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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	TIKOSYN	dofetilide	CAPSULE;ORAL	020931	NDA	Pfizer Laboratories Div Pfizer Inc	0069-5800-60	60 CAPSULE in 1 BOTTLE (0069-5800-60)	1999-10-01
Pfizer	TIKOSYN	dofetilide	CAPSULE;ORAL	020931	NDA	Pfizer Laboratories Div Pfizer Inc	0069-5800-61	14 CAPSULE in 1 BOTTLE (0069-5800-61)	1999-10-01
Pfizer	TIKOSYN	dofetilide	CAPSULE;ORAL	020931	NDA	Pfizer Laboratories Div Pfizer Inc	0069-5810-60	60 CAPSULE in 1 BOTTLE (0069-5810-60)	1999-10-01
Pfizer	TIKOSYN	dofetilide	CAPSULE;ORAL	020931	NDA	Pfizer Laboratories Div Pfizer Inc	0069-5810-61	14 CAPSULE in 1 BOTTLE (0069-5810-61)	1999-10-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 2, 2025

Introduction

Tikosyn (dofetilide) is a prescription medication primarily used for the management of atrial fibrillation and atrial flutter. As a Class III antiarrhythmic agent, it modulates cardiac electrical activity to restore and maintain normal heart rhythm. Since its approval by the U.S. Food and Drug Administration (FDA) in 1999, Tikosyn has become a critical component in arrhythmia treatment, necessitating reliable supply chains. This article analyzes the key suppliers of Tikosyn, considering manufacturing, distribution, and regulatory compliance to inform stakeholders about the drug’s market landscape.

Manufacturers of Tikosyn (Dofetilide)

Pfizer Inc.

Pfizer, a global pharmaceutical giant, holds the original patent and manufacturing rights for Tikosyn. Founded in 1849, Pfizer's extensive portfolio includes pharmaceutical innovator products, with Tikosyn being a strategic addition to its cardiac arrhythmia lineup.

Manufacturing Facilities: Pfizer's advanced biopharmaceutical plants globally produce dofetilide adhering to cGMP regulations to ensure quality and consistency.
Product Availability: Pfizer’s manufacturing ensures a consistent supply of Tikosyn across North America, with extensive distribution channels.
Regulatory Compliance: Pfizer maintains compliance with FDA regulations, including post-market surveillance and pharmacovigilance for Tikosyn.

Generic Suppliers

Following patent expiration in 2022 (patent protection typically lasts 20 years from filing, with extensions), several generic pharmaceutical companies have entered the market to manufacture dofetilide, increasing access and reducing costs.

Teva Pharmaceutical Industries Ltd.: A prominent generic manufacturer, Teva holds FDA approval for generic dofetilide. Their manufacturing facilities in Israel and the United States are compliant with cGMP standards, ensuring quality.
Sandoz (Novartis): As Novartis’ generics division, Sandoz has received FDA approval for generic dofetilide, leveraging its global manufacturing network including facilities in Europe and the U.S.
Mylan (now part of Viatris): Mylan’s generic dofetilide is supplied across multiple markets, with manufacturing adhering to stringent regulatory standards.
Others: Additional regional players may manufacture dofetilide depending on local approvals, but Pfizer, Teva, and Sandoz dominate the global supply landscape.

Distribution and Supply Chain Dynamics

Distribution Channels

Tikosyn’s distribution primarily involves specialty pharmacies, hospital formularies, and pharmacy benefit managers (PBMs). Its requirement for risk management, including monitoring renal function and QT prolongation, mandates specialized distribution.

Authorized Distributors: Pfizer and generic manufacturers partner with major pharmaceutical distributors like McKesson, Cardinal Health, and AmerisourceBergen to ensure availability in hospitals and clinics.
Regulatory Oversight: The distribution chain is tightly regulated under FDA and DEA guidelines to prevent diversion and assure product integrity.

Market Dynamics Post-Patent Expiry

The entry of generics has led to increased competition, significantly reducing prices and expanding access, especially in healthcare systems emphasizing cost containment.

Pricing Trends: Generic availability has resulted in price reductions of up to 80% compared to the brand-name Tikosyn.
Supply Security: Multiple manufacturers reduce dependency on a single source, mitigating supply disruptions.
Challenges: Potential manufacturing bottlenecks at generic companies could impact supply, emphasizing the importance of diversified sourcing strategies.

