Dofetilide - Generic Drug Details

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. Sixteen suppliers are listed for this compound.

Summary for dofetilide

US Patents:	0
Tradenames:	3
Applicants:	14
NDAs:	14
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	107
Clinical Trials:	12
Drug Prices:	Drug price trends for dofetilide
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dofetilide
What excipients (inactive ingredients) are in dofetilide?	dofetilide excipients list
DailyMed Link:	dofetilide at DailyMed

See drug prices for dofetilide

Recent Clinical Trials for dofetilide

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

Sponsor	Phase
Thryv Therapeutics, Inc.	Phase 1/Phase 2
Sanofi	Phase 4
Duke Clinical Research Institute	Phase 4

See all dofetilide clinical trials

Pharmacology for dofetilide

Drug Class

Antiarrhythmic

Anatomical Therapeutic Chemical (ATC) Classes for dofetilide

C01BD	Antiarrhythmics, class III
C01B	ANTIARRHYTHMICS, CLASS I AND III
C01	CARDIAC THERAPY
C	Cardiovascular system

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Granules	DOFETILIDE	dofetilide	CAPSULE;ORAL	212750-003	Oct 14, 2021	AB	RX	No	No
Granules	DOFETILIDE	dofetilide	CAPSULE;ORAL	212750-002	Oct 14, 2021	AB	RX	No	No
Accord Hlthcare	DOFETILIDE	dofetilide	CAPSULE;ORAL	213338-001	Jun 19, 2020	AB	RX	No	No
Novast Labs	DOFETILIDE	dofetilide	CAPSULE;ORAL	212410-003	Dec 27, 2019		DISCN	No	No
Granules	DOFETILIDE	dofetilide	CAPSULE;ORAL	212750-001	Oct 14, 2021	AB	RX	No	No
Pfizer	TIKOSYN	dofetilide	CAPSULE;ORAL	020931-003	Oct 1, 1999	AB	RX	Yes	Yes

Expired US Patents for dofetilide

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

EU/EMA Drug Approvals for dofetilide

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing 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

Dofetilide Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Dofetilide

Introduction to Dofetilide

Dofetilide, marketed under the brand name Tikosyn® by Pfizer, is an anti-arrhythmic medication used to treat irregular heartbeats such as atrial fibrillation and atrial flutter. The drug has seen significant developments in recent years, particularly with the introduction of generic alternatives.

Market Growth and Projections

The dofetilide market has experienced rapid and substantial growth in recent times. Projections indicate that this trend will continue, with the market expected to achieve remarkable growth at a significant CAGR from 2024 to 2031[1][4].

• Forecast Period: The market is anticipated to expand significantly during the forecast period of 2024-2031, driven by positive market dynamics and sustained expansion.
• Revenue Projections: The market size is expected to grow in terms of revenue, measured in USD million, across various segments including type (capsules, others), application (hospital, clinic), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[1][4].

Key Drivers of Market Growth

Several factors are driving the growth of the dofetilide market:

• Increasing Prevalence of Atrial Fibrillation: The rising incidence of atrial fibrillation and other arrhythmias contributes to the demand for effective treatments like dofetilide.
• Generic Alternatives: The approval of generic dofetilide capsules by companies like Mayne Pharma has increased accessibility and affordability, boosting market growth. Mayne Pharma's FDA approval in 2016, which included 180 days of market exclusivity, was a significant milestone[2].
• Improved Accessibility: The removal of the Tikosyn® Risk Evaluation and Mitigation Strategies (REMS) program has made dofetilide capsules more widely available at pharmacies, enhancing patient access[2].

Market Segmentation

The dofetilide market is segmented based on several criteria:

• Type: Capsules and other forms.
• Application: Hospitals and clinics.
• Geography: North America, Europe, Asia-Pacific, South America, and Middle-East and Africa[1][4].

Key Players and Market Competition

The market is dominated by several key players:

• Pfizer: The original developer and marketer of Tikosyn®.
• Mayne Pharma: Known for its generic dofetilide capsules.
• Sigmapharm Laboratories, Novadoz Pharmaceuticals, NorthStar Rx LLC, AvKARE Inc., Accord Healthcare, Bionpharma, and Sun Pharmaceutical Industries Ltd.: Other significant players in the market[1][4].

Pharmacokinetics and Clinical Use

Dofetilide has favorable pharmacokinetic properties:

• Oral Bioavailability: Greater than 90%, with maximal plasma concentrations occurring within 2-3 hours.
• Half-Life: Approximately 10 hours, with steady-state plasma concentrations attained within 2-3 days.
• Elimination: Primarily renal, with 80% of the drug excreted unchanged in the urine[3][5].

Safety and Efficacy

Dofetilide is effective in converting and maintaining sinus rhythm in patients with atrial fibrillation, but it comes with risks:

• QTc Interval Prolongation: A significant concern, necessitating in-hospital initiation and daily ECG monitoring.
• Torsades de Pointes (TdP): A risk associated with dofetilide, particularly in patients with certain risk factors[3][5].

Financial Impact and Market Exclusivity

The financial trajectory of dofetilide has been influenced by several factors:

• Generic Competition: The entry of generic alternatives has increased market competition, potentially reducing the market share of branded products.
• Market Exclusivity: Mayne Pharma's 180 days of market exclusivity for its generic dofetilide capsules has provided a significant financial advantage[2].

Market Opportunities and Challenges

• Opportunities: Growing demand for anti-arrhythmic medications, expanding into new geographical markets, and the potential for combination therapies.
• Challenges: Regulatory hurdles, competition from other anti-arrhythmic drugs, and the need for careful patient monitoring due to the risk of QTc interval prolongation and TdP[1][4].

Consumer Behavior and Economic Impact

Consumer behavior and economic factors play crucial roles in the dofetilide market:

• Affordability: The availability of generic alternatives has made dofetilide more affordable for patients, increasing its adoption.
• Healthcare Policies: Changes in healthcare policies and reimbursement strategies can impact the market's financial trajectory[1][4].

Key Takeaways

• The dofetilide market is poised for significant growth driven by increasing demand, generic competition, and improved accessibility.
• Key players are investing in developing high-quality generic products to capture market share.
• The market is segmented by type, application, and geography, with North America and Europe being key regions.
• Safety and efficacy concerns, particularly related to QTc interval prolongation, require careful monitoring.

FAQs

Q: What is dofetilide used for? A: Dofetilide is used to treat irregular heartbeats such as atrial fibrillation and atrial flutter.

Q: Who are the key players in the dofetilide market? A: Key players include Pfizer, Mayne Pharma, Sigmapharm Laboratories, Novadoz Pharmaceuticals, and others.

Q: What are the risks associated with dofetilide? A: Dofetilide is associated with QTc interval prolongation and the risk of torsades de pointes (TdP), requiring careful patient monitoring.

Q: How has the introduction of generic dofetilide impacted the market? A: The introduction of generic dofetilide has increased accessibility and affordability, boosting market growth and competition.

Q: What is the forecasted growth rate of the dofetilide market? A: The market is expected to grow at a significant CAGR from 2024 to 2031.

Cited Sources

1. Market Research Intellect - Global Dofetilide Market Size, Trends and Projections
2. BioSpace - Mayne Pharma Receives FDA Approval For Dofetilide Capsules
3. American College of Cardiology - Safety of Rapid Switching from Amiodarone to Dofetilide in Patients With AF With an ICD
4. Market Research Intellect - Global Dofetilide Market Size, Scope And Forecast Report
5. Pfizer - TIKOSYN ® (dofetilide) Capsules - Labeling Information