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DICLOXACILLIN SODIUM

ANDA

DICLOXACILLIN SODIUM | A061454 | CHARTWELL RX SCIENCES LLC

3 strengths0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Aurobindo Pharma USA, Inc. FDA-2020-P-1427 Aurobindo Pharma USA, Inc. filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA designate Dicloxacillin Sodium Capsules 500 mg (ANDA #062286) of Teva Pharmaceuticals USA Inc. as a new reference standard for in vivo bioequivalence studie	Other	2020-05-28	Withdrawn	Aurobindo Pharma USA

Source: Regulations.gov. FDA citizen petitions matched by application number.

Medicare Part D Spending

CMS annual spending data for Dicloxacillin Sodium (2023)

Total Spending

$1.2M

Total Claims

22,950

Beneficiaries

16,180

Avg Cost/Unit

$1.05

Spending Trend

$1.9M(2019)→$2.0M(2020)→$1.5M(2021)→$1.2M(2022)→$1.2M(2023)

YoY Change:+1.5%

5yr CAGR:+4.9%

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

API Supply Chain1 active DMF8 inactive

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

APITORIA PHARMA PRIVATE LTDDICLOXACILLIN SODIUM USP

DMF 195532006

CONSOLIDATED PHARMACEUTICAL GROUP INCInactiveDICLOXACILLIN SODIUM

DMF 132211998

FERMENTA PRODUCTS INCInactiveDICLOXACILLIN SODIUM

DMF 133521998

BRISTOL MYERS SQUIBB COInactiveDICLOXACILLIN SODIUM

DMF 134291998

BRISTOL MYERS SQUIBB COInactiveDICLOXACILLIN SODIUM

DMF 134311998

SMITHKLINE BEECHAM PHARMACEUTICALSInactiveDICLOXACILLIN SODIUM MONOHYDRATE

DMF 134971998

BARCELONETA INC DIV BRISTOL MYERSInactiveDICLOXACILLIN SODIUM

DMF 135581998

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveDICLOXACILLIN SODIUM

DMF 136571998

SANDOZ INDUSTRIAL PRODUCTS SAInactiveDICLOXACILLIN SODIUM

DMF 137981998

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

Products (3)

Sort:

#001 — EQ 250MG BASE

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#002 — EQ 125MG BASE

0 patents0 exclusivities▾

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

#003 — EQ 500MG BASE

0 patents0 exclusivities▾

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