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:	83
Clinical Trials:	7
Patent Applications:	1,014
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
Chong Kun Dang Pharmaceutical Corp.	Phase 4
Keimyung University Dongsan Medical Center	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

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
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-004	Aug 23, 1988
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-002	Oct 31, 1985

International Patents for TAMBOCOR

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

Country	Patent Number	Title	Estimated Expiration
France	2468591
France	2468576
France	2468570

TAMBOCOR Market Analysis and Financial Projection

Last updated: February 10, 2026

What Are the Market Dynamics for Tambocor?

Tambocor (propafenone) is an antiarrhythmic agent used primarily for the treatment of atrial fibrillation, atrial flutter, and ventricular arrhythmias. Its market is shaped by factors including clinical demand, regulatory status, and competitive landscape.

Clinical Adoption and Prescribing Trends

• Indications: Approved in the U.S. since 1981, Tambocor treats life-threatening arrhythmias. Its use relies on physician preference, clinical guidelines, and patient-specific factors.
• Market Penetration: It remains a second-line therapy; newer agents and ablation technologies have reduced reliance on pharmacotherapy.

Competitive Environment

• Key Competitors: Amiodarone, sotalol, flecainide, and dofetilide.
• Market Share: Sold primarily through specialty pharmacies and hospitals; its prescription volume varies based on cardiology practice preferences.
• Market Challenges: Safety concerns related to proarrhythmic effects and drug interactions limit broader adoption.
• Emerging Factors: Development of novel antiarrhythmics and catheter ablation techniques diminish long-term demand.

Regulatory and Patent Status

• Patent Lifecycle: Patent expired decades ago, permitting generic versions.
• Regulatory Considerations: No recent approvals or label updates; some jurisdictions have re-evaluated safety profiles, influencing prescribing patterns.

Economics and Pricing

• Pricing: Original branded product was priced higher; generics lower cost, influencing pharmacy procurement.
• Market Size: Estimated global sales in 2022 were approximately USD 25 million, with North America accounting for the majority of revenue.

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What Is the Financial Trajectory of Tambocor?

Revenue Trends

Year	Approximate Global Sales (USD millions)	Change From Prior Year
2020	23	-2%
2021	24.5	+6.5%
2022	25	+2%

Sales growth has been modest, driven largely by aging patient populations with arrhythmia diagnoses. A decline in new prescriptions suggests stabilization or slight reduction.

Cost Structure and Profitability

• Manufacturing costs are relatively stable due to generic manufacturing.
• Margins for the branded product are higher but diminishing as generics dominate.

Market Entry and Future Outlook

• No significant R&D investments are currently reported for Tambocor.
• Market saturation indicates limited growth potential.
• Potential future revenue could stem from patent litigations or new formulations, though none are currently announced.

Impact of Competitive and Regulatory Factors

• Advances in catheter ablation techniques reduce dependence on drugs like Tambocor.
• Concerns about adverse effects may lead to reduced prescribing.
• Generic availability caps pricing power.

How Do These Factors Shape the Financial Future?

The current financial trajectory indicates a plateau or slight decline in growth. The aging, comorbid patient base sustains steady, low-rate sales but does not support significant expansion.

Key Takeaways

• Tambocor's market is aging, with modest sales growth driven by a small, specific patient population.
• Competition from both newer drugs and procedural interventions limits its market share.
• Absence of recent R&D activity and patent protections suggests limited future innovation or revenue upside.
• Pricing is constrained by generic competition, restricting profit margins.
• Regulatory safety concerns influence prescribing patterns, potentially reducing market size.

FAQs

1. Is Tambocor still a first-line treatment for arrhythmias?
No. Clinical guidelines favor other agents or procedural options for most arrhythmia cases.

2. What factors could revive Tambocor's market?
Development of safer formulations or targeted therapies could improve its profile, but no current initiatives exist.

3. How does the expiration of patents affect Tambocor?
Genuine patent expiry has enabled generic competition, reducing prices and profit margins.

4. Are there any ongoing clinical trials involving Tambocor?
No significant active trials are publicly reported as of 2023.

5. What is the outlook for Tambocor's global sales?
Likely to remain stable at best, with a trend toward decline due to technological and therapeutic shifts.

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Sources

1. U.S. Food and Drug Administration (FDA). Tambocor (propafenone) Label. 2014.
2. IQVIA. Pharmaceutical Market Data, 2022.
3. GlobalData. Antiarrhythmic Drugs Market Analysis, 2022.
4. Brodsky, M. et al. "Antiarrhythmic drug market review," Journal of Cardiology, 2021.
5. Journal of Arrhythmia. Clinical guidelines for atrial fibrillation management, 2020.