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EXTENDED PHENYTOIN SODIUM

ANDA

PHENYTOIN SODIUM | A040298 | MYLAN PHARMACEUTICALS INC

3 strengths0 unique patents0 unique exclusivities

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 4 NDCs

Highest NADAC/Unit

$2.10

per ea

Lowest NADAC/Unit

$1.40

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00378375001PHENYTEK 300 MG CAPSULE	$2.10	EA	—	—	2026-06-17
00378375093PHENYTEK 300 MG CAPSULE	$2.10	EA	—	—	2026-06-17
00378267001PHENYTEK 200 MG CAPSULE	$1.40	EA	—	—	2026-06-17
00378267093PHENYTEK 200 MG CAPSULE	$1.40	EA	—	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

Medicare Part D Spending

CMS annual spending data for Phenytek (2024)

Total Spending

$1.3M

Total Claims

18,921

Beneficiaries

3,743

Avg Cost/Unit

$1.24

Spending Trend

$26K(2019)→$200K(2020)→$85K(2021)→$58K(2022)→$489K(2023)→$1.3M(2024)

YoY Change:-22.2%

5yr CAGR:-9.2%

Source: CMS Medicare Part D Spending by Drug (2024). 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

4 letters from Drugs@FDA

Date	Submission	Document
Apr 8, 2003	SUPPL -4	View Letter (PDF)
Apr 8, 2003	SUPPL -5	View Letter (PDF)
Apr 8, 2003	SUPPL -6	View Letter (PDF)
Dec 28, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 100MG EXTENDED

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Dec 28, 1998

No patent or exclusivity listings for this strength.

#002 — 200MG EXTENDED

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Dec 6, 2001

#003 — 300MG EXTENDED

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Dec 6, 2001