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. Sixteen 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:	108
Clinical Trials:	4
Patent Applications:	3,238
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
The Cleveland 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	020931-003	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 TIKOSYN

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

International Patents for TIKOSYN

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

Country	Patent Number	Title	Estimated Expiration
African Intellectual Property Organization (OAPI)	11350	Dofetilide polymorphs.
Iceland	2179
Colombia	4970768	POLIMORFOS DE DOFETILIDA
Bulgaria	64125
Norway	325630
China	1146537

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

TIKOSYN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TIKOSYN (Dofetilide)

Introduction

TIKOSYN, or dofetilide, is an anti-arrhythmic agent developed by Pfizer to treat irregular heartbeats such as atrial fibrillation and atrial flutter. This article delves into the market dynamics and financial trajectory of TIKOSYN, including its approval, market exclusivity, pricing, and the impact of generic alternatives.

FDA Approval and Indications

TIKOSYN was approved by the FDA on October 22, 2004, for the maintenance of normal sinus rhythm in patients with atrial fibrillation or atrial flutter of more than one week duration who have been converted to normal sinus rhythm[4].

Clinical Efficacy

The drug has been evaluated in several clinical trials, demonstrating its efficacy in converting patients to normal sinus rhythm and maintaining this rhythm over time. Two randomized, double-blind, placebo-controlled trials showed that TIKOSYN, especially at higher doses (500 mcg BID), significantly increased the number of patients maintained in normal sinus rhythm and delayed the time to recurrence of atrial fibrillation/atrial flutter[2][4].

Market Exclusivity and Generic Alternatives

In 2016, Mayne Pharma received FDA approval for dofetilide capsules, a generic alternative to TIKOSYN. As the first company to file a substantially complete Abbreviated New Drug Application (ANDA) with a Paragraph IV patent certification, Mayne Pharma was awarded 180 days of market exclusivity. This exclusivity period allowed Mayne Pharma to capitalize on the market without immediate competition from other generic manufacturers[1].

Impact of Generic Alternatives

The introduction of generic dofetilide capsules by Mayne Pharma marked a significant shift in the market dynamics for TIKOSYN. Generic alternatives typically reduce the market share and revenue of the branded drug, as they offer a more affordable option for patients. The removal of the TIKOSYN Risk Evaluation and Mitigation Strategies (REMS) program around the same time further increased accessibility to dofetilide capsules, making them broadly available at pharmacies nationwide[1].

Pricing and Cost Factors

The cost of TIKOSYN can vary widely based on several factors, including the patient's treatment plan, insurance coverage, and the pharmacy used. Without insurance, the cost is influenced by the quantity prescribed, dosage, and any available savings programs. With insurance, the price also depends on specific plan benefits and prior authorization requirements[5].

Financial Performance

Prior to the introduction of generic alternatives, TIKOSYN generated significant revenue. For instance, annual sales of TIKOSYN in the United States were approximately $200 million for the twelve months ended April 2016[1].

Market Trends and Projections

The pharmaceutical market, including the segment for anti-arrhythmic agents, is expected to grow exponentially due to the increasing global burden of chronic diseases. However, the return on investment (ROI) for pharmaceutical R&D has been declining, which may impact future innovation and investment in this sector[3].

Competitive Landscape

The anti-arrhythmic market is competitive, with various drugs available for treating atrial fibrillation and atrial flutter. The entry of generic dofetilide capsules has increased competition for TIKOSYN, potentially reducing Pfizer's market share and revenue from this product.

Patient Access and Affordability

The availability of generic dofetilide capsules has improved patient access to this medication. Generic drugs are generally more affordable, making them a viable option for patients who may not have been able to afford the branded version. This increased accessibility can lead to better health outcomes for patients with atrial fibrillation and atrial flutter.

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of pharmaceuticals. The FDA's approval process and the withdrawal of the REMS program for TIKOSYN have directly impacted the availability and accessibility of dofetilide capsules. These regulatory changes can significantly affect the financial trajectory of a drug by altering its market reach and competition.

Partnership and Supply Chain

Mayne Pharma's agreement with Johnson Matthey Inc. to supply the active pharmaceutical ingredient (API) for dofetilide capsules highlights the importance of strategic partnerships in the pharmaceutical industry. Such partnerships can ensure a stable supply chain and shared profits, contributing to the financial stability of the companies involved[1].

Future Outlook

Given the growing demand for treatments of chronic conditions like atrial fibrillation and atrial flutter, the market for anti-arrhythmic agents is expected to continue growing. However, the financial performance of TIKOSYN will likely be influenced by the presence of generic alternatives and the overall competitive landscape.

Key Takeaways

• FDA Approval and Indications: TIKOSYN was approved for maintaining normal sinus rhythm in patients with atrial fibrillation or atrial flutter.
• Generic Alternatives: Mayne Pharma's generic dofetilide capsules have reduced TIKOSYN's market share and revenue.
• Pricing and Cost: The cost of TIKOSYN varies based on insurance, treatment plan, and pharmacy.
• Financial Performance: TIKOSYN generated significant revenue before the introduction of generic alternatives.
• Market Trends: The pharmaceutical market is growing, but ROI for R&D is declining.
• Competitive Landscape: The anti-arrhythmic market is competitive, with generic options increasing competition.
• Patient Access: Generic dofetilide capsules have improved patient access to affordable treatment.

FAQs

Q: What is TIKOSYN used for? A: TIKOSYN (dofetilide) is used to convert atrial fibrillation and atrial flutter to a regular heart rhythm and to maintain this rhythm in adults[5].

Q: What is the impact of generic alternatives on TIKOSYN? A: The introduction of generic dofetilide capsules has reduced TIKOSYN's market share and revenue, making the treatment more affordable for patients[1].

Q: How does the cost of TIKOSYN vary? A: The cost of TIKOSYN varies based on factors such as treatment plan, insurance coverage, and the pharmacy used[5].

Q: What is the current market trend for anti-arrhythmic agents? A: The market for anti-arrhythmic agents is growing due to the increasing global burden of chronic diseases, but the ROI for pharmaceutical R&D is declining[3].

Q: What is the significance of the REMS program withdrawal for TIKOSYN? A: The withdrawal of the TIKOSYN REMS program has made the drug more accessible to patients by removing restrictions on its dispensing[1].

Sources

1. Mayne Pharma Receives FDA Approval For Dofetilide Capsules, A Generic Alternative To Tikosyn And Is Awarded 180 Days Market Exclusivity - Biospace
2. TIKOSYN ® (dofetilide) Capsules - Pfizer
3. Investment Trends in Pharmaceutical Research - DrugBank Blog
4. CENTER FOR DRUG EVALUATION AND RESEARCH - FDA
5. Tikosyn cost 2024: Coupons and more - MedicalNewsToday