Viewing data from:

TIKOSYN

NDA

DOFETILIDE | N020931 | PFIZER PHARMACEUTICALS PRODUCTION CORP LTD

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Tikosyn (2023)

Total Spending

$790K

Total Claims

626

Beneficiaries

186

Avg Cost/Unit

$10.88

Spending Trend

$6.8M(2019)→$2.4M(2020)→$412K(2021)→$640K(2022)→$790K(2023)

YoY Change:+0.3%

5yr CAGR:+1.6%

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

9 letters from Drugs@FDA

Date	Submission	Document
Aug 12, 2019	SUPPL -17	View Letter (PDF)
Mar 10, 2016	SUPPL -13	View Letter (PDF)
Mar 10, 2016	SUPPL -12	View Letter (PDF)
Nov 27, 2015	SUPPL -10	View Letter (PDF)
Jul 15, 2015	SUPPL -9	View Letter (PDF)
Dec 9, 2013	SUPPL -7	View Letter (PDF)
Jul 13, 2011	SUPPL -3	View Letter (PDF)
Oct 22, 2004	SUPPL -1	View Letter (PDF)
Oct 4, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 0.125MG

RLDAB

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Oct 1, 1999

No patent or exclusivity listings for this strength.

#002 — 0.25MG

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Oct 1, 1999

#003 — 0.5MG

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Oct 1, 1999