TIKOSYN Drug Patent Profile

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

Tikosyn is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in TIKOSYN is dofetilide. There are thirteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the dofetilide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tikosyn

A generic version of TIKOSYN was approved as dofetilide by DR REDDYS LABS SA on June 6^th, 2016.

Summary for TIKOSYN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	4
Patent Applications:	3,662
Drug Prices:	Drug price information for TIKOSYN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TIKOSYN
What excipients (inactive ingredients) are in TIKOSYN?	TIKOSYN excipients list
DailyMed Link:	TIKOSYN at DailyMed

See drug prices for TIKOSYN

Recent Clinical Trials for TIKOSYN

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

Sponsor	Phase
Food and Drug Administration (FDA)	Phase 1
Spaulding Clinical Research LLC	Phase 1
Mayo Clinic

See all TIKOSYN clinical trials

Pharmacology for TIKOSYN

Drug Class

Antiarrhythmic

Paragraph IV (Patent) Challenges for TIKOSYN

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 TIKOSYN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	TIKOSYN	dofetilide	CAPSULE;ORAL	020931-001	Oct 1, 1999	AB	RX	Yes	No
Pfizer	TIKOSYN	dofetilide	CAPSULE;ORAL	020931-002	Oct 1, 1999	AB	RX	Yes	No
Pfizer	TIKOSYN	dofetilide	CAPSULE;ORAL	020931-003	Oct 1, 1999	AB	RX	Yes	Yes

Expired US Patents for TIKOSYN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	TIKOSYN	dofetilide	CAPSULE;ORAL	020931-001	Oct 1, 1999	4,959,366
Pfizer	TIKOSYN	dofetilide	CAPSULE;ORAL	020931-003	Oct 1, 1999	6,124,363
Pfizer	TIKOSYN	dofetilide	CAPSULE;ORAL	020931-002	Oct 1, 1999	6,124,363
Pfizer	TIKOSYN	dofetilide	CAPSULE;ORAL	020931-003	Oct 1, 1999	4,959,366
Pfizer	TIKOSYN	dofetilide	CAPSULE;ORAL	020931-002	Oct 1, 1999	4,959,366
Pfizer	TIKOSYN	dofetilide	CAPSULE;ORAL	020931-001	Oct 1, 1999	6,124,363

EU/EMA Drug Approvals for TIKOSYN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Limited	Tikosyn	dofetilide	EMEA/H/C/000238Tikosyn 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

International Patents for TIKOSYN

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

Country	Patent Number	Title	Estimated Expiration
Finland	871898
Slovakia	5862000	DOFETILIDE POLYMORPHS
Hungary	0004735
Taiwan	449589
Luxembourg	90519
China	1278246

Supplementary Protection Certificates for TIKOSYN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0245997	SPC/GB00/005	United Kingdom		PRODUCT NAME: DOFETILIDE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/99/121/001 19991129; UK EU/1/99/121/002 19991129; UK EU/1/99/121/003 19991129; UK EU/1/99/121/004 19991129; UK EU/1/99/121/005 19991129; UK EU/1/99/121/006 19991129; UK EU/1/99/121/007 19991129; UK EU/1/99/121/008 19991129; UK EU/1/99/121/009 19991129; UK EU/1/99/121/010 19991129; UK EU/1/99/121/011 19991129; UK EU/1/99/121/012 19991129; UK EU/1/99/121/013 19991129; UK EU/1/99/121/014 19991129; UK EU/1/99/121/015 19991129
0245997	C300002	Netherlands		PRODUCT NAME: DOFETILIDE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/99/121/001 - EU/1/99/121/015 19991129
0245997	2000C/005	Belgium		PRODUCT NAME: DOFETILIDE; REGISTRATION NO/DATE: EU/1/99/121/001 19991129

Market Dynamics and Financial Trajectory for TIKOSYN (Dofetilide)

Last updated: July 28, 2025

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Introduction

TIKOSYN (dofetilide) stands as a critical antiarrhythmic agent approved by the U.S. Food and Drug Administration (FDA) for maintaining normal sinus rhythm in patients with atrial fibrillation or atrial flutter. Since its initial approval, TIKOSYN has navigated complex market dynamics dictated by regulatory, clinical, and competitive landscapes. This report explores the evolving market forces, revenue trajectories, competitive positioning, and future prospects for TIKOSYN, providing stakeholders with strategic insights into its commercial trajectory.

