TAMBOCOR Drug Patent Profile

Which patents cover Tambocor, and when can generic versions of Tambocor launch?

Tambocor is a drug marketed by Alvogen and is included in one NDA.

The generic ingredient in TAMBOCOR is flecainide acetate. There are ten drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the flecainide acetate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tambocor

A generic version of TAMBOCOR was approved as flecainide acetate by AMNEAL PHARM on July 31^st, 2001.

Summary for TAMBOCOR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	169
Clinical Trials:	7
Patent Applications:	3,987
Drug Prices:	Drug price information for TAMBOCOR
DailyMed Link:	TAMBOCOR at DailyMed

See drug prices for TAMBOCOR

Recent Clinical Trials for TAMBOCOR

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

Sponsor	Phase
Wojciech Zareba	Phase 2
Keimyung University Dongsan Medical Center	Phase 4
Chong Kun Dang Pharmaceutical Corp.	Phase 4

See all TAMBOCOR clinical trials

US Patents and Regulatory Information for TAMBOCOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-004	Aug 23, 1988		DISCN	Yes	No
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-002	Oct 31, 1985		DISCN	No	No
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-001	Oct 31, 1985		DISCN	Yes	No
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-003	Jun 3, 1988		DISCN	Yes	No

Expired US Patents for TAMBOCOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-002	Oct 31, 1985	3,900,481
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-001	Oct 31, 1985	4,005,209
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-003	Jun 3, 1988	4,642,384
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-004	Aug 23, 1988	3,800,481
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-003	Jun 3, 1988	3,900,481
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-002	Oct 31, 1985	4,005,209
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-001	Oct 31, 1985	4,642,384

International Patents for TAMBOCOR

See the table below for patents covering TAMBOCOR around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	H0149695
Sweden	447992	FORFARANDE FOR FRAMSTELLNING AV 2,5-BIS(2,2,2-TRIFLUORETOXI)-N-(2-PIPERIDYLMETYL)BENSAMID
France	2468591
Sweden	8002003
France	2468590
Ireland	840284
Japan	H022869

TAMBOCOR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Antiarrhythmic Drugs: A Focus on Tambocor (Flecainide)

Introduction

Antiarrhythmic drugs, including Tambocor (flecainide), play a crucial role in managing cardiac arrhythmias, a condition that affects millions worldwide. This article delves into the market dynamics and financial trajectory of antiarrhythmic drugs, with a particular focus on Tambocor.

Global Antiarrhythmic Drugs Market Overview

The global critical care antiarrhythmic drugs market is experiencing significant growth, driven by several key factors. As of 2019, the market size was valued at USD 796.8 million and is projected to reach USD 1,319.7 million by 2027, growing at a CAGR of 5.6% during the forecast period (2020-2027)[1].

Increasing Prevalence of Cardiovascular Disorders

Cardiovascular disorders are a major driver of the antiarrhythmic drugs market. According to the American Heart Association, cardiac disorders are the leading cause of death globally, with over 17.6 million deaths in 2016 and an expected increase to 23.6 million by 2030[1]. This rising prevalence of cardiovascular diseases, including arrhythmias, fuels the demand for effective antiarrhythmic medications.

Growing Adoption in Intensive Care Units (ICUs)

The use of antiarrhythmic drugs in ICUs is a significant factor in market growth. Atrial fibrillation is common in medical ICUs, affecting up to 30% of patients, and cardiac arrhythmias are a frequent complication, with rates as high as 40%[1]. This increased adoption in critical care settings boosts the market for drugs like Tambocor.

Market Segmentation and Key Players

The antiarrhythmic drugs market is segmented by drug class, with beta blockers expected to be the leading segment. However, other classes, including potassium channel blockers and sodium channel blockers (where flecainide belongs), are also witnessing substantial growth. Key players in the market include Sanofi, Pfizer, and Mylan N.V.[1].

Flecainide (Tambocor) Market Dynamics

Market Size and Projections

The flecainide market, which includes Tambocor, was valued at USD 1.4 billion in 2023 and is expected to reach USD 2.6 billion by 2031, growing at a CAGR of 8.2% from 2024 to 2031[3].

Application and Type

Flecainide is used in various forms, including tablets, extended-release capsules, injectable solutions, and oral suspensions. It is primarily used for treating arrhythmia, heart rhythm disorders, atrial fibrillation, and ventricular tachycardia. The hospital segment is expected to expand significantly, retaining its position throughout the forecast period[5].