Regulatory and Quality Standards

All suppliers must comply with cGMP guidelines specified by the FDA to ensure product safety and efficacy. The FDA’s Drug Shortages program emphasizes the criticality of maintaining a robust supply chain for drugs like Tikosyn.

Regulatory and Compliance Landscape

The pharmaceutical supply chain for Tikosyn involves rigorous regulatory oversight.

FDA Approval: Both Pfizer and generic manufacturers have to submit ANDA (Abbreviated New Drug Application) dossiers demonstrating bioequivalence, manufacturing quality, and safety profiles.
Pharmacovigilance: Ongoing safety monitoring is mandated post-approval, especially given Tikosyn's potential for arrhythmogenic effects and need for ECG monitoring.
Global Markets: While the U.S. market is predominant, other countries regulate through respective agencies like the EMA in Europe and the PMDA in Japan, influencing supplier eligibility.

Emerging Trends and Strategic Considerations

Supply Chain Resilience

Increasing focus on supply chain resilience has prompted manufacturers and healthcare providers to diversify suppliers, secure safety stock, and implement risk management plans.

Biosimilar and Alternative Treatments

While not biosimilars, alternative antiarrhythmic drugs are being developed to broaden options and prevent supply shortages.

Impact of Patent Expiry

Patent expiration in 2022 has been pivotal in increasing the number of suppliers. This shift improves access but necessitates ongoing regulatory oversight to ensure supply quality consistency.

Key Takeaways

Pfizer remains the primary manufacturer, with multiple generic companies now offering dofetilide post-patent expiry, notably Teva, Sandoz, and Viatris.
The supply chain is characterized by a tightly regulated distribution network managing specialty pharmacy channels, hospitals, and pharmacy chains.
Increased generic manufacturing enhances supply stability and reduces costs but introduces competition that can challenge manufacturing continuity.
Regulatory compliance under FDA cGMP standards remains central to manufacturing sustainability and product quality.
Diversification of suppliers and robust inventory management are crucial strategies to mitigate risks of shortages in the face of industry and supply chain disruptions.

FAQs

Q1. Who currently manufactures Tikosyn (dofetilide)?
A1. Pfizer remains the original patent holder and manufacturer. Post-patent expiry, generic manufacturers like Teva, Sandoz, and Viatris have obtained FDA approval to produce dofetilide.

Q2. How does patent expiry affect the availability of Tikosyn?
A2. Patent expiry has allowed multiple generic manufacturers to enter the market, increasing supply, reducing prices, and expanding access, while also emphasizing the need for ongoing quality oversight.

Q3. What are the main distribution channels for Tikosyn?
A3. Distribution is primarily through specialty pharmacies, hospitals, and pharmacy benefit managers, with strict regulatory oversight to prevent diversion and ensure patient safety.

Q4. Are there any regional differences in Tikosyn suppliers?
A4. Yes. While the U.S. market relies on FDA-approved manufacturers, other countries may have local or regional suppliers adhering to their respective regulatory standards.

Q5. What risks exist in the supply chain for Tikosyn?
A5. Primary risks include manufacturing disruptions at generic firms, regulatory delays, supply chain bottlenecks, and quality control issues. Diversification and inventory strategies mitigate these risks.

References

[1] U.S. Food and Drug Administration (FDA). “Tikosyn (dofetilide) prescribing information.” 1999.
[2] Pfizer Inc. “Tikosyn (dofetilide) product information.” 2023.
[3] FDA, “Abbreviated New Drug Applications (ANDA) Approvals.” 2023.
[4] IMS Health, “Generic Drug Market Trends.” 2022.
[5] Pharmaceutical Technology, “Supply chain strategies for antiarrhythmic drugs.” 2023.

This analysis aims to inform healthcare and business decision-makers on the current supply landscape for Tikosyn, emphasizing the importance of robust sourcing, regulatory compliance, and strategic planning to ensure uninterrupted patient access.

Suppliers and packagers for TIKOSYN

TIKOSYN

Suppliers for the Pharmaceutical Drug: Tikosyn (Dofetilide)