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Last Updated: July 28, 2025

Dofetilide - Generic Drug Details


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

Dofetilide is the generic ingredient in three branded drugs marketed by Aurobindo Pharma Ltd, Accord Hlthcare, Bionpharma, Dr Reddys Labs Sa, Granules, MSN, Novast Labs, Prinston Inc, Rk Pharma, Sigmapharm Labs Llc, Strides Pharma, Sun Pharm, Teva Pharms Usa, and Pfizer, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for dofetilide. Fifteen suppliers are listed for this compound.

Drug Prices for dofetilide

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Recent Clinical Trials for dofetilide

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

SponsorPhase
Thryv Therapeutics, Inc.Phase 1/Phase 2
SanofiPhase 4
Duke Clinical Research InstitutePhase 4

See all dofetilide clinical trials

Pharmacology for dofetilide
Drug ClassAntiarrhythmic
Paragraph IV (Patent) Challenges for DOFETILIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TIKOSYN Capsules dofetilide 0.125 mg, 0.25 mg, and 0.5 mg 020931 1 2014-05-01

US Patents and Regulatory Information for dofetilide

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Prinston Inc DOFETILIDE dofetilide CAPSULE;ORAL 211223-003 Dec 17, 2019 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Granules DOFETILIDE dofetilide CAPSULE;ORAL 212750-002 Oct 14, 2021 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Granules DOFETILIDE dofetilide CAPSULE;ORAL 212750-003 Oct 14, 2021 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 3 of 3 entries

Expired US Patents for dofetilide

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Pfizer TIKOSYN dofetilide CAPSULE;ORAL 020931-003 Oct 1, 1999 ⤷  Try for Free ⤷  Try for Free
Pfizer TIKOSYN dofetilide CAPSULE;ORAL 020931-001 Oct 1, 1999 ⤷  Try for Free ⤷  Try for Free
Pfizer TIKOSYN dofetilide CAPSULE;ORAL 020931-002 Oct 1, 1999 ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 3 of 3 entries

EU/EMA Drug Approvals for dofetilide

CompanyDrugnameInnProduct Number / IndicationStatusGenericBiosimilarOrphanMarketing AuthorisationMarketing Refusal
Pfizer Limited Tikosyn dofetilide EMEA/H/C/000238
Tikosyn is a Class III antiarrhythmic agent that is indicated for the following:Conversion of persistent atrial fibrillation or atrial flutter to normal sinus rhythm in patients in whom cardioversion by electrical means is not appropriate and in whom the duration of the arrhythmic episode is less than 6 months (see section 5.1).Maintenance of sinus rhythm (after conversion) in patients with persistent atrial fibrillation or atrial flutter. Because TIKOSYN can cause ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic and in whom other antiarrhythmic therapy is not appropriate.Dofetilide has not been shown to be effective in patients with paroxysmal atrial arrhythmias (including paroxysmal atrial fibrillation).
Withdrawn no no no 1999-11-29
>Company>Drugname>Inn>Product Number / Indication>Status>Generic>Biosimilar>Orphan>Marketing Authorisation>Marketing Refusal
Showing 1 to 1 of 1 entries

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: DOFETILIDE

Last updated: July 27, 2025


Introduction

Dofetilide, marketed under brand names such as Tikosyn, is an antiarrhythmic agent primarily prescribed for the management of atrial fibrillation and atrial flutter. Approved by the U.S. Food and Drug Administration (FDA) in 2000, dofetilide is characterized by its selective inhibition of the rapid component of the delayed rectifier potassium channel, prolonging cardiac repolarization. The drug's niche focus and safety profile significantly influence its market dynamics and financial prospects.

This analysis examines the evolving market landscape, competitive environment, regulatory factors, and financial trajectory of dofetilide, providing actionable insights for stakeholders across the pharmaceutical spectrum.


Market Landscape and Demand Drivers

Prevalence of Atrial Fibrillation and Market Opportunity

Atrial fibrillation (AF) remains the most common sustained cardiac arrhythmia, with an estimated 37.5 million cases globally by 2030 — driven by aging populations, hypertension, obesity, and comorbidities such as heart failure [1]. In the United States alone, approximately 6.1 million individuals are affected, with the prevalence expected to rise concomitant with demographic shifts. AF imposes substantial healthcare costs, emphasizing the need for effective rhythm control therapies.

Dofetilide occupies a significant role within this therapeutic landscape owing to its efficacy in maintaining sinus rhythm and its comparatively favorable safety profile when monitored appropriately. While newer agents have entered the market, dofetilide's niche remains valuable, especially for specific patient subsets contraindicated to other antiarrhythmics.

Market Penetration and Geographic Distribution

Currently, dofetilide’s penetration is concentrated predominantly in North America, where its approval status and clinical familiarity have facilitated sustained use. The drug's global uptake is limited by factors including regulatory hurdles, cost considerations, and the availability of newer agents such as dronedarone, flecainide, and sotalol. Additionally, outpatient management protocols and the requirement for hospitalization during initiation restrain its broader utilization, impacting overall market volume.


