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DOFETILIDE

ANDA

DOFETILIDE | A207058 | DR REDDYS LABORATORIES SA

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. Tiger Pharmaceuticals, LLC 1:2014cv01501 1 patentANDA 207058dofetilide	VAED	2014-11-10	Terminated 2015-02-23	—

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

Medicare Part D Spending

CMS annual spending data for Dofetilide (2023)

Total Spending

$81.1M

Total Claims

296,833

Beneficiaries

65,815

Avg Cost/Unit

$2.20

Spending Trend

$91.1M(2019)→$90.8M(2020)→$83.9M(2021)→$81.5M(2022)→$81.1M(2023)

YoY Change:-6.6%

5yr CAGR:-15.5%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 8, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 0.125MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jun 6, 2016

No patent or exclusivity listings for this strength.

#002 — 0.25MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jun 6, 2016

#003 — 0.5MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jun 6, 2016