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DILANTIN

NDA

PHENYTOIN SODIUM | N010151 | PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO

1 strength0 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

No ANDA patent litigation cases (NOS 835) matched from PACER

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 Dilantin (2023)

Total Spending

$30.2M

Total Claims

125,230

Beneficiaries

19,752

Avg Cost/Unit

$1.61

Spending Trend

$1.9M(2019)→$32.8M(2019)→$1.8M(2020)→$32.6M(2020)→$1.7M(2021)→$32.1M(2021)→$31.1M(2022)→$1.6M(2022)→$1.5M(2023)→$30.2M(2023)

YoY Change:+8.5%

5yr CAGR:+6.2%

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

API Supply Chain6 active DMFs

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

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPAPHENYTOIN SODIUM

DMF 45381982

ERREDUE SPA INNOVATIVE CHEMICAL AND LIFEPHENYTOIN SODIUM

DMF 163012002

HARMAN FINOCHEM LTDPHENYTOIN SODIUM USP

DMF 178622004

KUNSHAN ORIENTAL PHARMACEUTICAL CO LTDPHENYTOIN SODIUM

DMF 204332007

ORCHID PHARMA LTDPHENYTOIN SODIUM

DMF 204532007

UNICHEM LABORATORIES LTDPHENYTOIN SODIUM USP

DMF 326762018

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

Approval Letters

15 letters from Drugs@FDA

Date	Submission	Document
Aug 29, 2017	SUPPL -46	View Letter (PDF)
Dec 6, 2016	SUPPL -44	View Letter (PDF)
Dec 6, 2016	SUPPL -45	View Letter (PDF)
Jan 26, 2016	SUPPL -41	View Letter (PDF)
Apr 17, 2015	SUPPL -40	View Letter (PDF)
Apr 4, 2014	SUPPL -39	View Letter (PDF)
Jan 28, 2014	SUPPL -38	View Letter (PDF)
Mar 8, 2013	SUPPL -37	View Letter (PDF)
Nov 21, 2011	SUPPL -36	View Letter (PDF)
Nov 20, 2001	SUPPL -32	View Letter (PDF)
Nov 20, 2001	SUPPL -30	View Letter (PDF)
Nov 20, 2001	SUPPL -22	View Letter (PDF)
Nov 20, 2001	SUPPL -29	View Letter (PDF)
Nov 20, 2001	SUPPL -34	View Letter (PDF)
Nov 20, 2001	SUPPL -33	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MG/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.