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Market Landscape and Epidemiological Drivers

Atrial fibrillation (AFib) remains the most common sustained cardiac arrhythmia globally. According to the American Heart Association, an estimated 6 million Americans have AFib, with prevalence expected to double over the next few decades due to aging populations and rising cardiovascular risk factors [1]. The high incidence of AFib underscores the substantial demand for effective rhythm control therapies such as TIKOSYN.

However, the primary market for TIKOSYN is confined predominantly to North America and select markets with established cardiology practices, given its niche profile and specific indications. In these regions, the prevalence of AFib translates into an expanding patient pool requiring antiarrhythmic therapy, bolstering TIKOSYN’s potential market size.

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Regulatory and Clinical Considerations

FDA Approval and Labeling Constraints: Since its approval in 1999, TIKOSYN’s use remained conservative due to safety concerns—particularly, its propensity to cause torsades de pointes, a life-threatening arrhythmia linked to QT prolongation. The drug's boxed warning emphasizes the need for hospital initiation and diligent electrolyte monitoring, restricting its off-label use (Table 1).

Post-Marketing Surveillance: The drug’s safety profile has led to stringent prescriber restrictions, impacting market penetration. Nonetheless, in appropriate clinical settings, TIKOSYN remains a vital option for patients refractory to other antiarrhythmics.

Guideline Recommendations: Leading cardiology guidelines recognize dofetilide as an effective rhythm control agent for AFib, influencing prescribing patterns. Notably, the American College of Cardiology and the European Society of Cardiology endorse its use in specialized settings, although widespread adoption remains limited by safety protocols.

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Competitive Environment

TIKOSYN’s primary competition comprises other antiarrhythmic drugs, including amiodarone, flecainide, propafenone, and newer agents such as dronedarone. While amiodarone remains the most prescribed due to its efficacy and broad use, issues around toxicity and long-term safety affect its utilization.

The Impact of Novel Therapies: The emergence of interventional procedures, primarily catheter ablation, has shifted some patient management away from pharmacotherapy. As ablation techniques improve efficacy and safety profiles, the reliance on drugs like TIKOSYN could decline.

Market Share Challenges: TIKOSYN’s constrained safety profile limits its use to highly specialized settings, capping its market share. Its niche positioning is further challenged by generics and the reputation of other drugs with more favorable safety records or easier administration.

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Financial Trajectory and Revenue Trends

Historical Revenue Overview: Since its launch, TIKOSYN has maintained moderate but stable revenue streams, primarily fueled by the U.S. hospital and cardiology specialty markets. According to IQVIA data, its U.S. sales peaked around $100 million annually in the early 2010s but have experienced fluctuations due to safety concerns and market shifts [2].

Current Revenue Factors: Presently, TIKOSYN’s revenue reflects a plateau, with slight declines attributable to limited outpatient use and stringent inpatient requirements. Manufacturers, notably Johnson & Johnson (which has marketed TIKOSYN under various arrangements), have focused on maximizing clinical adoption within approved settings.

Future Revenue Projections: The trajectory suggests a modest decline absent significant formulary or guideline-driven shifts. However, targeted strategies—such as expanding clinical protocols, demonstrating cost-effectiveness, or integrating with new care pathways—could stabilize or slightly increase sales.

Pricing and Market Access: TIKOSYN’s pricing remains aligned with specialty drugs in cardiology, with high barriers to access in some healthcare systems due to its monitoring requirements and safety profile. Cost-control pressures and competitive generic availability further influence revenue potential.