Geographical Analysis

The market for flecainide is segmented geographically into North America, Europe, Asia-Pacific, South America, and the Middle East & Africa. North America and Europe are significant markets due to the high prevalence of cardiac disorders and favorable reimbursement policies. The Asia-Pacific region is expected to grow at a high rate due to increasing government initiatives and improving healthcare infrastructure[3][5].

Drivers of Market Growth

Increasing Prevalence of Cardiac Disorders

The rising incidence of cardiovascular disorders, particularly atrial fibrillation, is a major driver. As the global population ages, the prevalence of heart-related disorders increases, thereby boosting the demand for antiarrhythmic drugs like flecainide[3].

Research and Development

Continuous R&D initiatives to improve medication formulations and delivery systems are supporting market growth. The development of novel pharmacological formulations and increased funding for healthcare research enhance the therapeutic profile of flecainide[3].

Healthcare Infrastructure and Awareness

Improving healthcare infrastructure globally and increasing awareness among healthcare professionals about the benefits of flecainide in treating arrhythmias are also driving market expansion[3].

Financial Trajectory

Revenue Growth

The flecainide market is expected to see significant revenue growth, driven by the increasing need for efficient treatment alternatives for cardiac arrhythmias. The market's financial trajectory is positive, with a projected CAGR of 8.2% from 2024 to 2031[3].

Key Companies

Major pharmaceutical companies such as Pfizer Inc., Novartis AG, Sanofi S.A., and Mylan N.V. are key players in the flecainide market. These companies are focusing on expanding their product portfolios and conducting pilot studies to evaluate access to arrhythmia drug treatment[3].

Regional Market Analysis

North America

North America is a significant market for flecainide, driven by the high prevalence of cardiac disorders and the presence of major pharmaceutical companies. The U.S. market, in particular, is supported by a growing number of clinical trials and drug launches[1].

Europe

Europe is the second-largest region in terms of market share and revenue. The rapidly rising geriatric population, increasing number of cardiac issues, and favorable reimbursement policies contribute to the market growth in this region[1].

Asia-Pacific

The Asia-Pacific region is expected to expand at a high growth rate due to government initiatives to raise awareness about the ill effects of prolonged atrial fibrillation and improving healthcare infrastructure[1].

Challenges and Opportunities

Regulatory Environment

The regulatory environment plays a crucial role in the approval and launch of new antiarrhythmic drugs. Companies must navigate stringent regulatory requirements, which can sometimes halt development due to lack of funding or trials failing to meet endpoints[4].

Competitive Landscape

The market is competitive, with several key players. Companies need to focus on R&D and strategic partnerships to maintain their market position. The entry of generic versions of drugs can also impact the market dynamics[1][3].

Key Takeaways

• The global critical care antiarrhythmic drugs market is growing at a CAGR of 5.6% from 2020 to 2027.
• Flecainide (Tambocor) is expected to reach a market size of USD 2.6 billion by 2031, growing at a CAGR of 8.2%.
• Increasing prevalence of cardiovascular disorders, R&D initiatives, and improving healthcare infrastructure are key drivers.
• North America and Europe are significant markets, with the Asia-Pacific region showing high growth potential.
• Major pharmaceutical companies are focusing on expanding their product portfolios and conducting clinical trials.

FAQs

What is the projected market size of the global critical care antiarrhythmic drugs market by 2027?

The global critical care antiarrhythmic drugs market is projected to reach USD 1,319.7 million by 2027[1].

What is the expected CAGR of the flecainide market from 2024 to 2031?

The flecainide market is expected to grow at a CAGR of 8.2% from 2024 to 2031[3].

Which regions are expected to be the largest markets for antiarrhythmic drugs?

North America and Europe are currently the largest markets, with the Asia-Pacific region expected to grow significantly in the future[1][3].

What are the main drivers of the flecainide market?

The main drivers include the increasing prevalence of cardiac disorders, R&D initiatives, and improving healthcare infrastructure[3].

Which companies are key players in the flecainide market?

Key players include Pfizer Inc., Novartis AG, Sanofi S.A., and Mylan N.V.[3].

Sources

1. Fortune Business Insights: Critical Care Antiarrhythmic Drugs Market Size, Share & Report, 2027.
2. AHRQ Healthcare Horizon Scanning System: Status Update.
3. Market Research Intellect: Global Flecainide Sales Market.
4. AHRQ Healthcare Horizon Scanning System: Status Update.
5. Cognitive Market Research: Global Flecainide Market Report 2024 Edition.