DrugPatentWatch Database Preview

Dofetilide - Generic Drug Details

« Back to Dashboard

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, Bionpharma Inc, Mayne Pharma Inc, Par Pharm Inc, Sigmapharm Labs Llc, Sun Pharm, and Pfizer, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for dofetilide. Ten suppliers are listed for this compound.

Summary for dofetilide

US Patents:	0
Tradenames:	3
Applicants:	7
NDAs:	7
Drug Master File Entries:	13
Suppliers / Packagers:	10
Bulk Api Vendors:	82
Clinical Trials:	8
Patent Applications:	2,843
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for dofetilide
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dofetilide
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
Oregon Health and Science University	Phase 2
Gilead Sciences	Phase 1
VA Office of Research and Development	N/A

See all dofetilide clinical trials

Recent Litigation for dofetilide

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Pfizer Inc. v. Aurobindo Pharma USA Inc.	2017-12-08
Apicore US LLC v. Pfizer Inc.	2016-12-12
Pfizer Inc. v. Tiger Pharmaceuticals, LLC	2014-12-11

See all dofetilide litigation

Pharmacology for dofetilide

Drug Class

Antiarrhythmic

Synonyms for dofetilide

(Dofetilide) N-[4-(2-{[2-(4-Methanesulfonylamino-phenyl)-ethyl]-methylamino}-ethoxy)-phenyl]-methanesulfonamide

1-(4-methanesulfonamidophenoxy)-2-(N-(4-methanesulfonamidophenethyl)-N-methylamine)ethane

1-(4-Methanesulphonamidophenoxy)-2-[N-(4-methanesulphonamidophenethyl)-N-methylamino]ethane

1-(4-Methansulphonamidophenoxy)-2-[N-(4-methanesulphonamidophenethyl)-N-methylamino]ethane

1-MSPMPE

115256-11-6

256D116

A803396

AB0004775

AB00639976_09

AB00639976-06

AB00639976-08

AB2000201

AC-385

AC1L2FYH

AC1Q6VUS

ACT04222

AKOS005259921

AN-15862

API0002471

BC660134

BCP04770

BCP0726000009

BCP9000619

BDBM50031720

beta-((p-Methanesulfonamidophenethyl)methylamino)methanesulfono-p-phenetidide

BRD-K86887724-001-05-6

C-22372

C07751

C19H27N3O5S2

CAS-115256-11-6

CC-27363

CCG-101037

CHEBI:4681

CHEMBL473

CPD000466333

CS-2200

CTK8F9356

D00647

DB00204

Dofetilida

Dofetilida [INN-Spanish]

Dofetilide (JAN/USAN/INN)

Dofetilide (Tikosyn)

Dofetilide [USAN:BAN:INN]

Dofetilide [USAN:USP:INN:BAN]

Dofetilide, >=98% (HPLC)

Dofetilide, United States Pharmacopeia (USP) Reference Standard

Dofetilide;

Dofetilide(Tikosyn)

Dofetilidum

Dofetilidum [INN-Latin]

DSSTox_CID_26433

DSSTox_GSID_46433

DSSTox_RID_81610

DTXSID5046433

FC0019

FT-0631076

GTPL2604

HMS2051N14

HMS2089F03

HMS2232H19

HMS3261G03

HMS3370B18

HMS3393N14

HMS3655A17

HMS3715H20

HSDB 7927

HY-B0232

I06-0340

I881

IXTMWRCNAAVVAI-UHFFFAOYSA-N

J-003271

KB-09147

KS-00000XNN

LS-90151

Methanesulfonamide, N-(4-(2-(methyl(2-(4-((methylsulfonyl)amino)phenoxy)ethyl)amino)ethyl)phenyl)

Methanesulfonamide, N-(4-(2-(methyl(2-(4-((methylsulfonyl)amino)phenoxy)ethyl)amino)ethyl)phenyl)-

MFCD00869707

MLS000759442

MLS001424185

MLS006010154

MolPort-003-847-012

MRF-0000317

N-(4-(2-(methyl(2-(4-(methylsulfonamido)phenoxy)ethyl)amino)ethyl)phenyl)methanesulfonamide

n-(4-(2-{2-(4-(methanesulphonamido)phenoxyl)-n-methylethylamino}ethyl)phenyl)-methanesulphonamide

N-(4-{2-[methyl(2-{4-[(methylsulfonyl)amino]phenoxy}ethyl)amino]ethyl}phenyl)methanesulfonamide

N-[4-(2-{[2-(4-methanesulfonamidophenoxy)ethyl](methyl)amino}ethyl)phenyl]methanesulfonamide

N-[4-(2-{[2-(4-methanesulfonylamino-phenoxy)-ethyl]-methyl-amino}-ethyl)-phenyl]-methanesulfonamide

N-[4-(2-{[2-(4-Methanesulfonylamino-phenyl)-ethyl]-methyl-amino}-ethoxy)-phenyl]-methanesulfonamide (dofetilide)

N-[4-(2-{[2-(4-Methanesulfonylamino-phenyl)-ethyl]-methyl-amino}-ethoxy)-phenyl]-methanesulfonamide (UK-68798)

N-[4-(2-{[2-(4-METHANESULFONYLAMINO-PHENYL)-ETHYL]-METHYL-AMINO}-ETHOXY)-PHENYL]-METHANESULFONAMIDE DOFETILIDE

N-[4-(2-{2-[4-(methanesulphonamido)phenoxyl]-N-methylethylamino}ethyl)phenyl]-methanesulphonamide

N-[4-[2-[2-(4-methanesulfonamidophenyl)ethyl-methylamino]ethoxy]phenyl]methanesulfonamide

N-[4-[2-[2-[4-(methanesulfonamido)phenoxy]ethyl-methyl-amino]ethyl]phenyl]methanesulfonamide

N-[4-[2-[2-[4-(methanesulfonamido)phenoxy]ethyl-methylamino]ethyl]phenyl]methanesulfonamide

N-[4-[2-[methyl-[2-[4-(methylsulfonylamino)phenoxy]ethyl]amino]ethyl]phenyl]methanesulfonamide

N-[4-[2-[Methyl[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]methanesulfonamide

NC00287

NCGC00164549-01

NCGC00164549-02

NCGC00261036-01

R4Z9X1N2ND

s1658

SAM001246621

SC-76467

SCHEMBL16135

SMR000466333

SR-01000759368

SR-01000759368-4

ST24046670

SW197667-2

Tikosyn

Tikosyn (TN)

Tikosyn;UK68798

TL8000450

Tox21_112178

Tox21_112178_1

Tox21_500351

UK 68,798

UK 68789

UK 68798

UK-68,798

UK-68798

UK68789

UK68798

UNII-R4Z9X1N2ND

Xelide

ZINC596731

Paragraph IV (Patent) Challenges for DOFETILIDE

Tradename	Dosage	Ingredient	NDA	Submissiondate
TIKOSYN	CAPSULE;ORAL	dofetilide	020931	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
Mayne Pharma Inc	DOFETILIDE	dofetilide	CAPSULE;ORAL	207058-002	Jun 6, 2016	AB	RX	No	No
Par Pharm Inc	DOFETILIDE	dofetilide	CAPSULE;ORAL	208519-001	Oct 9, 2018	AB	RX	No	No
Pfizer	TIKOSYN	dofetilide	CAPSULE;ORAL	020931-003	Oct 1, 1999	AB	RX	Yes	Yes
Bionpharma Inc	DOFETILIDE	dofetilide	CAPSULE;ORAL	208625-003	Apr 10, 2018	AB	RX	No	No

Expired US Patents for dofetilide

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