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Emerging Trends and Future Opportunities

Off-Label and Expanded Use: While off-label prescribing is common in cardiology, regulatory restrictions limit TIKOSYN’s off-label promotion. Nonetheless, ongoing clinical studies exploring novel indications or improved formulations could alter its market scope.

Biotechnology and Generic Competition: Patent expirations and the entry of biosimilars or generics for similar antiarrhythmic drugs may influence TIKOSYN’s market share. Price erosion could further constrain revenues.

Potential for Combination Therapies: Research into combination regimens or depot formulations aimed at improving safety or adherence may unlock new revenue streams, provided they receive regulatory approval and demonstrate clinical benefit.

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Regulatory and Market Challenges

• Safety Profile and Monitoring: The need for inpatient initiation and electrolyte monitoring continues to be a barrier. Advances in real-time monitoring technologies and risk stratification tools could mitigate these barriers.

• Market Penetration: Limited outpatient use and the dominance of alternative therapies have hindered widespread adoption. Expansion into broader hospital settings may be limited due to safety concerns.

• Reimbursement Environment: Payer restrictiveness, especially in cost-conscious healthcare systems, constrains access. Demonstrating cost-effectiveness relative to other therapies remains critical.

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Strategic Outlook and Recommendations

1. Enhance Clinical Evidence: Invest in real-world evidence and outcome studies demonstrating TIKOSYN’s safety and efficacy in diverse populations to bolster clinical value.

2. Leverage Guideline Endorsements: Collaborate with cardiology societies to reinforce guideline positioning, encouraging wider clinician adoption within approved indications.

3. Innovate Delivery Platforms: Develop formulations or monitoring protocols that simplify administration and reduce safety concerns, expanding outpatient potential.

4. Explore Strategic Partnerships: Collaborate with healthcare providers and digital health firms to integrate TIKOSYN into comprehensive rhythm management programs.

5. Prepare for Competitive Disruption: Monitor emerging therapies and procedural advances, adapting market strategies accordingly.

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Key Takeaways

• Niche but Steady Market: TIKOSYN maintains a niche role in atrial fibrillation management, with stable but modest revenues driven by specialized inpatient use.

• Safety and Monitoring Constraints: Stringent safety protocols restrict outpatient use, limiting market expansion despite clinical efficacy.

• Evolving Market Dynamics: Advances in catheter ablation and alternative drugs threaten to further erode TIKOSYN’s market share.

• Revenue Impacts: Revenue has plateaued, with potential for decline unless innovative strategies are employed to overcome safety and access barriers.

• Strategic Opportunities: Focused investment in clinical data, monitoring technology, and guideline advocacy could prolong TIKOSYN’s relevance and revenue generation.

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FAQs

1. What is the primary indication for TIKOSYN?
TIKOSYN is indicated for the maintenance of normal sinus rhythm in patients with atrial fibrillation or atrial flutter, specifically in settings where other antiarrhythmic options are unsuitable or contraindicated.

2. Why is TIKOSYN prescribed only in hospital settings?
Due to its potential to cause torsades de pointes, TIKOSYN requires inpatient initiation and continuous electrolyte monitoring, limiting its use outside controlled hospital environments.

3. How does TIKOSYN compare to other antiarrhythmic drugs?
While effective for rhythm maintenance, TIKOSYN’s safety profile necessitates careful monitoring, making drugs like amiodarone or newer agents more favorable for outpatient use, despite their own limitations.

4. What future factors could influence TIKOSYN’s market trajectory?
Emerging procedural therapies, safety monitoring innovations, and new pharmacologic agents could either diminish TIKOSYN’s relevance or provide opportunities for expanded application.

5. Is TIKOSYN likely to see significant revenue growth in the coming years?
Given current market constraints and competition, significant revenue growth appears unlikely without strategic repositioning or technological advances that address safety barriers.

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References

[1] American Heart Association. "Atrial Fibrillation." 2022.
[2] IQVIA. "Pharmaceutical Market Insights." 2022.