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EXTENDED PHENYTOIN SODIUM

ANDA

PHENYTOIN SODIUM | A040298 | MYLAN PHARMACEUTICALS INC

3 strengths0 unique patents0 unique exclusivities

Medicare Part D Spending

CMS annual spending data for Phenytek (2023)

Total Spending

$489K

Total Claims

6,070

Beneficiaries

2,109

Avg Cost/Unit

$1.59

Spending Trend

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

YoY Change:-15.6%

5yr CAGR:-1.8%

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

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