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DOFETILDE

ANDA

DOFETILIDE | A210740 | AUROBINDO PHARMA LTD

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: TIKOSYN(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Pfizer Inc. et al v. Aurobindo Pharma USA Inc. 1:2017cv01775 1 patentANDA 210740dofetilide	D. Del.	2017-12-08	Terminated 2018-05-31	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain10 active DMFs1 inactive

10 active API suppliers hold Drug Master Files for this ingredient.

MATRIX PHARMACORP PRIVATE LTDDOFETILIDE USP, POLYMORPH P162B

DMF 297222015

INDUSTRIALE CHIMICA SRLDOFETILIDE USP

DMF 300422015

APITORIA PHARMA PRIVATE LTDDOFETILIDE USP

DMF 305602016

CHEMWERTH INCDOFETILIDE USP

DMF 307182017

SUN PHARMACEUTICAL INDUSTRIES LTDDOFETILIDE USP

DMF 310262016

MSN LIFE SCIENCES PRIVATE LTDDOFETILIDE USP

DMF 311582016

EMCURE PHARMACEUTICALS LTDDOFETILIDE USP

DMF 318112017

FARMAK ASDOFETILIDE

DMF 318582017

ENALTEC LABS PRIVATE LTDDOFETILIDE USP

DMF 319392018

INTAS PHARMACEUTICALS LTDDOFETILIDE USP

DMF 333052018

BIDDLE SAWYER PHARMA LLCInactiveDOFETILIDE USP

DMF 305082016

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (3)

Sort:

#001 — 0.125MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jan 22, 2019

No patent or exclusivity listings for this strength.

#002 — 0.25MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jan 22, 2019

#003 — 0.5MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jan 22, 2019