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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Fish and Richardson
Argus Health
Daiichi Sankyo
Cerilliant
Harvard Business School
Cipla
AstraZeneca
Chubb

Generated: November 12, 2018

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Dofetilide - Generic Drug Details

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What are the generic sources for dofetilide and what is the scope of dofetilide patent protection?

Dofetilide is the generic ingredient in two branded drugs marketed by Bionpharma Inc, Mayne Pharma Inc, Par Pharm Inc, Sigmapharm Labs Llc, Sun Pharma Global, and Pfizer, and is included in six NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for dofetilide. Nine suppliers are listed for this compound.

Pharmacology for dofetilide
Drug ClassAntiarrhythmic
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
AK161932
AKOS005259921
Ambap115256-11-6
AN-15862
API0002471
BC660134
BCP0726000009
BCP9000619
BDBM50031720
beta-((p-Methanesulfonamidophenethyl)methylamino)methanesulfono-p-phenetidide
C-22372
C07751
C19H27N3O5S2
CAS-115256-11-6
CC-27363
CCG-101037
CHEBI:4681
CHEMBL473
CPD000466333
CS-2200
CTK8F9356
D00647
D0NW3X
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
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
OR073605
OR205686
R4Z9X1N2ND
s1658
SAM001246621
SC-76467
SCHEMBL16135
SMR000466333
ST24046670
Tikosyn
Tikosyn (TN)
Tikosyn, UK68798, Dofetilide
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

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
Par Pharm Inc DOFETILIDE dofetilide CAPSULE;ORAL 208519-003 Oct 9, 2018 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sigmapharm Labs Llc DOFETILIDE dofetilide CAPSULE;ORAL 207746-002 Mar 26, 2018 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Bionpharma Inc DOFETILIDE dofetilide CAPSULE;ORAL 208625-003 Apr 10, 2018 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sun Pharma Global DOFETILIDE dofetilide CAPSULE;ORAL 210466-003 Oct 9, 2018 AB RX 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

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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 ➤ 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

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Supplementary Protection Certificates for dofetilide

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00002 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
00C/005 Belgium ➤ Sign Up PRODUCT NAME: DOFETILIDE; REGISTRATION NO/DATE: EU/1/99/121/001 19991129
C/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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Fish and Richardson
Argus Health
Daiichi Sankyo
Cerilliant
Harvard Business School
Cipla
AstraZeneca
Chubb

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