Competitive Dynamics and Therapeutic Landscape

Key Competitors and Alternatives

Dofetilide’s competitive landscape features drugs like:

  • Flecainide and Propafenone: First-line options for rhythm control, especially in structurally normal hearts.
  • Sotalol: Combines beta-blockade with antiarrhythmic properties but carries a risk of torsades de pointes.
  • Dronedarone: A multichannel blocker with a more favorable safety profile.
  • Amiodarone: Highly effective but limited by notable toxicity.

Market share depends on factors including efficacy, safety profiles, prescribing physicians’ familiarity, and hospitalization requirements.

Innovations and Adjuncts impact

Emerging technologies such as wearable cardiac monitors and rapid point-of-care testing have improved safety monitoring during dofetilide therapy, potentially expanding its appeal in select patient populations.


Regulatory Environment and Reimbursement Dynamics

Regulatory Considerations

Dofetilide's safety profile necessitates stringent regulatory adherence, notably in initiating therapy within hospital settings with continuous ECG monitoring. This prerequisite constrains outpatient adoption and influences healthcare reimbursement policies.

Any regulatory shifts that streamline initiation protocols or allow for outpatient management can significantly impact its market trajectory.

Reimbursement and Pricing

Dofetilide’s pricing is competitive relative to newer agents, partly due to its generic status – a critical factor in sustaining market share amid rising healthcare costs. Reimbursement policies that favor hospital-based administration, however, introduce pricing pressures and reimbursement complexities.


Financial Trajectory and Growth Opportunities

Revenue Trends

Over the last decade, dofetilide’s global sales have demonstrated modest growth, primarily driven by the US market. The drug’s sales are sensitive to changes in clinical guidelines, physician preferences, and patient acceptance. Patent expiry of branded formulations has catalyzed generic competition, leading to price reductions and margin compression.

Opportunities for Expansion

  1. Expanding Indications: Clinical trials exploring dofetilide's efficacy in other arrhythmia types or in combination therapies could unlock new revenue streams.
  2. Innovation in Formulation and Monitoring: Developing formulations allowing outpatient initiation or integrating remote monitoring could broaden its utilization.
  3. Geographical Expansion: Targeted regulatory strategies in emerging markets with rising cardiovascular disease burdens may enhance growth prospects.

Risks and Challenges

  • Safety Concerns: The potential for torsades de pointes necessitates meticulous monitoring and limits outpatient use.
  • Market Competition: The advent of safer, more convenient alternatives, and emergence of novel therapies like catheter ablation, could diminish demand.
  • Regulatory Hurdles: Stringent prescribing and monitoring requirements remain barriers to more widespread use.

Future Outlook

The future of dofetilide hinges on technological and regulatory innovations, clinical evidence supporting expanded indications, and strategic positioning within the arrhythmia management paradigm. As the global burden of AF persists, its market is likely to remain stable in core markets, with potential for growth through targeted initiatives that address current limitations.


Key Takeaways

  • Dofetilide remains a specialized, yet valuable, antiarrhythmic with steadiness driven by the global rise in atrial fibrillation cases.
  • The drug’s market growth is constrained by safety considerations, hospitalization protocols, and competition from newer agents.
  • Regulatory pathways and reimbursement strategies directly influence its market penetration; innovations in outpatient management could unlock new opportunities.
  • Price competition from generics and emerging therapies necessitates strategic differentiation, such as expanded indications and combination regimens.
  • Continuous market monitoring, alongside clinical research, is essential for stakeholders to capitalize on evolving landscape dynamics.

FAQs

1. What factors limit the broader adoption of dofetilide?
Dofetilide’s requirement for hospitalization during initiation and ongoing safety monitoring, especially for torsades de pointes risk, limit its outpatient utilization, restricting broader adoption.

2. How does patent expiration affect dofetilide’s market?
Patent expiry leads to generic competition, reducing prices and marginally impacting revenue, but also expanding access due to lower costs.

3. Are there ongoing clinical trials to expand dofetilide’s indications?
While specific new trials are limited, research continues into optimizing protocols and safety monitoring tools, which could support future indication expansion.

4. What is the outlook for dofetilide in emerging markets?
Growing cardiovascular disease burdens and increased healthcare infrastructure suggest potential for market growth, contingent on regulatory approvals and cost-effectiveness considerations.

5. How does dofetilide compare with newer antiarrhythmic agents?
Dofetilide offers efficacy in rhythm control with a predictable safety profile when monitored appropriately, but its complex administration process compares less favorably to newer agents with more convenient dosing and monitoring profiles.


Sources:
[1] Forbes, "Global Atrial Fibrillation Market: Industry Analysis & Outlook," 2022.
[2] FDA, "Tikosyn (Dofetilide) Prescribing Information," 2022.
[3] MarketWatch, "Antiarrhythmic Drugs Market Forecast," 2023.
[4] ClinicalTrials.gov, "Studies on Antiarrhythmic Agents," 2023.

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