Drugs in MeSH Category Cardiotonic Agents

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Am Regent	DOPAMINE HYDROCHLORIDE	dopamine hydrochloride	INJECTABLE;INJECTION	070799-001	Feb 11, 1987		DISCN	No	No
Azurity	QBRELIS	lisinopril	SOLUTION;ORAL	208401-001	Jul 29, 2016		RX	Yes	Yes	9,616,096
Kv Pharm	AMINOPHYLLINE	aminophylline	TABLET;ORAL	085284-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Panray	AMINOPHYLLINE	aminophylline	TABLET;ORAL	084552-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Sciegen Pharms Inc	LISINOPRIL	lisinopril	TABLET;ORAL	212041-003	Sep 15, 2020	AB	RX	No	No
Teligent	DOBUTAMINE HYDROCHLORIDE	dobutamine hydrochloride	INJECTABLE;INJECTION	074098-001	Feb 21, 1995		DISCN	No	No

Cardiotonic Agents Market Analysis and Financial Projection

The global cardiotonic agents market is experiencing robust growth driven by rising cardiovascular disease (CVD) prevalence and advances in drug innovation. Valued at $732 million in 2023, projections indicate a surge to $4.5 billion by 2031–2033, with a CAGR of 6.5%–21.3% depending on regional factors and therapeutic advancements[1][6][14]. Below, we analyze the market dynamics and patent landscape shaping this critical pharmaceutical sector.

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Market Dynamics

Growth Drivers

• Rising CVD Burden: Cardiovascular diseases remain the leading cause of death globally, with heart failure, arrhythmias, and post-surgical care driving demand for cardiotonic agents like digitalis glycosides (e.g., digoxin) and β-adrenergic agonists (e.g., dobutamine)[1][8][14].
• Aging Demographics: Over 20% of the global population will be aged 60+ by 2050, exacerbating heart failure rates and necessitating acute-care therapies[1][14].
• Innovative Formulations: New agents such as GRK inhibitors (e.g., WO2007034846A1) and gene-targeted drugs (e.g., US8916603B2) promise faster efficacy and fewer side effects, enhancing adoption[2][10].

Segment Dominance

• Drug Class: Digitalis glycosides hold the largest market share due to their established use in heart failure and atrial fibrillation[1].
• End User: Hospitals and emergency care settings account for >60% of usage, as these drugs are critical for stabilizing patients in acute cardiac crises[1][14].
• Regional Leadership: North America leads due to high CVD prevalence, advanced healthcare infrastructure, and R&D investments by companies like Sterling Drug and CardioPharma[1][11][15].

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Patent Landscape

Key Trends

1. Targeted Therapies:

   • GRK2 Inhibitors: Patents like WO2007034846A1 highlight compounds that enhance cardiac contraction without increasing heart rate, offering chronic prognosis benefits[2].
   • Genetic Targeting: US8916603B2 covers bucindolol for heart failure patients with specific genetic profiles, reflecting precision medicine trends[10].

2. Combination Drugs:

   • CardioPharma’s US Patent 11,737,988B2 (2023) combines antihypertensive and cholesterol-lowering agents, aiming to simplify CVD management[15].

3. Repurposing Existing Drugs:

   • Studies screen FDA-approved drugs (e.g., rotigaptide) for cardiotonic potential, expediting development timelines[5].

Innovation Challenges

• Approval Delays: Cardiology patents face median approval lags of 3.1–3.6 years, with imaging-related patents taking the longest[7][9].
• Patent Thickets: Over 40% of cardiovascular drugs are included in combination therapy patents, complicating generic competition despite expired core patents[13].

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Future Outlook

1. Emerging Markets: Asia-Pacific is poised for rapid growth due to aging populations and improving healthcare access[1][14].
2. Next-Gen Agents: Research on cardiotonic steroids (CTS) reveals multi-system applications, including anti-inflammatory and anticancer properties, broadening therapeutic potential[4].
3. AI-Driven Discovery: Computational drug screening (e.g., MM/GBSA modeling) identifies candidates like rotigaptide for dual cardiac and antiviral effects[5].

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"The integration of cardiotonic agents into comprehensive CVD management strategies presents significant growth opportunities, with innovation focusing on safety and multi-disease efficacy."[4]

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Key Takeaways

• The cardiotonic agents market is expanding due to demographic and epidemiological shifts.
• Patent activity emphasizes precision medicine and combination therapies, though regulatory delays persist.
• Future growth hinges on repurposing existing drugs and leveraging AI for accelerated R&D.

FAQs

1. What are cardiotonic agents?
   Drugs that enhance cardiac output, including digoxin, dobutamine, and GRK inhibitors.
2. Which region dominates the market?
   North America, driven by high CVD rates and R&D investment.
3. How long do cardiology patents take to approve?
   Median 3.1–3.6 years, with imaging-related patents slowest.
4. What innovations are shaping the market?
   Gene-targeted therapies and fixed-dose combinations.
5. What challenges hinder market growth?
   Patent thickets and regulatory approval delays.

References

1. https://datahorizzonresearch.com/cardiotonic-agents-market-7190
2. https://patents.google.com/patent/WO2007034846A1/en
3. https://profiles.umassmed.edu/profile/125480
4. https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2022.902459/full
5. https://pmc.ncbi.nlm.nih.gov/articles/PMC8646260/
6. https://www.marketresearchintellect.com/product/cardiotonic-agents-market/
7. https://pmc.ncbi.nlm.nih.gov/articles/PMC10627376/
8. https://meshb.nlm.nih.gov/record/ui?ui=D002316
9. https://cardiologyres.org/index.php/Cardiologyres/article/download/1417/1494
10. https://patents.google.com/patent/US8916603B2/en
11. https://www.drugpatentwatch.com/p/patent/4072746
12. https://pmc.ncbi.nlm.nih.gov/articles/PMC6491099/
13. https://d-nb.info/1113826665/34
14. https://www.globenewswire.com/news-release/2023/04/03/2639893/0/en/Cardiotonic-Agents-Market-Size-to-Reach-USD-4-5-Bn-by-2031-Due-to-the-Rise-in-Prevalence-of-Cardiovascular-Diseases-TMR-Study.html
15. https://www.biospace.com/cardiopharma-announces-issuance-of-global-patent-to-mitigate-the-world-s-top-killer