DOFETILIDE - Generic Drug Details

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What are the generic 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. Eighteen 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:	18
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
Duke Clinical Research Institute	Phase 4
American Heart Association	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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bionpharma	DOFETILIDE	dofetilide	CAPSULE;ORAL	208625-003	Apr 10, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Strides Pharma	DOFETILIDE	dofetilide	CAPSULE;ORAL	208519-002	Oct 9, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Strides Pharma	DOFETILIDE	dofetilide	CAPSULE;ORAL	208519-001	Oct 9, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novast Labs	DOFETILIDE	dofetilide	CAPSULE;ORAL	212410-002	Dec 27, 2019		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for DOFETILIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	TIKOSYN	dofetilide	CAPSULE;ORAL	020931-001	Oct 1, 1999	⤷ Sign Up	⤷ Sign Up
Pfizer	TIKOSYN	dofetilide	CAPSULE;ORAL	020931-002	Oct 1, 1999	⤷ Sign Up	⤷ Sign Up
Pfizer	TIKOSYN	dofetilide	CAPSULE;ORAL	020931-003	Oct 1, 1999	⤷ Sign Up	⤷ Sign Up
Pfizer	TIKOSYN	dofetilide	CAPSULE;ORAL	020931-002	Oct 1, 1999	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for DOFETILIDE

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

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