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DILANTIN-125

NDA

PHENYTOIN | N008762 | VIATRIS SPECIALTY LLC

2 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

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-125 (2023)

Total Spending

$186K

Total Claims

535

Beneficiaries

Avg Cost/Unit

$0.83

Spending Trend

$10K(2020)→$181K(2021)→$197K(2022)→$186K(2023)

YoY Change:+8.0%

5yr CAGR:+3.5%

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

API Supply Chain3 active DMFs2 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPAPHENYTOIN MICRO

DMF 45311982

KUNSHAN ORIENTAL PHARMACEUTICAL CO LTDPHENYTOIN

DMF 204342007

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPAPHENYTOIN

DMF 232262009

PARKE DAVIS DIV WARNER LAMBERT COInactivePHENYTOIN USP & PHENYTOIN SODIUM USP

DMF 72291987

CADILA LABORATORIES PVT LTDInactivePHENYTOIN USP & PHENYTOIN SODIUM USP

DMF 73481988

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

Approval Letters

27 letters from Drugs@FDA

Date	Submission	Document
Mar 7, 2022	SUPPL -66	View Letter (PDF)
Feb 17, 2021	SUPPL -65	View Letter (PDF)
Jul 15, 2019	SUPPL -63	View Letter (PDF)
Oct 23, 2018	SUPPL -62	View Letter (PDF)
Nov 6, 2017	SUPPL -60	View Letter (PDF)
Nov 6, 2017	SUPPL -61	View Letter (PDF)
Aug 29, 2017	SUPPL -59	View Letter (PDF)
Dec 6, 2016	SUPPL -57	View Letter (PDF)
Dec 6, 2016	SUPPL -58	View Letter (PDF)
Jan 26, 2016	SUPPL -54	View Letter (PDF)
Apr 17, 2015	SUPPL -52	View Letter (PDF)
Apr 4, 2014	SUPPL -51	View Letter (PDF)
Jan 28, 2014	SUPPL -50	View Letter (PDF)
Mar 8, 2013	SUPPL -47	View Letter (PDF)
Dec 1, 2011	SUPPL -40	View Letter (PDF)
Dec 1, 2011	SUPPL -39	View Letter (PDF)
Dec 1, 2011	SUPPL -32	View Letter (PDF)
Dec 1, 2011	SUPPL -41	View Letter (PDF)
Dec 1, 2011	SUPPL -43	View Letter (PDF)
May 31, 2011	SUPPL -42	View Letter (PDF)
Jan 24, 2011	SUPPL -38	View Letter (PDF)
Apr 29, 2009	SUPPL -36	View Letter (PDF)
Mar 26, 2003	SUPPL -31	View Letter (PDF)
Nov 20, 2001	SUPPL -20	View Letter (PDF)
Nov 20, 2001	SUPPL -26	View Letter (PDF)
Nov 20, 2001	SUPPL -21	View Letter (PDF)
Nov 20, 2001	SUPPL -22	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 125MG/5ML

RLDAB

0 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 30MG/5ML

0 patents0 exclusivities▾

SUSPENSION;ORAL | Approved: Approved Prior to Jan 1, 1982