TIKOSYN Drug Patent Profile

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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. Eighteen 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.

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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

Drug patent expirations by year 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
VA Office of Research and Development

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

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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
Pfizer	TIKOSYN	dofetilide	CAPSULE;ORAL	020931-001	Oct 1, 1999	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	TIKOSYN	dofetilide	CAPSULE;ORAL	020931-002	Oct 1, 1999	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	TIKOSYN	dofetilide	CAPSULE;ORAL	020931-003	Oct 1, 1999	AB	RX	Yes	Yes	⤷ 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 TIKOSYN

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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 TIKOSYN

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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

International Patents for TIKOSYN

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

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Country	Patent Number	Title	Estimated Expiration
German Democratic Republic	268937	VERFAHREN ZUR HERSTELLUNG BESTIMMTER SULFONAMIDE UND IHRE VERWENDUNG ALS ANTIARRHYTHMISCHE MITTEL	⤷ Sign Up
Japan	3569495		⤷ Sign Up
Poland	265418		⤷ Sign Up
Spain	2190620		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for TIKOSYN

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0245997	SPC/GB00/005	United Kingdom	⤷ Sign Up	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	⤷ Sign Up	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	⤷ Sign Up	PRODUCT NAME: DOFETILIDE; REGISTRATION NO/DATE: EU/1/99/121/001 19991129
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description