADENOSINE	adenosine	SOLUTION;INTRAVENOUS	077897-001	Nov 27, 2017	AP	RX	No	No
Heritage	FELODIPINE	felodipine	TABLET, EXTENDED RELEASE;ORAL	201964-003	Nov 8, 2013	AB	RX	No	No
Wyeth Pharms	INDERAL	propranolol hydrochloride	TABLET;ORAL	016418-009	Oct 18, 1982		DISCN	Yes	No

Anti-Arrhythmia Agents Market Analysis and Financial Projection

The market for antiarrhythmic drugs is shaped by both clinical needs and intellectual property developments. Below is an analysis of key dynamics and patent trends for drugs classified under the NLM MeSH category "Anti-Arrhythmia Agents."

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Market Dynamics

Growth Drivers

• Expanding Cardiovascular Disease Burden: Cardiovascular diseases (CVDs) cause 32% of global deaths[2][4], with atrial fibrillation (AF) affecting ~33 million people worldwide. Aging populations (2.1 billion aged ≥60 by 2050)[2] will further increase demand for antiarrhythmic therapies[4][15].
• Drug Development Advances:
  • New agents target specific ion channels (e.g., sodium, potassium) to reduce proarrhythmic risks[5][7].
  • Personalized medicine approaches optimize treatment based on genetic profiles[2].
  • Amiodarone, a multi-class agent, exemplifies innovation with unique effects across all four Singh-Vaughan Williams categories[1][14].
• Regulatory Support: Expedited FDA/EMA pathways (e.g., Breakthrough Therapy Designation) accelerate approvals for novel therapies like dronedarone[2][9].

Market Challenges

• Proarrhythmic Risks: Class I agents (e.g., flecainide) and QT-prolonging drugs (e.g., sotalol) carry safety concerns[2][15].
• Non-Pharmacological Competition: Catheter ablation and implantable devices reduce reliance on long-term drug use[15].

Projected Growth

• The market was valued at $1.1 billion in 2024 (CAGR 6.35% to 2030)[2], with alternate projections reaching $2.8 billion by 2030 (CAGR 6.5%)[15]. North America leads due to high AF prevalence, while Asia-Pacific is the fastest-growing region (CAGR 8.9%)[15].

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Patent Landscape

Key Innovations

Patent Focus	Example	Significance
Novel Compounds	Sulfonanilide derivatives (Patent 5,155,268)[8]	Targets arrhythmias with reduced toxicity
Administration Routes	Pulmonary delivery (Patent 8,974,828)[10]	Enables rapid drug absorption via inhalation
Enantiomer Specificity	Pure enantiomers (Patent 6,362,223)[10]	Reduces ventricular premature beats vs. racemic mixtures
Combination Therapies	Amiodarone + Class I agents (e.g., encainide)[3]	Slows ventricular tachycardia and improves hemodynamic stability

Notable Litigation

• Sanofi vs. Generics: Sanofi defended patents for dronedarone (Multaq®), a Class III agent with multi-channel effects. Courts ruled generic labels encouraged infringing uses by citing ATHENA trial data (reducing cardiovascular hospitalization in AF patients)[9][11].

Emerging Trends

• Precision Medicine: Genetic screening for ion channel mutations guides drug selection[2][7].
• Digital Integration: Wearables (e.g., ECG monitors) enable real-time arrhythmia detection and treatment adjustments[2].
• New Candidates: Windtree’s istaroxime, a dual-mechanism therapy, shows antiarrhythmic effects in heart failure models[12].

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Regulatory and Competitive Outlook

• FDA/EMA Roles: Harmonized guidelines streamline global drug approvals while enforcing pricing transparency[2].
• M&A Activity: Large pharma acquires biotech firms to access novel candidates (e.g., sodium/potassium channel blockers)[2][16].

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Summary

The antiarrhythmic drug market is growing steadily due to aging populations and arrhythmia prevalence. While safety concerns persist, innovations in targeted therapies, combination regimens, and delivery systems drive progress. Patent disputes and regulatory frameworks will continue shaping market access, with personalized and digital health technologies poised to redefine treatment paradigms.

References

1. https://pubmed.ncbi.nlm.nih.gov/8237825/
2. https://www.grandviewresearch.com/industry-analysis/antiarrhythmic-drugs-market-report
3. https://pubmed.ncbi.nlm.nih.gov/1905591/
4. https://www.gminsights.com/industry-analysis/antiarrhythmic-drugs-market
5. https://pubmed.ncbi.nlm.nih.gov/1313200/
6. https://pubmed.ncbi.nlm.nih.gov/2275886/
7. https://pubmed.ncbi.nlm.nih.gov/19038282/
8. https://www.drugpatentwatch.com/p/patent/5155268
9. https://www.robinskaplan.com/newsroom/insights/sanofi-v-glenmark
10. https://patents.justia.com/patents-by-us-classification/514/821
11. https://www.ded.uscourts.gov/sites/ded/files/opinions/14-264_0.pdf
12. https://www.globenewswire.com/news-release/2024/12/09/2993691/0/en/Windtree-Announces-New-Istaroxime-Patent-Filing-for-Preventing-or-Reducing-the-Risk-of-Acute-Myocardial-Arrhythmia.html
13. https://pmc.ncbi.nlm.nih.gov/articles/PMC10627376/
14. https://meshb.nlm.nih.gov/record/ui?ui=D000638
15. https://www.strategicmarketresearch.com/market-report/antiarrhythmic-drugs-market
16. https://www.globenewswire.com/de/news-release/2025/03/06/3038018/28124/en/Antiarrhythmic-Drugs-Beta-Blockers-Sodium-Channel-Blockers-Market-Research-and-Forecasts-Report-2025-2030-Rising-Prevalence-of-Cardiovascular-Diseases-and-Advancements-in-Drug-Deve.html