ADENOSINE - Generic Drug Details

What are the generic sources for adenosine and what is the scope of freedom to operate?

Adenosine is the generic ingredient in three branded drugs marketed by Astellas, Am Regent, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Mylan Labs Ltd, Norvium Bioscience, Rising, Teva Pharms Usa, Wockhardt, Avet Lifesciences, Eugia Pharma, Hospira, Meitheal, and Mylan Asi, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-six drug master file entries for adenosine. Twelve suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for ADENOSINE

US Patents:	0
Tradenames:	3
Applicants:	15
NDAs:	23
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	161
Clinical Trials:	610
Drug Prices:	Drug price trends for ADENOSINE
What excipients (inactive ingredients) are in ADENOSINE?	ADENOSINE excipients list
DailyMed Link:	ADENOSINE at DailyMed

See drug prices for ADENOSINE

Recent Clinical Trials for ADENOSINE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
MedSIR	Phase 2
The University of Texas Health Science Center, Houston	Phase 4
Society of Cardiovascular Anesthesiologists	Phase 4

See all ADENOSINE clinical trials

Generic filers with tentative approvals for ADENOSINE

Applicant	Application No.	Strength	Dosage Form
		3MG/ML	INJECTABLE; INJECTION
		3MG/ML	INJECTABLE; INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ADENOSINE

Drug Class	Adenosine Receptor Agonist
Mechanism of Action	Adenosine Receptor Agonists

Medical Subject Heading (MeSH) Categories for ADENOSINE

Analgesics

Anti-Arrhythmia Agents

Purinergic P1 Receptor Agonists

Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for ADENOSINE

C01EB	Other cardiac preparations
C01E	OTHER CARDIAC PREPARATIONS
C01	CARDIAC THERAPY
C	Cardiovascular system

Paragraph IV (Patent) Challenges for ADENOSINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ADENOSCAN	Injection	adenosine	3 mg/mL, 20 mL and 30 mL vials	020059	1	2005-04-18

US Patents and Regulatory Information for ADENOSINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wockhardt	ADENOSINE	adenosine	INJECTABLE;INJECTION	090220-001	Jul 20, 2009		DISCN	No	No
Teva Pharms Usa	ADENOSINE	adenosine	INJECTABLE;INJECTION	078676-001	Jul 31, 2008		DISCN	No	No
Fresenius Kabi Usa	ADENOSINE	adenosine	INJECTABLE;INJECTION	205568-001	Apr 16, 2018	AP	RX	No	No
Eugia Pharma	ADENOSINE	adenosine	SOLUTION;INTRAVENOUS	205331-002	Nov 2, 2017	AP	RX	No	No
Teva Pharms Usa	ADENOSINE	adenosine	INJECTABLE;INJECTION	076564-001	Jun 16, 2004		DISCN	No	No
Meitheal	ADENOSINE	adenosine	SOLUTION;INTRAVENOUS	077425-001	Aug 29, 2013	AP	RX	No	Yes

Expired US Patents for ADENOSINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	ADENOCARD	adenosine	INJECTABLE;INJECTION	019937-002	Oct 30, 1989	4,673,563
Astellas	ADENOSCAN	adenosine	SOLUTION;INTRAVENOUS	020059-002	May 18, 1995	5,731,296
Astellas	ADENOSCAN	adenosine	SOLUTION;INTRAVENOUS	020059-001	May 18, 1995	5,731,296
Astellas	ADENOSCAN	adenosine	SOLUTION;INTRAVENOUS	020059-001	May 18, 1995	5,070,877

ADENOSINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Adenosine Injections

Introduction to Adenosine Injections

Adenosine injections have become a crucial component in the management of cardiac arrhythmias, particularly in emergency medicine. Here, we will delve into the market dynamics, financial trajectory, and key factors influencing the growth of the adenosine injection market.

Market Overview

The global adenosine injection market is poised for significant growth, driven by several key factors. The market is expected to grow at a Compound Annual Growth Rate (CAGR) of 5.17% from 2024 to 2030, reaching a market size of US$ 2.59 billion by 2030[1][3].

Drivers of Market Growth

Rising Prevalence of Chronic Diseases

The increasing prevalence of chronic diseases such as cardiovascular diseases, cystic fibrosis, lung cancer, and atrial fibrillation is a major driver of the market. According to the American Heart Association, 40% of people in the U.S. will be affected by heart disease by 2030, which is likely to increase the number of cardiac surgeries and the demand for adenosine injections[1].

Aging Population and Increased Healthcare Spending

The aging population and increased healthcare spending are significant drivers. As the global population ages, the incidence of heart-related conditions increases, leading to a higher demand for adenosine injections. Increased healthcare spending and advancements in medical technology also contribute to market growth[3].

Awareness and R&D Activities

Rising awareness about cardiac conditions and ongoing research and development (R&D) activities are enhancing market growth. The development of new and advanced products, such as prefilled syringes and wearable devices, is further boosting the market[1][3].

Regional Analysis

North America

North America is expected to hold a dominant share of the global adenosine injection market during the forecast period. This dominance is attributed to the rising number of people undergoing cardiac surgeries, the growing geriatric population, and increased funding for healthcare research and development[1].

Asia Pacific

The Asia Pacific region is anticipated to be the fastest-growing region, driven by improved medical infrastructure, a large target population, increased awareness, and the development of innovative and cost-effective products. Countries such as Japan, China, India, and South Korea are expected to drive this growth[1].

Applications and End-Users

Applications

Adenosine injections are primarily used in the treatment of paroxysmal supraventricular tachycardia (PSVT) and as an adjunct to thallium-201 in myocardial perfusion scintigraphy. They are also used in various surgical procedures, including general surgery, cardiac surgery, cancer surgery, and neurological surgery[1][5].

End-Users

The key end-users of adenosine injections include diagnostics laboratories, pathology labs, hospitals, and life sciences and research labs. The demand from these sectors is driven by the need for rapid and effective solutions for managing cardiac arrhythmias[1].

Competitive Landscape

The global adenosine injection market is competitive, with several key players such as Torrent Laboratories, Sun Pharmaceuticals, Celon Laboratories, Pfizer, Teva Pharmaceuticals, and others. These companies are focusing on innovation, manufacturing, and global distribution to maintain their market share[1].

Financial Trajectory

Market Size and Growth

The adenosine injection market was valued at US$ 1.82 billion in 2023 and is expected to reach US$ 2.59 billion by 2030, growing at a CAGR of 5.17% during the forecast period[1].

Investment Opportunities

The market offers significant investment opportunities, particularly in innovation, manufacturing, and global distribution channels. Investors can tap into this growing market by focusing on the development of new products and technologies, such as prefilled syringes and wearable devices[3].

Challenges and Restraints

Side Effects

One of the major restraints on the market is the potential side effects of adenosine injections, such as triggering convulsions in patients. The administration of adenosine must be carefully monitored to mitigate these risks[1].

Role in Emergency Medicine

Adenosine injections are revolutionizing emergency medicine by providing a fast, effective, and affordable solution for managing life-threatening cardiac arrhythmias. Their rapid onset of action and ability to stabilize heart rhythms within seconds make them indispensable in emergency departments and pre-hospital settings[3].

Clinical Trials and R&D

There is ongoing research and development in the field of adenosine receptors, with a focus on developing subtype-selective agonists and antagonists. Clinical trials are underway for various indications, including inflammatory diseases, neurodegenerative afflictions, and cancer. The recent approval of the A2A adenosine receptor antagonist istradefylline for Parkinson’s disease has energized the field and opened up new avenues for research[2].

Key Takeaways

• The global adenosine injection market is expected to grow at a CAGR of 5.17% from 2024 to 2030.
• The market is driven by the rising prevalence of chronic diseases, an aging population, and increased healthcare spending.
• North America and the Asia Pacific region are key markets, with the latter expected to be the fastest-growing.
• Adenosine injections are crucial in emergency medicine for managing cardiac arrhythmias.
• Side effects and careful administration are critical considerations.
• Ongoing R&D activities and clinical trials are expanding the therapeutic potential of adenosine.

FAQs

What is the expected CAGR of the global adenosine injection market from 2024 to 2030?

The global adenosine injection market is expected to grow at a CAGR of 5.17% from 2024 to 2030[1].

Which region is expected to dominate the global adenosine injection market?

North America is expected to hold a dominant share of the global adenosine injection market during the forecast period[1].

What are the primary applications of adenosine injections?

Adenosine injections are primarily used to treat paroxysmal supraventricular tachycardia (PSVT) and as an adjunct to thallium-201 in myocardial perfusion scintigraphy[5].

Who are the key players in the global adenosine injection market?

Key players include Torrent Laboratories, Sun Pharmaceuticals, Celon Laboratories, Pfizer, Teva Pharmaceuticals, and others[1].

What are the potential side effects of adenosine injections?

Adenosine injections can trigger side effects such as convulsions in patients, requiring careful monitoring during administration[1].

Sources

1. Maximize Market Research: Adenosine Injection Market - Industry Analysis, Forecast 2030.
2. Pharmacological Reviews: International Union of Basic and Clinical Pharmacology. CXII.
3. Market Research Intellect: The Role of Adenosine Injections in Revolutionizing Emergency Medicine.
4. Pharmaceutical Technology: Adenosine Receptor A1 drugs in development, 2024.
5. DrugBank: Adenosine: Uses, Interactions, Mechanism of Action.